Minutes for 256th Meeting Registration Board held on 03-04th February, 2016.
Item No. Detail of Item Page No. Item No.I Confirmation of minutes of 254th and 255th meeting Registration Board 05-06 Item No.II Cases referred by Biological Drugs Division 07-59 Item No.III Cases referred by Medical Device Division 60-72 Item No.IV Cases referred by Pharmaceutical Evaluation & Registration Division 73-296 Item No.V Cases referred by Quality Assurance & Laboratory Testing Division 297-318 Additional cases Item No.VI Cases referred by Pharmacy Services Division 319 Item No.VII Cases referred by Pharmaceutical Evaluation & Registration Division 320-442
Minutes 256th Meeting Registration Board 1
256th meeting of Registration Board was held on 03-04th February, 2016 in the Committee Room, M/o National Health Regulation, Services & Coordination, Islamabad. The meeting was chaired by Mr. Ghulam Rasool Dutani, Director Pharmaceutical Evaluation & Registration Division, DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by the following:- 1. Lt General (R) Karamat Ahmed Karamat. Member
2. Brig (R). Dr. Muzammil Hasan Najmi, Member Associate Dean, Basic Sciences Division, Foundation University Medical College, Rawalpindi
3. Mr.A.Q.Javed Iqbal Member
4. Sheikh Sarfraz Ahmad Member Additional Draftsman, M/o Law and Justice 5. Mr.Ghulam Mujtaba, Assistant Director Member Representative of IPO 6. Dr.Muhammad Arshad Member President, Pakistan Veterinary Medical Council 7. Dr.Amanullah Khan Member Director Drugs Testing Laboratory Government of Baluchistan, Quetta 8. Dr.Muhammad Khalid Khan Member Director Drugs Testing Laboratory Government of Khyber Pakhtunkhwa, Peshawar 9. Shaikh Ansar Ahmad, Member Director Biological Drugs, DRAP 10. Dr.Noor Muhammad Shah Member Director MD&MC, DRAP 11. Dr.Abdur Rasheed Chairman, Quality Control Representative of QA< Division 12. Dr. Obaidullah, Deputy Director General (Reg.I) Secretary/Member
Dr.Muhammad Khalid Khan, Lt General (R) Karamat Ahmed Karamat and Dr.Muhammad Arshad attended the meeting on 03.02.2016 Dr.Masud-ur-Rehman (DDG Biological), Zaheer ud Din M Babar (DDC R.I/R IV), Muhammad Akhter Abbas (DDC/Incharge, PEC), Dr.Hafsa Karam Elahi (DDC,PEC), Muhammad Amin (DDC,PEC), Tehreem Sara (DDC R.V/RRR), Adnan Faisal Saim (DDC,QC), Babar Khan (ADC R.II/RIII), Dr.Ghazanfar Ali Khan (ADC RRR), Asif Jalil
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(ADC,MD), Salateen Waseem Phillips (ADC,PEC), Muhammad Ansar (ADC,PEC) and Rana Ahsan ul Haq (ADC,PEC) assisted relevant Directors and Secretary of the Board with agenda. Shafiq Ahmad Abbasi (03.02.2016) / Hamid Raza (04.02.2016), Ahsan Naseer Awan, Nadeem Alamgeer and Abuzar Faizi Rattu attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA respectively. In addition to routine agenda, following was also discussed and decided:
Registration Board, while discussing the issue of drugs which are not approved for free sale in their country of origin but are approved for sale in reference countries, deliberated upon its following decisions taken in previous meetings:-
(i) In 244th meeting of Registration Board held on 22nd -23rd July, 2014, it was decided that if an imported drug is not on free sale in its respective country of origin / manufacture, such product will be registered in Pakistan if the product manufactured in the applied facility is approved by any of the regulatory authorities from USFDA, EMA, Australian TGA or PMDA Japan.
(ii) In 249th meeting held on 18-19th May, 2015, Registration Board decided that in addition to already accepted reference drug regulatory agencies i.e. USFDA, Health Canada, EMA, TGA Australia and PMDA Japan, the molecules/ formulations (in same dosage form and strength) alongwith clinical trials registered by the regulatory authorities of United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in at least three European Union counties will also be taken as reference for consideration of Registration Board, as authorities of these countries have robust drug regulatory mechanisms and long standing strong litigation systems. However Registration Board shall also consider the safety and efficacy parameters of the drug under domestic circumstances / practices.
Registration Board observed that since the list of reference countries has been expanded in 249th meeting, so it would be more appropriate that the same list would also be applicable for products not approved for free sale in their country of origin but are approved for sale in reference countries. In view of foregoing observations the Board revised its earlier decision taken in 244th meeting, as follows:- "if an imported drug is not on free sale in its respective country of origin / manufacture, such product will be registered in Pakistan if the product manufactured in the applied facility is approved by any of the regulatory authorities from USFDA, EMA, PMDA Japan, Australia TGA, Health Canada, Switzerland or any of regulatory authority of former erstwhile Westren Europe (United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Belgium, Denmark, Finland, Sweden, Italy, Ireland, Luxemburg, Norway, Scotland and Spain) or three stringent regulatory bodies of former erstwhile Eastren Europe. However, references countries regarding availability of drug / molecule / formulation shall remain the same as specified in 249th meeting of Registration Board.”
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Mr. A.Q. Javed Iqbal (Member Registration Board) apprised that Meningococcal vaccine is required for Hajj Pilgrims and M/s GSK Karachi is only registration holder of the said vaccine. Registration Board advised to Biological Division to present all pending applications of meningococcal vaccines in forthcoming meeting.
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Item No. I: Confirmation of minutes of 254th and 255th meeting Registration Board.
254th Registration Board meeting: 254th meeting of Registration Board was held on 10-11th November, 2015. In 255th meeting, the Board confirmed partial/draft minutes related to investigation of the authenticity/genuineness of data (import of raw material and stability data submitted for registration) of Sofosbuvir with advise to forward remaining part of minutes to members. Confirmation of 254th Registration Board meeting minutes will be considered in next meeting. Accordingly, draft minutes for 254th Registration Board meeting was circulated to members who participated in the meeting. Dr. Amanullah, Director DTL, Quetta forwarded following comment. a. Case No. 02 Deferred Cases. Case No.34.
Decision of the Board.
The Board approved the product and the area FID is directed to conduct specific inspection report for verification of technology / technology for filling two different dosage forms in the final finished dosage form of pellets and soft gelatin capsule into hard gelatin shell and apprised the Board in upcoming meeting of the Board. The Board authorized its chairman for issuance of registration letter after confirmation of facility by FID.
“My point is that as the product is approved by the Board and subject to PSI by area FID and after confirmation of the technology then there is no need to apprise the Board and already the Board has authorized the chairman of the Board for issuance of the registration letter.” b. Case No.27.
The decision of the Board at point No. a, b and c are approved, however point No. “d” may be reconsidered for approval and in case if they are not found in the reference regulatory authorities then the same may be cancelled , as these are ordinary products and they are produced by the same firm for many years. c. Observation regarding Biological Cases.
The following cases as per my record have been approved by in the 254 RB Meeting, however when going through the minutes (M-254) it was revealed that the following products have been found deferred without reason and during the meeting there was no deficiency found and the documents were also found complete by all means so therefore I just want to know the reason for its deferment because to me these products stands approved.
S.# Name of indenter/ Manufacturer Name of Drug(s) 01 Marush (Pvt) Limited, K-123, Model Town Lahore Avisan Multi 02 Marush (Pvt) Limited, K-123, Model Town Lahore Calvenza-03
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03 Marush (Pvt) Limited, K-123, Model Town Lahore Elite 9 HS 04 Marush (Pvt) Limited, K-123, Model Town Lahore Avisan Secure 05 Marush (Pvt) Limited, K-123, Model Town Lahore HipraBovis-4 06 Marush (Pvt) Limited, K-123, Model Town Lahore Cevac Ibird 07 Marush (Pvt) Limited, K-123, Model Town Lahore Hipraviar-Clon/HI20 08 Marush (Pvt) Limited, K-123, Model Town Lahore Hipraviar-ILT 09 Marush (Pvt) Limited, K-123, Model Town Lahore Voctormune HVT 10 Marush (Pvt) Limited, K-123, Model Town Lahore Circomune
Draft minutes were approved with advice to place comments of Dr. Amanullah Khan, Director DTL, Quetta in forthcoming meeting of Registration Board. 255th Registration Board meeting: 255th meeting of Registration Board was held on 17-18th December, 2015. Draft minutes were circulated to all members (who attended the meeting) on 28.01.2016 through e-mail with the request to forward their comments (if any) within 05 days. None of the member forwarded their comments.
Decision: Registration Board deliberated observations on draft minutes for 254th meeting and then confirmed minutes for 254th meeting Registration Board. The Board also confirmed draft minutes for 255th meeting Registration Board
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Item No.II: Cases referred by Biological Drugs Division.
Case No.01 Cases of imported products of human Biological Drugs (SRA countries)
S.#. Name of Name of the Name of Drug Fee status Date of Decision of RB Company Manufactur and Application/Do er Composition cuments details 1. Eastern Trade Biotest Intratect ® Fee Date of Approved as per & Pharma Solution for Rs.15000 application Import Policy Distribution GmbH, Infusion dated 28- 15-12-2010 for Finished Co. Landsteinerst Each 1ml 12- Drugs. (Pvt) Ltd., rass solution for 2010+3500 CoPP No. Karachi. D-63303 infusion 0 dated 09- KABO 86 dated Dreieich, contains:- 10-2012+ 04-3-2015 Germany. Human plasma 50000 dated proteins……50 09-9-2013 Prod Reg No mg/ml PEI.H.02901.01. Thereof Total 1 dated 27-9- immunoglobuli Rs.100000/- 2004 n G >…....96% (Human Balance fee Legalized and Immunoglobuli Notarized. n). Nil (For Human Me too os are Use) 5% while this product is 6% of Immunoglobulin .
i. Globulin IV 5% by Genesis Pharma, Karachi bearing Reg No 023679
ii. Octagaim 5% by Hakimsons Impex bearing Reg No. 022664. Product is registered in U.K (MHRA) SI1994/3144. In Swissmedic IT No. 08.09,ATC Code J06BA02 in 50ml & 100ml infusion
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2. Novartis Novartis Xolair Solution Date of New Strength Approved as per Pharmaceutica Pharma Stein for injection application Import Policy l 15-West AG, 75mg. 29-9-2011 (Xolair 150mg for Finished Wharf Road, Schaffhauser (Omalizumab) Fee Reg No. 047599 Drugs. Karachi strasse, 4332 deposited injection for Stein, Indication: Rs.15000/- soloution is Switzerland dated 1st already Chronic October, registered Spontaneous 2011+ product from Urticaria (CSU) Rs.35000 the same dated 15- company) 10-2012+ Rs.50000 EMA Certificate dated 29- No. 10-2015 01/15/85708 dated 06-3-2015 Balance fee Nil Prod Reg No. EU/1/05/319/00 1,dated 25-10- 2005 3. Novartis Vetter Xolair Solution Date of New formulation Approved as per Pharmaceutica Pharma- for injection application in pre-filled Import Policy l 15-West Fertigung 150mg pre- 15-2-2015 syringe for Finished Wharf Road, GmbH & Co. filled syringe. Drugs. Karachi KG, (Omalizumab) Fee (Xolair 150mg Eisenbahnstr Deposited Reg No. 047599 asse 2-4, Indication: Rs.50000 injection for 88085 dated 09-2- solution is Langenargen, Chronic 2015 already Germany. Spontaneous Challan registered Urticaria (CSU) No.0276922 product from the same Balance fee company) Nil EMA Certificate No. 02/15/84060 dated 16-1-2015
Prod Reg No. EU/1/05/319/00 5-010 dated 10- 2-2009. 4 Eli Lilly LILLY, SA, Cyramza 100 Date of New Molecule Keeping in view Pakistan, AVDA DE mg /10ml application approval status Karachi. LA (10mg/ml) 04-12-2015 EMA CoPP No. of product by Industria, 30, Each Vial 11/15/92448 EMA, 28108 Contain: Fee dated 06-10- Registration
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ALCOBEND Ramucirumab deposited 2015. Board approved AS, 100 mg/10ml Rs.50000/- the product as MADRAID, (10mg /ml) dated 02- Prod Reg No. per Import SPAIN. 12-2015 EU/1/14/957/00 Policy for Indications: challan no. 1, dated Finished Drugs. 0513731 19.12.2014 Anticancer (Gastric cancer, Balance fee non small cell Nil lungs cancer and Colorectal cancer)
Eli Lilly LILLY, SA, Cyramza 500 Date of New Molecule Keeping in view 5 Pakistan, AVDA DE mg /50ml application approval status Karachi. LA (10mg/ml) 04-12-2015 EMA CoPP No. of product by Industria, 30, Each Vial 09/15/92450 EMA, 28108 Contain: Fee dated 06-1 Registration ALCOBEND Ramucirumab deposited 0-2015. Board approved AS, 500mg/50ml Rs.50000/- the product as MADRAID, (10mg/ml) dated 03- Prod Reg No. per Import SPAIN. 12-2015 EU/1/14/957/00 Policy for Indications: challan no. 3, dated Finished Drugs. 0513732 19.12.2014. Anticancer (Gastric cancer, Balance fee non stomall cell Nil lungs cancer and Colorectal cancer)
6 Sanofi-aventis Site-1 MYOZYME Date of New Molecule Keeping in view Pakistan Genzyme (ALGLUCOSI application approval status Limited, Ireland Ltd DASE ALFA) 9/6/2015 of product by Karachi. IDA The company is EMA, Industrial Drug Substance Deposited not providing Registration Park Old manufacturing fee water for Board approved Kilmeaden site. injection as part the product as Road Rs.100000/- of drug pack in per Import Waterford, (Genzyme challan No. its dossiers. Policy for Ireland. (site Flanders buba 0063319 Finished Drugs. also Cipalstraat 8 dated 4-6- responsible 2440 Geel , 2015 for batch Belgium) EMA CoPP No. release in the Balance 02/15/84489 EU, Each vial Fee Dated 28-1-2015 QUALITY contains 52.5 CONTROL mg Nil Prod Reg No. AND alglucosidase EU/1/06/333/00 PRIMARY alfa (Each vial 1-003 dated 29-
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PACKAGIN contains 50mg 3-2006. G). Site of alglucosidose responsible alfa when for batch reconstituted release in the with 10.3ml EU and water for secondary injection. packaging: Genzyme Indication: Ltd., 37 Hollands Diagnosis of Road, Pompe disease Haverhill, (acid a- Suffolk CB9 glucosidase 8PU, United deficiency) Kingdom.
7 OBS Pharma Merck Sharp ROTATEQ Date of Me too Approved as per (Pvt) Ltd., C- & Dohme Oral Solution application USFDA Import Policy 14, SITE, Corp, US. 2ml I 20.03.2015 Approved for Finished Karachi. / License # Rotavirus The case was Drugs. 0002 Vaccine,Live, Deposited also discussed in 770 Sumney Oral fee the last 254th town Pike, Pentavalant Rs.100000/- meeting of RB. West Point, 1 Single Dose dated 30-3- PA 19486, Tube 2015 CoPP No. USA. CT 0862-14 Balance WHO dated 01- Major Fee 7-2014 Indication. Prod License Nil No. Rota virus STN 125122 induced dated 03-2-2006 gastroenteritis. GMP Certificate No. NL/H 11/0074 dated 30-8-2011
Alternate Brand in Pakistan
Rotarix vaccine Oral Solution GSK (Pvt) Ltd Karachi. 8 M/s Acumen Laboratorios Fertigest 100 Date of Me too Deferred for Pharmaceutica Leon Farma mg soft gelatin application provision of Rawalpindi C/La Vallina capsules 14-1-2015 CoPP No. legalized COPP s/n.P.I 2015/03628 and proof of Navatejera (Micronized Fee Issuance date approval by
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24008 progesterone) deposited October, 2015 reference villaquilambr valid for one regulatory e (Leon) Rs.100000/- year authorities. Spain Indication: dated 14-1- 2015 Progesterone Prod lic No. hormonal 60879 deficiencies Date of issuance Balance fee 30-10-1995 Available in the Nil country of Free Sale origin. Certificate No. 2015/046/164 Alternate Brands GMP Certificate Glaxy Pharma / No. 4208/15 OBS Pharma dated 24-6-15 Pakistan
09 M/s Acumen Laboratorios Fertigest 200 Date of Me too Deferred for Pharmaceutica Leon Farma mg soft gelatin application provision of Rawalpindi C/La Vallina capsules 14-1-2015 legalized COPP s/n.P.I CoPP No. and proof of Navatejera (Micronized Fee 2015/03629 approval by 24008 progesterone) deposited Issuance date reference villaquilambr October, 2015 regulatory e (Leon) Rs.100000/- valid for one authorities. Spain. Indication: dated 14-1- year 2015 Progesterone Prod license No. hormonal 64560 deficiencies Date of issuance Balance fee 02-13-2002 Available in the Nil country of Free Sale origin. Certificate No. 2015/046/164 Alternate Brands GMP Certificate Glaxy Pharma / No. 4208/15 OBS Pharma dated 24-6-15 Pakistan
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Case No.02: Cases of imported products of human Biological Drugs (Non-SRA countries)
All the above firms have provided detailed documents regarding their availability in the country of the origin, the manufacturing process relative to the innovative research products, bio stability data of their product in the country of origin and clinical data regarding efficacy of product developed by them in comparison to the innovative / standard bio similar products. The documents provided by the firm needs evaluations for safety quality and clinical biosimilarity through panel of experts as the Registration Board may nominate from the panel of experts are make a committee of experts for the proper and scientific evaluation. Registration Board decided as follows: a. For all current and future anti-flu vaccines, latest strains as notified by WHO will be adopted and registration holders will inform Registration Board accordingly. b. For biological therapeutic proteins (interferon, erythropoietin etc), mono-clonal anti bodies, above mentioned data will be required for technical evaluation by experts as finalized by Registration Board.
S.# Name of Name of the Name of Drug and Date of Documents Decision of RB . Company Manufacture Composition application/ details r Fee status 1. M/s. Sind M/s. Sinovac ANFLU 0.5ML PFS Date of CoPP No. Registration Medical Biotech Co., Influenza Vaccine application 151100B0/2352 Board approved Stores, Ltd, (Split Version), 17-1-2011 2 dated 05-5- the product as Karachi. Mfg. Site 1: Inactivated; 2015 Beijing per Import (Bulk Injection Fee deposited Food and Drug Policy for production) For Adult use 15,000 + Administration. Finished Drugs. No.39 Shangdi Each dose 0.5ml 85,000 Latest strain as Xi Road, contains: 30.07.2013 per WHO Haidian NYMC X-179A Prod License notification shall District, reassortant derived Balance fee No. be adopted and Beijing,10008 from Nil S20053056 will inform 5, China A/California/7/2009. dated 22-7-2005 Registration Mfg. Site 2: .15µg Board (Formulation, NIB-88 reassortant accordingly. filling & derived from Free Sale packing) A/Switzerland/9715 Certificate No. No. 15, Zhi 293/ 2013 151100B0/2352 Tong Road, ……………… 15µg 9 Changping B/Phuket/3073/2013 Science Park, .15µg 2014 (14) 101 Changping Excipients: Dated 05-9-2014 District, Sodium Chloride Validity Beijing – …4.4mg 02 years. China. Disodium hydrogen phosphate ……….. 0.6mg Sodium dihydrogen
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phosphate ……….0.12mg Water for injection..0.5ml
(VACCINE)
PFS of 0.5ml /Dose 2. M/s. Sind M/s. Sinovac Date of CoPP No. Registration Medical Biotech Co., ANFLU 0.25ML application 151100B0/2352 Board approved Stores, Ltd, PFS 17-1-2011 1 the product as Karachi. Mfg. Site 1: Influenzae Vaccine per Import (Bulk (Split Virion) Fee deposited Issuance date Policy for production) Inactivated; 05-5-2015 Finished Drugs. No.39 Shangdi Injection 15,000 + Beijing Food Latest strain as Xi Road, For Junior use 85,000 and Drug per WHO Haidian Each dose 0.25ml 30.07.2013 Administration notification shall District, contains: be adopted and Beijing,10008 NYMC X-179A Balance fee Prod License will inform 5, China reassortant derived Nil No. Registration Mfg. Site 2: from S20053055 Board (Formulation, A/California/7/2009 dated 22-7-2005 accordingly. filling & 7.5µg packing) NIB-88 reassortant Free Sale No. 15, Zhi derived from Certificate No. Tong Road, A/Switzerland/9715 151100B0/2352 Changping 293/ 2013 6 Science Park, ………………7.5µg Changping B/Phuket/3073/2013 2014 (14) 100 District, …………………… Dated 05-9-2014 Beijing – …….7.5µg validity 02 years. China. Excipients: Sodium Chloride …2.2mg Disodium hydrogen phosphate ……….. 0.3mg Sodium dihydrogen phosphate ……….0.06mg Water for injection 0.25ml
(VACCINE)
PFS of 0.25ml/Dose
3. M/s Sindh M/s. SK SK ALBUMIN 20% Date of CoPP No. Approved as per Medical Plasma Co., INJECTION , 50ML Application 2015-AJ-1143 Import Policy for Stores, 13- Ltd. Human Serum 19-2-2013 Date 18-9-2015 Finished Drugs.
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B, Block 6, Office Albumin PECHS, address: 310, Each 100ml Fee Deposited GMP No. 2015- Shahrah e Pangyo-ro, contains ….. 50,000 + D1-1563 Dated Faisal, Bundang-gu, Human Serum 50,000 5-6-2015 Karachi. Seongnam-si, Albumin ………20g 28.08.2013 Gyeonggi-do, Sodium Caprylate DML No. 352 463-400, ……………0.2659g Balance fee dated 01-5-2015 Korea. N-Acetyl-D, L- Nil Plant Tryptophan…… The same address: 430- 0.3940g product having 11, Nambu- Sodium Chloride composition daero, Osan-si, …..…… q.s. 100ml the same Gyeonggi-do, Sodium strength has Republic or Hydroxide…. Q.s. been approved in Korea. - Water for Injection the last meeting ….q.s. of Registration board. This (BLOOD strength got DERIVATIVES) omitted erroneously. Rs.7207.00/ Vial of 50ml
4. Macter Dr. Reddy’s Reditux TM Date of The reference Deferred for Internation Laboratories Injection 100mg application product is expert opinion of al (Pvt) Ltd., Ranga Each 10ml vial 2.02.2011 Ristova by following: Limited, Reddy contains :- Roche. a. Brig, (Retd), Karachi. District, Rituximab (r-DNA Fee deposided The case was Muzamil Hyderabad, origin)…...... 15000 (02-2- recommended in Hussain India. 100mg 2011)+ 48th ECBD + Najmi, (Antineoplastic 85000 (09-10- Biosimilarity Foundation Monoclonal 2011) +PICS Medical Antibody). Copies of COPP College, (For Human Use) Total. 100000 provided, valid Rawalpindi. up to 18-12- b. Brig. Amir Original Notarized Balance fee 2015. Ikram, AFIP, and Legalized GMP Nil Rawalpindi certificate no. Bioequivalence c. Dr. Masud-ur- 259//M3B/2014 Structural and efficacy Rehman, issued by Drug similarity of Clinical trials DDG, DRAP, Control subject data is Islamabad Administration, biological submitted Andhra Pradesh. product is Safety Studies Date Of Issue available in Four years post 13/02/2014 and provided DMF marketing valid up to by surveillance data 18/12/2015. COPP manufacturer. of 818 patients. no. 2821/M3B/2014 Protein for finished drug of sequence is Animal toxicity strength 100 mg compared with studies are
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issued by Drug WHO available in Control sequence. provided DMF Administration, by manufacturer Govt. of Andhra Pradesh. Original notarized and Legalized. Valid up to 18/12/2015.
Indications: Non Hodgkin Lymphoma Antineoplastic Monoclonal Antibody
5. Macter Dr. Reddy’s Reditux TM Date of The reference Deferred for Internation Laboratories Injection 500mg application product is expert opinion of al (Pvt) Ltd., Ranga Each 50ml vial 02.02.2011 Ristova by following: Limited, Reddy contains :- Roche. a. Brig, (Retd), Karachi. District, Rituximab (r-DNA Fee deposited The case was Muzamil Hyderabad, origin)…...... … 15000+85000 recommended in Hussain India 500mg 48th ECBD + Najmi, (Antineoplastic Biosimilarity Foundation Monoclonal Balance fee +PICS Medical Antibody). Nil Copies of COPP College, (For Human Use) provided, valid Rawalpindi. up to 18-12- b. Brig. Amir COPP no. 2015. Ikram, AFIP, 2381/M3B/2014 Rawalpindi issued by Drug Bioequivalence c. Dr. Masud-ur- Control and efficacy Rehman, Administration, Animal Clinical trials DDG, DRAP, Govt. of Andhra toxicity data is Islamabad Pradesh. Date Of studies submitted Issue 22/03/2014. are available Safety Studies: Valid up to in provided Four years post 18/12/2015. DMF by marketing Original notarized manufacturer surveillance data and Legalized of 818 patients.
Indications: Non Hodgkin Lymphoma Antineoplastic Monoclonal Antibody
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6. Aster Life M/s Serum Repoitin 2000 Date of Me too Deferred for Sciences, Institute of IU/0.5ml Solution application expert opinion of New India, Ltd, for Injection 20-12-2011 CoPP No. following: Garden 212/2, Each 0.5ml pre- WHO-GMP- a. Dr. Abid Town, Hedapser, filled syringe Fee deposited CERT/PD/EX13 Azhar, Lahore/ Pune, India. contains:- 15000 dated 4 Dated 23-9- A.Q.Khan Erythropoietin 20-12-2011+ 2011 valid until Institute of Concentrated 35000 dated 24-3-2012 Biotechnolog Solution Ph. 04-11-2013 + y, University Eur…2000 IU 50000 dated Prod License of Karachi. (Biopharmaceutical/ 16.9.2015 No. 10 (in form b. Dr. Zeeshan Erythropiosises 28-D) dated 20- Danish, stimulating agent. Balance fee 11-2009. University Anatomic agent) Nil College of Free Sale Pharmacy, Certificate Punjab No.Drugs/Mfg/F University SC/2214/2010/1 Islamabad. Dated 21-9-2010 c. Dr. Riaz Butt, PIMS GMP No. Islamabad. Mfg/Drugs/GMP /27/2011/Z-1 Dated 23-3-2011
7. Aster Life Serum Repoitin 4000 Date of Me too Deferred for Sciences, Institute of IU/0.4ml Solution application expert opinion of New India, Pune, for Injection 20.12.2011 CoPP No. following: Garden India. Each 0.4ml pre- WHO-GMP- a. Dr. Abid Town, filled syringe Fee deposited CERT/PD/EX13 Azhar, Lahore/ contains:- 15000 dated 4 Dated 23-9- A.Q.Khan Erythropoietin 20-12-2011+ 2011 valid until Institute of Concentrated 35000 dated 24-3-2012 Biotechnolog Solution Ph. 04-11-2013+ y, University Eur…4000 IU 50000 dated Prod License of Karachi. (Biopharmaceutical/ 16.9.2015 No. 10 (in form b. Dr. Zeeshan Erythropoies is 28-D) dated 20- Danish, stimulating agent 11-2009 University Anatomic agent) Balance fee College of Nil Free Sale Pharmacy, Certificate Punjab No.Drugs/Mfg/F University SC/71/2011/Z-1 Islamabad. Dated 02-9-2011 c. Dr. Riaz Butt, PIMS GMP No. Islamabad. Mfg/Drugs/GMP /27/2011/Z-1 Dated 23-3-2011
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8. Aster Life Serum Repoitin 10000 Date of Me too Deferred for Sciences, Institute of IU/0.4ml Solution application expert opinion of New India, Pune, for Injection 20.12.2011 CoPP No. following: Garden India. Each 1.0ml pre- WHO-GMP- a. Dr. Abid Town, filled syringe Fee deposited CERT/PD/EX13 Azhar, Lahore/ contains:- 15000 dated 4 Dated 23-9- A.Q.Khan Erythropoietin 20-12-2011+ 2011 valid up to Institute of Concentrated 35000 dated 24-3-2012 Biotechnolog Solution Ph. 04-11-2013+ y, University Eur…10000 IU 50000 dated Prod License of Karachi. (Biopharmaceutical/ 16.9.2015 No. 10 (in form b. Dr. Zeeshan Erythropoies is 28-D) dated 20- Danish, stimulating agent Balance fee 11-2009 University Anatomic agent) Nil College of Free Sale Pharmacy, Certificate Punjab No.Drugs/Mfg/F University SC/71/2011/Z-1 Islamabad. Dated 02-9-2011 c. Dr. Riaz Butt, PIMS GMP No. Islamabad. Mfg/Drugs/GMP /27/2011/Z-1 Dated 23-3-2011
9 Aster Life CSPC Baike PEGLEUKIM Date of New Molecule Deferred for Sciences, (Shandong 3MG/ML application expert opinion of New )Bio PEGYLATED 24.08.2012 CoPP No. CN following: Garden Pharmacetical RECOMBINANT 20120416 Dated a. Dr. Abid Town, Co. Ltd HUMAN Fee deposited 16-4-2012 Azhar, Lahore/ Manufacturing GRANULOCYTE 15000 dated A.Q.Khan Site: 24-8-2012+ Institute of 212 Jinbu 35000 dated GMP No. Biotechnolog Avenue, South 04-11-2013 CN20120027 y, University Koreas Dated 09-3-2012 of Karachi. Industrial Total Rs valid until 08-3- b. Dr. Zeeshan Park, Qinshi 50000/- 2017 Danish, Muping Confirmed University District, DML No. College of Yantai City, LU20100007 Pharmacy, Shandong Pro. Balance fee Dated 01-1- Punjab China. Nil 2011 University Islamabad. c. Dr. Riaz Butt, PIMS Islamabad.
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10 Aster Life CSPC Baike PEGLEUKIM Date of New Molecule Deferred for Sciences, (Shandong 6MG/ML application expert opinion of New )Bio PEGYLATED 24.08.2012 CoPP No. CN following: Garden Pharmacetical RECOMBINANT 20120416 Dated a. Dr. Abid Town, Co. Ltd HUMAN Fee deposited 16-4-2012 Azhar, Lahore/ Manufacturing GRANULOCYTE 15000 dated A.Q.Khan Site: 24-8-2012+ GMP No. Institute of 212 Jinbu 35000 dated CN20130550 Biotechnolog Avenue, South 04-11-2013 Dated 30-12- y, University Koreas 2013 valid until of Karachi. Industrial Total Rs 29-12-2018 b. Dr. Zeeshan Park, Qinshi 50000/- Danish, Muping Confirmed Free Sale University District, Certificate No. College of Yantai City, Balance fee 2012-044 Dated Pharmacy, Shandong Pro. Nil 19-4-2012 Punjab China. University DML No. Islamabad. LU20100007 c. Dr. Riaz Dated 01-1- Butt, PIMS 2011 Islamabad. 11 Aster Life LG Life Epotiv 2000 Date of Me too Deferred for Sciences, Sciences, Ltd, IU/0.5ml Pre- filled application expert opinion of New Factory:- syringe. 02.10.2012 CoPP No. 2012- following: Garden 601, Yongje- Each 0.5ml A1-1460 Dated a. Dr. Abid Town, Dong, Iksan-si contains:- Fee Deposited 20th June, 2012 Azhar, Lahore/ Jeonbuk- do, rh confirmed A.Q.Khan Korea. Erythropoeitin…… 50000 GMP No/date. Institute of Head Office:- …. Dated 2nd (2007-A4-0011) Biotechnolog LG Twin ……………….2000 October, 2012 y, University Towers, 20, IU + DML No 2012- of Karachi. Yoido-Dong, (For Human Use) 50000 dated F1-0108 Dated b. Dr. Zeeshan Youngdungpo 6th November, 16-5-2012 Danish, -gu, Seoul, 2013 University Korea. College of Total Pharmacy, Rs.100000/- Punjab University Balance fee Islamabad. Nil c. Dr. Riaz Butt, PIMS Islamabad. 12 Aster Life LG Life Epotiv 4000 Date of Me too Deferred for Sciences, Sciences, Ltd, IU/0.4ml Pre- filled application expert opinion of New Factory:- syringe. 02.10.2012 following: Garden 601, Yongje- Each 0.4ml CoPP No. 2012- a. Dr. Abid Town, Dong, Iksan-si contains:- Fee Deposited A1-1460 Dated Azhar, Lahore/ Jeonbuk- do, rh confirmed 20th June, 2012 A.Q.Khan Korea. Erythropoeitin…… 50000 Institute of Head Office:- …. Dated 2nd GMP No/date. Biotechnolog
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LG Twin ……………….4000 October, 2012 (2007-A4-0011) y, University Towers, 20, IU + of Karachi. Yoido-Dong, (For Human Use) 50000 dated DML No 2012- b. Dr. Zeeshan Youngdungpo 6th November, F1-0108 Dated Danish, -gu, Seoul, 2013 16-5-2012 University Korea College of Total Pharmacy, Rs.100000/- Punjab University Balance fee Islamabad. Nil c. Dr. Riaz Butt, PIMS Islamabad. 13 Aster Life LG Life Epotiv 10000 IU/1 02.10.2012 Me too Deferred for Sciences, Sciences, Ltd, ml Injection. expert opinion of New Factory:- Each 1ml contains:- Fee Deposited following: Garden 601, Yongje- rh confirmed CoPP No. 2012- a. Dr. Abid Town, Dong, Iksan-si Erythropoietin…… 50000 A1-1459 Dated Azhar, Lahore/ Jeonbuk- do, …. Dated 2nd 20th June, 2012 A.Q.Khan Korea. ……………….1000 October, 2012 Institute of Head Office:- 0 IU + GMP No/date. Biotechnolog LG Twin (For Human Use) 50000 dated (2007-A4-0011) y, University Towers, 20, 6th November, of Karachi. Yoido-Dong, 2013 DML No 2012- b. Dr. Zeeshan Youngdungpo F1-0108 Dated Danish, -gu, Seoul, Total 16-5-2012 University Korea Rs.100000/- College of Pharmacy, Balance fee Punjab Nil University Islamabad. c. Dr. Riaz Butt, PIMS Islamabad. 14 A.A. Shenyang EPIAO 2000IU/ML Date of Me too Deferred for Pharma, Sunshine PFS application expert opinion of 2nd floor Pharmaceutica Recombinant 04-4-2011 CoPP. following: Shafi kot l Co Ltd. Human Approval for re- a. Dr. Abid Meriwethe China. Erythropoietin (Pre- Fee deposited registration No. Azhar, r Road Address No filled Syringe) Rs.15000 2010R001086 A.Q.Khan Civil 3,A1, Road dated 29-3- dated 30-8-2010. Institute of Lines, 10th Road, Indications. 2011 +35000 Liaoning Food Biotechnolog Karachi Economic & dated 13-11- and Drug y, University Technology Erythropiosiss. 2012 Administration, of Karachi. Development Dialysis induce +50000 dated China. b. Dr. Zeeshan Zone, anemia 30-12-2014 Danish, Shenyang, Total GMP Certificate University Liaoning As per detail of Rs. 100000/- No. L5335 College of Province, firm, EPIAO has Issuance date Pharmacy, China. been a bioequivalent Balance fee 12-7-2010 valid Punjab
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product when Nil until 11-7-2015 University compared with Islamabad. similar Recombinant Free Sale c. Dr. Riaz Human Certificate (No.): Butt, PIMS Erythropoietin 2009037 Islamabad. product from different countries like USA, Korea. It is deduced from the results that the bioavailability of EPIAO is same with that of other Recombinant Human erythropoietin. Patients were improving in the same manner as with other products and no other significant toxicity was found. The testing was done in randomized two- way cross design. The pharmacokinetic parameters were found to be similar when the product was injected subcutaneously. The fundamental parameters like Cmax, AUC0-1 AUC0- 0 were indentical as well. The clinical study demonstrated that EPIAO therapy for renal anemia was safe and effective.
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15. A.A. Shenyang EPIAO 4000IU/ML Date of Me Too Deferred for Pharma, Sunshine PFS application expert opinion of 2nd floor Pharmaceutica Recombinant 04-4-2011 CoPP. Approval following: Shafi kot l Co Ltd. Human for re- a. Dr. Abid Meriwethe China. Erythropoietin (Pre- Fee deposited registration No. Azhar, r Road Address: filled Syringe) Rs.15000 2010R003551 A.Q.Khan Civil No 3,A1, dated 29-3- dated 30-8-2010. Institute of Lines, Road 10th Indications: 2011 +35000 Liaoning Food Biotechnolog Karachi Road, dated 13-11- and Drug y, University Economic & Erythropiosiss. 2012 Administration, of Karachi. Technology Dialysis induce +50000 dated China. b. Dr. Zeeshan Development anemia 30-12-2014 Danish, Zone, Total GMP Certificate University Shenyang, As per detail of Rs. 100000/- No. L5335 College of Liaoning firm, EPIAO has Issuance date Pharmacy, Province, been a bioequivalent Balance fee 12-7-2010 valid Punjab China. product when Nil until 11-7-2015 University compared with Islamabad. similar Recombinant Free Sale c. Dr. Riaz Human Certificate (No.): Butt, PIMS Erythropoietin 2009037 Islamabad. product from different countries like USA, Korea. It is deduced from the results that the bioavailability of EPIAO is same with that of other Recombinant Human erythropoietin. Patients were improving in the same manner as with other products and no other significant toxicity was found. The testing was done in randomized two- way cross design. The pharmacokinetic parameters were found to be similar when the product was injected subcutaneously. The fundamental
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parameters like Cmax, AUC0-1 AUC0- 0 were indentical as well. The clinical study demonstrated that EPIAO therapy for renal anemia was safe and effective.
16. A.A. Shenyang EPIAO Date of Me too. Deferred for Pharma, Sunshine 10000IU/ML application expert opinion of 2nd floor Pharmaceutica PFS 04-4-2011 CoPP. following: Shafi kot l Co Ltd. Recombinant Approval for re- a. Dr. Abid Meriwethe China Human Fee deposited registration No. Azhar, r Road Address No Erythropoietin (Pre- 2010R003547 A.Q.Khan Civil 3,A1, Road filled Syringe) 15000 dated dated 30-8-2010 Institute of Lines, 10th Road, 29-3-2011 Liaoning Food Biotechnolog Karachi Economic & Indication +35000 dated and Drug y, University Technology 13-11- Administration, of Karachi. Development Erythropiosiss. 2012+50000 China. b. Dr. Zeeshan Zone, Dialysis induce dated 30-12- Danish, Shenyang, anemia 2014 GMP Certificate University Liaoning No. L5335 College of Province, As per detail of Issuance date Pharmacy, China firm, EPIAO has Balance fee 12-7-2010 valid Punjab been a bioequivalent Nil until 11-7-2015 University product when Islamabad. compared with Free Sale c. Dr. Riaz similar Recombinant Certificate (No.): Butt, PIMS Human 2009037 Islamabad. Erythropoietin product from different countries like USA, Korea. It is deduced from the results that the bioavailability of EPIAO is same with that of other Recombinant Human erythropoietin. Patients were improving in the same manner as with other products and no other significant toxicity
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was found. The testing was done in randomized two- way cross design. The pharmacokinetic parameters were found to be similar when the product was injected subcutaneously. The fundamental parameters like Cmax, AUC0-1 AUC0- 0 were identical as well. The clinical study demonstrated that EPIAO therapy for renal anemia was safe and effective.
17. A.A. Shenyang TPIAO® 15000 Date of Me too Deferred for Pharma, Sunshine IU/1ml Solution for application expert opinion of 2nd floor Pharmaceutica Injection 09.04.2012 CoPP No. following: Shafi kot l Co Ltd. Each vial contains:- 2011043 a. Dr. Abid Meriwethe China. Recombinant Fee deposited Date of issuance Azhar, r Road Address: Human 30-8-2010 A.Q.Khan Civil No 3,A1, Thrombopoietin…1 15000 dated Liaoning Food Institute of Lines, Road 10th 5000IU 19-1-2012 and Drug Biotechnolog Karachi Road, (Recombinant +35000 dated Administration, y, University Economic & protein drug) 13-11-2012 China. of Karachi.
Technology +50000 dated Approval for re- b. Dr. Zeeshan Development Indications: 30-12-2014 registration No. Danish, Zone, 2010R003572 University Shenyang, Thrombolytic, Heart Balance fee dated 30-8-2010 College of Liaoning coronary disease Nil Liaoning Food Pharmacy, Province, and Drug Punjab China As per documents Administration, University TPIAO is an China. Islamabad. innovative c. Dr. Riaz recombinant protein GMP Certificate Butt, PIMS drug. TPIAO is No. L5335 Islamabad. registered as Class I Issuance date New Drug by SFDA 12-7-2010 valid of China. It is the until 11-7-2015 first and the only product in the Free Sale market, therefore the Certificate (No.): concept of 2013004 “biosimilar” does
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not apply to TPIAO. All clinical studies and post-marketing safety data are provided. clinical data, together with the extensive clinical experience suffice the requirement of registration.
18 A.A. Caspian (Heparodic 5000) Date of Me too Deferred for Pharma, Tamin Injection. application expert opinion of 2nd floor Pharmaceutica Heparin Sodium CoPP. Product following: Shafi kot l Co. Tehran. 5000 U/1ml 03-12-2012 Lic No. a. Dr. Abid Meriwethe Iran. Injection. 1228049750 Azhar, r Road Address: Fee deposited Dated 04-7-2011 A.Q.Khan Civil No.1, Darou Active Ingredient (s) Institute of Lines, Gostar Bldg. and amount (s) per 50000 dated Manufacturing Biotechnolog Karachi Beastoon unit dose: 03-12-2012 + license No. y, University Ave., Dr 50000 dated 34083 of Karachi. Fatemi Sq. Heparin Sodium 31-12-2014 Issuance date 4- b. Dr. Zeeshan Tehran (USP) 5000IU. 7-2011 valid for Danish, 143166113 three years University Iran. Excipients: Balance fee Department College of Nil Food and Drugs Pharmacy, Benzyl Alcohol Ministry of Punjab (BP), Sodium Health Islamic University Chloride (BP), Republic of Iran Islamabad. Sodium Hydroxide c. Dr. Riaz (BP), Water for Butt, PIMS Injection (USP. Islamabad.
Indications:
Anti-Coagulant. Thrombolytic.
According to the guidelines of FDA, Heparin has been considered as a bio waiver product. The composition of Heparin for injection formulation is identical to already approved drug
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product, this new formulation qualifies for an in vivo bioavailability waiver as per the following CFR,: Ref # 21 CFR320,22(B):. FDA shall waive the requirement for the submission of evidence obtained in vivo measuring the bioavailability or demonstrating the bioequivalence of these products. A drug product’s in vivo bioavailability or bio equivalence may be considered self-evident based on other data in the application if the product meets specified criteria
Case No.03: Cases of imported products of veterinary Biological Drugs (SRA countries)
Name of Manufactu Name of Drug Date of Document Remarks Decision of RB Sr #. Indenter/ rer (s)/ applica ary Manufactu Composition & tion / Details rer Therapeutic Fee Group status 1. Vet. KBNP, Himmvac ND 10- CoPP No. Me too Approved as Pharma INC, Oil Vaccine Sep-12 100906 per Import Trading Dugok-ri, Each vial dated 18- Merial Policy for Company, Sinam, contains:- Deposit 10-2010 Inc / Zafa Finished Drugs. New Steel Yesan, Inactivated ND ed fee Internatio Firm will Market, Chungnam, virus Prod Lic nal provide valid Near Korea (B1)…..30% 15000+ No. 6-136 COPP and Regent (At least 108.8 35000 dated 30- Sole Chairman will Cinema, EID50/dose) dated 12-1986 Agent permit issuance G.T. Road, (Biological 15-5- Authoriz of registration Gujranwala Products). 14+ Free sale ation letter. - Pakistan./ (For 50000 certificate agreemen
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Veterinary / yes t shall be Poultry Use). Balanc in effect e Fee M/S Vet from Indications: Pharma Jan.29,20 For vaccination Nil Trading 15 to Jan. of health Company 29, 2018 chickens, as an agreement aid in the with. preventing KBNP, Newcastle Inc,Korea. disease. Agreemen t shall be in effect from Jan.29, 2016 to jan.29, 2018
Paking: 500 doses. 1000 doses
2. Vet. KBNP, Himmvac Dy No CoPP Me too Approved as Pharma INC, Dalguban AN 941 113688 per Import Trading Dugok-ri, Oil Vaccine dated dated 23- Merial Policy for Company, Sinam, (Poultry 17-07- 2-2012 Inc / Zafa Finished Drugs. New Steel Yesan, vaccine) 12 Internatio Firm will Market, Chungnam, Prod Lic nal provide valid Near Korea Each vial Deposit No. 6-218 COPP and Regent contains:- Low ed fee dated 26- Chairman will Cinema, pathogenic AIV 3-2007 Sole permit issuance G.T. Road, strain “A/ 15000 Agent of registration Gujranwala Chicken/ Korea/ dated Free Sale Authoriz letter. - Pakistan./ Sole Agent 01310/ 2001 19-07- Certificate ation Authorizati (H9N2) Min .10 12 dated 26- agreemen on 8.5 EID50 85000 3-2007 t shall be agreement NDV Strain dated in effect shall be in Lasota Min 10 15-02- . from 9.5 effect from EID50 2014 Dec.15,2 Dec.15,201 015 to 5 to Dec. Biological ( Balanc Dec. 14, 14, 2017. vaccine ) e fee. 2017 Nil (For Veterinary / Poultry Use). Indications: For
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immunization of healthy chickens against low pathogenic Avaian Influenza Virus (H9N2) and New Castle disease
3. Vet. KBNP, Himmvac Date of CoPP No. Sole Deferred for Pharma INC, DHPPL applica 113686 Agent expert opinion Trading Dugok-ri, vaccine, Canine tion dated 23- Authoriz of following Company, Sinam, vaccine 11-7- 2-2012 ation regarding New Steel Yesan, 2012 agreemen confirmation of Market, Chungnam, Active Prod Lic t shall be need vis-a-vis Near Korea ingredients and Fee No. 6-148 in effect compatibility Regent amounts per deposit dated 29- from with local Cinema, unit gram. ed 3-1988 Dec.15,2 immunogenic G.T. Road, For complete 15000 015 to requirement, Gujranwala qualitative dated Free Sale Dec. 14, safety profile: - Pakistan./ composition 19-7- Certificate 2017 a. Dr. Qurban including 2012 + Ali, Animal Indication: recipients. 85000 Yes Husbandry dated Commission For the Freeze-dried 15.5.20 er, Ministry active fraction : 14 vide Food & immunizati DHPP Live challan National on of dogs vaccine per no. Security, against dose 013345 Islamabad. Canine 0 b. Prof. Khushi distemper, Active Muhammad, Infectious ingredients UVAS, canine Balanc Lahore hepatitis, Freeze dried, e fee c. Prof. Akram Parvovirus Modified Live Nil Munir, infection, Ripha Parainfluen Canine University, za-2 virus distemper virus The Lahore. infection Qty 25% (at Product and least 103.5 EID is Leptospiros 50/Dose) availab is. Infectious le in Canine the Hepatitis virus country Qty 10% (at of least 103.0 TCID origin 50/Dose) Packin g: Canine 1
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Parvovirus doses, Qty 25% (at 5 doses least 105.0 TCID 50/Dose) Shelf Canine life Parainfluenza 12 type 2 virus months Qty 30% (at after least 104.0 manufa TCID50/Dose) cturing date Liquid fraction (LCI): Leptospira Bacterin per dose
Active ingredients Inactivated
Leptospira icterohaemorrha giae Qty (at least 108.0/ml)
Leptospira canicola Qty (at least 108.0/ml) 4. Mustafa Federal Virus Vaccine 12-Jun- Prod Reg May be Deferred for Brothers Governmen against 12 No. deferred submission of Faisalabad. tal infectious 10477962 due to balance fee & Budgetary bursal disease Deposit 96437 documen legalized CoPP. Institution from BG strain ed fee dated 11- ts not “Federal Contains:- 8-2011 complete. Centre for Infectivity of 15000 Animal the virus Balanc Health” vaccine shall be e DML (FGBI at least 104.5 No.00-11- “ARRIAH” EID50/cm3 One Fee 1-001221 , Vladimir, dose of the 85000 dated 11- Russia. vaccine shall 8-2011 contain 103 EID 50 (Vaccine).
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5. Mustafa Federal Vaccine against 12-Jun- Prod Reg May be Deferred for Brothers Governmen infectious 12 No. deferred submission of Faisalabad. tal chicken 1023/3012 due to balance fee & Budgetary bronchitis from Deposit 83720 documen legalized CoPP. Institution strain “H-120” ed fee Dated 26- ts not “Federal dry live 7-2011 complete Centre for Contains:- 15000 Animal One Balanc GMP No. Health” immunizing e 10477962 (FGBI vaccine dose 96437 “ARRIAH” contains not Fee Dated 26- , Vladimir, less than 104 85000 12-2011 Russia. EID50 of IB virus (Strain H- 120) (Vaccine). 6. Mustafa Federal Associated 12-Jun- DML No. May be Deferred for Brothers Governmen Vaccine 12 00-11-1- deferred submission of Faisalabad. tal Against 001220 due to balance fee & Budgetary Newcastle Deposit Dated 11- documen legalized CoPP. Institution Disease ed fee 8-2011. ts not “Federal Infectious complete Centre for Chicken 15000 Free Sale Animal Bronchitis and Balanc Certificate Health” egg drop e Fee No. N4- (FGBI 29yndrome-76 4056 “ARRIAH” inactivated 85000 Dated 11- , Vladimir, emulsion 10-2011 Russia. 7. Mustafa Federal Virus vaccine 12-Jun- Prod Reg May be Deferred for Brothers Governmen against Bursal 12 No. deferred submission of Faisalabad. tal disease from 10233012 due to balance fee & Budgetary Winterfield Deposit 83720 documen legalized CoPP. Institution Disease 2512 ed fee Dated 26- ts not “Federal strain 7-2011 complete. Centre for 15000 Animal One Balanc GMP No. Health” Immunizing e Fee 0011-1- (FGBI dose of vaccine 001221 “ARRIAH” shall contain: 85000 26-12- , Vladimir, 4,0 lg EID50nof 2011 Russia. attenuated virus of infectious Free Sale bursal disease Certificate of Winter field No. 4- strain 2512 4078
Prophylactic Immunization of chickens & chicks against
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Infectious Bursal Disease.
8. M/s SNAM BIOVETA, Biofel PCH Date of CoPP No. Me too Approved as Pharma a. s. emulsion for applica 047/2014 per Import 61-G Komenskeh injection for tion dated 01- Policy for Defense o 212, 683 cats 25-11- 4-2014 Finished Drugs. Housing 23 2014 Authority , Ivanovice Active Prod Lahore na Hane, Substance Fee License Czech deposit No. Republic, Virus ed 97/004/06- panleucopeniae C dated contagiosae Rs.100 01-06- felis 000/- 2006 inactivatum, vide satrain FPV-Bio Challan Free Sale 7 No Certificate 022788 No. Calicivirus felis 0 dated 048/2014 inactivatum, 27-11- dated 01- strain FCV F 9- 2014 4-2014 Bio 8 Balanc GMP Herpesvirus e fee Certificate felis Nil No. inactivatum, 178/2012/ strain FHV-1- CGMP Bio 9 dated 03- 9-2012
9. M/s SNAM BIOVETA, Biocan Puppy Date of CoPP No. Me too Deferred for Pharma 61- a. s. lyophilisate for applica 057/2014 expert opinion G Defense Komenskeh the preparation tion dated 01- of following Housing o 212, 683 of injection 25-11- 4-2014 regarding Authority , 23 suspension with 2014 confirmation of Lahore Ivanovice diluent Prod need vis-a-vis na Hane, Fee License compatibility Czech Composition- 1 deposit No. with local Republic, ml (1 dose): ed 97/011/04- immunogenic a) Component C dated requirement, D (freeze-dried) Rs.100 04-02- safety profile: Virus febris 000/- 2004 a. Dr. Qurban contagiosae vide Ali, Animal canis min. 10 Challan Free Sale Husbandry 4.2 TCID50 – No Certificate Commission MAX. 10 5,0 022787 No. er, Ministry TCID50 9 dated 058/2014 of National 27-11- dated 01- Food b) Component P 2014 4-2014 Security,
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(fluid) Islamabad. Parvovirus Balanc GMP b. Prof. Khushi enteritidis canis e fee Certificate Muhammad, inact. Min. Nil No. UVAS, 1024 HAU- 178/2012/ Lahore max. 4096 CGMP c. Prof. Akram HAU dated 03- Munir, 9-2012 Ripha University, Lahore. 10. M/s SNAM BIOVETA, Biocan Date of CoPP No. Me too Deferred for Pharma 61- a. s. DHPPi+L applica 209/2014 expert opinion G Defense Komenskeh lyophilisate for tion dated 03- of following Housing o 212, 683 the preparation 25-11- 7-2014 regarding Authority , 23 of injection 2014 confirmation of Lahore Ivanovice suspension with Prod need vis-a-vis na Hane, diluent Fee License compatibility Czech deposit No. with local Republic, Composition- 1 ed 97/046/02- immunogenic ml: C dated requirement, Rs.100 06-06- safety profile: Freeze-dried 000/- 2002 a. Dr. Qurban Component vide Ali, Animal Virus febris Challan Free Sale Husbandry contagiosae No Certificate Commission canis min. 10 022787 No. er, Ministry 3.0 TCID50 – 8 dated 210/2014 of National max. 10 4.5 27-11- dated 03- Food TCID50 2014 7-2014 Security, Virus Islamabad. laryngotracheiti Balanc GMP b. Prof. Khushi dis contagiosae e fee Certificate Muhammad, canis min. 10 3.5 Nil No. UVAS, TCID50 – max. 178/2012/ Lahore 4.5 10 TCID50 CGMP c. Prof. Akram dated 03- Munir, Parvovirus 9-2012 Ripha enteritidis canis University, min. 10 4.5 Lahore. TCID50 – max. 5.5 10 TCID50
Virus parainfluensis canis min. 10 3.0 TCID50 – max. 10 4.2 TCID50
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b) Liquid component
Leptospira icterohaemorrha giae inact. Min.titre 32 defined by MAT*)
Leptospira canicola inact. Min.titre 32 defined by MAT*)
Leptospira grippotyphosa inact. Min.titre 32 defined by MAT*) *) geometrical mean of titres of specific antibodies defined by microagglutinat ion test 11. M/s CEVA- Vectormune Date of U.S New Keeping in Marush BIOMUNE HVT NDV & applica Veterinary Molecule view approval (Pvt) Ltd. Veterinary Rispens tion License status of
K 123, Biologicals Ingredients per 29-11- No. 368 USDA, Model company dose: 2011 dated 12- Registration Town 8901 3-2014 Board approved Marek’s Lahore Resohill disease- Fee the product as Road, Newcastle deposit USDA per Import Lenexa, Ks disease virus---- ed Code Policy for 66215 ----min 3420 16N1.R0 Finished Drugs. USA. 50000 dated 05- pfu’s at release and min 2280 6-2007
pfu’s through expiration. Balanc Certificate e fee of Cryoprotectant Nil Licensing No.1 + and HVT/NDV inspection Strains------No 50-90% 1401818
Cryoprotectant dated 17- No.2------10- 6-2014 Minutes 256th Meeting Registration Board 32
50% Preservative
Gentamicin------max 30 µg/ml
Amphotericin B------max 2.5 µg/ml
Indications: Prevention of Newcastle Disease in chicks 12. M/s Vaxxinova Cevac new Flu Date of Manufactu New Deferred for Marush GmbH H9 K applica rer molecule expert opinion (Pvt) Ltd. Anton- tion authorizati of following K 123, Flettner-Str. Each dose on regarding Model 6 27472 contains:- 03-2- DE 03010 confirmation of Town Cuxhaven, Atleast 109.0 2014 EBA need vis-a-vis Lahore Germany EID50 of compatibility Distributed inactivated Fee with local by: CEVA Newcastle Deposit immunogenic SANTE disease Virus ed requirement, ANIMALE (strain LaSota) safety profile: 10 avenue and atleast 108.0 50000/- a. Prof Dr. de la EID50 Avian dated0 Iftikhar Ballastiere Influenza Virus 9-5- Ahmad, Libourne, (strain H9N2), 2015 University of 33500 suspended in Agriculture France the amnio- Balanc Faisalabad. allantoic fluid e fee b. Dr Masood from Nil Rabanni, embryonated UVAS, SPF hen’s eggs. Lahore c. Dr Khalil Indication: Rifah University Inactivated Islamabad. vaccine against Newcastle Disease
13. M/s Laboratorie Hipraviar SHS Date of Number of Me too Deferred for Marush s Hipra applica License/au expert opinion (Pvt) Ltd. S.A.Avda. Each dose tion thorization The case of following K 123, La Selva contains: 03-8- No. 2238 already regarding Model Amer Live Turkey 2010 ESP sent to confirmation of Town (Girona) Rhinotracheitis Date of expert in need vis-a-vis
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Lahore Spain. Virus, strain Fee issuance NVL compatibility 1062------deposit 16-2-2011 times has with local ≥102.4 TCID50 ed been immunogenic reminded requirement, Excipiants 15000/- experts safety profile: q.s……….0.03 + reply is a. Prof Dr. ml 35000/ still Iftikhar + awaited. Ahmad, 50000 It is University of Shelf life 24 dated proposed Agriculture months 11-5- the case Faisalabad. 2015 may be b. Dr Masood Vaccine for sent to Rabanni, Poultary some UVAS, Balanc other Lahore e fee experts c. Dr Khalil Nil for Rifah opinions. University Islamabad.
Confirmation of approval status by reference regulatory authorities 14. M/s CEVA- Sterile Diluent Date of Certificate Deferred for Marush BIOMUNE applica of clarification for (Pvt) Ltd. Veterinary Each 1000 ml tion Licensing usability with K 123, Biologicals contains: and already Model company inspection registered Town 8901 Sucrose 10.0 Fee No product or Lahore Resohill g deposit 1400671 otherwise with Road, NZ Amine AS ed dated 30- any other Lenexa, Ks 4.0 g 50000/- 12-2013 product 66215 Sorbitol 45.0 dated USA. g 08-12- US K2HPO4 1.20 2014 Veterinary G License KH2PO4 0.50 Balanc No. 368 G e fee Phenol Red Nil Prod Lic 0.02 g Code Demonized 16N1.R0 Water qs to dated 5-6- 10000ml 2007
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15. M/s Laboratorie Hipraviar Date of Number of The case Deferred for Marush s Hipra B1/H120 applica License/au already expert opinion (Pvt) Ltd. S.A.Avda, tion thorization sent to of following K 123, La Selva 1 dose contains: 08-7- No 2275 expert in regarding Model Amer Live Newcastle 2010 ESP. NVL confirmation of Town (Girona)Sp disease (ND) Date of times has need vis-a-vis Lahore ain. Virus, strain Deposit issuance been compatibility B1………….1 ed fee 05-5-2011 reminded with local 5.5 0 EID50 50000/- experts immunogenic dated reply is requirement, Live infectious 11-5- still safety profile: bronchitis (IB) 2015 awaited. a. Prof Dr. Virus, strain It is Iftikhar H120…………. Balanc proposed Ahmad, .………….103 e fee the case University of EID50 Nil may be Agriculture sent to Faisalabad. some b. Dr Masood Indication: other Rabanni, experts UVAS, Against for Lahore Newcastle opinions. c. Dr Khalil disease Rifah University Islamabad.
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Case No. 04 Miscellaneous Cases
Case. No. i CASE OF M/s. GRATON PHARMA, KARACHI FOR THE REGISTRATION OF INTERFERON ALFA 2B 3000IU /VIAL (LIPHERON FROM BEIJING SHANGLU, CHINA) ALONG WITH DILUENT.
The firm M/s. Graton Pharma, Karachi has informed that they applied for the registration of Interferon Alfa 2b 300MIU injections 22.6. 2011 but their application has not been considered in any meeting till date .The firm has provided evidence of documents and fee challans submitted by them. 2. The case of the firm belongs to pre devolution at the time to Drugs Control Organization, Ministry of Health. The section tried to retrieve the application from old record but still the record is not found. Copy of GMP shows its validity till 14.03.2015. Copy of CoPP has also been provided by the company.
Earlier Decision of the Board: The Board deferred the case for completion of documents by the firm and to present the case with all available details in the next meeting of Registration Board.
M/s Graton Pharma, Karachi as has requested in the previous meeting for the import of their interferon. The case was considered and deferred for provision of original documents. The firm has submitted photocopies of their documents. In the instant shifting of record of biological division and touring abroad of DDC (BIO) their file are not traceable instantly. 2. The firm has also submitted documents regarding registration of steroil water for injection for their products. They have provided on form-5 CD version of registration dossiers, certificate of pharmaceutical product (Photocopy). However the firm has not submitted additional fee required for water for injection and that promised to submitted at the earliest before issuance of any letter regarding inspection abroad are registration letter. 3. The Board may consider their case on merit, whereas biological division is retrieving their documents and shall present before the Board as soon as they are available. Meanwhile the process of foreign inspection as per import policy may be considered and the firm may be directed to give undertaking on judicial stamp paper that outcome of the inspection what so ever will not confer the right of consideration if the firm could not qualify for the GMP certification. The firm shall be exempted from inspection, if their inspection has waiver as per import policy.
Minutes 256th Meeting Registration Board 36
It is a similar case of finished import for which policy decision has been asked however the case is pending since Ministry of Health before the DRAP Act 2012. Decision of 254th RB: The Registration Board upheld the previous decision and deferred the case for completion of documents by the firm as no any new documents/files was submitted by the firm.
The firm has provided undertaking on the stamp paper dated 07-12-2015 as follows: In continuation with our application for registration of Interferon Alpha 2b 300MIU injection (LIPHERON 300IU) dated 22.6.2011. It is stated we have provided evidence of documents & fee challan submitted to biological division of DRAP. Our case belongs to pre devolution at the time to drug control organization, Ministry of health. Our application record due to shifting of record is not traceable instantly by biological division of DRAP. We have submitted on request of biological division of DRAP photocopies of following documents on 20th November 2015 via R&I Unit DRAP TF Complex 1) Copy of (lipheron 300iu) dossier 2) Copy of water for injection dossier 3) Copy of COPP 4) Copy of GMP 5) Copy of challans
Firm is in process of getting fresh COPP & GMP & these documents legalized & attested by embassy of Pakistan in PR CHINA, it is going to take 3-4 months. Firm has requested that case should be approved on merit & as per import policy process of foreign inspection should be done to save our time. The Firm undertake to submit fresh COPP & GMP duly legalized & attested by embassy of Pakistan in PR CHINA, before getting final approval by honorable registration board & registration letter. S.No Company Name of Name of Date of Documentary Name Manufacturer Products application / Details Fee status 1. M/s Graton Beijing SL Recombinant Date of CoPP No. Pharma Pharmaceutical Human application 20150204 dated office # 102, Co., Ltd. Interferon alfa 10-2-2015 First Floor, No.9. 2b for injection The Plaza, Zhongyuan Strength: 3M Fee Deposited Prod License Block-9 Road, Badachu IU/vial Rs.15000/- No. S20100501 Clifton, High Tech. dated 22-6- dated 18-9-
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Karachi. Park, 2011 + 2010. Shijingshan 35000/- dated District, 09-10-2012+ GMP Beijing, 50000/- dated Certificate No. P.R.China 11-6-2015 CN 20130327 DATED 31-10- 2013 Free Sale Certificate No. 2015-14 dated 02-1-2015 validity 02 years.
Note. Photocopy of the COPP which is not legalized and not notarized bears the date 10- 2-2015 whereas the dossier was submitted on 20-6-2011.
The case is holistically placed before the board for a decision as per policy adapted for NON SRA countries and considering the above documentary details
Decision: Registration Board upheld its previous decision and deferred the case for completion of documents by the firm, as firm has still not submitted any new documents/files.
Case No.ii: CHANGE OF MANUFACTURING SITE OF (PEG INTERFERON ALFA 2A) MANUFACTURED BY (M/S F.HOFFMANN LA-ROCHE PAKISTAN LTD, APPROVED IN 237TH MEETING OF REGISTRATION BOARD.
The Registration Board in the last meeting decided to take up all the cases of 237th meeting of Registration Board holistically. However due to lake of human resource and time constraints the issue of 237th meeting could not be taken up in this meeting. Meanwhile Roche Pakistan Ltd has requested to grant change of manufacturing site of their product which was approved in the above said meeting. The firm has submitted the legalized and notarized CoPP issued by EMA of the new site. The firm submits that the bridging stocks from previous site are about to be finished, which will create problems for those patients who are on this specific medicament. The request of the firm is placed before the Registration Board. The new EMA approved site is at F. Hoffmann-La Roche Ltd., Wurmiweg, 4303 Kaiseraugust, Switzerland.
Decision of RB: The Registration Board deliberated in detail on the issue of 237th meeting of the Registration Board specifically on the issue of not recording the minutes and issuance of a registration letter. There were varied view points of the members. The consensus was developed to defer the case for the next meeting; meanwhile Biological Division was directed to bring parawise
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comments of Biological Division, as submitted in the Sindh High Court, regarding the fake registration of Ropegra.
The relevant files about Ropegra / and submitted parawise comments before Sindh High Court are provided for overseeing by the Registration Board. The request of the firm for change of manufacturing site may be considered in the light of decision of last 254th meeting of RB and available evidence from the record. Furthermore NCLB is issuing lot releases certificates of Ropegra regularly.
Furthermore the firm has requested on January 14, 2016 for special permission to import 60000 vials of Ropegra before the approval of site change to avoid the stock out situation and its after effects of shortage and unavailability of next doses/ hardship being faced by the Hepatitis B &C patients.
Proceeding of 256th Registration Board Meeting:
Registration Board was apprised that case of Ropegra vial (Peg-interferon 140 mcg, 40KD) Registration No. 077512 was discuused by the Board in various meetings as follows:
Discusion in 240th Meeting:
Mr. A.Q. Javed Iqbal, Chief pharmacist, PIMS: It was informed that Registration Board in 238th meeting decided that all products which were discussed in 237th meeting will be evaluated by ECBD and Registration Board will then consider recommendation of ECBD for further decision. Mr. A.Q. Javed Iqbal requested Directorate of Biological Evaluation & Registration to share the registration applications submitted for Ropegra and vaccines of M/s Pak cure, Rawat. These registration applications were handed over to Mr.A.Q. Javed Iqbal for evaluation. The member will submit its report for consideration of Registration Board in its next meeting. Registration Board was informed that Pharmaceutical Evaluation & Registration Directorate sent copy of all registration letters to all Provincial Health Secretaries. However, the Board advised to send copy of registration letter to Chief Commissioner, Islamabad as well.
Discussion in 241st meeting:
Item No: II. Evaluation of registration dossiers- Ropegra & Pak Cure Vaccines: In 240th Registration Board meeting, registration dossiers of Ropegra, M/s Roch and vaccines of M/s Pak cure, Rawat were handed over to Mr.A.Q. Javed Iqbal for evalution. The Board advised aforementioned member to submit its report for consideration of Registration
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Board in its next meeting. Accordingly, Mr.A.Q. Javed Iqbal submitted its report which is as follows for consideration of Registration Board: Ropegra (Pegylated Interferon Alpha 2 in vial) by M/S Roche Pakistan: I had an opportunity to scan through the product dossier of “Ropegra (Pegylated Interferon Alpha 2 in vial) by M/S Roche Pakistan. I was expecting a very comprehensive and complete dossier from M/S Roche, being the inventor and original patent holder of this product and being approved by the Stringent European Regulators. However, there are some observations, inconsistencies regarding this dossier as follows; According to our previous RB meeting, on the submission of Biological Directorate, it was allowed to give fast tract processing to molecules from Stringent Regulatory Authorities if they fulfill the following criteria, “2.1.3. RECOMMENDATION FOR APPROVAL OF MARKETING AUTHORIZATION OF FINISHED BIOLOGICAL DRUGS: Recommendation: All applications which have gone through the rigorous review processes and already succeeded to get market authorization from the World Health Organization (WHO) defined Stringent Regulatory Authority (SRA), International Conference of Harmonization (ICH) countries are recommended for approval and will also be forwarded under default mechanism in future within shortest period of time, if applicant could: Submit summary of regulatory review report and approval, Submit Common Technical Documents both via CD in Electronic format and paper format Manage to arrange Process Verification and Inspection of manufacturing facility (s) Demonstrate that transportation, storage, handling will not impact on predefined attributes However, there is only one Module 3 of “Quality” is attached out of the five modules of CTD. MODULE 1- ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION MODULE 2 - COMMON TECHNICAL DOCUMENT SUMMARIES MODULE 3 – QUALITY MODULE 4 – NONCLINICAL STUDY REPORTS MODULE 5 – CLINICAL STUDY REPORTS There are many inconsistencies in different dates as follows; · First date of submission of dossier is Nov.06, 2012 (Page 2 of dossier) · Form 5A submitted on Nov. 6, 2012 · While submitted fee challan is on Nov.14, 2012 (Page 3of dossier) All other documents in the dossier are of 30/11/2012, which means after the dossier submission (Fail to understand this inconsistency) There are many documents which are incomplete or missing as required in “Form 5 A” as follows No 24 . Facility of water processing with specification (Missing) No 25 . Environmental control processing with complete detail, waste management etc. (Missing) No 27. Clinical data and trails (Missing which is also part of module 5 of CTD) No 15. Proposed shelf life claimed is 3 Years While on page 55 of Pharmaceutical development is as follows, “Based on the available stability profile, it is anticipated that the Ropegra vials will have a shelf life of at least 24 months when stored at the recommended temperature of 2-8 degree centigrade” And also on Page 63 as follows; “Ropegra vials are physically and chemically stable during 18 months at the recommended storage temperature of 2-8 degree centigrade as demonstrated by real time data. An expiry dating of at least 24 months is anticipated on the basis of these data.” While on page 287, the stability data was on batches manufactured in Sep, and Nov.2000 (13 years old, when Ropegra brand was nonexistent) but the documentation date is 30/11/2012 while the graph is labelled with Ropegra (How can this be correlated?) and then based on these batches stability claimed is 3 years (in WHO climate zones 1 to IV). Another important requirement is credentials of manufacture abroad which is also missing. The product dossier is one of the most important regulatory and legal document and need a very careful and thorough examination to make any decision to ensure the quality, safety and efficacy of local community and globally documentation is the mains take of product evaluation, audit and registrations. I shall request all our respected members to make it a practice to sample some
Minutes 256th Meeting Registration Board 40 of the representative product dossier as a regular policy being the custodian of drug regulation. Decsion: The Board after thorough discussion decided that ECBD will review evaluation report of Mr. A Q Javed Iqbal on Ropegra vials and Pakcure vaccines. ECBD will frame its recommendations about registration status of aforementioned products for consideration of Registration Board.
Discussion in 244th meeting:
Item No II: Agenda point referred by Dr. Amanullah Khan (Director DTL, Quetta) – Hepatitis C drug marketed without approval. Dr. Amanullah Khan (Director DTL, Quetta) has referred to news published in the News dated Jun 27, 2014 captioned Hepatitis C drug marketed without approval and requested that case may be placed in agenda of Registration Board meeting for discussion. The report pertains to registration of Ropegra injection for M/s Roche, Karachi. Decision: Registration Board discussed the News report dated Jun 27, 2014 and advised Biological Division to bring record regarding registration of Ropegra injection in forthcoming meeting. Moreover, officers who processed the case will brief the Board about proceedings of registration of Ropegra injection.
Discussion in 251st meeting:
Case No.11: Application for the change of manufacturing site of Ropegra Injection The firm M/s. Roche Pakistan, Karachi has requested to grant the approval of change of manufacturing site their drug namely Ropegra from Hoffman La Roche Basel, Switzerland to Hoffman La Roche, Wurmisweg, Kaiseraugust, Switzerland. The firm has submitted following documents; 1. Application as per Form 5 A. 2. Fee Rs. 50000/- 3. Notarized/ legalized CoPP of the product. 4. CRF clearance not applicable. 5. Site master file. It is submitted that the previous registration letter issued to the company was challenged in the honorable Sind High Court. The issue is still in the honorable Sind High Court.
Decision: Registration Board deferred the case for further details regarding status of biological drugs considered in 237th Meeting.
Registration Board deliberated in detail on all the aspects of subject agenda item. After detail deliberations the Registration Board concluded the discussions as follows: “That the recorded minutes of 237th meeting of Registration Board pertaining to Biological Division are not available in routine format. The unsigned agenda and later communications including letter of the then DDC dated 29.05.2013 and F.1-11/2013-DDC 2nd ECBD dated 11.03.2013 reflect that the case of registration of Ropegra (Peg-interferon 180mcg 40 KD) 1 ml vial was discussed in 237th meeting RB. Then registration letter of aforementioned product
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was issued by the then Director, Biological Drugs vide letter No. Human Biological Import-5 (HBI-5) dated 19th September, 2013 bearing Registration No. 077512. Accordingly, product is being granted lot release certificate by National Control Laboratory of Biologicals, Islamabad and thus product is available in market. In the meanwhile a petition was filed in Honorable High Court of Sindh (W.P. No 1025/ 2015 and D-2190/ 2014 filed by M/s Getz Pharma Karachi Vs FOP & others) challenging status of registration of Ropegra vial, Registration No. 077512. In this case, DRAP has submitted para wise comments admitting that Ropegra vial, Registration No. 077512 was registered after due process of evaluation in accordance with Drug (L R & A), Rules 1976 and prayed that the Registration letter issued by the DRAP is based on European Medicine Agency Certificate of Pharmaceutical Product, declaring Ropegra for Pakistan is synonym of brand “Pegasys” as internationally available.
Decision: Keeping in view above discussion and stance of DRAP in above writ petitions, Registration Board acceded to the request of the firm for change of manufacturing site from F.Hoffmann La Roche Ltd., Basel, Switzerland to F.Hoffmann La Roche Ltd., Wurmisweg, 4303 Kaiseraugust, Switzerland. The firm will provide valid legalized CoPP of new site for issuance of letter.
Case No.iii Request for Change of Brand Name of ATG-Freseniuss concentrate for solution for Infusion Allmed Laboratories, Karachi
S.No. Registration Manufacturer Name of Existing Proposed Date of Documents No. Name Importer Brand Brand Application/ Detail Name name Fee Status
1. 033134 M/s. Neovii M/s Allmed ATG- Grafalon Date of CoPP No. Biotech, Laboratories, Freseniuss w.e.f 1st application N211-1-30- Germany Karachi January, 21st August, 2015 dated 2016 2015 08-6-2015 Legalized Fee and deposited Notarized. Rs.100000/- Prod License Balance Fee No. 452a/87 Nil dated 02-2- 1988
Federal Institute for Vaccine & Bio Medicine
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Ref No. 2.01.02.030 dated 12-1- 2015
Market Authorization No. 452a/87
Decision: Registration Board acceded to the request of the firm for change of brand name as per CoPP.
Case No. iv Transfer of registration of Shan-5 bearing registration no 053823 from M/s Majeed Sons to Sanofi-Aventis Ltd Pakistan, Karachi.
Company Manufacturer Product Date of Documenta Remarks Name Name Composition Application / ry Detail Fee Status Sanofi- Shantha SHAN – 5 03.06.2015 CoPP No. aventis biotechnics Diptheria, Pakistan Private Limited Tetanus, Deposited DML No. Limited, (a sanofi Bivalent fee Karachi. company) Pertussis, Free Sale Survey No. Hepititus B and 100000 Certificate 274, Athvelli Haemophilus Balance Fee Village, Influenzae Type Indications Medchal – 501 b Nil 401, Ranga Conjugate Reddy District, Vaccine Telangana, (adsorbed) India
The instant the case was discussed in the last 254th meeting and was deferred due to completion of documents. The firm has requested for transfer of registration of Shan-5 bearing registration no 053823 from M/s Majeed Sons to Sanofi-Aventis Ltd Paksitan, Karachi. The NOC from the M/s Majeed Sons is placed in the dossiers. The firm has applied on form-5A and submitted requisite fee of Rs.100000/- on 02-12-2014. M/s Majeed Sons has applied of renewal of registration of Shan 5 bearing registration no 053823 and submitted renewal fee of Rs.40000/- on 30th May, 2014.
Due to creation of new province in India the place of manufacturer has been reallocated from Andra Pardesh to province Telangana, India. There is a change of name of the firm from Shantha Biotechnics Limited Survey No. 274, Athvelli Village, Medchall Mandal – 501 401,
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Ranga Reddy District, Andhra Pradesh, India to Shantha Biotechnics Private Limited Survey No. 274, Athvelli Village Medchal Mandal – 501 401, Ranga Reddy District, Telangana, India.
All of the rest of the parameter of manufacturing, quality control and lot release remains as the previous one. The case is placed before the Registration Board for change of name of the manufacturer and cancellation of registration from the name of previous importer and grant of registration on the name M/s Sanofi-Aventis, Karachi on the same term and conditions. Furthermore as the vaccines originates from non SRA countries and exemption of the inspection abroad shall be waved off if the firms provides latest WHO Prequalification status. Decision: Registration Board cancelled the above registrations in name of M/s Majeed Sons and granted same registrationin in name of M/s Sanofi, Karachi. The address of the manufacturing site is approved as per valid COPP and as per import policy for finished drugs. Comments will be solicited from Cost & Pricing Division before issuance of registration for price fixation.
Case No.v: Extension in Shelf life from 01year to 02years on the product Himmvac ND LaSota Live Vaccine (Reg. No.052303), Himmvac IB- ND Combined Live Vaccine (Registration No. 052304), Himmvac IBD Live Vaccine (Reg. No. 052305) M/s Vet Pharma Trading Company, Gujranwala.
Sr.No. Company Manufacturer Product composition Date of Documentary Name Name application/Fee Details status 1. M/s Vet KBNP, INC, 254- 1. Himmvac ND Date of GMP Pharma 18, DUGOK-RI, LaSota Live Vaccine application Certificate Trading Sinam, Yesan, (Reg. No.052303) No. 6 dated Company, Chungnam, Korea Renewal Date 29-10- 09-4-2015 15-2-2007 Gujranwala (235-9), Chusaro, 2013 validity until sinam, Yesan, Shelf life Fee 31-12-2020. Chungnam, Korea) Prod License No. 6- Deposited 127 dated 2-7-2015 In the Free Rs.5000 sale certificate 2. Himmvac IB- ND Rs.5000 the shelf life Combined Live Rs.5000 of the product Vaccine (Registration Vide Challan is 24 months. No. 052304) Renewal No 0283099, The document date 29-10-2013 0283100, has the 0283101, dated attestation of Prod License No. 6- 21.4.2015 Korean 145 dated 2-7-2015 Regulatory Agency, 3. Himmvac IBD Animal and
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Live Vaccine (Reg. plant No. 052305) Quarantine Renewal Date Agency 29-10-2013 Ministry of Agriculture Prod License No. 6- Republic of 137 dated 2-7-2015 Korea.
M/S Vet Pharma Trading Company agreement with. KBNP, Inc,Korea.
Agreement shall be in effect from Jan.29, 2016 to Jan.29, 2018
Decision: Registration Board acceded to the request of the firm for increase in shelf life of above mentioned products from one year to two years as per CoPP.
Case No. vi Measles Vaccine by NIH, Islamabad
Decision 248th RB: The case was discussed in detail while appreciating the quick work done by the section and found the application deficient in vital information satisfying safety, efficacy and quality parameters which NIH has to attend before formal approval. The Board advised NIH representatives to provide the above mentioned documents/information. The board also constituted the following committee to re-evaluate the case and submit its report in the next meeting of Registration Board for its disposal as per rules.
1. Lt. Gen (R) Karamat A Karamat 2. Brig. Dr. Aamer Ikram, SI (M) Member Registration Board Professor & Consultant Islamabad. Dept of Microbiology, AFIP, Rawalpindi 3. Mr. Zafar Mahmood Minhas 4. Mr. Faisal Shahzad Dy. Drugs Controller (DDC) National Dy. Drugs Controller (Biological Drugs) Control Laboratory Biological, NIH, DRAP, Islamabad Islamabad
Minutes 256th Meeting Registration Board 45
The reply of following three Experts has been received. The fourth member Mr. Faisal Shahzad Dy. Drugs Controller (Biological Drugs) DRAP, Islamabad could not furnish his report. The three members have submitted their following comments, in respect of registration of “Measles Vaccine” Formulation with imported concentrate by NIH Islamabad:-
Brig. Aamer Ikram, Armed Forces Prof. Dr. K.A. Karamat, Dr. Zafar Institute of Pathology, Rawalpindi. Quide-e-Azam Mahmood International Hospital, Minhas, Deputy Islamabad. Director NCLB
(1) It is initiated that couple (1) It is initiated that I have reviewed of meetings have been held between Lt couple of meetings have the provided data Gen (Retd) Karamat Ahmed Karamat, been held between Lt Gen and reached at the HI(M), and Brig Aamer Ikram. (Retd) Karamat Ahmed conclusion that the Meanwhile, there has also been a Karamat, HI(M), and Brig queries/observatio thorough discussion with NIH Aamer Ikram. Meanwhile, ns raised on the representatives. there has also been a good matter has been deal of discussion with justified/explained (2) Following has been the NIH representatives. by NIH. The outcome:- provided data is (2) Following has been for the combined (a) The main objective was to have the outcome:- Measles-Rubella the seed virus from WHO Vaccine and not prequalified firm. Discussion with (a) The main objective for the individual NIH revealed that for three was to have the seed measles vaccine consecutive years it was tried but virus from WHO component. The no vendor showed interest, so in prequalified firm. Manufacturer 2015 this requisite was omitted. Discussion with NIH abroad is not a revealed that for three WHO pre- (b) NIH is already preparing tetanus consecutive years it qualified source toxoid, rabies, typhoid and was tried but no but conforms to cholera vaccines. vendor showed the requirements interest, so in 2015 of the Chinese (c) NIH claims the capability to this requisite was GMP Standards. If prepared measles vaccine from omitted. considered seed virus. necessary the unit can physically be (d) NIH replied to previous (b) NIH is already verified through on observations vide above preparing tetanus site inspection. mentioned letter:- toxoid, rabies, typhoid and cholera vaccines. On the basis of the evaluation of (1) One of the (c) NIH claims the provided data and points was capability to prepared justifications Regarding neuro-surveillance protocol. measles vaccine from provided by NIH, NIH has provided details of the seed virus. the matter may be manufacture’s testing for neuro- proceed further. surveillance. Protocol for neuro- (d) NIH replied to suirveillance at NIH has also to be previous observations
Minutes 256th Meeting Registration Board 46 prepared as reversion of seed virus might raised vide letter No.F.2- become an issue. 11/2015-DDC(BD)(M-248) dated 2 July, 2015:-
(1) One of the points (2) DRAP need was to clarify the regarding neuro- Legal stance regarding claims by NIH: surveillance protocol. NIH has provided details i. Lot of the manufacture’s rele testing for neuro- ase surveillance. Protocol for for neuro-suirveillance at bulk NIH has also to be is prepared as reversion of not seed virus might become required in importing country. an issue. ii. Tests on bulk are not mandatory in (2) DRAP need to importing country. clarify the legal stance regarding (3) As mentioned claims by NIH: for QC testing methods, NIH has provided i. Lot WHO references. NIH needs to confirm release the requisite equipment and expertise is for bulk available for QC at NIH. is not required in importing (4) Has NIH the country. capability to check residual moisture offer freeze ii. Tests on drying? bulk are not (5) For mandatory in importing pharmaco- country. vigilance, NIH mentioned that system is available at (3) As mentioned for QC NCLB/NRA. Protocol needs to be testing methods, NIH has developed for that as per international provided WHO references. standards. NIH needs to confirm the requisite equipment and 3. DRAP needs to clarify: expertise is available for QC at NIH (a) General safety test mentioned at Annex-X to be sufficient or (4) Has NIH the some other to be added. capability to check residual moisture offer (b) The manufacturer freeze drying? conforms to Chinese GMPs in accordance with WHO recommendation. (5) For pharmaco-vigilance,
Minutes 256th Meeting Registration Board 47
DRAP needs to provide information NIH mentioned that regarding sufficiency of this information. system is available at NCLB/NRA. Protocol (c) (c )Point at para 2d (2). needs to be developed for that as per international 1. It is suggested that standards. Once the pre-requisites are addressed, NIH needs to arrange third party 3. DRAP needs to evaluation of initial batches through clarify: authentic international source like National Institute of Biological Control & (a) General safety test Standards London. mentioned at Annex-X to be sufficient or some other to be added.
(b) The manufacturer conforms to Chinese GMPs in accordance with WHO recommendation. DRAP needs to provide information regarding sufficiency of this information.
4. It is suggested that once the pre-requisites are addressed, NIH needs to arrange third party evaluation of initial batches through authentic international source like National Institute of Biological Control & Standards London.
5. In next meeting of DRA Board, Brig. Amir Ikram may please be invited discuss this case.
In the above reports some concerns have been shown by the expert members. It is proposed the NIH, may be informed of the report and NIH may deliberate on the reports before the Board. The case is submitted before the Board.
Discussion : Registration Board deliberated about the capcity of NIH for its installed facility where the NIH was once manufacturing its own vaccine from the measles virus seed. NIH representatives were also called to explain to the Board the circumstances under which the previous manufacturing could not be carried out. The NIH is of view tha the seed culture
Minutes 256th Meeting Registration Board 48 is got out of stock and no one has showed its interst to supply the seed culture to NIH. The only way is to import the bulk concentrate from china and its local repacking at NIH facilty. Forthermote NIH claimed that all the supplies shall be for Suply to EPI and its lot release will be through NCLB. Moreover, representatives of NIH also explained points observed by panel of experts and members of the Board. The responsibility of quality, efficacy, and safety shall be of NIH and EPI shall report AEFI of the said vaccine.
Decision: Keeping in view the above mentioned discussion, Registration Board approved the request of NIH, Islamabad for bulk import of measles vaccine concentrate from M/s Beijing Minhai Biotechnology Co-operative Ltd, No.1, SI Miao Road, Bio- engineerung & Pharmacetical Industrial park, Daxing District, Beijnig, China and its local packing and labeling at NIH licensed facility for manufacturing of measle vaccine for supply to EPI. The NIH shall arrange the test/ analysis of first batch from manufacturer at China and submit the reports to DRAP.
Case No. vii: WP NO. 38284/ 2015 IN THE LAHORE HIGH COURT LAHORE DATED 25-01-2016 GHAZANFER ABBAS VS FOP AND OTHERS
It is submitted that Writ petition No. 38284 on dated 25-01-2015 has been filed by Mr. Ghazanfar Abbas resident of Garhi Mumbran Pindi Bhattian, District Hafizabad, in the Lahore High Court, Lahore in which he has paryed that immediate ban may be imposed on the production, importing, selling and using of Boostin- 250 (rBST Recombinant Bovine Somatotropin Hormone) in the larger interest of people and to save lives of the animal and Human beings. The brief of the case is as follow: The US Food and Drug Administration (FDA) in 1993 approved the use of Recombinant Bovine Growth Hormone (rBGH) here after referred to as rBST for increased milk production in dairy cows. This genetically engineered hormone was developed by M/s Monsanto and sold to M/s Elanco, a Division of M/s Eli Lilly Drug Company, in 2008. Its trade name is Posilac®. Whereas Boostin-250 and Boostin-S products developed by another company namely LG Life Sciences, Korea and are marketed through M/s Ghazi Brothers, Karachi.
In Pakistan, there are four products which are registered for sale and marketed through import as detailed under:-
S # Name and Composition & Packages Importing Packing Registration No company
a Boostin-250 Boostin-250 Ghazi Brother Per
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Injectable Injectable Solution Karachi from LG Cartridge Solution Each Cartridge contains:- Chemical Ltd. Korea of 250mg Reg # 020819 rBST (Recombinant dated 20.1.1998 Bovine Somatotropin manufactured by 250mg. M/s LG Chemical Vitamin E…1460mg Ltd, Korea. (Annexure-A) b Boostin-S Boostin-S Injectable Ghazi Brother Plastic Injectable Each Cartridge Contains:- Karachi from LG Cartridge Reg # 069645 rBST (Recombinant Chemical Ltd. Korea of 500mg. dated 30.4.2011 Bovine Somatotropin) manufactured by …..500mg. M/s LG Life (Alanyl BST or Methionyl Sciences Ltd, BST) Tocopherol Acetate South Korea. (K.P) 1400mg. (Annexure-A/1) Lecithin (K.P) …..100mg c Eltosil- Fish Each kg Contains:- Ghazi Brother 100gm Powder. Reg # rBST (Recombinant Karachi from LG 500gm 069646 dated Bovine Somatotropin) Chemical Ltd. Korea 1kg 30.04.2011 Lyophilized 10gm. 5kg Growth Promoter for Fish) (Annexure-A/2) d SOMATECH Recombinant Bovine Developed by Prefilled INJECTION Somatotropin 500mg/PSF Monsanto and sold syringe Reg # 020827 Syringe of 1.4ml to Elanco, (Division 500mg / dated 16.01.1998 of the Eli Lilly) PSF (Annexure- B) marketed in USA Syringe of under the Trade 1.4ml name Posilac® and marketed in Pakistan by ICI Pakistan.
In April, 2015, two writ petitions (W.P. 10663/2015 and 11803/2015) were filed before the Honourable Lahore High Court alleging that the drug rBST is unsafe for humen and for animals. While, the Government of Punjab (“GoPb”), who was listed as one of respondent in the said petitions, fully supported the allegations leveled in the Petitions.
On the direction of Honourable Lahore High Court, the Registration Board, reviewed the document submitted by the petitioner and defendants viz-a-viz recommended indications for usability in lactating cows, latest regulatory status in country of origin i.e. USFDA and Korean Food and Drug Administration (KFDA), and to decide whether any restriction needs to be imposed on the sale of the above drugs and also to see whether a drug
Minutes 256th Meeting Registration Board 50 in any manner is harmful to the public at large. In this regard, a meeting was called in the end of July, 2015, inviting all the stakeholders including Secretary, Livestock and Dairy Development, Government of Punjab for in-depth discussion and reached to the conclusion that there is no established scientific evidence having direct harm to the human health as alleged. The details were submitted to the Honourable Lahore High Court Lahore by the CEO (DRAP) in person.
Secretary, Livestock and Dairy Development, Government of Punjab and other heads of research organizations who were actively involved in local research on the same product appeared in a subsequent meeting of the Registration Board wherein they submitted additional facts notifying that the product should not be allowed for marketing in public interest. On the recommendation of Government of Punjab and Associated Dairy and Veterinary Associations, the Registration Board decided cancellation of the registered products namely, Boostin-250 Registration No. 020819, Boostin-S Injectable Registration No. 069645 and Somatech Registration No. 020827. The intimation was accordingly issued on 11th November, 2015 vide letter No. 2-16/2015-DDC (BD) (M-252). Which is reproduced as under:- …..The registration of rBST containing formulations are in contravention of clause(c)and (d) of subsection (11) of section 7 of Drugs Act, 1976 read with clause (a) of sub-rule (10) of rule 30 of Drug (Licensing, Registering and Advertising) Rule, 1976 and thus non-maintainable, therefore following registrations are hereby cancelled. Cancellation of registration will be communicated to the registration holders after the confirmation of minutes by members of the Board.
a. Boostin-250 Injection, Registration No. 020819, M/s Ghazi Brothers, Karachi.
b. Boostin-S Injectable Registration No. 069645, M/s Ghazi Brothers, Karachi.
c. Somatech Registration No. 020827, M/s Eli Lilly, Karachi.
It is to submit that the officers of the DRAP had taken action pursuant to the intimation about subject drugs. However, in compliance to the order dated 25.11.2015 of this honorable Court in instant suit, no further action has been taken against registration holders of rBST by DRAP.
M/s Ghazi Brothers Karachi filed two appeals under Section 9 of the Drug Act, 1976, for the subject drugs, received on 30th September, 2015 in the DRAP. However, these appeals had not been made in the prescribed manner and form, as under the rules and some
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documents, the orders of the Registration Board appealed against in particular, were missing. The appeals as such were not tenable. The appeal documents were completed on 01.12.2015 and included in the agenda of the meeting of the Appellate Board, scheduled on 22nd December, 2015. However, the Appellant through a letter received on 21.12.2015 agitated that his appeal may not be taken up by the Appellate Board as the matter was subjudice. Accordingly, the appeals have been deferred till pendency of the matter before the Honorable High Court.
There are two others suits no. 2200/2015 and 2333/2015 along with instant suit no. 2297/2015 wherein in the honorable High Court of Sindh at Karachi has already stayed on 25th November, 2015 and 26th November, 2015. Upon receipt of these interim orders, all the field offices have been instructed for no further action. A public petition under HRC No. 17376-P/2015 field by Major ® Syed Jamshid Hassan of M/s Naseem Traders International Rawalpindi is under consideration at Honourable Supreme Court on the same issue
Decision: Registration Board deliberated on the issue and decided to obtain the certified copy of the petition from Lahore High Court through the DRAP regional office at Lahore for further processing.
Case No.viii Request for additional pack size by M/s. Snam Pharma, Lahore
M/s SNAM Pharma, Lahore has requested to approve additional pack against their already registered products. The firm has deposited an amount of Rs.5, 000/- as prescribed fee for each product. The detail is as under with justification: -
S.No. Product Regn Existing Additional Justification Name No./Composition pack size Pack 1 Biocan R Reg.No. 057167 10x5ml. (1m1)x20 The single Injection ad 5x20ml single dose of us vet Composition 1ml : dose Biocan R Virus rabiei inactivatum, strain is necessary SAD vnukovo-32 min.2 IU as it will be used in Excipients single dog Algedratum Thiosmersalum vaccination, Nutrimentum MEM and it is Demanded by the market. 2 Ornipest Reg.No. 059171 200doses. 5000 x 10 Large dose
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lyof.ad.us.vet 500 doses pack size in Composition 1dose: doses. poultry is Active ingredient: 1000 convenient Paramyxovirus pseudopestis doses. in the avium (La Sota,SL 93) min.106.0 2500 large poultry 8.0 EID50, max. 10 EID50* doses. formers and *EID50 – 50% infectious dose for 10x200 dose of 5000 chicken embryos doses bird packing 10x500 is Excipient: Nutrimentum pro doses demanded lyophilisatione 10x1000 by the doses market. 10x2500 doses 3 Ornibron Reg.No.057169 10x200 5000 x 10 Large dose lyof.ad.us.vet doses doses pack size in Composition: 10x500 poultry is Active ingredients and amount doses convenient per unit dose: 10x100 in the 1dose doses large poultry Virus bronchitidis infectosae 10x2500 formers and 3.0 avium H 120 min.10 EID50, doses dose of 5000 5.3 max.10 EID50 bird packing *EID – 50% infectious dose for is chicken embryos demanded by the Excipients: Lyophilisation market. medium 4 Orniprim Reg.No.057170 10x200 5000 x 10 Large dose lyof.ad.us.vet doses doses pack size in Composition 1 dose: 10x500 poultry is Active ingredient: Paramyxovirus doses convenient pseudopestis avium, strain Bio 10x100 in the 52: NDV BI doses large poultry 6.0 7.5 Min. 10 EID50 – max 10 10x2500 farmers and EID50 Doses dose of 5000 bird packing *EID50 – 50% infection dose for is chicken embryos demanded by the Excipients: Nutrimentum pro market. lyopilisatione
5 Ornibur Reg.No.059172 500 doses 2500 x 10 Large dose intermediate 1000 doses. pack size in lyof.ad.us.vet Composition 1dose: doses poultry is 1000 convenient Virus bursitidis infectiosae avium doses in the 4.0 5.3 min.10 TCID50,max.10 TCID50 2000 large poultry *TCID50 – 50% infectious dose doses farmers and
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for tissue culture 5000 dose of 2500 doses bird packing Excipients: Nutrimentum pro 10x500 is lyphilisatione doses demanded 10x1000 by the doses market. 10x2000 doses 10x5000 doses
Decision 246th Meeting: Registration Board deferred the request and advised the firm to provide legalized CoPP of the product for confirmation of availability of applied packs.
The decision of Registration Board communicated to the firm by the Division on 09-2-2015 with the request to provide legalized CoPP of the product indicating pack size for confirmation and further processing to the request. Now the firm has replied to the letter of the DRAP and submitted required documents Free Sale Certificate and CoPP the detail of which is reproduce as under:
S.#. Compan Name of Name of Existing Additiona Justification Required y Name manufact Product/Reg. Pack size l Documentar urer No. Pack y detail 1 M/s Snam Bioveta, Biocan R 10x5ml. (1m1)x20 The single CoPP No. Phamra a.s., Injection ad 5x20ml single dose dose of Biocan 021/2015 61-G Komenske us vet R is necessary dated Defense ho as it will be 13.1.2015 Housing 212,683 Reg.No. used in single Authority, 23 057167 dog Prod Lic No. Phase-1, Ivanovice vaccination, 97/086/02-C Lahore na Hane, Product is and it is dated 16-12- Czech available in demanded by 2002 Repubic the country of the market. origin. CoPP legalized by Embassy of Pakistan PRAGUE,4/2 015 dated 03- 2-2015 2 M/s Snam Bioveta, Ornipest 200doses. 5000 x 10 Large dose CoPP No. Phamra a.s., lyof.ad.us.vet 500 doses. doses pack size in 019/2015 61-G Komenske 1000 doses. poultry is dated Defense ho Reg.No.05917 2500 doses. convenient in 13.1.2015 Housing 212,683 1 10x200 the large Authority, 23 doses poultry Prod Lic No. Phase-1, Ivanovice Product is 10x500 formers and 97/1188/97-C Lahore na Hane, available in doses dose of 5000 dated 05-12- Czech the country of 10x1000 bird packing is 1997
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Repubic origin. doses demanded by 10x2500 the market. CoPP Doses legalized by Embassy of Pakistan PRAGUE,4/2 015 dated 03- 2-2015 3 M/s Snam Booveta, Ornibron 10x200 5000 x 10 Large dose CoPP No. Phamra a.s., lyof.ad.us.vet doses doses pack size in 013/2015 61-G Komenske 10x500 poultry is dated Defense ho Reg.No. doses convenient in 13.1.2015 Housing 212,683 057169 10x100 the large Authority, 23 doses poultry Prod Lic No. Phase-1, Ivanovice Product is 10x2500 formers and 97/059/00-C Lahore na Hane, available in doses dose of 5000 dated 25-9- Czech the country of bird packing is 2000 Repubic origin demanded by the market. CoPP legalized by Embassy of Pakistan PRAGUE,4/2 015 dated 03- 2-2015 4 M/s Snam Bioveta, Orniprim 10x200 5000 x 10 Large dose CoPP No. Phamra a.s., lyof.ad.us.vet doses doses pack size in 017/2015 61-G Komenske 10x500 poultry is dated Defense ho Reg.No. doses convenient in 13.1.2015 Housing 212,683 057170 10x100 the large Authority, 23 doses poultry Prod Lic No. Phase-1, Ivanovice Product is 10x2500 farmers and 97/062/02-C Lahore na Hane, available in doses dose of 5000 dated 26-8- Czech the country of bird packing is 2002 Repubic origin demanded by the market. CoPP legalized by Embassy of Pakistan PRAGUE,4/2 015 dated 03- 2-2015 5 M/s Snam Booveta, Ornibur 500 doses 2500 x 10 Large dose CoPP No. Phamra a.s., intermediate 1000 doses doses. pack size in 015/2015 61-G Komenske lyof.ad.us.vet 1000 doses poultry is dated Defense ho 2000 doses convenient in 13.1.2015 Housing 212,683 Reg.No. 5000 doses the large Authority, 23 059172 10x500 poultry Prod Lic No. Phase-1, Ivanovice doses farmers and 97/539/97-C Lahore na Hane, Product is 10x1000 dose of 2500 dated 19-6-
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Czech available in doses bird packing is 1997 Repubic the country of 10x2000 demanded by origin. doses the market. CoPP 10x5000 legalized by Doses Embassy of Pakistan PRAGUE,4/2 015 dated 03- 2-2015
Decision: Registration Board approved the request of the firm for additional packs of above registered products as per COPP issued by the Regulatory Authority of the country of origin and as per import policy.
Case No.ix Change of manufacturing site of our already Registered Imported Product Namely: Terlip (Terlipressin Acetate) Lyophilized Powder for injection 1mg [Reg.No. 066098.
M/s Hybio Terlip (manufacturer of Terlipressin Acetate) Lyophilized Powder for injection [Reg.No. 066098. 1mg from No.37, Keji C, Str. 2nd. Shenzhen Hi-tech industrial Park, China has planned to change the manufacturing site to 2nd Luhui Rd, Kengzi Jinsha community, Pingshan, district, Shenzhen, China. The Getz Pharma (Pvt.) Ltd, is to import bulk unlabelled vials of Terlip Lyophilized Powder for injection 1mg from China and will perform labeling & packing locally. Furthermore, The firm has to add locally registered & manufactured 2ml ampoule of “Sodium Chloride Solution 0.9% w/v” (Reg.# 067418) for reconstitution. The Board is requested to grant approval for change of manufacturing site of Terlip (Terlipressin Acetate) Lyophilized Powder for Injection 1mg. The detail of case as under:
S.No. Name of Name of Name of Existing Name New Name Documenta Importer Manufacturer Product of of ry Details Manufacturing Manufacturi site ng site / Fee status 1 M/s Getz M/s Hybio Terlip M/s Hybio M/s Hybio GMP Pharma Pharmaceutical (Terlipressin Pharmaceutical Pharmaceutic Certificate (Pvt) Ltd Co., Ltd. No.37, Acetate)) Co., Ltd. al Co., Ltd. No. 29-30/27, Keji C. Str.2nd . Lyphilized No.37, Keji C. 2nd Luhui Rd, CN2013057 Korangi Shenzhen Hi- Powder for Str.2nd. Kengzi 0 date of Industrial tech Industrial Injection 1mg Shenzhen Hi- Jinsha issuance 30- Area Park, China [Reg.No.066098] tech Industrial community, 12-2013 Karachi – Park, China Pingshan, valid until 74900, district, 29-12-2018 Pakistan Shenzhen, by the China China Food
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Fee deposited and Drug Rs.l100,000/- Adminstrati vide challan on. No. 0232377 dated 22-0- 2015
The firm has enclosed following documents as per the decision of 240th drug Registration board Meeting for change of manufacturing site:
Application on form 5A with required fee as per relevant SRO. Copy of registration letter and last renewal status. NOC for CRF clearance. Original legalized GMP certificate of new manufacturing site. Site master file of new manufacturing site. The case is submitted is before the Board
Decision: Registration Board deferred request of the firm for submission of valid legalized COPP.
Case No.x: Registration of Import Product Namely Medirin Heparin Sodium 5000IU/ml & 25000IU/ml M/s Medi Mark Pharmaceutical Lahore and Hepacin Injection 25000 iu/5ml, Bajwal Sons, Lahore
Two Companies, M/s Medi Mark Lahore and M/s Bajwasons, Lahore had applied for Heparin Injection 25000 IU/ML WHEREAS; M/s Medi Mark Lahore had also applied 5000IU/ml Heparin from the same manufacturer. The decision of 254th Registration Board meeting as follows:
Decision of RB: “M/s Medi Mark and Bajwa Sons both companies has same source Firms will be advised to provide latest Whole sale Agency Certificate from Manufacturer”.
2. The Medi Mark has provided copy of whole sale agreement with its Chinese manufacturer. The document is not on the company letter head nor has been notarized. The Medi Mark provided a copy of CoPP. Original legalized and notarized CoPP is required from the country of origin.
3. The case is being placed before the Board on the written direction of Director (Biological Division).
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S.No Company Name of Name of Product Date of Remarks Name Manufacturer / Composition application / Fee status
1. Medi Mark Furen MEDIRIN Date of Me too Pharma, Pharmaceutical INJECTION Application Lahore. Group Co., Ltd, 5000IU/ML 23-05-2013
Xuan Wu Fee deposited Economic Composition Rs.100000/- Developing - (Heparin Sodium area, Luyi Injection 5000 Balance fee Country, Henan IU/ml ) Nil China. Anti Coagulant 2. Medi Mark Furen MEDIRIN Date of Me too Pharma, Pharmaceutical INJECTION Application Lahore. Group Co., Ltd, 25000 IU/5ML 23-05-2013
Xuan Wu Fee deposited Economic Composition Rs.100000/- Developing - (Heparin Sodium area, Luyi 25000IU/5ml) Balance fee Country, Henan Nil China. Anti Coagulant 3. Bajwa Sons, Furen Hepacin Injection Date of Me too Lahore. Pharmaceutical 25000 iu/5ml Application Group Co. Ltd., Each 5ml contains:- 07.05.2012
Henan, China. Heparin Sodium Fee deposited eq to 15000+ Heparin...25000 i.u 35000+ (Anticoagulant). 50000
Balance fee Nil
Decision: Registration Board considered above applications of Medi Mark Pharma, Lahore and advised to provide legalized CoPPs and notorized sole agency agreement.
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Case No.xi: Extension of shelf life and approval of chronic Migraine an additional indication Barrett Hodgson Pakistan (Pvt) Ltd.
S.No. Name of Name of Name of Product / Date of application Documenta Importer Manufacturer Reg. No / Fee Status ry Details 1. Barrett Allergan BOTOX Fee Deposited CoPP No. Hodgson Pharmaceuticals (BOTULINUM Rs.1000/- dated C15/2778 Pakistan Castlebar Road TOXIN TYPE A) 24.6.2011 for dated (Pvt) Ltd Westport county VIAL. approval of chronic 01/12/2015 F/423, Mayo Ireland. Migraine Indication SITE, Each vial contains:- Botox Injection Prod Karachi- Clostridium License No. 75700 Botulinum Toxin PA type A…100Units. Fee Deposited 148/060/001 Rs.1000/- dated Date of Human 20.8.2011 for issuance 7th albumin…0.5mg change of shelf life January, of Botox. 2000. Sodium Chloride…0.9mg Required extension Documents
Product of shelf life for 03 are legalized Registration years and No.018959 notarized
Available in the country of origin.
Decision: Registration Board approved the request of post market variation of the firm the for increase in shelf life from two to three year and chronic migraine as additional indication based on the approval of MHRA.
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Item No.III: Cases referred by Medical Device Division.
Case No.01. Applications for registration of Medical Devices for import.
th th The Expert Committee on Medical Devices in its 14 meeting held on 16 December, 2015, considered the following applications for registration of medical devices for import and decided as mentioned against each for consideration of Registration Board:-
A) INFUSION SET:
S.No. Name of Importer and Name of Price & Pack Shelf Decision Manufacturer/Exporter. Medical size life Device 1. M/s. Excel Corporation, A-Star Decontrolled till 5 Rejected due 435 BYJ Society, Disposable policy decision years to poor Bahadurabad, Karachi. Infusion Set by the Policy physical Manufactured by Board/ Federal parameters like M/s. Changzhou Jinliyuan Government kinking of tube Medical Devices, Co., Ltd., part, loose No.6 West Xihe Road, roller clamp. Sanhekou, Zhenglu Town, (25 per box) Wujin District, Changzhou City, China.
B) STENTS
S.No Name of Importer/ Name of Price & Pack Shelf Decision Manufacture Medical Device size life 1. M/s. Promed International, BioMatrix Flex Decontrolled till 36 Approved. CB-6349, Amar Pak Plaza, TM Drug Eluting policy decision months Jhelum Road, Rawalpindi. Coronary Stent by Policy Board/ Federal System Government Legal Manufacturer M/s Biosensors Europe SA, (Biolimus A9) Rue De Lausanne 29 1110 1’s Morges, Switzerland.
Manufacturing Site Nominal Stent M/s Biosensors Interventional Inner Diameter Technologies Pte Ltd, 36 Jalan (mm): Tukang, Singapore 619266, 2.25, 2.5, 2.75, Singapore. 3.0, 3.5, 4.0.
Sterilization Sites: Stent Length BGS Beta-Gamma-Service (mm): GmbH & Co KG. Fritz-Kotz- (unexpanded) : Strasse 16, 51674 Wiehi, 8, 11,14, 18, 24, Germany. 28, 33, 36.
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Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Kalang, Selangor, Malaysia.
2. M/s Promed International, Biofreedom Decontrolled till 18 Approved. CB-6349,Amar Pak Plaza, J Drug Coated policy decision months 2helum Road, Rawalpindi. Coronary Stent by Policy Board/ System Federal Legal Manufacturer Government M/s Biosensor Europe SA,. (Biolimus A9) Rue de Lausanne 29, 1110 1’s Morges, Switzerland.
Manufacturing Site: Stent Length Biosensor Interventional (mm) Technologies Pte Ltd, 36 Jalan (unexpanded) Tukang, Singapore 619266. 8, 11, 14, 18, 24, 28, 33, 36. Sterilization Sites: BGS Beta-Gamma-Service Nominal Stent GmbH & Co KG. Fritz-Kotz- Inner Dia (mm) Strasse 16, 51674 Wiehi, 2.25, 2.5, 2.75, Germany. 3.00, 3.50, 4.00.
Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Kalang, Selangor, Malaysia.
3. M/s. Trans Angio System, Yukon Choice Decontrolled till 18 Approved. 507 Progressive Square, PC Sirolimus policy decision months P.E.C.H.S, Block-6, Shahra-e- Eluting Stent by Policy Board/ Federal Faisal, Karachi. System Government Manufactured by M/s. Translumina GmbH, Neue Rottenburger StraBe 50, 1’s 72379, Hechingen, Germany. Sterilization Site: Stent Length M/s Rose GmbH, (mm): Gottillstrasse 25-30, 54294 8, 12, 16, 18, 21, Trier, Germany. 24, 28, 32, 40.
Balloon Dia (mm) 2.00, 2.50, 2.75, 3.00, 3.50, 4.00.
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C) CANULAS
S.No Name of Importer/ Name of Price & Pack Shelf Decision Manufacturer Medical size life Device 1. M/s Hashir Surgical Services Venfic Safety Decontrolled till 5 Approved. (Pvt) Ltd, 1st Floor, House I.V Catheter policy decision years No.16, Street 1, Sector F-2, (Straight) by the Policy Phase-6, Hayatabad, Board/ Federal Peshawar. Government
Manufactured By: (50 per box) M/s Laboratories Macrimasa- Pharma S.A, CL Marie Curie, Sizes: 3; PC: 29590, Campanillas, 14G, 16G, 18G, Malaga, Spain. 20G, 22G, 24G.
2. M/s Hashir Surgical Services Venfic Safety Decontrolled till 5 Approved. (Pvt) Ltd, 1st Floor, House WP I.V policy decision years No.16, Street 1, Sector F-2, Catheter by the Policy Phase-6, Hayatabad, Peshawar (with Wings Board/ Federal and Injection Government Manufactured By: Port) M/s Laboratories Macrimasa- Pharma S.A, CL Marie Curie, (25 per box) 3; PC: 29590, Campanillas, Malaga, Spain. Sizes:
14G, 16G, 18G, 20G, 22G, 24G.
3. M/s Hashir Surgical Services Venfic WP Decontrolled till 5 Approved. (Pvt) Ltd, 1st Floor, House I.V Catheter policy decision years No.16, Street 1, Sector F-2, (With small by the Policy Phase-6, Hayatabad, Peshawar Wings) Board/ Federal Government Manufactured By: M/s Laboratories Macrimasa- (50 per box) Pharma S.A, CL Marie Curie, Sizes: 3; PC: 29590, Campanillas, 14G, 16G, 17G, Malaga, Spain. 18G, 20G, 22G,
24G, 26G.
4. M/s Hashir Surgical Services Venfic SW Decontrolled till 5 Approved. (Pvt) Ltd, 1st Floor, House I.V Catheter policy decision years No.16, Street 1, Sector F-2, (With wings by the Policy Phase-6, Hayatabad, Peshawar & injection Board/ Federal port) Government Manufactured By: M/s Laboratories Macrimasa- (50 per box)
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Pharma S.A, CL Marie Curie, Sizes: 3; PC: 29590, Campanillas, 12G, 13G, 14G, Malaga, Spain. 16G, 17G, 18G,
20G, 22G, 24G, 26G.
5. M/s Hashir Surgical Services Venfic I.V Decontrolled till 5 Approved. (Pvt) Ltd, 1st Floor, House Catheter policy decision years No.16, Street 1, Sector F-2, (Straight) by the Policy Phase-6, Hayatabad, Peshawar Board/ Federal Government Manufactured By: M/s Laboratories Macrimasa- (50 per box) Pharma S.A, CL Marie Curie, Sizes: 3; PC: 29590, Campanillas, 14G, 16G, 17G, Malaga, Spain. 18G, 20G, 22G, 24G, 26G.
D) CATHETERS.
S.No Name of Name of Price & Pack Shelf Decision Importer/Manufacture Medical Device size life 1. M/s Otsuka Pakistan Ltd, EasyLoop TM Decontrolled till 2 years Approved. 30-B, S.H.C.H.S, Karachi/ Electrophysio- policy decision Manufacturer: logical Circular by Policy M/s Shanghai MicroPort EP Mapping Board/ Federal MedTech Co. Ltd, Building Catheter Government No.28, 588 Tianxiong Road, Pudong New District, 1’s Shanghai, China. Model: EPQ7P012, EPQ7P015, EPQ7P020, EPQ7P025.
2. M/s Otsuka Pakistan Ltd, EasyFinder TM Decontrolled till 2 years Approved. 30-B, S.H.C.H.S, Karachi/ Electrophysio- policy decision Manufacturer: logical Fixed by Policy M/s Shanghai MicroPort EP Curve Board/ Federal MedTech Co. Ltd, Building Diagnostic Government No.28, 588 Tianxiong Road, Catheter Pudong New District, 1’s Shanghai, China. Model: EPD 6AB252, EPD6AB005, EPD6AB010, EPD6DB252,
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EPD6DB005, EPD6DB010, EPD6FB252, EPD6FB005, EPD6FB010, EPD5PC282, EPD6PC282, EPD6DC282, C0G004, C0G010.
3. M/s Otsuka Pakistan Ltd, FireMagic TM Decontrolled till 2 years Approved. 30-B, S.H.C.H.S, Karachi/ Electrophysiolo policy decision Manufacturer: gy Cardiac RF by Policy M/s Shanghai MicroPort EP Ablation Board/ Federal MedTech Co. Ltd, Building Catheter Government No.28, 588 Tianxiong Road, Pudong New District, 1’s Shanghai, China. Model: EPA7ATC, EPA7BTC, EPA7CTC, EPA7DTC, EPA7ETC, EPA7FTC, EPA8BTC, EPA8DTC, EPA8ETC, EPA8FTC, EPWB4, EPWST, EPWAK.
Case No.02. Misclellaneous cases.
A) Inspection of Manufacturer Abroad M/s Sumbow Medical Instruments Co. Ltd, China (Deferred in 253rd & 254th Meeting).
Registration Board in its 242nd meeting held on 24th& 25th February, 2014 considered and approved the following medical devices of M/s BNS Trading Est, Lahore subject to inspection of manufacturer abroad, verification of storage facilities etc as per policy:- S.# Name of Importer and Name of Medical Device Pack size Shelf Manufacturer/Exporter Life (i) M/s BNS Trading Est, Safe 1 Brand IV Cannula 1’s 3 years 244-Allama Iqbal Road, (Pen Type) Mustafabad, Lahore. Manufactured by (14G, 16G, 18G, 20G, M/s Sumbow Medical Instruments 22G, 24G)
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Co. Ltd, 16F Chengtou Building, No.68 Heji Street, Jiangdong District, China.
(ii) -do- 3S Safe Infusion Set 1’s 3 years
Dr. Sheikh Akhtar Hussain, Deputy Director General, DRAP, Lahore and Mr. Khalid Mahmood, the then DDC (QC), DRAP, Islamabad were nominated for inspection of aforesaid manufacturer. The panel conducted inspection on 25th & 26th May, 2015 and submitted the report.
The applicant firm submitted the documents in registration application dossier including Form 5-A, ISO 13485 certificate, EC certificate (Production Quality Assurance), Credential of manufacturer abroad, Free Sale Certificate issued by SFDA, China and letter of authorization claiming M/s Sumbow Medical Instruments Co., Ltd, 16F Chengtou Building, No.68 Heji Street, Jiangdong District, China as the manufacturer of the applied products. The inspection letter was also issued with aforesaid manufacturer’s name and address but in the inspection report manufacturer name was not clear and site address was also different. The name and address of manufacturer in the inspection report was mentioned as M/s Sumbow Medical Instruments Co. Ltd, Jiangsu Webest Medical Product Co. Ltd, No.5, Yingchun Road, Industrial Park, Xuyi, Jiangsu, China. In the inspection report the address “16F Chengtou Building, No.68 Heji Street, Jiangdong” is shown as postal address. Furthermore, all the documents attached with the inspection report including copy of Free Sale Certificate, copies of bill of lading, stability study data and other documents written in Chinese language have been stamped by M/s Jiangsu Webest Medical Product Co. Ltd. The panel recommended the above products for registration.
In this regard both panel members were requested to clarify regarding status of manufacturer. Both the members of panel have submitted as under:- Mr. Khalid Mahmood, FID-II, DRAP, Islamabad. “You have desired to clarify that in the inspection report manufacturers name is not clear and site address is also different for M/s Sumbow Medical Instruments Co., Limited, China. I have already clarified that there are number of firms working in the China in the name and style of Sumbow Medical Instruments, China and the one we have visited for inspection was Sumbow Medical Instruments. It was further clarified that the Division of Medical Devices and Medicated Cosmetics need to go by the book. The firm which we have inspected submitted the report accordingly (The report is submitted by Dr. Sheikh Akhter Hussain from Lahore). Further it is necessary to clarify that the credentials already submitted by M/s Sumbow Medical
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Instruments Company Limited, China through its importer M/s B.N.S Trading Est, Lahore needs to be matched and if some anomalies are found then the case may be decided as per prevailing law/SOPs etc. It is further clarified that the report is submitted in accordance with the tour arranged by the importers of Pakistan from China and the panel is not conversant with the geographical limits of provinces in China. The panel submitted the reports in accordance with the facilities visited and provided with the names of their sites/cities/provinces in China and no facts have been concealed in writing the reports that is why you may be experiencing in variation of documents/information submitted by M/s B.N.S. Trading Est, Lahore. It is therefore again requested that the report is submitted in accordance with the Manufacturer got visited by the importer to us. The copies of pictures of the plant addresses, disposable packs are attached for your further necessary action as per law. Any further clarification may be solicited if desired so and the firm M/s B.N.S.Trading Est, Lahore may also be intimated as may be the exporter name is M/s Sumbow Medical Instruments Limited, China.”
Dr. Sheikh Akhter Hussain, DDG, DRAP, Lahore. “It is to inform you that name and address of the manufacturer has been misinterpreted by considering two different names as one, as “M/s Sumbow Medical Instrument Co., Limited, Jiangsu Webest Medical Product Co., Ltd, No.5, Yingchum Road, Industrial Park, Xuyi, Jiangsu, China”. The factual position with regard to name and addresses of these two concerns is clarified that M/s Jingsu Webest Medical Product Co., Ltd., No.5, Yingchum Road, Industrial Park, Xuyi, Jiangsu, China is the manufacturer and M/s Sumbow Medical Instruments Co., Ltd., is a sister concern, hence referred to documents, attached with the inspection report, have been stamped by the manufacturer. A copy of the certificate, dated 11- 03-2014, signed by the manufacturer as well as sister concern thereof, which is self- explanatory with respect to status of both the said concerns, is attached herewith for further clarification in this regard. It would not be out of place to mention here that the inspection report submitted by the nominated panel is based on facts observed by it during the inspection/visit.”
Furthermore, the certificate by the manufacturer and exporter attached with the clarification, is reproduced as under:-
“It is certified that M/s Sumbow Medical Instruments Co., Add:16F, Chengtou Building, No.68 Heji Street, Jiangdong District, Ningbo 315041 China is a sister concern of M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China. All the goods supplied, distributed and exported are manufactured by M/s Jiangsu Webest Medical Products Co., Ltd, Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China. Registered office of M/s Sumbow Medical Instruments Co is 16F, Chengtou Building No.68 Heji Street, Jiangdong District, Ningbo 315041 China and manufacturing site with the name of M/s Jiangsu Webest Medical Products Co., Ltd located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China. The products manufactured by M/s Jiangsu Webest Medical Products Co., Ltd, located at Yingchun Rd, Industrial Park, Xuyi, Jiangsu, China are exported to Pakistan through the sole rights of M/s Sumbow Medical Instruments Co., is 16F, Chengtou Building No.68 Heji Street, Jiangdong District, Ningbo 315041 China.”
The case was placed before the Registration Board in its 254th meting but the Board decided to discuss the matter in the next meeting. Minutes 256th Meeting Registration Board 66
Decision: Registration Board discussed in detail the applications for registration of below mentioned products and inspection report of foreign manufacturer M/s Jingsu Webest Medical Product Co., Ltd., No.5, Yingchum Road, Industrial Park, Xuyi, Jiangsu, China alongwith certificate from manufacturer and exporter. The Board decided to reject the applications for registration due to following reasons:-
Name of Drugs/ Reasons of Rejection Medical Devices 1. Safe 1 Brand The applicant firm submitted the documents in registration IV Cannula application dossiers including Form 5-A, ISO 13485 (Pen Type) certificate, EC certificate (Production Quality Assurance),
(14G, 16G, Credentials of manufacturer abroad, Free Sale Certificate 18G, 20G, issued by SFDA, China, letter of authorization and other 22G, 24G) documents claiming M/s Sumbow Medical Instruments Co., Ltd, 16F Chengtou Building, No.68 Heji Street, Jiangdong 2. 3S Safe District, China as the manufacturer of the applied products Infusion Set while the inspection team and certificate from manufacturer and exporter revealed that M/s Sumbow Medical Instruments Co., Ltd, 16F Chengtou Building, No.68 Heji Street, Jiangdong District, China is not the manufacturer of the products and is only distributor and exporter and infact the manufacturer of the product is M/s Jingsu Webest Medical Product Co., Ltd., No.5, Yingchum Road, Industrial Park, Xuyi, Jiangsu, China which was not mentioned in registration application dossiers. As the applicant has concealed the facts and the inspection report does not reveal the availability of required manufacturer mentioned in the applied dossiers, therefore, Registration Board decided to reject both applications.
B) Request for Permission of Printing Registration Number, Manufacturing date, Expiry date, MRP and Urdu version
M/s Universal Enterprises, Karachi requested for permission of printing Registration Number, manufacturing date, expiry date, MRP and Urdu version from Mission Pharmaceutical, Karachi (Manufacturing Licence No. 000809) on their already registered following imported medical devices i.e.Terumo Syringes manufactured by Terumo (Phillipines) Corporation, Laguna, Phillipines:-
S.No. Regn. No. Name of Medical Device (s) 1. 062230 Terumo 3cc Syringe 2. 062231 Terumo 5cc Syringe 3. 062232 Terumo 10cc Syringe 4. 062233 Terumo 20cc Syringe 5. 062234 Terumo 30cc Syringe Minutes 256th Meeting Registration Board 67
The firm has informed that the manufacturer has been producing the syringes in bulk quantities and huge batches, according to their cyclical system. For small quantities like ours, they have to make special arrangements for breaking the cycle, which is not only time consuming but also capital intensive issue. They are coping with us on their very special request with the interval of 3-4 months. The manufacturer has informed the importing firm that this arrangement will not be available in the coming months because of this special arrangements, they have to break the cycle for printing purposes just for a small quantities, creating hurdles for them resulting delay of the other orders in bulk quantities and as a result incurred financial losses which is not acceptable for them. In this regard, finally the principal manufacturer has given them a deadline of December, 2015 to have some alternate arrangements for printing otherwise they are unable to continue their supplies. Firm has further informed that they have made agreement with Mission Pharmaceutical, Karachi wherein Mission Pharmaceutical is agreed to provide service of aforesaid printing matter on their imported syringes. The firm Universal Enterprises has also submitted that they will follow all the rules and regulations of DRAP including labeling rules before marketing of Terumo Syringes. The firm has submitted the following documents:-
(i) Fee challan of Rs.5000/- for each product. (ii) Number of consignment imported from the time of registration uptil now and quantity of each size imported. (iii) Samples of Syringes. (iv) Copy of Drug Sale License. (v) Copy of manufacturing license of Mission Pharmaceutical Pvt. Ltd, Karachi. (vi) MoU between Universal Enterprises and M/s Mission Pharmaceutical, Karachi.
The case was placed before the Registration Board in its 254th meting but the Board decided to discuss the matter in the next meeting. Decision: Registration Board after detailed discussion and in light of rule 3 of the Drugs (Labeling and Packing) Rules, 1986 granted relaxation to M/s Universal Enterprises, Karachi for their above mentioned registered medical devices to print Urdu version only through laser jet printing at licensed premises of M/s Mission Pharmaceutical, Karachi (Manufacturing Licence No. 000809) after import and before sale of the products for a period of one year. All other provisions of labeling and packing under the Drugs (Labeling and Packing) Rules, 1986 shall be strictly complied with.
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C) Change of Importer’s Address.
M/s Tech Zone, Lahore has informed that they have shifted their office/warehouse as follows:-
Previous Address New address M/s Tech Zone, M/s Tech Zone, 764, Street 24, Zarar Shaheed Road, Askari- Ground floor, Weal House, 8-Faiz Road, Old IX, Lahore Cantt. Muslim Town, Lahore.
Warehouse: 1102, Q-Block, Johar Town, Lahore.
The firm has submitted the following documents:-
(i) Fee challan of Rs.5000/-. (ii) New Drug Sale License with new address dated 22-10-2015. (iii) Copy of previous Drug Sale License. (iv) Copy of registration certificate.
Decision: Registration Board approved the new address of M/s Tech Zone, Ground floor, Weal House, 8-Faiz Road, Old Muslim Town, Lahore for already registered products subject to verification of local storage facility.
D) Approval of pack size of already approved medical devices.
The Registration Board in its 236th meeting held on 20th November, 2012 considered and approved the following medical devices of M/s K.M Enterprises, Lahore subject to inspection of manufacturer abroad, verification of storage facilities, price fixation/calculation etc as per policy and recommendations of Expert Committee on Medical Devices:-
S.# Name of Importer and Name of Medical Demanded Shelf Manufacturer/Exporter Device price & Pack Life size 1. M/s K.M. Enterprises, AMD I.V.Cannula Decontrolled 05 years 9-F/B, Sharaf Mansion, Ganga with Wings and Ram Hospital Chowk, 16- Injection Port. (18G, 20G, Fatima Jinnah Road, Lahore. 22G, 24G). Manufactured by M/s Changzhou Medical Appliances General Factory Co. Ltd, Hengshanqiao Town, Changzhou, Jiangsu, China.
2. -do- AMD I.V. Burette Decontrolled 05 years Infusion Set with needle. Minutes 256th Meeting Registration Board 69
2. Accordingly the inspection of manufacturer abroad has been carried out by the panel comprising Dr. Sheikh Akhtar Hussain, Deputy Director General, DRAP, Lahore and Mr. Khalid Mahmood, Ex-DDC (QC), DRAP, Islamabad on 20th – 22nd May, 2015. The panel recommended the above products for registration. The local storage facility has been recommended by the area FID. The products were also recommended by Expert Committee on Medical Devices in its 2nd meeting held on 24th January, 2013.
Registration certificates of above mentioned products could not be issued as pack size of above mentioned products were inadvertently missed in the agenda and minutes of the meeting of Registration Board whereas pack size of (1x100s) of AMD I.V.Cannula with Wings and Injection Port and (1x50s) of AMD I.V. Burette Infusion Set with needle were mentioned in Form 5-A.
Decision: Registration Board approved the following pack sizes of already approved medical devices in 236th meeting as mentioned against each:-
S.# Name of Importer and Name of Medical Price & Pack size Shelf Manufacturer Device Life 1. M/s K.M. Enterprises, AMD I.V.Cannula Decontrolled till policy 05 9-F/B, Sharaf Mansion, Ganga (with Wings and decision by Policy Board/ years Ram Hospital Chowk, 16-Fatima Injection Port) Federal Government Jinnah Road, Lahore. Manufactured by (1x100s) M/s Changzhou Medical Appliances General Factory Co. (18G, 20G, 22G, 24G) Ltd, Hengshanqiao Town, Changzhou, Jiangsu, China.
2. -do- AMD I.V. Burette Decontrolled till policy 05 Infusion Set decision by Policy Board/ years (with needle) Federal Government
(1x50s)
E) Inclusion of Sterilization Site in already approved medical device.
The Registration Board in its 246th meeting held on 10th and 11th December, 2014 considered and approved the following medical devices of M/s A. Feroz & Co., Karachi subject to inspection of manufacturer abroad, verification of storage facility etc as per policy:-
Minutes 256th Meeting Registration Board 70
S.No Name of Importer and Name of Medical Price Pack Shelf Manufacturer/Exporter Device size life 1. M/s. A. Feroz & Co., Star IV. Catheter Decontrolled (14G, 5 Medicine Street No.1, with Injection till policy 16G, years Marriot Road, Karachi Port. decision by the 18G, Manufactured by Policy Board/ 20G, M/s. Engineering Federal Govt. 22G, Technical Plastic 24G) Industries (Enteplin- Egypt) 10th of Ramadan 100 per City, Industrial Zone, A- box 1 Part 41/3. Sharqia, Egypt.
Inspection of the manufacturer abroad is yet to be carried out. In the meanwhile, the importer has submitted that their Principal manufacturer has informed that the sterilization process is being outsourced to M/s EG Med (S.A.E) having their plant at Part 100-Industrial Zone, B-3, , 10th of Ramadan City, Egypt. They have enclosed a copy of medical device License of M/s EG Med and performance qualification report conducted by Egyptian Engineering Systems.
It is submitted that the importing firm had not mentioned sterilization site in the application Form 5-A. Now they have requested to include the aforementioned sterilization site of above mentioned product.
Decision: Registration Board discussed the case and deferred for provision of any document showing approval of regulatory body of Egypt regarding outsourcing of sterilization process to M/s EG Med (S.A.E) Part 100-Industrial Zone, B-3, 10th of Ramadan City, Egypt.
F) Local storage facility of M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi.
Registration Board in its 253rd meeting held on 5th & 6th October, 2015 approved the new address of M/s Johnson & Johnson Pakistan (Pvt) Ltd i.e. Fl-19, Sub-Plot F-1, Kehkashan Scheme No.5 Main Boat Basin, Clifton, Karachi-75600 subject to verification of local storage facility.
Now M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has informed that under the revised Business Model in Pakistan, they have appointed M/s Pak Punjab Cardex Medical System situated as 257-K-Block, DHA, Lahore Cantt holding License No.21-
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A/Cantt/11/2015 as Authorized Distributor who is responsible for import, store, sale and exhibit for sale. This process is fully in accordance with Drug Import Rule 3 by issuance of NOC/Indent to the designated distributor.
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has also submitted following documents:- i) Copy of Drug Sale License of M/s Pak Punjab Cardex Medical System Lahore Cantt.
ii) NOC for import authorization in respect of M/s Pak Punjab Cardex Medical System, Lahore Cantt
M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested that the local storage condition of their designated warehouse (M/s Pak Punjab Cardex Medical System situated at 257-K-Block, DHA, Lahore Cantt) may kindly be verified.
Decision: Registration Board allowed to verify the local storage conditions of M/s Pak Punjab Cardex Medical System, 257-K-Block, DHA, Lahore Cantt with the direction to bring the case alongwith the inspection report in the next meeting of Registration Board.
Minutes 256th Meeting Registration Board 72
Item No.IV: Cases referred by Pharmaceutical Evaluation & Registration Division
Case No.01: Grant of registration for export purpose.
Registration Board discussed cases for grant of registration for export purpose in various meetings, as per following detail: 240th meeting held on 07th November, 2013 approved standard operating procedure for various processes including grant of registration for export purpose, which is as follows: a. Application on Form 5 with required fee as per relevant SRO. b. NOC for CRF clearance. c. Copy of approved section from CLB. d. Copy of last inspection report. e. An undertaking that applied registration is exclusively for export purpose and will not be sold in Pakistan. f. If formulation / product is not registered in Pakistan, then export order from importing country.
241st meeting held on 23-12-2013 discussed grant of registration of export purpose and decided as follows:
a. If formulation is already registered in Pakistan, then Board authorized its Chairman to dispose off the application. b. If formulation is not registered in Pakistan, but has been approved by USFDA, EMA, Australian TGA, regulatory body of Japan or western Europe as drug, then Registration Board will decide the application keeping in view status of the product in aforementioned countries / regulatory authorities. c. If formulation does not fall in above two categories, then applicant will be asked to provide import order from the importing country duly approved by the regulatory authority of importing country. Case will be then presented before Registation Board for decision.
246st meeting held on 10-11th December, 2014 discussed grant of registration of export purpose, as follows:
Mr.A Q Javed Iqbal, Director QA < opined that for export purpose only those formulations should be registered, which are already registered in Pakistan. For new fornulations (which are not registered in Pakistan), manufacturers should first conduct
Minutes 256th Meeting Registration Board 73 stability studies and then registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it. Registration Board after deliberation decided that inorder to facilitate export of quality drugs (non-me too drugs), export registration will be granted and manufacturer will comply following conditions before export of drug:
Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No objection certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignemnet for analysis from CDL, Karachi. Manufacturer will also furnish export documents endorsed from custom authorities in order to ensure the export of the product.
Registration Board authorized its Chairman for grant of registration for export purpose on contract manufacturing basis excluding controlled drugs and new drug as per contract manufacturing policy.
254th meeting held on 11-12th November, 2015 discussed grant of registration of export purpose and deliberated that formulations which are approved by reference regulatory authorities will be considered for grant of export registrations. Other formulations (not approved by reference regulatory authorities) will be deferred for detailed deliberations in forthcoming meeting.
Decision: Registration Board deliberated on the matter in detail. Chairman shared that DRAP is doing utmost efforts to facilitate pharmaceutical exports keeping in view safety, efficacy and quality of drugs. The Board again advised PPMA and Pharma Bureau to submit proposal in this regard at the earliest for consideration of Registration Board.
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Miscellaneous cases Registration-I
Case No.02. Change in Company name from M/s. Bayer Schering Pharma AG to M/S.Bayer Pharma AG.
M/s. Medipharm (Private) Limited, Lahore have informed that due to Bayer Group- wide initiative to change the name of the pharmaceutical company, they have requested to approved the change of the manufacturer name of their following registered imported drug.
Reg. No. Name of Drug. Current Name of Proposed Name of Manufacturing Site. Manufacturing Site / Source of Import 012367 Progyluton M/s. Bayer Schering Manufactured by: Tablets. Pharma AG, Germany. M/s. Bayer Weimar GmbH und Co. KG, Weimar, Germany. Source of Import: M/s. Bayer Pharma AG, 13342 Berlin, Germany.
M/s. Medipharm (Private) Limited, Lahore have deposited fee Rs.100000/- and supporting documents including ,Notarized Declaration from their Principal regarding the Name Change from Bayer Schering Pharma AG to Bayer Pharma AG, Original legalized CoPP Progyluton Tablets etc.
In the registration letter the manufacturer/ source of import was mentioned as M/s. Bayer Schering Pharma AG, Germany, while the firm claimed that the manufacturer even at that time was the same i-e M/s. Bayer Weimar GmbH und Co. KG, Weimar, Germany.
M/s. Medipharm (Private) Limited, Lahore was advised to clarify the following:-
i) As per CoPP the product is neither has valid license to be placed on market nor freely available in the country of origin as its “Re-registration was not granted, being manufactured by the exporting country which need clarification. ii) Brand name is different on CoPP as registered in Pakistan.
In response, M/s. Medipharm (Private) Limited, Lahore has submitted the following clarification:- Product is already approved by competent authorities and available in Switzerland (Approval submitted with letter No. BHC-DRAP-14-075). They have already submitted Notarized Declaration which state that product has never withdrawn not due to safety of efficacy reason in Germany.
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They have provided CPP from Germany where this product is manufactured and GMP inspections are conducted. The current request from authorities is only for Name Change the manufacturing site is same as registered with the authorities.
The Drug Registration Board in its 245th meeting held on 29-30th September, 2014 deferred the case due to non-availability in the country of origin i.e. Germany.
Now the firm has again requested to consider their case for change of manufacturer site/ source of import as the DRB in its 249th meeting recommended that products approved by USFDA, Health Canada, EMA, TGA Australia and PMDA Japan along with the regulatory authorities of United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway or drugs registered in at least three European Union countries will also be taken as reference for consideration of Registration Board for approval.
The firm claimed that the product is available in Switzerland and provided CoPP from Swiss Medic, Switzerland. The case was deferred by the Registration Board in its 252nd meeting for further deliberations regarding products which are available in reference countries but do not have free sale status in country of origin. The case could not be considered in the 253rd the Board due to paucity of time.
The Board discussed in detail the existing policy/practice for considering cases of drugs which are not for free sale in their country of origin but are available in other reference countries. It was noted that in case if the drug is approved for free sale by USFDA, TGA Australia, Pharmaceutical & Medical Devices Agency, Japan or having WHO prequalification status can be considered for registration even if not available for free sale in country of origin subject to fulfillment of other prescribed conditions. The case was considered in 254th meeting of the Registration Board and the Board decided to defer the case to provide opportunity to the firm for submitting registration status, if any, in SRA countries/WHO Prequalification.
Decision:- Since the drugs is registered for free sale in Switzerland from the same source / manufacturing site, which is one of the reference country approved by the Registration Board, so the Board approved the change of name of manufacturing site of Progyluton Tablets (Regn. No. 012367) from M/s. Bayer Schering Pharma AG, Germany to M/s. Bayer Pharma AG, Germany on same terms and conditions. The Board further approved the source of import as M/s. Bayer Pharma AG, 13342 Berlin, Germany as requested by the firm.
Minutes 256th Meeting Registration Board 76
Case No.03. Registration of Drugs under the Drugs Act, 1976-M/s. Nawan Laboratories Request for Correction of Formulation.
The Registration Board in its 236th meeting held on 20th November, 2012 approved the registration of following veterinary drugs of M/s. Nawan Laboratories (Pvt.) Ltd; Karachi for local manufacturing as mentioned in column-I. The firm later requested to correct the formulation as per composition mentioned in column-II, as incorrect composition was inadvertently mentioned while typing the agenda and minutes of the Registration Board:- S. I II No. Name of Drug(s)/Composition Name of Drug(s)/Composition approved by Registration Board. applied by the firm/correct. 1. Colibac-SP 160 Powder Colibac-SP 160 Powder Each Kg powder contains:- Each Kg powder contains:- Penicillin Procaine.B.P…….....1.6 Kg Procaine Penicillin B.P…………16gm. Streptomycin Sulphtae B.P…...4.0 Kg Streptomycin Sulphtae B.P……..40gm. Zinc Bacitracin 10% BP Vet..10.0 Kg Zinc Bacitracin 10% B.P. Vet…100gm. Colistin Sulphate.BP………….0.4Kg Colistin Sulphate.B.P………….80MIU
2. PSB-Excel Powder. PSB-Excel Powder. Each Kg powder contains:- Each kg powder contains:- Pencillin Procaine BP………..12.0Kg Procaine Penicillin B.P…….....12gm. Streptomycin Sulphate BP…...36.0Kg Streptomycin Sulphate B.P……36gm. Zinc Bacitracin10% BP……...52.0Kg Zinc Bacitracin 10% B.P Vet…52gm. Neomycin Sulphate BP………10.0Kg Neomycin Sulphate B.P………10gm.
Licensing Directorate was requested to give opinion that the products containing Penicillin derivative along-with other veterinary API as mentioned above, can be manufactured in human section or otherwise. In reply Licensing Division has communicated that sub section 5.2 of Schedule-B of Drug (Licensing, Registering & Advertising) Rules, 1976 which, inter alia, specify that Veterinary products containing ingredients similar to those used for human health and of the same quality, can be manufactured in the same premises used for manufacture of pharmaceuticals. The firm has provided copy of inspection report dated 26-02-2011, wherein the panel has verified that the firm possesses the facilities for manufacturing penicillin Non-Sterile Dry Powder Syrup for human preparations. However, the issue that whether the formulation containing non penicillin antibiotics / antibacterial i.e Streptomycin Sulphate, Zinc Bacitracin, Colistin Sulphate etc in combination with penicillin products can be permitted in human Penicillin Dry Powder/ Syrup section, is yet to be clarified. The case was considered
Minutes 256th Meeting Registration Board 77 in 254th meeting the Registration Board and the Board decided to defer the case for detail deliberation in the next meeting. Subsequently M/s. Nawan Laboratories (Pvt.) Ltd; Karachi vide a letter has requested to defer the case so that they will be able to submit the approval of veterinary penicillin area/section from Licensing Directorate. Decision:- Registration Board discussed the issue in detail and observed that in the light of above quoted rule, the veterinary products having ingredients, alone or combination, requiring dedicated area can be manufactured in dedicated areas for similar human products provided that ingredients have contamination hazard and / or different intended use. However, case will be taken again in forthcoming meeting for more clarity. The case of M/s. Nawan laboratories (Pvt) Ltd., Karachi was deferred on request of the firm
Case No.04 Change of Manufacture from M/s. DSM Pharmaceuticals Inc., Greenville, North Carolina, 27834, USA to M/s. Patheon Manufacturing Services LLC, Greenville, North Carolina, 27834, USA.
M/s. Atco Laboratories Limited, Karachi has requested to approve the change of manufacturer name of their registered product “Aggrastat Injection (Reg. No.025299) (Tirofiban HCl equivalent to 0.25mg Tirofiban)” from M/s. DSM Pharmaceuticals Inc., Greenville, North Carolina, 27834, USA to M/s. Patheon Manufacturing Services LLC, Greenville, North Carolina, 27834, USA. The firm further submitted that their is only change of name of manufacturing site and the physical location of premises used to manufacture the product remains the same, therefore, there is no change in manufacturing and primary packaging site.
M/s. Atco Laboratories Limited, Karachi have deposited the fee Rs.100,000/- and submitted following supporting documents:-
i) Copy of registration letter. ii) Copy of change of manufacturing site. iii) Copy of transfer of registration letter. iv) Copy of last renewal status. v) Copy of CRF Clearance Certificate. vi) Original CPP Legalized by Embassy of Pakistan. vii) Copy of GMP Certificate. viii) Certification of Manufacturing Site Name Letter. ix) Certification of Establishment Registration. x) Screenshot of the FDA website showing that the site is registered as Patheon Manufacturing Services LLC.
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As per CPP issued by USFDA, the product is “Not Approved for free sale in country of origin. Therefore, M/s. Atco Laboratories Limited, Karachi was advised to explain the position.
In response, M/s. Atco Laboratories Limited, Karachi has submitted as under:- i) The subject product is approved and registered in USA, approval of US-FDA and updated list of US-FDA products. ii) M/s. Correvio is supplying branch for Pakistan who does not have the marketing rights for USA. In USA marketing rights are with M/s. Medicure. Since M/s. Correvio has no marketing rights for USA, therefore, US-FDA issued the CPP to M/s. Correvio mentioning it as un-approved with the comments that M/s. Correvio can only export the product (because they cannot market the product in USA). iii) It is clearly mentioned on CPP that US-FDA conducts periodic inspection of the manufacturing facility.
The claim of the firm about registration of the product with USFDA is not correct as the approved produt is “Aggrastat (12.5mg / 250ml) (i.e. 0.05mg/ml) and belongs to M/s. Medicure and not the property of M/s. Correvio. The product of the firm registered with DRAP under registration No. 025299 is “Tirofiban HCl (0.25mg/ml) and pack size is 50ml but the US product is of 250ml. Although the US Certificate verify GMP compliance but the product registered in the name of M/s. Atco Laboratories Limited, Karachi is not registered / approved by US FDA as per CoPP submitted.
Later on the firm informed that the product is approved under the US register under NDA#020912 and is discontinued in USA and belongs to M/s. Medicure and not the property of M/s. Correvio.
Registration Board in its 248th meeting held on 18th & 19th March, 2015 considered and deferred the request of the firm for decision on cases in which finished drug is not available in country of origin. The Chairman again advised PPMA, Pharma Bureau and PCDA to forward their comments to the committee (Prof. Muzammil Najmi and Mr. A.Q. Javed Iqbal) constituted for framing recommendations for this purpose.
With reference to the above said decision of the Board M/s. Atco Laboratories Limited, Karachi stated that this condition is not applicable on their case. Aggrastat is available and being marketed in the country of origin. The only difference in product marketed in country of origin & product imported in Pakistan is only of pack size. The pack which is marketed in Pakistan is registered by FDA having local marketing discontinued but
Minutes 256th Meeting Registration Board 79 allowed for legal export. In support of their justification they enclosed the screenshots of the FDA website showing that the product Aggrastat NDA 020912 is approved in USA.
The firm has now submitted Certificate of Pharmaceutical Products (CoPP) issued by MHRA, UK and TGA Australia legalized and attested by the concerned Pakistan Embassy as evidence of its free sale in UK & Australia from the same source. There is no change in already approved packaging site i.e. M/s. Orion Corporation, Finland.
Decision:- Since the drugs is registered for free sale in TGA Australia and MHRA UK from the same source, which are reference countries approved by the Registration Board, so the Board approved the Change of Manufacturer of their registered drug Aggrastat Injection (Reg. No.025299 ) from M/s. DSM Pharmaceuticals Inc., Greenville, North Carolina, 27834, USA to M/s. Patheon Manufacturing Services LLC, Greenville, North Carolina, 27834, USA on same terms and conditions.
Case No.05 Import of veterinary drugs by M/s. Zoic International, Lahore.
Dr. Muhammad Aslam Niazi of Lahore vide a complaint alleged that M/s. Zoic International, Lahore has got registration of number of veterinary/poultry medicines of M/s. Tithebarn Limited UK illegally by submitting fake and forged documents. The complainant further alleged that M/s. Tithebarn Limited UK is not a manufacturer of medicines. As per record, following drugs of M/s. Tithebarn Limited UK were registered for import by M/s. Zoic International, Lahore:- S. No. Reg. No. Name of Drug (s). 1. 021297 Cocostop 20% Water Soluble Powder. 2. 021298 Quincure 20% Liquid. 3. 021299 Quintril 20% Liquid. 4. 021300 Quintril 10% Liquid. 5. 021301 Grow More Water Soluble Powder. 6. 023422 Premix PL300 Powder. 7. 049580 Tithedox Water Soluble Powder. 8. 049581 Tithemox Injection. 9. 049582 Tithemox Water Soluble Powder. 10. 049583 Enrobarn Water Soluble Liquid. 11. 057176 Tithemycin Water Soluble Powder. 12. 057177 Tithechlore 20% Water Soluble Powder.
M/s. Zoic International, Lahore was given a show cause notice to clarify their position with regard to the complaint. The firm, in response, denied the allegations stating that their
Minutes 256th Meeting Registration Board 80 principle M/s. Tithebarn Limited UK abroad is a manufacturer. M/s. Zoic International, Lahore was again directed to submit fresh original latest approval letter for the products (CoPP) / Defra I&II issued by Regulatory Authority of United Kingdom, within 7days, failing which it will be presumed that they have nothing to offer in their defence and an ex- party decision will be took against them.
In response M/s. Zoic International, Lahore vide letter dated 15-06-2015 informed that in order to submit fresh documents from concern / issuing department i.e VMD UK (Veterinary Medicine Directorate) they may require 42 to 56 days. The firm has further given undertaking that they will immediately stop any further import of these products until the matter is resolved.
In accordance with decision taken by the Board in its 252nd meeting, representative of M/s. Zoic International, Lahore was called for personal hearing in 253rd meeting of the Board. Mr. S.M Wasim Khan, Chief Executive, M/s. Zoic International, Lahore and Mr. Salman Tauqeer, Advocate, appeared on behalf of firm and claimed that the name and address of the complainant is fake, therefore, the complaint is not valid .They were of the view that no action can be initiated on the complaint due to aforementioned reasons. The representatives further informed that they have not imported any of the above drugs since the issue has been raised and requested for another 45 days time for submission of legalized and attested CoPP from abroad. In view of the above position, the Board decided to allow 45 days time for submission of the properly legalized CoPP for the products in question. In the meantime the firm will not import any of the above products until the matter is resolved/ clarified.
In the meantime a letter, purported to be written by Dr. Muhammad Aslam Niazi, the complainant in this case, is received, wherein, he has withdrawn the complaint stating that his complaint was based on jealousy and disinformation.
The for submission of original legalized documents regarding their registered products manufactured by M/s. Tithebarn, has already been expired and firm is requesting more time for this purpose. After expiry of 45 days time, given by the Board to M/s. Zoic International, Lahore, the firm requested for more time. The Registration Board in its 255th meeting defered the case for giving the firm final opportunity for submission of original legalized documents (CoPP, Certificate etc) regarding their registered products. in the meantime the firm was not allowed to import the drugs in question as per its own undertaking.
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M/s. Zoic International, Lahore vide a letter has requested to allow to import following drugs, for which they claim to have submitted/enclosed original documents issued by V.M.D UK.
S. No. Reg. No. Name of Drug (s). 1. 021297 Cocostop 20% Water Soluble Powder 2. 021301 Grow More Water Soluble Powder 3. 023422 Premix PL300 Powder 4. 049580 Tithedox Water Soluble Powder 5. 049583 Enrobarn Water Soluble Liquid 6. 057177 Tithechlore 20% Water Soluble Powder
As per original documents provided by the firm the following position emerges.
(i) As per certificate issued by Veterinary Medicines Directorate UK M/s. Tithebarn Limited UK is in establishment for m manufacturing feeding stuffs. (ii) Payment Agency UK Veterinary Medicines Directorate UK certified that products" Grow More Water Soluble Powder" and "Premix PL300 Powder" are animal feed stuff and may be permitted in UK for sale. (iii) For other remaining above mentioned products, the export certificates endorsed by Veterinary Medicines Directorate, the manufacturer is M/s. Provimi Ltd. Staffordshire, UK and these products do not hold marketing authorization in UK.
For other products the process for issuance of required documents will take some time. Submitted for consideration of Registration Board.
Decision:- In view of the position explained above the Board decided as under:-
(i) The import of drugs Grow More Water Soluble Powder (Regn. No. 021301) & Premix PL300 Powder (Regn. No. 023422) is allowed. (ii) Registration of the following products manufactured by M/s. Tithebarn Limited UK is suspended for three months, as in the export certificates endorsed by Veterinary Medicines Directorate, the manufacturer of these products is M/s. Provimi Ltd. Staffordshire, UK, as against the claimed M/s. Tithebarn Limited UK, and these products do not hold marketing authorization in UK:-
S. No. Reg. No. Name of Drug (s). 1. 021297 Cocostop 20% Water Soluble Powder. 2. 021298 Quincure 20% Liquid.
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3. 021299 Quintril 20% Liquid. 4. 021300 Quintril 10% Liquid. 5. 049580 Tithedox Water Soluble Powder. 6. 049581 Tithemox Injection. 7. 049582 Tithemox Water Soluble Powder. 8. 049583 Enrobarn Water Soluble Liquid. 9. 057176 Tithemycin Water Soluble Powder. 10. 057177 Tithechlore 20% Water Soluble Powder.
The Board further directed to M/s. Zoic International, Lahore to provide the prescribed original documents, in support of its claim that the registration of above products is in accordance with the approved terms and conditions, within the suspension period otherwise the proceeding for cancellation of registrations would be initiated.
Case No.06. Registration of Veterinary Drugs for export purpose.
M/s. Star Laboratories (Pvt.) Ltd, Lahore has applied for registration of the following veterinary drugs for export: -
S # Name of Drug (s)/Composition. Pack Size. 1. Prazistar Tablet. As per importing Each tablet contains:- country Praziquantel (BP) ...... 20mg. requirement. Pyrantel Pamoate (BP) ....230mg. 2. Carprofen Tablet. As per importing Each tablet contains:- country Carprofen I.H.S) ...... 50mg. requirement. 3. Tilmisin Oral Solution. As per importing Each ml contains:- country Tilmicosin (as sulphate) (USP) 250mg. requirement. 4. Levozan Plus DS Suspension. As per importing Each 100ml contains:- country Levamisol HCl ...... 3gm. requirement. Oxyclozanide...... 6gm. Cobalt Sulphate ...... 764mg. 5. Diclavet Oral Solution. As per importing Each 100ml contains:- country Dicalzuril (BP) ...... 1gm. requirement.
The firm have deposited required fee Rs.20,000 x 6= Rs.120,000/- and submitted the following supporting documents:- i) Copy of Drug Manufacturing Licence. ii) Copy of acknowledgement of receipt of application for renewal of Drug Manufacturing Licence No.000130) (Formulation). iii) Copy of NOC for CRF.
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i) Applications on Form-5. ii) Copy of inspection report dated 13-06-2011 for renewal of DML, as evidence of availability of the Section iii) Undertaking that applied registrations are exclusively for export purpose and will not be sold in Pakistan. iv) Notarized Photocopy of export order from importing country..
However the firm has not been able to provide appropriate evidence of Mee-to status of above product.
The case was deferred by the Drug Registration Board in its 254th meeting for deliberation in forthcoming meeting as the firm did not provide any evidence of approval of these formulations from reference regulatory authorities.
Decision:- The Board deferred the case for detail deliberation on the products not approved by the reference countries.
Case No. 07 Revision of Import Policy for Medicines.
The Policy Board of DRAP, in its 14th meeting revised the import policy for medicines 2013 as under:-. (i) Dosage form specific inspection of manufacturer abroad will be carried out before grant of registration. (Substitution of word “Product” with the word “Dosage form” in clause (i) of Import Policy of Medicines, 2013). (ii) cGMP inspection will also be conducted at the time of renewal of registration. (iii) The fee for grant of registration and renewal will be payable as already notified vide SRO.1117(I)/2012. (iv) Products approved by regulatory authorities of US FDA, EU EMA, PMDA Japan, Australia TGA, Health Canada, Switzerland or any of regulatory authority of former erstwhile Western Europe (United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Belgium, Denmark, Finland, Sweden, Italy, Ireland, Luxemburg, Norway, Scotland and Spain) or minimum three stringent regulatory bodies of former erstwhile Eastern Europe may be exempted from inspection of manufacturing facility, irrespective of the fact that the manufacturing unit is not located in these countries. (Substitution of the clause (iv) and (vi) of Import Policy of Medicines, 2013 with this clause). (v) The product pre-qualified by the World Health Organization will also be exempted from inspection of manufacturing units abroad. (vi) In case of cancellation or suspension of registration of the product from the importing country or WHO pre-qualification, the registration holders will be bound to inform the Registration Board about this cancellation or suspension with in fifteen days of such suspension. In case of non-compliance, the Registration Board will take action against the Importer, which may also lead to the cancellation of registration of that product or prosecution.
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The following points/proposal relating to the revised policy was submitted for consideration of Policy Board:-
(i) As per clause (i) of revised policy, dosage form specific inspections are to be carried out for the purpose of registration. As per discussion in the Minutes of 14th Policy Board meeting, the Board considered the issues as raised by many firms relating to product specific inspection abroad which includes multiple inspection for the same section, where same facilities and process are used for another product; without a specific scientific rational. It was also argued that it is against international practices by regulatory authorities like MHRA (UK) and US-FDA and is causing un-necessary difficulties, delays and cost to DRAP and company resources and finally cost to patients. In general, as per international practices of regulatory authorities, inspection is mostly based on dosage form specific or is based on "whole facility of production" and thus the subject section or whole facility, as the case may be, is authorized/approved by the authority. The products specific inspections are generally applicable to specific situations like tender purchasers or pre-qualification for such purchase. Therefore, in clause (i), the term product to be substituted by dosage form. As per the discussion, the rational to change from products specific inspection to dosage form inspection was "to avoid burden of un-necessary inspection on DRAP and manufacturers and additional delays in registration; keeping in view practices of other regulatory agencies like MHRA (UK), US-FDA"
(ii) In view of above mentioned discussion of Policy Board, and when clause (i) of import policy is read with clause (iv), logically, the dosage form facility approval by reference regulatory authorities (referred in clause iv) would form the basis for qualifying for exemption from the inspection for the purpose of registration. Apparently, the word "product" used in clause (iv) refer to dosage form facility in the context of above discussion.
The above mentioned interpretation was agreed upon after thorough discussion among officers of PE&R Division and is scientifically rational. It was proposed that such cases may be processed accordingly and the Policy Board may also be informed the above position in its next meeting with request to amend the word product with facility (whole or dosage form) in clause (iv) for further clarity.
Decision:- The Board noted and endorsed the proposal.
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Case No.08 Inspection of Manufacturer Abroad M/s. Shanghai Xudong Haipu Pharmaceutical Co., Ltd., No.897 Jinhu Road, Pudong New Area, Shanghai, China.
Registration Board in its 245th meeting held on 29-30th September, 2014 considered and approved the registration of following drug for import in the name of M/s. Network Marketing Services, Lahore manufactured by M/s. Shanghai Xudong Haipu Pharmaceutical Co., Ltd., No.897 Jinhu Road, Pudong New Area, Shanghai, China subject to inspection of manufacturer abroad as per policy, verification of storage facilities and price fixation / calculation etc where applicable:-
S # Name of Drug (s) Composition Demand Price Shelf Life & Pack Size 1. Megluvision Injection Rs.168/20ml 03 years Each 20ml ampoule contains:- Rs.5 x 20ml Diatrizoate…………...12.64g Meglumine…………...3.20g (Contrast Media)
In accordance with approval in 245th meeting, the inspection was carried out by the nominated panel comprising Mr. Ahmad Din Ansari, Deputy Drugs Controller (PS), DRAP, Islamabad and Mrs. Muneeza Khan, Federal Inspector of Drugs, DRAP, Karachi with reference to registration application of Megluvision Injection. The panel, while recommending the registration of above mentioned products, rated the firm as satisfactory. The panel further pointed out the improvement in various areas including storage condition of raw materials, warehouse, secondary packaging area, Ampoules Lamp inspection etc.
Decision:- Registration Board noted that the shortcomings pointed out by the panel are of minor nature, therefore, in view of recommendations of the panel, approved the registration of Megluvision Injection. Case No.09. Change of Artwork Design of Protexin Compounder (Vet Products) Registration No.019907 M/s. Hilton Pharma (Private) Limited, Karachi have requested to approve the change of color of Sachet from gray to white and designing dimension from 319 x 125mm to 350 x 125mm of artwork design of their registered imported veterinary drug “Protexin Compounder (Reg. No. 019907)” as their principal abroad M/s. Probiotic International Ltd., England intends to make a minor modification in the artwork. The sachet foil on back side will now be of white color. Previously it was silver colored. M/s. Hilton Pharma (Private) Ltd., Karachi have deposited the required fee Rs.5000/- and submitted following supporting documents:- Minutes 256th Meeting Registration Board 86
i) Copy of initial registration letter. ii) Copy transfer of registration letter. iii) Copy of last renewal. iv) Copy of NOC for CRF. v) Justification of proposed change. vi) Existing artwork design of the product. vii) Proposed artwork design of the product. viii) Difference between the existing and proposed artwork design in tabulated form. ix) Undertaking. x) Letter from Principle abroad M/s. Probiotic International Ltd., England.
The firm have confirmed that the dosage, administration, indication & direction for use etc. on the label are in accordance with registration / marketing authorization. Decision:- In view of the position submitted by the firm, the Board approved the proposed changes in dimension and color of Sachet of Protexin Compounder (Reg. No. 019907) on same terms and conditions and in compliance to Drugs (Labeling & Packing) Rules, 1986.
Case No.10. Registration application of M/s. GlaxoSmithKline Pakistan Limited, Karachi for Altargo Ointment.
The data /technical documents of following product was referred to below mentioned experts for opinion:- v) Brig. Dr. Zafar, Military Hospital, Rawalpindi. vi) Prof. Dr. Ikram Ullah Khan, Professor & Head of Dermatology Department, Pakistan Institute of Medical Sciences, Islamabad. vii) Prof.Dr.Syed.Shamsuddin, Head Department of Dermatologist, Sandaman Provincial Hospital, Quetta.
S.No. Name of Drug (s). Demanded Name of Indentor/ Price. Manufacturer. 1. Altargo Ointment Price not M/s. GlaxoSmithKline Pakistan Each gram contains:- mentioned Limited, Karachi-74000. / Retapamulin……10mg M/s. Glaxo Operations UK (1%W/W). Limited* Barnard Castle, United (Topical Antibacterial). Kingdom.
The above three experts did not respond despite four reminders.
Decision:- Since the product is approved by European Medicines Agency (EMA) so the Board approved the grant of registration to Altargo Ointment manufactured by M/s. Glaxo Operations UK Limited, Barnard Castle, United Kingdom subject to price fixation, confirmation of local storage facility and provision of legalized valid CoPP.
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Case No.11. Change of Importer from M/s. Orient Animal Health (Pvt) Ltd, Karachi to M/s. Orient Traders International, Karachi & Amend Status of Manufacturer/ Pepackers.
M/s. Orient Traders International, Karachi have requested for transfer of registration of their various registered imported veterinary drugs from the name of previous importer M/s. Orient Animal Health (Pvt) Ltd, Karachi to their name. The detail of the drugs along with status of documentation as provided by the applicant is given as under:-
S. No. Regn. Name of Drug (s)/composition Manufactur Manufacturer as per Remarks No. er as per CoPP Registration Letter (i) (ii) (iii) (iv) (v) (vi) 1. 017932 Tyloveto-20 Injectable Solution M/s. V.M.D. Product License Free sale in Each ml contains:- N.V. Holder: Belgium. Tylosin Tartrate equivalent to Belgium. M/s. V.M.D. N.V. GMP from 200mg Tylosin base Arendonk-Belgium. French Manufacturer: Authorities for M/s. Lab. BIOVE, 3 Biove. Rue de Lorraine, GMP for M/s. Arques, France. V.M.D. N.V. Labelling, Packaging Arendonk- & Release: Belgium from M/s. V.M.D. N.V. Belgium Arendonk-Belgium. Authorities. 2. 020771 Prednisolone 2.5 Injectable M/s. V.M.D. -do- -do- Solution N.V. Each ml contains:- Belgium. Prednisolone…...... 25mg 3. 020806 Retardoxi-20 LA Injectable M/s. V.M.D. -do- -do- Solution N.V. Each ml contains:- Belgium. Oxytetracycline 88ehydrate equivalent to 200mg Oxytetracycline base
4. 023473 Moxaject 15% Pro Injection M/s. V.M.D. -do- -do- Each ml contains:- N.V. Amoxycillin trihydrate equivalent Belgium. to 150mg Amoxycillin base 5. 023472 Coliveto-1000 Injectable Solution M/s. V.M.D. Product License -do- Each ml contains:- N.V. Holder: Colistin Sulphate………. Belgium. M/s. V.M.D. N.V. 1.000.000 I.U. Arendonk-Belgium. Manufacturer: M/s. Lab. BIOVE, 3 Rue de Lorraine, Arques, France. Labelling, Packaging & Release: M/s. V.M.D. N.V. Arendonk-Belgium. 6. 023476 Coliveto-4800 Soluble Powder M/s. V.M.D. -do- -do- Each gm contains:- N.V. Colistine Sulphate ..4,800.000 I.U. Belgium. 7. 023470 Doxyveto-50 S Soluble Powder M/s. V.M.D. -do- -do- Each gm contains:- N.V. Doxycycline Hyclate…500mg Belgium. 8. 049540 Fenylbutazon-20 Injectable M/s. V.M.D. Manufacturer, -do- Solution N.V. Packaging & Lot
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Each ml contains:- Belgium. Analysis: Phenylbutazon…200mg M/s. Laboratoires Biove, 3 Rue de Lorraine, Arques, France. Packaging, Lot Analysis & Batch Release: M/s. V.M.D. N.V. Arendonk-Belgium. 9. 049541 Gentaveto-5 Injectable Solution M/s. V.M.D. -do- -do- Each ml contains:- N.V. Gentamycin sulphate equivalent to Belgium. Gentamycin base...... 50mg
10. 049542 L-Spec 100 S Soluble Powder M/s. V.M.D. -do- -do- Each 150gm contains:- N.V. Lincomycin hydrochloride Belgium. equivalent to Lincomycin 33.3g Spectinomycin dihydrochloride equivalent to Spectinomycin 66.6g
11. 049543 Myogaster-E Injectable Solution M/s. V.M.D. -do- -do- Each ml contains:- N.V. Vitamin E acetate……100mg Belgium. Sodium Selenite Pentahydrate …...... 2mg
12. 049544 Amoxyveto-50 S Oral Powder M/s. V.M.D. -do- -do- Each gram contains:- N.V. Amoxicillin trihydrate….574 mg Belgium. equivalent to Amoxicillin…...... 500mg
13. 049546 L-Spec 5/10 Injectable Solution M/s. V.M.D. -do- -do- Each ml contains:- N.V. Lincomycin base (as Belgium. hydrochloride)……………50mg Spectinomycin base (as dihydrochloride)…………100mg
14. 049549 Vitamin AD3E 50/25/20 Injectable M/s. V.M.D. Product License -do- Solution N.V. Holder: Each ml contains:- Belgium. M/s. V.M.D. N.V. Vitamin A…..50,000 IU Arendonk-Belgium. Vitamin D3…25,000 IU Manufacturer, Vitamin E acetate..20mg Packaging & QC: M/s. Laboratoires Biove, 3 Rue de Lorraine, Arques, France. Packaging Batch Release: M/s. V.M.D. N.V. Arendonk-Belgium. 15. 023475 Pen-Dihydrostrep 20/20 Injection M/s. V.M.D. Bulk Manufacturer, Not Free Sale Each ml contains:- N.V. Primary & Secondary in Belgium. Procaine Penicillin G 200mg Belgium. Packaging, Batch No GMP for Dihydrostreptomycin base (as Analysis: UK. sulphate)……………200mg M/s. Norbrook Laboratories Ltd., Newry (Northern Ireland). Co. Down, United Kingdom. Secondary Packaging, Minutes 256th Meeting Registration Board 89
Batch Release: M/s. V.M.D. N.V. Arendonk-Belgium. 16. 018408 Tyloveto-S Soluble Powder M/s. V.M.D. Product License Not free sale Each gram contains:- N.V. Holder: in Belgium Tylosin tartrate…1000mg Belgium. M/s. V.M.D. N.V. (For export Arendonk-Belgium. only). Manufacturer: GMP from M/s. Lab. BIOVE, 3 French Rue de Lorraine, Authorities for Arques, France. Biove. Labelling, Packaging GMP for M/s. & Release: V.M.D. N.V. M/s. V.M.D. N.V. Arendonk- Arendonk-Belgium. Belgium from Belgium Authorities. 17. 020807 Albeveto-10 Oral Suspension M/s. V.M.D. Product License Not free sale Each ml contains:- N.V. Holder: in Belgium Albendazole…….100mg Belgium. M/s. V.M.D. N.V. (For export Arendonk-Belgium. only). Manufacturer: GMP from M/s. Lab. BIOVE, 3 French Rue de Lorraine, Authorities for Arques, France. Biove. Packaging & Release: GMP for M/s. M/s. V.M.D. N.V. V.M.D. N.V. Arendonk-Belgium. Arendonk- Belgium from Belgium Authorities. 18. 049545 Oxyveto-50 S Soluble Powder M/s. V.M.D. -do- Not free sale Each gm contains:- N.V. in Belgium Oxytetracycline...500mg (as Belgium. (For export hydrochloride). only). GMP from French Authorities for Biove. GMP for M/s. V.M.D. N.V. Arendonk- Belgium from Belgium Authorities. 19. 049548 Diminaveto Soluble Granules M/s. V.M.D. Applicant for Not free sale Each gm contains:- N.V. Certificate: in Belgium Diminazene Belgium. M/s. V.M.D. N.V. (For export Diaceturate………………..445mg Arendonk-Belgium. only). Antipyrine ...... 555mg Bulk Manufacturer, GMP not Packing, Lot provided. Analysis,Batch Release: M/s. Laboratoria Smeets BVBA Fotografielaan, Wilrijk, Belgium.
2. The firm has deposited required fee Rs.100000 x 19 = 1900,000/- and submitted the following documents:-
i) No Objection Certificate from M/s. Orient Animal Health (Pvt) Ltd, Karachi. ii) Legalized GMP Certificate of M/s. V.M.D. N.V., Belgium.
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iii) Legalized GMP Certificate of M/s. Laboratories Biove, France. iv) Legalized CoPP of the products. v) Distributor Agreement. vi) Copies of registrations letters & Renewal status. vii) Copy of Drug Sale License. vii) Registration applications on Form-5-A.
3. The firm has made following two requests;
(i) Change of importer from M/s. Orient Animal Health (Pvt) Ltd, Karachi to M/s. Orient Traders International, Karachi. (ii) Amend status of manufacturer/ repackers as per detail given in column (v) above.
4. As per the status provided in remarks column the following position emerges:-
(i) The products from Serial No. 1-14 are for free sale in Belgium where labeling and packaging is being carried out while manufacturing is carried out in France. (ii) The products at Serial No.15-19 are not free sale in country of origin/repacking i.e. Belgium.
Decision:- Registration Board decided as under:-
(i) Cancel the registration of the drugs mentioned from Serial No. 1-14 above from the name of M/s. Orient Animal Health (Pvt) Ltd, Karachi and grant registrations of the same products to M/s. Orient Traders International, Karachi on same terms and conditions with following changes.
Product License Holder: M/s. V.M.D. N.V. Arendonk-Belgium.
Manufacturer: M/s. Lab. BIOVE, 3 Rue de Lorraine, Arques, France. (Manufacturing, Packaging, Labeling & Lot Analysis)
Labeling, Packaging, Lot Analysis & Batch Release: M/s. V.M.D. N.V. Arendonk-Belgium.
(ii) For products at Serial No.15-19 the clarification shall be sought from the firm.
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Case No.12 Change of Manufacturing Site from M/s. Merck Sharp & Dohme (Italia) S.P.A. Via Emilia 21, 27100 Pavia, Italy to M/s.Aesica Pharmaceuticals GmbhH Galileistraβe 6,08056 Zwickau, Germany.
M/s. OBS Pakistan (Private) Limited, Karachi has requested to approve the change of manufacturing site of their following registered imported drugs from M/s. Merck Sharp & Dohme (Italia) S.p.A. Via Emilia 21, 27100 Pavia, Italy to M/s.Aesica Pharmaceuticals GmbH, Galileistraβe 6,08056 Zwickau, Germany :-
S. No. Reg. No. Name of Product (s). 1. 027385 Fosamax Once Weekly 70mg Tablets Each tablet contains:- 91.37mg alendronate sodium (70mg free acid equivalent)
M/s. OBS Pakistan (Private) Limited, Karachi has deposited required fee Rs.100,000/- and submitted following supporting documents:- i) Application on Form-5A. ii) Copy of registration letter. iii) Copy of renewal letter. iv) Copy of NOC for CRF. v) Original Certificates of Pharmaceutical Products of Netherlands legalized by Pakistan Embassy. vi) Original GMP Certificate of Germany legalized by Pakistan Embassy. vii) Site master file of new manufacturing site.
The CoPP provided is of Netherlands while request for change of source is for Germany. Decision:- The drug is registered for free sale in Switzerland from the same source/manufacturing site, which is one of the reference country approved by the Registration Board. Moreover, the firm has also provided CoPP of country of origin i.e. Germany, so the Board approved the Change of Manufacturing Site of Fosamax Once Weekly 70mg Tablets (Regn. No.027385) from M/s. Merck Sharp & Dohme (Italia) S.P.A. Via Emilia 21, 27100 Pavia, Italy to M/s.Aesica Pharmaceuticals GmbhH Galileistraβe 6,08056 Zwickau, Germany on same terms and conditions.
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Case No.13 Request of M/S. G.S.K. for change of manufacturing and packaging site of their registered imported drug Valtrex Tablets.
M/s. GlaxoSmithKline Pakistan Limited, Karachi has requested to approve the change of packaging site transfer of their following registered imported drugs as follows:-
S# Reg. No. Name of Existing Future Manufacturing & Product (s). Manufacturing & Packaging Site. Packaging Site. 1. 020468 Valtrex Tablets Manufacturing Site: Manufacturing & M/s. Glaxo Wellcome Packaging Site: SA Avenida, Spain. M/s. Glaxo Wellcome S.A, Packaging Site: Aranda, Spain. M/s. Glaxo Wellcome Australia Ltd.,
M/s. GlaxoSmithKline Pakistan Limited, Karachi have deposited fee Rs. 50,000/= and submitted following supporting documents:- i) Copy of registration letter of the products. ii) Original legalized CoPP of MHRA UK from new packaging site. iii) Copy of NOC for CRF. iv) Copy of last renewal receiving. v) Applications on Form 5(A). vi) Site Master File.
The CoPP provided is of UK while request for change of source is for Spain. Decision:- Since, the drug is registered for free sale in UK from the same source/manufacturing site, which is one of the reference country approved by the Registration Board, so the Board approved the Change of Packaging Site of Valtrex Tablets (Regn. No.020468) from M/s. Glaxo Wellcome Australia Ltd to M/s. Glaxo Wellcome S.A, Aranda, Spain on same terms and conditions.
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Registration–II
Case No.14: Approved/Deferred cases.
a. M/s Hiranis Pharmaceutical, Karachi. Registration Board in its 244th and 246th meeting deferred following products of M/s Hiranis Pharmaceutical Pvt. Ltd. Plot.No. E-145-149, North western Industrial Zone, Port Qasim, Karachi for taking expert opinion. Now, the firm has requested that since the Registration Board in its 250th meeting decided not to take expert opinion about a molecule/ formulation, if it is already approved (in same dosage form and strength) by regulatory agency of any of the reference country viz. USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, MHRA United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway. However Registration Board can take views / opinion of experts (if requires) regarding safety and efficacy parameters of the drug under domestic circumstances / practices, risk-benefit ratio in light of existing therapies etc. In the light of above decision of Registration Board, the firm has requested to reconsider their following formulations as these formulations are approved by the reference drugs agencies mentioned in the last column: Sl.# Name of Demanded Date and dy Decision and Status of Drug(s) and pack size No. with fee meeting of formulation in Composition and price Registration Board. reference drugs agencies
1 Safcort Tablet Form-5 D Deferred for Deferred for expert Approved in UK Tablet 04-03-2014 submission of evaluation by: (MHRA) Each Tablet Dy.No. 186 safety & 1. Dr. Jamal Zafar, contains 04-03-2014 clinical data PIMS Deflazacort 6mg Rs.50,000/- 2. Syed Irfan, Benazir (Glucorticosteroi Rs. 180/ Bhutto Hosp. d) 10’s pack 3. Dr. Ayesha Amir, Finished product Assist. Prof. Army specifications are Medical College. USP MC (M-244)
2. Gastocon Liquid Form-5D Deferred for: Deferred for Approved in UK Sachet 1) Evidence of evaluation of stability (MHRA) Each 10ml New approval of data & expert opinion sachet contains: License same by the following: Sodium alginate formulation by 1.Brig.Amjad (BP) 500 mg 28-05-2014 reference drug Salamat Sodium 809 R&I agencies e.g., 2.Dr.Najam, Shifa
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bicarbonate (BP) FDA, TGA, 3.Prof.Umer, RMC 267mg Rs. 100 / MHLW, EMA Calcium per 10’s and Health (M-246) carbonate Canada. (BP)…. 160 mg Rs. 50,000/- 2) Stability (BP data. Specifications)
Reflux suppressant / Antacid 3. Glucort S.R. Form-5D CLIPPER Deferred for expert Approved in UK Tablet 5mg Each Gastro- opinions by Brig (MHRA) enteric coated New resistant Aslam, Dr.Rehana tablet contains:- License prolonged Kauser and Dr.Shazli Beclomethasone release tablet Manzoor and Dipropionate ... 28-05-2014 5mg evaluation of stability 5mg 808 R&I MHRA studies by Incharge, PEC. (Manufacturer’s Rs. 1,000 / Specs) per 10’s (M-246) Corticosteroid Rs. 50,000/-
4. Relevo Sachet Form-5D Deferred for Deferred for Approved by the 20mg evidence of evaluation of stability reference drug Each sachet New approval of data & expert opinion agencies of contains: License same by the following: France and formulation by 1. Dr.Abid Farooki, Norway Piroxicam beta- 28-05-2014 reference drug PIMS cyclodextrin 810 R&I agencies e.g., 2.Brig.Mushtaq, MH 191.2 mg eq. to FDA, TGA, 3.Dr.fareedullah Piroxicam Rs. 150 / MHLW, EMA Zimri, NIRM ………… 20mg per 10’s and Health Canada. (M246) (Manufacturer’s Rs. 50,000/- Specs)
NSAIDs
Decision: Registration Board considered above registration applications and deferred for submission of scientifically rational laboratory scale data as per guidelines approved in 251st meeting.
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b. M/s Genix Pharma, Karachi.
The Registration Board in its 234th meeting approved the following product of M/s Genix Pharma, Karachi subject to reconfirmation of codal formalities jointly by the following officers: 1. DDG (Reg) 2. DDC (Concerned) 3. Prof. Rafi-uz-Zaman (Member Reg. Board) Policy of 5 products per section and decisions of me too committee should be followed. Later on the said committee recommended to defer the product due to the reason that assay Method submitted in the dossier was of Diclofenac instead of applied product i.e. Levofloxacin The details are as under:- S-Flox Infusion Per100ml Rs.700/- 03-11-2011 Each 100ml Contains: Dy.No.314 Levofloxacin……500mg Form-5 (Anti bacterial) Rs.8000/- Rs.12000/-
Now the firm has submitted the assay Method of the drug S-Flox Infusion (Levofloxacin) 500mg per 100ml. Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. S-Flox Infusion.
c. M/s Sante (Pvt) Ltd., Karachi
Registration Board in its 243rd meeting deferred registration of following products of M/s Sante (Pvt) Ltd., Karachi and decided as recorded in last column.
Xenase Rs.800/15ml 1.Form-5D 1. PATANASE Deferred for Ear/Nasal Nasal Spray Plastic Bottle 2. 23-11- (ALCON (i) expert drops Each100 micro 2011 PHARMS LTD) opinion (General) liter contains: Dy.No.379 SPRAY, (ii) Product section vide Olopatadine Rs.15000/- METERED;NAS Specific letter no F.2- hydrochloride 3. 08-04- AL Inspection 12/2006-lic …………..665 2013 OLOPATADINE for dated 25-02- mcg equivalent Rs.35,000/- HYDROCHLORI manufacturi 2011 to 0.6% DE ng facility. (600mcg) of 0.665MG/SPRAY base. (FDA) (Anti Allergic) 2.Acceptable level of GMP (09.05.13)
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According to the decision of 243rd meeting of Registration Board the Product Specific Inspection of premises has been conducted by Director DTL (Mr. Abdul Razzaq Jawinda) and Area FID (Syed Hakim Masood) on 16th April, 2015. The panel was of the view to recommend Registration of Xenase Nasal Spray (Olopatadine HCl 0.6% w/v) to the firm subject to the approval of Competent Authority. Regarding expert opinion since product is FDA approved there is no need to take opinion as per M-250 decision of Registration Board. Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Xenase Nasal Spray. d. M/s Winthrox Laboratories, Karachi. Registration Board in its 249th meeting deferred the registration of following product of M/s Winthrox Laboratories, Plot No. 219-A, SITE, Super Highway Phase-II, Karachi and decided as recorded in last column. -do- Kid-H2 40mg/5ml Form 5 PEPCID Deferred for confirmation of Dry Suspension 16-04-2015 40mg/5ml Dry installation and operational Each 5 ml (Dy no. 407) Suspension qualification of Potentiometer Contains: Rs. 20,000/- Salix by the area FID. Famotidine … 40 Pharmaceuticals mg. As per DRAP USA (H2 receptor policy Blocker. ZEPSIN40mg/5 Antipeptic ml Dry Ulcerate) Suspension USP Specification Cirn Pharma Pvt Ltd
Grant of DML by way of formulation recommended (25.02.2015).
Now the firm has informed that they have installed the potentiometer Model No. KF 787, Metler (Switzerland) in their quality Control Lab. Which is operational and validated. Meanwhile the area FID has also inspected the unit and stated that in response to the letter of M/s Winthrox Laboratories (Pvt) Ltd., on 14th September, 2015. The firm requested to inspect for confirmation of installation and operational qualification of Potentiometer incorporated in their inventory list of Quality Control Laboratory in light of the decision of Honourable Registration Board meeting 249th. Syed Hakim Masood, Federal Inspector of Drugs Hyderabad stationed at Karachi has visited the factory situated at K-219-A, Plhase-II, SITE, Super Highway, Karachi on 28th October, Minutes 256th Meeting Registration Board 97
2015. The company has been granted DML # 000807( by way of formulation) on 25th February, 2015. It was observed that no production activity is being carried out in the premises since the firm has recently received registration of drugs. Firm has started importing some of the raw materials and packing materials. “It has also now installed and done operational qualification of the instrument namely Potentiotitration meter Model No. KF 787. Metler (Switzerland) for testing of Famotidine Dry Suspension and Pizotifen Liquid Syrup products which were applied for registration Standard Operating Procedure has also been developed by the department”. Now, the firm has requested for grant of registration of above product Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Kid-H2 40mg/5ml Dry Suspension.
e. M/s Atco Laboratories, B-18, S.I.T.E., Karachi. Registration Board in 237th meeting deferred the registration of following product of M/s Atco Laboratories, B-18, S.I.T.E., Karachi and decided as recorded in last column.
Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form Betacal Ointment 15gm Rs.1400/- 03-11-2011 Deferred for Each gm contains: 30gm Rs.2500/- Dy.No.303 confirmation of Betamethasone dipropionate Form-5 steroidal 0.643mg Rs.8000/- manufacturing (eq. to Betamethasone Rs.52,000/- facility ……..………….0.05 % w/w) 24-1-2013 Calcipotriol monohydrate 52.2 mcg (eq.to calcipotriol………...50mcg or 0.005 %) (Topical Antipsoriasis)
Now, the firm have submitted that as per decision of 248th meeting of Registration Board the products containing steroidal topical preparations like eye/ear drops, sterile eye ointment, external preparations i.e. cream / ointment / gel, lotions, spray /a aerosols, suppositories, vaginal preparation, intra oral preparations, nasal drops etc shall be permitted for manufacturing in general facility / area provided that manufacturers shall have segregated dispensing booths, cleaning validation and control studies for processes and adequate system to minimize the potential risk of cross contamination. The firm have submitted following documents in support:
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i) Evidence of full registration fee paid of it’s request. ii) Copies of DML and CRF clearance certificate. iii) Evidence of international approval. iv) Role of inactive ingredients. v) SOP for list of technical staff. vi) Last inspection report. vii) Undertaking regarding label specimen, undertaking regarding brand name similarity, undertaking regarding submission of data before marketing of product, undertaking for segregated dispensing booths, cleaning validation and controls studies.
Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Betacal Ointment.
f. M/s Pharmatec Pakistan, Karachi Registration Board in its 248th meeting referred the case of M/s Pharmatec Pakistan, Karachi to the experts applied for registration of following drug which was deferred for clarification of formulation by the Registration Board in its 227th meeting. Name of Drug & Composition Pack Demanded MRP Decision of 248th meeting Polimod Syrup 120ml Rs.950.00 Registration Board Each 5ml contains:- referred case for Pidotimod……………..285.7mg expert opinion of (Immunostimulant) Head of Medicine, PIMS and BBH, Rawalpindi.
The Board considered the following expert opinion given by Brig. (R). Prof. Dr. Muzammil Hasan Najmi, Chairman, Department of Pharmacology, Foundation Medical College Rawalpindi and Prof. Dr. Maqsood Ahmad, Campus Director, Bahauddin Zakria University in its 248th meeting.
Birg. (R). Prof. Dr. Pidotimod of M/s Pharmatec is a synthetic dipeptide with Muzammil Hasan immunomodulant activity. The drug has been reported to be Najmi, useful in treatment and prevention of certain infections in Chairman, children and adults. However the efficacy and safety of Department of pidotimod requires further evaluation. The drug has not yet Pharmacology, earned a mention in any standard textbook of pharmacology. Foundation Medical Although it is being marketed in a few countries like China, College Korea and Russia, but it is not approved by EMA and FDA. Rawalpindi In my opinion it would be prudent to wait till more elaborate and authentic assessment of the drug becomes available. Not recommended for registration.
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Now, the firm has submitted evidence of availability in three non-reference countries which a members of European Union i.e. Greece, Italy & Russia and India. In Greece and Russia, it is available in 400mg/7ml oral vial solution. While in Italy it is available as 400mg and 800mg oral solution. The firm has therefore, requested for reconsideration/grant of registration of above product. Decision: Registration Board rejected the application of firm applied for registration of above drug on the basis that the efficacy and safety of the drug has not been well established and the approval by referred the agencies of Greece, Italy & Russia and India could not satisfy / fulfill and satisfy the criteria required for the registration of drug viz. safety, efficacy and quality.
g. M/s Safe Pharmaceutical (Pvt) Ltd., Karachi. Registration Board in 236th meeting approved the registration of following product of M/s Safe Pharmaceutical (Pvt) Ltd., Plot C-I-20, Sector 6-B, North Karachi Industrial Area, Karachi and decided as recorded in last column. M/s Safe Alitra 100mg Tablet As per As per SRO Approved Pharmaceut Each tablet contains: SRO subject to ical, Aceclofenac ……..…100mg submission of Karachi (NSAID) dissolution test
In response to the decision of Registration Board the firm has submitted dissolution test protocol / method & requested for grant of registration of above products Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Alitra 100mg Tablet.
h. M/s Martin Dow, Limited, Karachi. M/s Martin Dow, Limited, Plot No. 37, Sector, 19, Korangi Industrial Area, Karachi have requested for issuance of registration letter of their following product: S.# Product Name Pack Size 1. Eurosin Capsules 0.4mg 10’s Each capsules contains: 30’s Tamsulosin HCl…………….0.4mg (USP Specifications) Source of Pellets: - M/s Vision Pharmaceuticals, Islamabad.
The firm has requested that the product is approved in various meetings but registration letter has not been issued yet. The following is the details:
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The said product was approved in M-200 meeting of Registration Board held on 05-06- 2006 in the name of M/s Martin Dow Pharmaceutical, Lahore however registration letter could not be issued because the MRP was not fixed at that time. In 237th Registration Board meeting M/s Martin Dow Pharmaceutical, Lahore requested the Registration Board that M/s Mastin Dow, Lahore have been acquired by M/s Seatle Pharmaceutical, Lahore so transfer it from its name to M/s Seatle Pharmaceutical, Lahore. The Board approved the request of the firm subject to submission of differential fee, valid GMP of source of pellets, stability data and COA” In compliance to decision of 237th DRB meeting, they submitted the differential fee Rs. 100,000/- GMP certificate COA & stability studies with source of pellets as M/s Vision Pharmaceutical, Islamabad. The Board in M-249th meeting decided as below: “Registration Board decided to cancel registration of Eurosin Capsule 0.4mg from M/s Seatle (Pvt) Ltd., Lahore to M/s Martin Dow Ltd., Karachi. Registration Board authorized Chairman for issuance of registration letter after MRP fixation by Cost & Pricing Division”.
Now, while processing the case of firm in the light of Registration Board M- 249th meeting decision & asking about MRP by the Pricing Division, it was realized that since registration letter has never been issued to the firm, so the case can’t be sent to the Pricing Division. If approved we may issue the registration letter to the firm without asking for fixation of MRP by the Cost & Pricing Division. Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Eurosin Capsules 0.4mg.
i. M/s Martin Dow, Limited, Karachi (Registration of drugs – Colotab MR Capsule 200mg and Cyclorest ER Capsule 15mg & 30mg)
Registration Board in its 247th meeting deferred following drugs of M/s Martin Dow Pharmaceuticals, Karachi for reason mentioned in last column.
Name of drug(s) & Proposed Demanded Date of Decision Composition Pack size Price application, Diary No. & Form Colotab MR 200mg 10’s Rs.250/- 26-01-2012 Registration Board Capsule 20’s Rs.500/- Dy.No.495 deferred above Each modified release 30’s Rs.750/- Rs.15000/- products for evaluation capsule contains: Form-5 of registration Mebeverine HCl …200 mg application as per (Antispasmodic) check list approved by
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registration Board.
Cyclorest ER 15mg 10’s Rs.215.43/- 18-04-2012 Registration Board Capsule 20’s Rs.430.86/- Dy.No.744 deferred above Each capsule contains: 30’s Rs.646.29/- Rs.15000/- products for evaluation Cyclobenzaprine Form-5 of registration hydrochloride as extended application as per release pellets……..15 mg check list approved by (Muscle relaxant) registration Board.
Cyclorest ER 30mg 10’s Rs.358.43/- 19-04-2012 Registration Board Capsule 20’s Rs.716.86/- Dy.No.745 deferred above Each capsule contains: 30’s Rs.1075.84/ Rs.15000/- products for evaluation Cyclobenzaprine - Form-5 of registration hydrochloride as extended application as per release pellets……..30 mg check list approved by (Muscle relaxant) registration Board.
Now the section has evaluated the above applications and found complete in respect of cordal formalities. Further the products at Sl No. 2 & 3 found already approved by the Registration Board in its 237th meeting with the condition of submission of balance fee which has also now been confirmed. Formulation at Sl No. 01 is found available in UK while Sl No. 2&3 US-FDA.
Decision: Registration Board approved the request of the firm for grant of registration of above products i.e. Colotab MR 200mg Capsule, Cyclorest ER 15mg Capsule and Cyclorest ER 30mg Capsule.
j. M/s Helix Pharma, Karachi (Registration Cocard Plus 75/75MG Tablet – M/S Helix Pharma, Karachi).
Registration Board in its 237th meeting approved following products of M/s Helix Pharma, Karachi subject to the reason mentioned in last column below:
S. Name of drug(s) & Composition Proposed Deman Decision No Pack size ded Price 1 Cocard Plus 75/75mg Tablet 10’s As per Approved subject to Each tablet contains: PRC confirmation of Clopidogrel bisulfate eq. to Bilayered tablet clopidogrel……….75 mg manufacturing facility Aspirin as enteric coated pellets………….…75 mg (Anti coagulant anti platelet)
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Accordingly provided data was referred to expert for views. Comments are as under
Dr. Amanullah Khan, Mr. Abdul Razzaq, Mr. Muhammad Jamil Director, Drug Testing Director, Drug Testing Anwar, Laboratory, Laboratory, Director, Drug Testing Government of Government of Sindh, Laboratory, Baluchistan, Karachi Government of Punjab, Quetta Lahore
COCARD PLUS 75/81MG Tablet COCARD PLUS COCARD PLUS 75/81MG TABLET dissolution profile is a bilayered film coated TABLET is different from the (Antiplatelets) having 02 It is observed that necessary originator brand (OGREL years shelf life is indicated equipment, particularly PLUS 81 TABLET OF M/S in different kind of CV Bilayered Tableting Machine is BOSCH PHARMA, diseases. available for manufacturing of Karachi) and scientifically The comparative Cocard Plus 75mg /81mg the dissolution method dissolution profile of Tablet. applied is incorrect because M/s Helix Pharma The accelerated stability studies they use separate tablet of Products “ COCARD for the product has been carried Cocard for acid and buffer PLUS Tablets” with out with the concluded results of stages rather replacing the originator Brand “ active ingredient within the buffer medium from acid to OGREL PLUS 81 limits and also shows that no buffer stage, hence on TABLETS” by M/s significant physical and scientific grounds of Bosch chemical change occurred dissolution profile the Pharmaceuticals, during accelerated stability product COCARD PLUS Karachi” was study carried out for six months. 75/81MG TABLET is not thoroughly checked & The Dissolution Profile of the recommended. evaluated. product Batch TF001 has been The stability profile studied in acidic and buffer shows that stability stage and observed satisfactory. studies was carried The comparative study with the out, and there was no other brand “Ogrel Plus 81mg significant physical Tablets of M/s Bosch Pharma, and chemical changes Karachi was also carried out when product was with the acceptable results. kept at 40o C + 2o C In the light of above and as /75% RH + 5%, per data / information provide provided proof of the drug “Cocard Plus 75mg climatic chamber, also /81mg (Clopidogrel 75mg + complies the other Aspirin 81mg) Tablet is tests performed such recommended for registration. as weight variation, Assay, disintegration time, dissolution and other aspects that meets the required quality specifications. The data provided also reflects that
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manufacturing method / equipments / instruments are properly validated and calibrated. The last panel inspection was conducted on 28-06- 2013 & for verification of bilayered tablets manufacturing facilities was conducted 06-12-2013 wherein they stated that the firm has good facilities provided for manufacturing and quality control and GMP Compliance was found good / satisfactory. The data provided is sufficient regarding raw material specification & finished product specification & analytical procedures, labeling, packing is also available. So In the light of above mentioned facts & data provided the drug COCARD PLUS Tablets is recommended for registration.
It is to mention here that following is correct formulation submitted by the firm and same has been evaluated by experts. However, erroneously wrong formulation has been mentioned in agenda and minutes of 245th Registration Board meeting:- Cocard Plus 75/81mg Tablet Each tablet contains: Clopidogrel bisulfate eq. to clopidogrel…….75 mg Aspirin as enteric coated pellets………….…81 mg
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(Anti coagulant anti platelet)
The Registration Board in its 246th meeting decided to forward comments of Director DTL, Quetta to the manufacturer for clarification. In response to these comments, the reply of the firm was sent to the Director DTL, Quetta who after thorough review of the re-submitted dissolution profile of COCARD Plus 75/81 tablet Clopidogral + Asprin) gives his comments that “the resubmitted data is in accordance with the originator. Therefore, on scientific grounds he is of the opinion to Recommend the registration of the COCARD PLUS 75/81 Tablet under the Drug Act 1976”. Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Cocard Plus 75/75mg Tablet. k. M/s Kaizen Pharmaceutical (Pvt) Ltd., Karachi.
The Registration Board in its 236th meeting deferred the following product of M/s Kaizen Pharmaceutical (Pvt) Ltd., Karachi due to reasons mentioned in the last column:
Dismect Oral Powder 14’s As per PRC 18-10-2012 Review of Each packet contains: 28’s Dy.No.1660 formulation Dioctahedral 30’s Form-5 by experts smectite…………..3.00 g Rs.20000/- required (Anti diarrheal)
Now the firm has submitted that since same formulation has already been approved by the Registration Board in its 250th meeting and therefore, the firm has requested for the grant of registration Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Dismect Oral Powder. l. M/s Hiranis Pharmaceutical Karachi. Registration Board in its 254th meeting deferred the following product of M/s Hiranis Pharmaceutical Karachi applied for registration for export purpose due to the non availability in the reference countries. 1. Naprozol Tablet 375mg/20mg 30.09.2015 Copy of Not Each delayed-release tablet 960 export order contains: Rs. 50,000/- from Naproxen (enteric coated)….375mg Uzbekistan Esomeprazole magnesium trihydrate eq to esomeprazole……….20mg (Manufacturer’s Specification)
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Now, the firm has submitted that the same formulation is approved in USFDA and requested for grant of registration Decision: Registration Board approved the request of the firm for grant of registration of above product (Naprozol Tablet 375mg/20mg) exclusively for export purpose.
Case No.15 Revision of formulation – inclusion of Sodium Carbonate as API currently listed as inactive.
The Registration Board in its 252nd meeting deferred the request of firm for inclusion of Sodium by Carbonate as API in the composition of their following products for evidence of approval of the same formulation by any reference drug regulatory authority. 1. Eno Fruit Salt Regular (Reg No. 000180) 2. Eno Fruit Salt Lemon (Reg No. 016868) 3. Eno Fruit Salt Orange (Reg No. 019645)
Now, the firm has submitted an evidence of Global Data Sheet of M/s GSK verifying the above claim of the firm. The SmPC approved by the MHRA also confirms the firms claim. Decision: Registration Board approved the request of the firm for inclusion of Sodium by Carbonate as API in the composition of above products.
Case No. 16 Registration of drugs (change of title of firm only) M/s Martin Dow Ltd, Karachi has informed that the Licensing Board in its 235th meeting has approved the change of company name from M/s Martin Dow Pharmaceutical Ltd, Karachi to M/s Martin Dow Ltd., Karachi DML No. 000267. The firm has therefore, applied for transfer of registrations on form – 5 of following products to their new title:
S.# Regn. Product name Renewal Remarks No. valid up to 1. 000568 Librax Dragees 5mg + 28.06.2020 Approved in 2.5mg Switzerland Each dragees contains Chlordiazepoxide…..5mg Clidinium bromid....2.5mg 2. 001049 Rivotril Tablet 0.5mg 28.06.2020 Approved in Each tablet contains: UK Clonazepam……..0.5mg 3. 000584 Valium Ampoule 10mg/2ml 28.06.2020 Approved in Each ml contains UK Diazepam………5mg 4. 001047 Rivotril Drops 0.25% 28.06.2020 TGA approved
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Each ml contains Clonazepam…….0.25% 5. 003480 Valium Tablets 10mg 28.06.2020 Approved in Each tablet contains: UK Diazepam………10mg 6. 003066 Valium Tablets 5mg 28.06.2020 Approved in Each tablet contains UK Diazepam………..5mg 7. 003626 Rivotril Tablet 2mg 28.06.2020 Approved in Each tablet contains UK Clonazepam……..2mg
In support of its request the firm has submitted following documents as per requirement by SOP approved by the Registration Board: 1) Required fee as per relevant SRO Rs. 20,000/- for each product. 2) Application on form -5 3) Copy of registration letter/renewal status. 4) Copy of NOC for CRF clearance. 5) Approval of new name/title from CLB 6) Under taking for unchanged formulation, API source manufacturing procedure, analytical test methods & finished product specifications.
Decision: Keeping in view of decision taken in its 246th meeting, Registration Board approved registration of all above products in name of M/s Martin Dow Ltd, Karachi.
Case No. 17: Request for increase of Shelf Life M/s Nabiqasim Industries, Karachi have requested for increase in shelf life from 02 years to 03 years for the formulation of following products: 1. Lungair (Montelukast) 4mg (053136) 2. Meflox (Moxifloxacin) 400mg (055621) 3. Bacip (Ciprofloxacin) 500mg (055591).
The same was referred to following three experts. Two out of three have responded in favor of firm’s request while the opinion of third expert is still awaited and rest is not responded till now. The views of the experts are as tabulated below: Director, Drugs Testing Prof. Dr. Zafar Iqbal Dr. Akhlaq Hayat, Laboratory, Department of Pharmacy, Faculty of Pharmacy, Lahore University of Peshawar Gomal University, D.I. Peshawar Khan Please refer to your letter Reference to your letter The expert not responded No. F.1-2/2015-Reg-II, No.F. 1-2/2015-Reg-II, dated 24.04.2015, regarding dated 24th April, 2015. the increase in shelf life for company now provided following products of M/s detailed data of the stability Nabiqasim Industries, studies. The stability data of
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Karachi from 02 years to 03 three batches of studies at years both at 40oC and 75% and at 30oC 65% RH. Following are my comments about the above mention subject: (053136) Lungair 4mg Lungair 4mg Sachet (055621) Meflox 400mg (053136) (055591) Bacip 500mg The stability data of three As per information /d data batches for the stability provided by M/s Naibqasim studies. The furnished data Industries on 31.08.2015, it support the stability of the reveals that 03 batches each drugs for three years of the above said products were tested by the Meflox 400mg Tablet respective manufacturer (055621) regarding Stability for 36 The furnished data support months (both at 30oC + 2oC. the stability of the drugs for Humidity RH = 65% + 5% three years. and 40oC + 2oC. Humidity RH = 75% + 5%) and no Bacip 500mg tablet change was observed as per (055591) physical & chemical The furnished data support parameter, particularly the the stability of the drugs for limit of unspecified three years impurity and the assay of the contents. In physical examination test, the colour physical appearance and packing characteristics remained unchanged even up to last observation i.e. after 36 months. The results are acceptable as per information / data provided by M/s Nabiqasim Industries (Pvt) Ltd., Karachi. It is recommended that the said manufacturer may be allowed to increase the shelf life of above tabulated 03 products from 02 years to 03 years
Decision: Keeping in view above expert opinions, Registration Board approved the request of the firm for increase in shelf life of above products from 02 years to 03 years.
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Case No.18 Registration of Infusion M/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423, SITE, Karachi have been granted the registration of Barimox IV (Moxifloxacin) Infusion 400mg/100ml on February, 26th 2011 (Reg No. 067447). Due to the problem of crystallization in 100ml volume, the firm has applied for change of pack size from 100ml to 250ml on 13th May, 2013 as per following decision of Registration Board taken in its 243rd meeting. “Registration Board approved firm’s request for changing pack size of moxifloxacin infusion to 250ml with MRP as approved by Drug pricing Committee. Moreover, the Board advised that all other manufacturers will be advised to change the existing 100 ml pack size with 250ml and authorized its Chairman to grant this approval”.
Decision: Registration Board approved the request of the firm for revision / correction in the formulation of above product (Barimox IV (Moxifloxacin) Infusion ) as 400 mg / 250 ml.
Case No.19 Change of brand name due to similarity.
M/s Atco Laboratories, Karachi has requested for change of brand name of their following already registered products: S. No Exiting Name Reg No. Proposed Name Justification / Reasons 1. Foci Cream 039337 Melas (Fusidic acid 2% ) Similarity of brand Cream name Focin DS 2. Foci Ointment 039338 Melas (Fusidic acid 2% ) Suspension Reg Ointment No. 042286 M/s 3. Foci – H Cream 048512 Melas – H () Cream Tabros Pharma, Karachi
At the time of registration, the brand name “Melas was granted to M/s Atco Laboratories, Karachi. Later on, the firm has requested for change of name from Melas to Foci which was approved. Now the firm has once again requested for reversion of their previous name i.e. Melas. Since the firm has submitted the justification that Foci resembles with the brand name of another registered product i.e. Focin of M/s Tabros Pharma, Karachi. And both the names are spelled alike with same sound and could be misinterpreted by the doctors and patient. To void any confusion and assuming their responsibility, the firm intends to revert to the previous name i.e. Melas. The firm has further stated that they are still owner of the trade mark “Melas”. Decision: Registration Board advised to discuss all relevant record and authorized chairman for decision on request of the firm.
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Case No. 20: Registration of Drugs for export purpose.
a. Non me-too & new drugs.
Following firms have requested for registration of following drugs for export purpose only which are not me-too & are new drugs. Details are as under:-
S. Name of Name of product(s) Date of Import Order Approval No. Company application, status by Diary No. & reference Form regulatory authorities 1. M/s Noa HC-Buvir 400mg tablet 61.07.2015 Import order from USFDA Hemis Each Film coated tablet 61 Tajikistan approved Pharmaceutical contains Rs. 20,000/- , Plot No. 154, Sofosbuvir…………..400 Sector 23, mg Korangi Industrial Area, Karachi 2. M/s Faas Faasbpvor 400mg tablet 16.11.2015 Not provided USFDA Pharmaceutical Each film coated tablet 995 approved (Pvt) Ltd., F- contains: Rs. 20,000/- 748L, SITE, Sofosbuvir…………400 Karachi mg 3. M/s. Bosch Lesovir 400mg tablet 16.12.2015 Copy of export In USA Pharmaceutical Each film coated tablet 950 order from (Pvt) Ltd, contains: Rs.20,000/- Vietnam Bosch House Ledipasvir 221, Sector 23, (M.S.)……….90mg Korangi Sofosbuvir……..400mg Industrial Area, 4. M/s Medisure Fosipas tablet 05.11.2015 Copy of export In USA Laboratories Each film coated tablet 881 order from Pak (Pvt) Ltd., contains Rs.20,000/- Myanmar A-115, SITE – Ledipasvir……….90mg 1181 II, Super Sofosbuvir……..400mg 23.12.2015 Highway Rs. 30,000/- Karachi. 5. -do- Sosapavir 400mg 05.11.2015 -do- USFDA Each film coated tablet 882 approved contains Rs. 20,000/- Sofosbuvir……..400mg 23.12.2015 1182 Rs. 30,000/- 6. M/s OBS Viratron – Plus Tablet 13.01.2016 Copy of export In USA Pakistan (Pvt) Each film coated tablet 30 order from Kenya
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Ltd., C-14, contains Rs. 50,000/- Manghopir Ledipasvir……….90mg Road, SITE, Sofosbuvir……..400mg Karachi 7. M/s Getz Daclavia 30mg tablet 26.01.2016 Not provided USFDA Pharma, 29- Each film coated tablet 100 approved 30/27, Korangi contains: Rs. 20,000/- Industrial Daclatasvir Area, Karachi dihydrochloride eq. to Daclatasvir………30mg 8. -do- Daclavia 60mg tablet 26.01.2016 Not provided -do- Each film coated tablet 99 contains: Rs. 20,000/- Daclatasvir dihydrochloride eq to Daclatasvir…………….6 0mg 9. M/s Pharmatec Tigrelor 90mg tablet 29.01.2016 Copy of export Approved in UK Pakistan (Pvt) Each film coated tablet 117 order from Kenya Ltd., D-86/A, contains: Rs. 50,000/- SITE, Karachi Ticagrelor………..90mg 10. -do- Double Gel 14.01.2016 Copy of export Approved in UK Each 100gram contains: 47 order from UK Isopropyl Rs. 20,000/- Myristate…….15%w/w 28.01.2016 Liquid 108 Paraffin…………15%w/ Rs. 30,000/- w 11. -do- Aziltan 40mg tablet 18.01.2016 Copy of export Approved in UK Each tablet contains 53 order from Kenya Azilsartan Medoxomil (as Rs. 20,000/- potassium)…………..40 28.01.2016 mg 109 Rs. 30,000/- 12. Hilton Pharma Ketop 20mg Capsules 10.11.2015 Export order from Nexcede / (Pvt) Ltd., Each capsule Contains: Dy. No. 1006 Afghanistan Novartis - FDA Progressive Ketoprofen…….25mg Rs. 50,000/- Plaza, Beaumont Road, Karachi 13. -do- Ketop 50mg Capsules 10.11.2015 Export order from Nexcede / Each capsule contains: Dy. No. 1007 Afghanistan Novartis – FDA Ketoprofen…..50mg Rs. 50,000/- 14. -do- Ketop 75mg Capsules 10.11.2015 Export order from Nexcede / Each capsule contains: Dy. No. 1008 Afghanistan Novartis – FDA Ketoprofen…..75mg Rs. 50,000/-
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Decision: Registration Board approved the above products for registration of drugs for export purpose only. For products at S. No.7 & 8 the firm shall submit Rs.50,000/- per product and Chairman will permit issuance of registration letter.
b. M/s Aspin Pharma, Karachi. Registration Board in its 254th meeting discussed registration for export purpose of following product of M/s Aspin Pharma, (Pvt) Ltd., 91-Shahrah-e-Iran, Block Clifton, Karachi and decided as recorded in last column
1. M/s Aspin Sepidyl 5% solution 06.11.2015 Copy of Present in the Pharma, Each ml Sepidyl 5% solution 967 export order same strength (Pvt) Ltd., contains: Rs. 50,000/- from and dosage 91-Shahrah- Chlorhexidine Gluconate Afghanistan form in WHO e-Iran, BP….50mg (5%w/v) model list of Block essential Clifton, medicines Karachi 2015 as Chlorhexidine digluconate 2. -do- Sepidyl 7.1% Gel 06.11.2015 -do- -do- Each gram gel contains: 968 Chlorhexidine Gluconate Rs, 50,000/- BP….71mg (7.1%w/v) 3. -do- Sepidyl 7.1% solution 06.11.2015 -do- -do- Each gram solution contains: 969 Chlorhexidine Gluconate Rs, 50,000/- BP….71mg (7.1%w/v)
Decision: Registration Board approved above products for registration of drugs for export purpose only.
c. M/s Medisure Laboratories Pakistan, Karachi
Registration Board in its 254th meeting deferred the following products applied for registration for export purpose by M/s Medisure Laboratories Pakistan, Karachi for the reasons that the formulation is not available in the reference agencies. Now the firm has submitted that the same formulation is found available in UK. On evaluation the formulation was not available in UK. Since the approved formulation is 1mg/ml Norepinephrine injection wherein 2mg Norepinephrine tartrate is eq. to 1mg norepinephrine base. While the firm applied with the base as below:
Amipine Injection 1ml ampoule Each ml contains: Norepinephrine……….………2mg
Minutes 256th Meeting Registration Board 112
The firm has requested to re-consider its formulation in accordance with that approved by MHRA:
Name of Name of product(s) Date of Export International Company application, Order Availability Diary No. & Form M/s. Amipine Injection 1ml ampoule 864; Copy of UK Medisure Each ml contains 05.03.2015 export order Laboratories Norepinephrine tartrate injection eq. Rs.20000/- from Pakistan to 2mg per ml Philippines (Pvt.) (2mg noradrenaline tartrate equivalent to 1mg noradrenaline Limited base) A-115, S.I.T.E., Super Highway Karachi.
Decision: Registration Board approved above products for registration of drugs for export purpose only. The firm shall submit Rs.30,000/- remaining fee and authorized Chairman for issuance of registration letter.
Case No.21: Registration of product from M/s Bosch Pharmaceutical (Pvt)., Plant–II.
M/s Bosch Pharmaceutical (Pvt) Ltd., Karachi has requested for transfer of registration from M/s Bosch Pharmaceuticals (Pvt) Ltd., Karachi plant – I DML No. 000350 to Bosch Pharmaceutical (Pvt) Ltd., Plant – II Situated at Plot No. 209, Sector 23, Korangi Industrial Area, Karachi having DML No. 000707:
S.# Product for registration with generic Reg. Renewal Remarks name No. up to 1. Tonact Injection 033962 20.09.2019 - Each 3ml ampoule contains: Thiamine HCl (Vitamin B1)…….100mg Pyridoxine HCl (Vitamin B6)….100mg Cyanocobalamin (Vitamin B12)…..1mg (Manufacturer Specification)
The firm have provided following documents with support: 1) Application with form 5 and requirement fee amounting to Rs. 20,000/-. 2) Copy of registration letter with renewal status 3) Copy of approved Section by Central Licensing board. 4) Copy of NOC for CRF Clearance. 5) Copy of last inspection report.
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6) NOC from Existing Manufacturer/registration holder, permitting for transfer of product.
Decision: Registration Board decided as follows:
1. Cancellation of registrations of product from M/s Bosch Pharmaceuticals (Pvt) Ltd., Karachi plant–I, DML No. 000350 2. Registration of products in the name of to Bosch Pharmaceutical (Pvt) Ltd., Plant – II Situated at Plot No. 209, Sector 23, Korangi Industrial Area, Karachi, DML No. 000707. 3. Registration Board authorized its Chairman for issuance of registration letters after MRP fixation by Cost & Pricing Division.
Case No. 22: Approval of Source of pellets Esomeprazole Registration Board in its 188th meeting approved following product in the name of M/s Atco Laboratories, Karachi. Accordingly, the registration letter of the same was issued on 31.12.2004 without mentioning of source of pellets. Now the firm has applied for approval of following source of pellets for these products: S.# Name & Composition of drug(s) Applied source of pellets. 1. Ecorox Capsules 20mg M/s Alphamed Formulations Each capsule contains: Pvt. Ltd., Sy No. 225, Esomeprazole magnesium trihydrate Sampanbole Village, Shamirpet (enteric coated pallets) eq to Mandal, Ranga Reddy District – Esomeprazole……..20mg 500 078 Telangana State, India Reg No. 035721 2. Ecorox Capsules 40mg M/s Alphamed Formulations Each capsule contains: Pvt. Ltd., Sy No. 225, Esomeprazole magnesium trihydrate Sampanbole Village, Shamirpet (enteric coated pallets) eq to Mandal, Ranga Reddy District – Esomeprazole……..40mg 500 078 Telangana State, India Reg No. 036249
2. Product was registered in 2004 when source was not fixed for pellets. The firm has provided the following documents in support: 1) Application with required fee as per relevant SRO @ Rs. 100,000/- per products 2) Copy of registration letter and renewal status. 3) NOC for CRF clearance. 4) Real time stability studies of pellets conducted by manufacturer as per conditions of zone IV-A as per ICH guidelines (Both real time & accelerated studies). Certificate of analysis of manufacturer 5) Original GMP certificate from regulatory authority of exporting country 6) Undertaking that shelf life of finished product would be assigned from date of manufacturing of pellets from manufacturer.
Decision: Registration Board approved the request of the firm for fixation of source of pellets for Ecorox Capsules 20mg and 40 mg as M/s Alphamed Formulations, Pvt. Ltd., Sy No. 225, Sampanbole Village, Shamirpet Mandal, Ranga Reddy District – 500 078 Telangana State, India. Minutes 256th Meeting Registration Board 114
Case No. 23 Registration from import to local by contract manufacturing. a) M/s Laderly Bio Tech Pharma, have applied for transfer of registration of their following product from import to local through contract manufacturing from M/s Bio –Lab, Islamabad. The product was registered for import from M/s CSPC Zhongnuo Pharacutical (Shijiazhuang) Co. Ltd, China in finished form. The firm has deposited an amount of Rs. 50,000/- for the purpose. Reg No. Zoletech Injection 40mg Rs. 300.00 072568 Each vial (lyophilized) contains: Omeprazole Sodium 42.6mg eq. to 40mg Omeprazole.
Firm has provided following documents: Copy of registration letter dated 13.06.2013. Form-5
Decision: Registration Board approved the contract manufacturing permission of Zoletech Injection 40mg, Reg No. 072568 from M/s Bio Lab, Islamabad for 05 years in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976. b) M/s Al-Habib Pharmaceutical, Karachi have applied for transfer of registration of their following products from import to local through contract manufacturing from M/s Safe Pharmaceutical, Karachi. These products (Sl No. 1-3) were transfer in the name of M/s Al-Habib from M/s Tec-Man Internatianl, Rawalpindi on 10th June, 2008 thereafter the firm has applied for transfer of the same for contract manufacturing on 18th October, 2010 for products at Sl. No. 1-3 and for product at Sl No. 4 on 20th November, 2010. The firm has deposited an amount of Rs. 50,000/- each for the product.
Sl No. Regn No. Name of drug(s) and Source of import composition 1. 021179 Tecifin 1gm Korea United Pharm Inc., Each vial contains: Seoul, Korea. Ceftriaxone (as sodium)…1gm 2. 021180 Tecifin 500mg -do- Each vial contains: Ceftriaxone (as sodium)…500mg 3 021181 Tecifin 250mg -do- Each vial contains: Ceftriaxone (as sodium)…250mg 4. 039854 Paratam Inj M/s Korea Prime Pharm, Each vial contains: Co. Ltd. Korea
Minutes 256th Meeting Registration Board 115
Cefoperazone sodium 500mg Sulbactam Sodium 500mg
The firm has requested for change of brand name for product at Sl. No. 4 from Paratam to Qurasol. The firm submitted the renewal fee for the product at Sl. No. 4 on 1st July, 2010 which was registered in the name of firm on 7th July, 2005.
Decision: Registration Board approved the contract manufacturing permission of above four products from M/s M/s Safe Pharmaceutical, Karachi for 05 years in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976 alongwith change in brand name of product at S.No.4 from Paratam to Qurasol. For products at S.No.01-03, firm will select either IM or IV and Chairman will permit issuance of letter.
Case No. 24 Request for extension along with change in contract manufacturing The following products were deferred by the Registration Board in its 250th meeting for evaluation. The evaluation has now been completed and the request of the firm found as per requirement. These products are valid till 30.06.2015.
1) Al Habib Standpharm M/s Safe 023655 Kopamin Injection 10.06.2015 Pharmaceutic Pak. Pvt. Ltd., Pharma, Each ampoule contains: Rs. 50,000/- al, Karachi Lahore Karachi. Mecobalamin…… 10.06.2015 500 mcg 2) -do- PharmEvo -do- 020487 Chef 1g IV Injection 10.06.2015 Karachi Each vial contains: Ceftriaxone Rs. 50,000/- Sodium……..1g 10.06.2015 3) -do- -do- -do- 020488 Chef 500mg IV Injection 10.06.2015 Each vial contains: Ceftriaxone Rs. 50,000/- Sodium…….500mg 10.06.2015 4) -do- Amarant -do- 023644 Kopamin tablet 10.06.2015 Pharma, Each tablet contains: Karachi Mecobalamin .500mcg Rs. 50,000/- 10.06.2015
Decision: Registration Board approved extension in contract manufacturing permission of above products till 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976 alongwith change in contract manufacturer from M/s Standpharm Pak. Pvt. Ltd., Lahore M/s Safe Pharma, Karachi.
Minutes 256th Meeting Registration Board 116
Registration-III Case No.25 Deferred cases.
a. M/s Caraway Pharmaceuticals, Islamabad. Registration Board in M-246 meeting deferred the following product of M/s Caraway Pharmaceuticals for the reasons stated in last column below:
Name of firms Name of product and Meeting Decision composition No. Caraway Ondenles Injection 8 mg M-246 Deferred for the Pharmaceuticals Each ml contains: followings Islamabad Ondansetron hydrochloride 1. Confirmation of dehydrate equivalent to installation and Ondansetron……2mg operational 5HT -3 Antagonist qualifications of USP TOC analyzer and liquid particle counter by FID. 2. Latest inspection report is required.
Now the firm has submitted an undertaking in the light of Registration Board’s decision taken in its M-248 meeting and the latest inspection report conducted on 18-08-2015 verifying the GMP status of the firm and recommended the issuance of GMP Certificate for export of drugs.
The firm has now requested for the grant of registration of above product.
Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Ondenles Injection 8 mg.
b. M/s Shaigan Pharmaceuticals, Rawalpindi. Registration Board in its M-235th meeting approved the following products of M/s Shaigan Pharmaceuticals, Rawalpindi with the conditions mentioned in the last column below.
Name of Drug(s) with Decision of Registration Board composition Nepafen Opthalmic Suspension Approved if the products is me-too Each ml contains: otherwise the firm has to apply afresh Nepafenac……………0.1% on from 5-D along with requisite fee. (NSAID)
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Now the firm has submitted that the above formulation has already been registered in the name of various firms like Nevafac with Reg.No. (047563) of M/s Novartis. Decision: Registration Board approved the request of the firm for grant of registration of above product i.e. Nepafen Opthalmic Suspension.
c. M/s Shaigan Pharmaceuticals, Rawalpindi. Registration Board in its M-237th meeting approved the following formulation of M/s Shaigan Pharmaceuticals, Rawalpindi with the conditions mentioned in the last column below.
1. Ruwin DS 400mg Capsule Approved subject to submission of Each capsule contains: dissolution test in finished product Cefixim Trihydrate specification in the dossier Cefixime….400mg (Cephalosporin) 2. Boost –D Tablets Approved subject to Each tablet contains: 1. Verificaiton of Atomic Absorption Ossein Mineral Spectrophotometer. Complex……………….830mg 2. Submission of dissolution test in eq to calcium…………177.6mg finished product specification. phosphorous …………..82.2mg residual mineral salts… 24.9mg collagen ……………….224mg other proteins …………66.4mg trace elements (F1, Mg, Fe, Ni, Cu) corresponding to Approx...... 440mg Hydroxyapatite) Vitamin D………400 IU (Minerals +Vit.D Supplement)
Now, the firm has submitted the dissolution test for both products and also provided evidence of atomic Absorption as evident from the inspection report dated 22-04-2014 and therefore requested for grant of registration of above product. However, firm has not submitted the composition of Ossein Mineral Complex. Decision: Registration Board approved the request of the firm for grant of registration of above products i.e. Ruwin DS 400mg Capsule and Boost –D Tablets. Brand name of Boost –D Tablets will be changed after permission of Chairman, registration Board.
d. M/s Shaigan Pharmaceuticals, Rawalpindi.
Minutes 256th Meeting Registration Board 118
Registration Board in its M-238th meeting deferred the following formulation of M/s Shaigan Pharmaceuticals, Rawalpindi due to paucity of time.
Decision of Reply of the firm Sr.No. Name of Drug(s) with Registration Board composition 1. Mark Injection The board deferred To be include in the Each 5ml ampoule contains: agenda item due to next Board Zoledronic Acid as Monohydrate paucity of time (M- meeting. ……..4mg 238) (Bisphosphonic)
The firm actually applied in Liquid Ampoule. Due to this reason, the committee approved by the Registration Board recommended to defer for confirmation of dosage form. Now, the firm has clarified that due to typographic error they applied in ampoule dosage form. But actually dosage form / presentation of the formulation is Vial. The firm is therefore, requested to issue the registration of above product in Vial.
Decision: Registration Board approved request of the firm for grant of registration of above product i.e. Mark Injection in vial form.
Case No.27
Chief Drug Controller Punjab, Lahore has forwarded the case regarding non availability of Folic Acid 5 mg at pharmacies and medical store, desires attention of the DRAP, towards this issue. Whereby, patients are suffering at large scale due to monopoly of manufactures for the said Drug. According to him it is the responsibility of manufacturer to ensure the constant availability of medicine in the market as per condition of Drug Manufacturing License in order to avoid the public / patients form miseries.
2. He has requested to look into the matter and make necessary arrangements for the availability of the product.
3. He has further requested to direct the manufacturers to resume the manufacturing of the said tablets and ensure the constant availability in order to prevent the patients from miseries.
Decision: Registration Board considered the issue and decided to: a. Inform the Chief Drug Controller Punjab, Lahore that Registration Board considered his concerns and directed the registration holders of the product to ensure the availability of the drug as per condition of registration.
Minutes 256th Meeting Registration Board 119
b. Write letters to all registration holders of drug for making ensure for the availability of drugs in the market as per condition of registration of drug.
Case No 26. Registration Board in 250th meeting deferred the following products of M/s Qintar Pharmaceutical Sargodha for evaluation of registration applications, as firm has applied for change in contract manufacturer from M/s Kings Pharmaceutical, Islamabad to M/s Aventek Pharmaceuticals Lahore. S. No. Name of Contract Reg. Name of drug(s) & Date of Applicant Manufacturer No. Composition application, Diary No. & Form 1. M/s Qintar M/s Kings 059848 Qin-Bact 2g Injection 30-06-2015 Pharmaceuti Pharmaceutical, Each Vial Contains: Dy.No.1527 cal, Rawat. Islamabad Cefoperazone…..1g Rs.50,000/= Sulbactum………1g
2. -do- -do- 057737 Qisdim 1g Injection 30-06-2015 Each Vial Contain: Dy.No.1527 Ceftazidime…..1g Rs.50,000/= (Product complies with USP Specification) 3. -do- -do- 057362 If-tar 400mg Capsule 30-06-2015 Each Capsules Contains: Dy.No.1527 Cefixime………400mg Rs.50,000/= (Product Complies to USP) 4. -do- -do- 057734 Graxime 250mg Injection 30-06-2015 Each Vial Contains: Dy.No.1527 Cefotaxime 250mg Rs.50,000/= (Product Complies to USP) 5. -do- -do- 057365 On tri 1g Injection 30-06-2015 Each Vial contains: Dy.No.1527 Ceftriaxone Sodium Rs.50,000/= equivalent to Ceftriaxone……..1gm 6. -do- -do- 059846 Qin- Pime 1g Injection 30-06-2015 Each vial Contains Dy.No.1527 Cefepime (as HCl)….1gm Rs.50,000/= Sterile Arginine….500mg
Minutes 256th Meeting Registration Board 120
7. -do- -do- 059846 Qin- Pime 500mg 30-06-2015 Injection Dy.No.1527 Each vial Contains Rs.50,000/= Cefepime (as HCl)….500mg Sterile Arginine….250mg 8. -do- -do- 057364 On tri 500mg Injection 30-06-2015 Each Vial contains: Dy.No.1527 Ceftriaxone Sodium Rs.50,000/= equivalent to Ceftriaxone…..500mg 9. -do- -do- 057361 If-tar 200mg/5ml 30-06-2015 Suspension Dy.No.1527 Each 5ml Contains: Rs.50,000/= Cefixime………200mg (Product Complies with USP Specification ) 10. -do- -do- 057363 On tri 250mg Injection 30-06-2015 Each Vial contains: Dy.No.1527 Ceftriaxone Sodium Rs.50,000/= equivalent to Ceftriaxone…..250mg 11. -do- -do- 057736 Qisdim 250mg Injection 30-06-2015 Each Vial contains: Dy.No.1527 Ceftazidime (as Rs.50,000/= Pentahydrate) .. 250mg 12. -do- -do- 057366 Graxime 500mg Inj 30-06-2015 Each Vial contains: Dy.No.1527 Cefotaxime as Sodium Rs.50,000/= …….500mg 13. -do- -do- 057735 Graxime 1g Inj 30-06-2015 Each Vial contains: Dy.No.1527 Cefotaxime as Sodium… Rs.50,000/= 1gm 14. -do- -do- 059847 Qin-Bact 1g Injection 30-06-2015 Each Vial contains: Dy.No.1527 Cefoperazone Sodium + Rs.50,000/= Sulbactum as Sodium ….1gm 15. -do- -do- 057360 If-tar 100mg suspension 30-06-2015 Each 5 ml contains: Dy.No.1527 Cefixime as Rs.50,000/= Trihydrate….100 mg
Now, the firm has requested for withdrawal of its application for change of contract manufacturing and requested to extend the contract manufacturing with previous contract manufacturer viz. M/s King Pharmaceuticals Lahore.
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Decision: Registration Board approved the extension in contract manufacturing permission of above products till 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.
Case No.27: Registration of drugs for export purpose.
a. Registration Board’s in its M-254 meeting deferred the following product of M/s Global Pharmaceuticals Islamabad & M/s scotmann Pharmaceuticals, Islamabad which were applied for registration of export purpose for detailed deliberation in forthcoming meeting on the policy that whether formulations not approved by the reference agencies should be approved or not. Since, previously the Registration Board in its 241st and 246th meeting used to approve such formulations just only the basis/provision of import order from any country.
S. Name of Brand Name / Deman Deman Date of Remar International No. the Firm Label Claim ded ded initial ks availability Pack Price application Size with fee, date of differential fee deposited 1. M/s Nogram 500mg N.A. As Per 29-07-2015 Copy of Not found Global Capsules SRO Dy.No.1608 export approved in Pharmaceu Each capsule Rs.20,000/= order reference ticals contains:- from agencies Islamabad Nalidixic Tajikist . Acid……500mg an (Global’s Specifications)
M/s Sunny-D Softgel 1’s As Per 10-11-2015 Copy of Not found Scotmann Each softgel SRO Dy.No.1709 export approved in Pharmaceu contains:- Rs.50,000/= order reference ticals Vitamin D3 from agencies Islamabad (Cholecalciferol) Afghani . …200000 IU stan (Vitamin Supplement)
Accordingly, M/s Global Pharmaceuticals, Islamabad & M/s scotmann Pharmaceuticals, Islamabad have submitted import order of the above products from Tajikistan & Afghanistan and requested for grant of registration of above products for export purpose only.
Minutes 256th Meeting Registration Board 122
Decision: Registration Board deferred the case for decision on export registration applications not approved by regulatory authorities of reference agencies.
b. M/s Aurik have applied for registration of following products for export purpose only through contract manufacturing from M/s Bio-Labs, Islamabad.
Name of Name of Name of drug(s) & Date of application, Applicant Contract Composition Diary No. & Form manufacturer M/s Aurik M/s Bio-Lab’s Zone 3 1gm Injection I.M 10-12-2015 Pharmaceuticals Pharmaceuticals Each vial contains: Dy.No.1969 (Pvt) Ltd, Islamabad. Ceftriaxone Sodium Rs.50,000/= Islamabad. Equivalent to Ceftriaxone………1gm (USP Specs.)
Decision: Registration Board approved grant of export registration by contract manufacturing as per above details in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.
c. Non me too -New Drugs.
Following firms have requested for registration of following drugs for export purpose only which are not me-too & are new drugs. Details are as under:-
S. Name of Name of product(s) Date of Import Approval status by No. Company application, Order reference regulatory Diary No. & authorities Form
1. M/s Glitz Sofoglit – L Tablet 29.01.2016 Copy of FDA approved Pharma, Plot Each film coated tablet 20128 export No. 265, contains: Rs. 50,000/- order from Industrial Ledipasvir……..90mg Triangle, Sofosbuvir………400mg Kahuta Road, Islamabad 2. -do- Linaglipt 5mg tablet 14.12.2015 -do- Each film coated tablet 1983 contains: Rs. 20,000/- Linagliptin………..…..5mg 3. -do- Sofoglit 400mg tablet 14.12.2015 -do- Each film coated tablet 1984 contains: Rs. 20,000/- Sofosbuvir………400mg 4. M/s. Focus & C-Cure 400mg Tablet 12.10.2015 Copy of USFDA approved Rulz Each film Coated tablet 1742 export Pharmaceutic contains: Rs. 20,000/- order from
Minutes 256th Meeting Registration Board 123
al (Pvt) Ltd., Sofosbuvir………400mg Afghanista 44-Industrial n Triangle, Kahuta Road, Islamabad 5. M/s Viracid 400mg Tablet 14.01.2016 Export Paramount Each film Coated tablet 1994 order not Pharmaceutic contains: Rs. 20,000/- provided. al, 36- Sofosbuvir…….……400mg Industrial Triangle, Kahuta Road, Islamabad
Decision: Registration Board approved the request of the firm for grant of registration of above product except for product at S.No.02 due to comments of IPO.
Case No.28.
Registration Board in its M-250th meeting deferred the following products of M/s Medera Pharmaceuticals, Islamabad for evaluation of the case.
Name of Name of Reg. Name of drug(s) & Date of Contract permission Applicant Contract No. Composition applicatio valid up till and manufact n, Diary Registration Board urer No. & Meeting of previous Form approval M/s Medera M/s 056068 Medixim 100mg 26-06-2015 Extended till Pharmaceutic Caraway Suspension Dy.No.323 30.06.2015. The firm als (Pvt) Ltd, Pharmaceut Each 5ml contains:- Rs.50,000/ submitted the Islamabad. icals Cefixime (as = evidence of Rawat. trihydrate)…….…100 remaining fee mg Rs.8000/- deposited (USP Specs.) on 29.06.2010.. -do- -do- 056069 Medixim 200mg 26-06-2015 -do- Suspension Dy.No.325 Each 5ml contains:- Rs.50,000/ Cefixime (as = trihydrate)…….…200 mg (USP Specs.)
-do- -do- 056070 Medixim 200mg 26-06-2015 -do- Capsules Dy.No.326 Each capsule contains:- Rs.50,000/ Cefixime (as = trihydrate)…….…200 mg (USP Specs.)
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-do- -do- 056071 Medixim 400mg 26-06-2015 -do- Capsules Dy.No.324 Each capsule contains:- Rs.50,000/ Cefixime (as = trihydrate)…….…400 mg (USP Specs.)
M/s Medera M/s Global 031695 Gigantic 250mg 26-06-2015 Extended till Pharmaceutic Pharmaceut Injection IM Dy.No.328 30.06.2015. als (Pvt) Ltd, icals Each vial contains:- Rs.50,000/ Islamabad. Islamabad. Ceftriaxone Sodium eq. = to Ceftriaxone………250 mg ( USP Specs.)
-do- -do- 031696 Gigantic 1gm Injection 26-06-2015 -do- IV Dy.No.329 Each vial contains:- Rs.50,000/ Ceftriaxone Sodium eq. = to Ceftriaxone………1gm (USP Specs.)
-do- -do- 053023 Gigantic 500mg 26-06-2015 -do- Injection IM Dy.No.327 Each vial contains:- Rs.50,000/ Ceftriaxone Sodium eq. = to Ceftriaxone………500 mg (USP Specs.)
Decision: Registration Board approved the extension in contract manufacturing permission of above products for till 30.06.2020 in light of Rule 20 A (Contract manufacturing) of Drugs (Licensing, Registering & Advertising) Rules, 1976.
Case No.29
Registration Board has been considering the registration of Tamsol-D tablets in various meetings. The history of the case is summarized as below: a) The Registration Board in its 229th meeting registered the following formulation of M/s Global Phramaceuticals, Islamabad. Tamsol-D Tablets Each film coated tablet contains: Tamsulosin hydrochloride……0.4 mg (as modified release tablet)
Minutes 256th Meeting Registration Board 125
Dutasteride……………………...0.5 mg
b) Accordingly, the registration letter was issued on 11th September, 2012. Later on, the Registration Board in its 239th meeting reconsidered the above formulation on recognition of the fact that the same has no approval internationally (or by any reference drug agencies) and decided to ask the manufacturer to appear before the Board for presenting his opinion regarding efficacy of the above formulation. The Board further ordered to suspend the registration of said product under section 7(11)(a&d) of Drugs Act, 1976 till final decision on the formulation.
c) In M-246th meeting, the Registration Board reconsidered the case and decided to issue the show cause notice to M/s Global pharmaceutical, Islamabad for the cancellation of registration of above product. Accordingly, the show cause notice was issued to the firm on 23rd January, 2015. The firm in response to the said show cause notice replied & submitted following informations as under and requested for withdrawal of show cause notice:-
i. Introduction of formulation (Tablets in Tablets) in relation with BPH ii. Approval of Dutasteride as a tablet by USP Medicine Compendium iii. Approval of Tamsulosin as a tablet by MHRA, UK iv. Proof of in-vitro efficacy of the Tamsol-D Tablets according to the ICH Guidelines Q8 (R2) v. Availability of same technology (Tablet in Tablet) in India (Cipla Pharma) vi. Comparative Dissolution Study of Tamsol-D Tablets vs Duodart Capsule of GSK, showing no difference of Assay and Drug Release Pattern vii. Stability Study of Tamsol-D Tablets (Accelerated and Real Time), which again shows Efficacy of Tamsol-D Tablets even after 22 months result of Real Time Study. viii. Clinical survey of Tamsol-D Tablets from top most Chief Consultants, Consultants, Head of Urology, Professors, Assistant Professors which include their comments regarding the Efficacy of the product showing Effectiveness of the Tamso-D Tablets ix. 40% less Retail Price as compared to the available marketed brand. x. Company’s Investment in the “Tablet in Tablets Technology”.
d) The above reply of the firm was considered by the Board in its M-248th meeting. The Board deferred the case for personal hearing on the request of the firm till next meeting. In the next meeting the case could not be placed on the agenda and hence was not discussed in the meeting.
e) Since the formulation was already under review as applied by many other firms, the Board in its M-250th meeting after completion of its review on the formulation decided as below: Minutes 256th Meeting Registration Board 126
i. Applicants shall either revise their formulation to capsule dosage form as per innovator, if not registered previously and if manufacturing facility is approved by CLB (new registration application with complete fee) or,
ii. Shall submit Pharmaceutical development data including stability, bioavailability/ bioequivalence studies within six months period.
iii. For already registered drugs if any, same procedure as mentioned above (at Sr. No. i & ii) shall be adopted. Otherwise show cause notice shall be issued for de-registration of registered drugs in this formulation
iv. All such application shall be processed on priority basis.
In the light of above decision, the firm has submitted that they have already conducted the Pharmaceutical Development studies and stability studies (both Accelerated and Real- Time) and they are in the process of conducting the Bioequivalence studies of above formulation. Now, they have asked what would be the status of their above registered product in case they complete the Bioequivalence studies and the studies prove that their product is Bioequivalent with that of innovator. The firm stated if it would be acceptable by the DRAP then could they manufacture this product in Tablet general on campaign manufacturing with all necessary measures including cleaning validation.
Further, the Area FID & Chief Drug Inspector, Punjab & other Provincial Inspectors have been asking about the registration status of the said product & also about the query that whether the firm can manufacture the product in the light of Registration Board decision.
Registration Board in view of the above situation in its M-254th meeting defer the case for personal hearing against the show cause Notice already served the firm on dated 23rd January, 2015, considering the following two aspect of the case: a) The firm cannot manufacture the product since the efficacy of the product has now come under question in the light of decision of Registration Board taken in its M-250 meeting and untill the firm will submit the required studies like Bioequivalence studies, Pharmaceutical Development studies and Stability studies etc. for approval of the same by the Registration Board.
b) The firm does not possess the Steroid section for Tablet dosage form which is evident from the latest inspection report conducted by the FID on dated 08-16- 2016.
The firm has been called for personal hearing on the issue and final decision by the registration board on the registration of subject Drug i.e. Tamsol-D Minutes 256th Meeting Registration Board 127
Decision: Muhmmad Suleman, Manager Regulatory Affair appeared before the Board and informed that lawyer of firm could not due to disrupted flight schedule. Registration Board deferred the case till next meeting with direction that next opportunity will be final and decision will be taken accordingly.
Case No.30
Registration Board in M-254 meeting discussed the following product while considering the request of the firm M/s Vision Pharmaceuticals, Islamabad for transfer the following product from their previous site Plot No.224, Street No.1, I-10/3, Islamabad to new site Plot No.22- 23, Industrial Triangle, Kahuta Road, Islamabad and decided to discuss in light of approval status in reference regulatory authorities.
Reg.No. Brand Name / Label Claim Demande Demande Date of d Pack d Price Submission Size 041730 Sebastin 10mg Tablets 10’s As Per 03-07-2015 Each tablet contains: SRO Dy.No.1526 Ebastine…..……10mg Rs.20,000/=
Now, it has been confirmed that the product is found approved in the Germany. Therefore, request of firm is submitted for consideration before Registration Board. Decision: Registration Board approved request of the firm for manufacturing of above product at its new manufacturing site i.e. M/s Vision Pharmaceuticals Plot No.22-23, Industrial Triangle, Kahuta Road, Islamabad.
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Registration-IV Case No.31: Registration of Drugs for export purpose.
The following firm has applied for registration of drugs for the purpose of export only
S. # Name of Name of Drug (s)/Composition. Remarks Manufacturer 1. M/s. Medicraft Pikovit-C Syrup Notarized Export Pharmaceuticals, Each 5ml contains:- order Peshawar Retinol (Vitamin A)……….1.5mg Vitamin D3 (Colecalciferol)…..0.700gm Riboflavin (B2)…………………1mg Pyridoxin hydrochloride(B6)….0.6mg Cyanocobalamin (B12)……….1mcg Nicotinamide………………………5mg Dexpenthenol……………...2mg Thiamine Hydrochloride (B1)…..1mg Ascorbic Acid (Vit.C)…………..50mg
2 M/s. Fedro Rovits Syrup Notarized Export Pharmaceuticals, Each 5ml contains:- order Peshawar. Vitamin A (Palmitate)…..1200IU Vitamin D3 Cholecalciferol..100IU Thiamine HCl(VitB1)…………..01mg Riboflavin (VitB2)……………01mg Pyridoxine HCl (Vit B6)………0.50mg Nicotinamide (B3)……………0.5mg Calcium Lactate Gluconate…40mg Dexpanthenol………….02mg Vitamin C………………….50mg Vitamin E Acetate………….1mg Vitamin B12………………….10mcg
3 -do- Fediplex-L Syrup Notarized Export Each 30ml contains:- order Thiamine HCl(Vit B1)……..6mg Riboflavin (Vit B2)………..6mg Pyridoxine HCl(Vit B6)……….4mg Nicotinamide……………….46mg Lysine Mono.HCl…………100mg
4 M/s. Frontier Multi-A Tablets Notarized Export Dextrose Each tablet contains:- order Pharmaceuticals, Ascorbic Acid…..…………….200mg Hattar Vit.B1…………………………..10mg Contract Vit. B2…………………………..5mg manufactured by by Vit.B6…….…………………….5mg M/s. Curatech Vit.B12………………………6mcg Pharma, Lahore Calcium Pantothenate………20mg
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Calceferol…………………..10mcg Iron Salt……………………10mg Iodine………………………150mcg Magnesium hydroxide & Oxide….5mg Copper……………………………..1mg Cobalt…………………………..0.1mg Maganese………………………..1mg Nicotinamide……………………100mg Molybdenum……………………0.2mg Potassium salt……………………5mg Retinol Vit.A…………………….1.5mg Zinc Ozide…………………….1.5mg
5 -do- Calci-D Tablets Notarized Export Each tablet contains:- order Vitamin D………………….100IU Calcium as Carbonate…….400mg
6 -do- Ironmult Capsule Notarized Export Each capsule contains:- order Cyanocobalamin……………….7.5mcg Folic Acid……………..………..1.0mg Copper Sulphate……………….0.2mg Magnese sulphate………………0.2mg Sorbitol……………………….…25mg Ferrous Gluconate………………250mg
7 -do- Multi-C Tabelts Notarized Export Each tablet contains:- order Ascorbic Acid…………………..500mg Calcium Carbonate……………327mg Sodium Bicarbonate……………..1.0gm Calcium Lactate…………………1.0gm 8 -do- Paradin Tablets Notarized Export Each tablet contains:- order Paracetamol ………………500mg Codeine Phosphate………..15mg
9 -do- Paradex Tablets Notarized Export Each tablet contains:- order Paracetamol………………….325mg Dextropropoxyphene HCl……32.5mg
10 M/s. Wnsfeild Rafin 3mg Tabelts Notarized Export Pharmaceuticals, Each film coated tablet contains:- order Hattar Warfarin sodium ≡Warfarin….…..3mg
The firm submitted all the relevant documents along with the fee of Rs.20000/- each and requested for registration of drugs for export purpose only.
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Decision:- Registration Board decided as follows:
i) Approved items at S.No. 1-3 and 10 for registration for export purpose only. Firm will deposit remaining fee and authorized Chairman for issuance of letter. ii) Approved items at S.No. 4-7 for registration for export purpose only. Products will be contract manufactured by M/s. Curatech Pharmaceuticals, Lahore in light of Rule 20A of Drugs (L,R &A) Rules, 1976.
iii) Items at S.No. 8-9 are rejected as contract manufacturing for Narcotic/Psychotropic drugs is not permitted.
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RRR section
Case No.32: Renewal of products of M/s Global Veterinary & Technical Services (Pvt) Ltd. and change of manufacturer name from M/s Eagle Chemical Co. Ltd., Korea to M/s Eagle Vet Tech Co. Ltd., Korea.
The firm M/s Global Veterinary & Technical Services (Pvt.) Ltd., Multan applied for Renewal/Change of manufacturer name from M/s Eagle Chemical Co. Ltd., Korea to M/s Eagle Vet Tech Co. Ltd., Korea in January 2007 with fee of Rs. 15000/- per product for the following registered products.
S. # Regn. No. Name of Drug(s) Initial letter Validity of of Regn. Regn. 1. 021437 Enprotil Solution 04-09-1998 Validity until 03-09-2008 2. 021438 Enprotil-50 Injection -do- -do- 3. 021440 Collie-SP Powder -do- -do- 4. 021441 Cocci-AF Powder -do- -do-
The case for renewal / change of manufacturer name was not taken up due unsatisfactory report by the Panel of Inspectors with reference to non-compliance of cGMP by the manufacturer abroad. However the second Panel of Inspectors approved the cGMP compliance of the firm. The firm had deposited a fee of fee Rs. 7500/- for each product on 19-12-2011 for renewal of each product. In addition to this the firm had also deposited a fee of Rs. 100000/- (Rs. 85000/- (14-07-14) and Rs. 15000/- (15-09-14) for the above referred to products. The case for renewal / change of manufacturer name was brought for deliberation in the Registration Board (RB) in its 249th Meeting but was deferred, however, the case was considered by the RB in its 251st Meeting and the decision was made. The case presented and the decision made in the 251st Meeting of the RB is reproduced as under:
M/s. Global Veterinary & Technical Services (Pvt.) Ltd; Multan has applied for renewal of drug registration with following details:-
M/s. Global Reg.No. Name of Initial letter Validity of Last renewal Veterinary & Drug(s) of Registration Technical Services Registration (Pvt.) Ltd; Multan has applied for renewal of drug registration with following details:- S. No.
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1. 021437 Enprotil 04-09-1998 Validity until Due on 03- Solution 03-09-2008 09-2013 but no application received in this section. 2. 021438 Enprotil- -do- -do- -do- 50 Injection 3. 021440 Collie-SP -do- -do- -do- Powder 4. 021441 Cocci-AF -do- -do- -do- Powder
Registration-I section was requested in the matter to verify the above said application. The Reg-I section has informed that the request of the firm was received in R-I section but decision was not occurred due to GMP compliance of the manufacturing facility of the firm in Korea, later on the issue of GMP resolved but approval of change of name was still not done. He has proposed that to place the matter before the Registration Board for further deliberation and decision on the matter please. Decision: Registration Board acceded to the request of the firm for the grant of renewal of the above mentioned products, as firm applied for change in manufacturer’s name in 2011 and was also considered as renewal of registered product.”
The decision made in 251st Meeting is not clear as validity period of the renewal of registration of above referred to products was not mentioned, hence, the case is submitted for consideration of the RB.
Decision: Registration Board deferred the case with advise to bring complete record for consideration.
Case No. 33: SOPs for renewal of registration.
Under Rule 27 of Drugs (Licensing, Registering & Advertising) Rules, 1976 a Certificate of Registration shall be valid for a period of 5 years and may thereafter be renewed for periods not exceeding 5 years. Application for renewal of registration of a drug shall be made in form 5-B. The check list for import and local drugs is as under: For imported products 1. Form F-B 2. Attested copy of initial Registration letter/certificate. 3. Attested copy of post registration variations (if applicable) 4. Attested copy ADC release / clearance of consignment imported last time 5. Attested copy of valid Drugs Sales License 6. Attested copy of last Renewal / challan 7. Undertaking that the applied products were never de-registered
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8. Certificate of Pharmaceutical Products 9. Free Sale Certificate in country of origin 10. Foreign inspection of the manufacturing firm as per prevailing Import Policy 11. Attested copies of subsequent renewals with an undertaking by the Director / Owner of the firm or an Authorized person on his behalf declaring that the submitted documents are true copy of the originals and that, if at any stage any discrepancy / misinformation is detected / observed the firm/company will be held responsible as per law. For locally manufactured products 1. Form F-B 2. Attested copy of initial Registration letter/certificate. 3. Attested copy of post registration variations (if applicable) 4. Name of Production Manager and Quality Control Manager approved by the Central Licensing Board as required for completion of Form 5-B 5. Last production of the batch of drug with date 6. Approval of the section (by Central licensing Board) 7. Approval of the Incharge of Section (by Central licensing Board) 8. Attested copy of Drug Manufacturing License (DML) 9. Attested copy ADC release / clearance of consignment imported last time 10. Attested copy of last Renewal / challan 11. Undertaking that the applied products were never de-registered 12. Copy of NOC of Central Research Fund (CRF) 13. Attested copies of subsequent renewals with an undertaking by the Director / Owner of the firm or an Authorized person on his behalf declaring that the submitted documents are true copy of the originals and that, if at any stage any discrepancy / misinformation is detected / observed the firm/company will be held responsible as per law.
The check list for renewal of Registration of Drugs for import and local drugs is placed for consideration before the Registration Board.
Decision: Registration Board deferred for comments of stakeholders i.e. PPMA, Pharma Bureau and PCDA.
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B. Pharmaceutical Evaluation Cell
Case No. 01. Personal Hearing Cases of Sofosbuvir 400 mg Tablets considered in 253rd meeting of Registration Board.
The following cases were considered by RB in 253rd meeting and passed the orders as follows.
S # Name of firm Name of the Drug Decision of the Board in 253rd Meeting
1. M/s Crystolite Hepvir tablets Mr.Amir Raza, Quality Control Manager presented Pharma, (Sofosbuvir) 400 the data. Registration Board observed that the Islamabad mg stability data provided by the firm is in accordance with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. 2. M/ s Searle Tablet Sobvi 400mg Mr.Anwar Jamal presented the data. Registration Company Ltd Board observed that the stability data provided by Karachi the firm is in accordance with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. 3. M/s Wilson Saferon Tablets Mr.Tipu Sultan Akram presented the data. Pharmaceuticals 400mg Registration Board observed that the stability data Islamabad provided by the firm is in accordance with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. 4. M/s Werrick Cell-tab Tablets Mr.Tipu Sultan Akram presented the data. Pharmaceuticals 400mg Registration Board observed that the stability data Islamabad provided by the firm is in accordance with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal
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Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. 5. M/s Scottmann HEPALDI Tablets Mr.Tipu Sultan Akram presented the data. Pharmaceuticals 400mg Registration Board observed that the stability data Islamabad provided by the firm is in accordance with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.
6. M/s Max Sofavir tablets Mr.Riaz, Quality Control Manager presented the Pharmaceuticals (Sofosbuvir) 400 data. Registration Board observed that the stability Islamabad mg data provided by the firm is in accordance with the guidelines approved by the Board in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. 7. M/s Everest Ledisovir tablets Mr.Muhammad Usman, CEO presented the data. Pharmaceuticals (Ledipasvir 90 mg + He informed that firm has requested DRAP, Islamabad Sofosbuvir) 400 mg Islamabad four times dated 21-03-15, 26-03-15, 14- 04-15 and 27-04-15 for conduction of GMP inspection and also deposited fee Rs5000/- as per DRAP’s requirement. Registration Board inquired from representative of QA & LT Division about GMP status of the manufacturer. GMP inspection report was presented before the Board on 06.10.2015 and tablet section was found satisfactory. Registration Board observed that the stability data provided by the firm is in accordance with the recommendations of the Board finalized in 251st meeting. Therefore, Board granted approval of registration of Ledipasvir 90 mg + Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product. 8. M/s Everest Sovir tablets Mr.Muhammad Usman, CEO presented the data. Pharmaceuticals (Sofosbuvir) 400 He informed that firm has requested DRAP, Islamabad mg Islamabad four times dated 21-03-15, 26-03-15, 14-
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04-15 and 27-04-15 for conduction of GMP inspection and also deposited fee Rs5000/- as per DRAP’s requirement. Registration Board inquired from representative of QA & LT Division about GMP status of the manufacturer. GMP inspection report was presented before the Board on 06.10.2015 and tablet section was found satisfactory. Registration Board observed that the stability data provided by the firm is in accordance with the recommendations of the Board finalized in 251st meeting. Therefore, Board granted approval of registration of Sofosbuvir 400 mg tablets to the firm. However, manufacturer will inform concerned Federal Inspector of Drugs for taking sample of Active Pharmaceutical Ingredient (used in manufacture of first commercial batch) for test/ analysis from Central Drugs Laboratory, Karachi before sale of finished product.
2. In 254th meeting of RB, all the above cases were again discussed and a panel was constituted to verify the genuineness / authenticity of stability data. A panel comprising of Brig. M.H.Najmi, Member RB, Dr. Saif-Ur-Rehman Khattak, FGA, CDL, Karachi and Dr. Obaidullah, Secretary RB, conducted inspections of all the firms mentioned above. Details reports of above firms are as follows:-
1. M/s Crystollite Pharma, Islamabad Hepvir Tablets (Sofosbuvir 400 mg)
253rd Registration Board Meeting Investigation Date and Time: 8th December 2015 (Forenoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has imported 500g sofosbuvir API import of sofosbuvir API? through DHL. Proper tracking can be made from the available documents with address of head office. However no approval from DRAP has been taken. 2. What was the rationale behind selecting The rationale behind selecting the the particular manufacturer of API? manufacturer is its GMP Status only. 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard import of sofosbuvir standard and impurity and impurity standards? standard. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API API, reference standards and impurity only. standards? 5. Do you have any approval of API or GMP The firm has GMP certificate of API certificate of API manufacturer issued by manufacturer issued by regularity authority of regulatory authority of country of origin? country of Origin. 6. Do you use API manufacturer method of The firm uses their own developed method for testing? API testing.
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7. Do you have stability studies reports on The firm does not have stability studies API? reports on API. 8. If yes, whether the stability testing has No Data Available. been performed as per SIM method and degradation products have been quantified? 9. Do you have method for quantifying the The firm is using their own method for testing impurities in the API? the API which is not capable to quantify the impurities in the API. 10. Do you have some remaining quantities of The firm has some remaining quantities of the the API, its reference standard and API only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients import of the used excipients? are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain quality on the excipients used? parameters of the some of the excipients used. 14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of sofosbuvir tablets however there is no written sofosbuvir tablets? and authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any drug- compatibility studies? excipient compatibility studies although the composition of their tablets is different from that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has not performed comparative dissolution studies? dissolution studies however their product show acceptable dissolution profile as per general monograph of BP for dissolution test . 17. Do you have product development (R&D) The firm does not have proper dedicated section product development (R&D) section. 18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets? 19. Are the equipments in product The whole development work has been development section qualified? performed on equipment used for commercial production and there is no qualification of any of these equipment. 20. Do you have proper maintenance / The firm has calibration program in place calibration / re-qualification program for however there is no such program for the equipment used in PD section? maintenance and re qualification of their any equipment in production or quality control.
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21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper product development. knowledge and training in product development? 22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablet with batch number (T-CP-001, T-CP- 002 and T-CP-003 respectively. Each batch has a size of 400 tablets. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of The firm has complete record of production of production of stability batches? stability batches. All the Log Books are proper maintained. 25. Do you have protocols for stability testing The firm has detailed protocols for stability of stability batches? testing of stability batches. 26. Do you have developed and validated the The firm has developed and validated the method for testing of stability batches? method of testing for testing their stability batches however the method has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in Not Applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The firm does not have any documented qualification of equipments / instruments evidence confirming the qualification of being used in the test and analysis of equipment / instruments being used in the test Sofosbuvir API and the finished drug? and analysis of Sofosbuvir API and the finished drug. 29. Do your method of analysis stability The method of analysis for the stability studies indicating? is not stability indicating. The Chromatograms in the HPLC are not software secured, even there is no date on the chromatograms which can justify the minimum traceability hence systems traceability of the analytical record cannot be made. 30. Do your HPLC software is 21CFR The HPLC software is not 21CFR Compliant. compliant?
31. Can you show Audit Trail reports on Audit trail on the testing reports cannot be sofosbuvir testing? made.
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32. Do you have some remaining quantities of The firm has remaining quantities of stability degradation products and stability batches however there is no quantity of batches? degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches kept stability testing? on stability testing for real time stability testing. 34. Do you have valid calibration status for The firm has valid calibration status for the the equipments used in sofosbuvir tablets equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Since no system traceability at any level can be made therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Hepvir Tablets ( Sofosbuvir 400mg ) is not verifiable.
2. M/s Searle Company, Karachi Sobvi tablets (Sofosbuvir 400 mg) 253rd Registration Board Meeting Investigation Date and Time: 30Th November 2015 (Forenoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The Firm has imported 200g API (Sofosbuvir) import of sofosbuvir API? from M/S Bejing Methong China and has approval from DRAP for import. 2. What was the rationale behind selecting There is proper vendor evaluation form being the particular manufacturer of API? implemented by the firm and the rationale behind selecting the manufacturer is its GMP Status 3. Do you have documents confirming the The firm has the API working standard import of sofosbuvir reference standard documents and there is no documents for any and impurity standards? impurity standard. Moreover no impurity standard has been procured by the firm. 4. Do you have certificate of Analysis of the The firm has certificates of an analysis for the API, reference standards and impurity API and the working standard. standards? 5. Do you have any approval of API or The firm has GMP certificate of API GMP certificate of API manufacturer manufacturer issued by regularity authority of issued by regulatory authority of country country of Origin but it is not the API Specific of origin? 6. Do you use API manufacturer method of The firm has used API manufacturer method testing? of testing. 7. Do you have stability studies reports on The firm does not have stability studies API? reports on API.
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8. If yes, whether the stability testing has Not Applicable been performed as per SIM method and degradation products have been quantified? 9. Do you have method for quantifying the The firm has method for quantifying the impurities in the API? impurities in the API. 10. Do you have some remaining quantities The Firm does not have remaining quantities of the API, its reference standard and of the API and impurities standards however impurities standards? some quantities of the working standard for the API is still available with the firm 11. Have you used pharmaceutical grade The firm has used Pharmaceuticals grade excipients? excipients. 12. Do you have documents confirming the The firm has documents confirming the import of the used excipients? import of the used excipients. 13. Do you have test reports and other records The firm has test reports and other records on on the excipients used? the excipients used. 14. Do you have written and authorized There is no written and authorized protocols protocols for the development of for the development of sofosbuvir tablet being sofosbuvir tablets? produced by the firm. 15. Have you performed Drug-excipient The firm has not performed Drug-Excipient compatibility studies? compatibility studies. The composition of the tablets being manufactured by the firm is different from that of Sovaldi Tablets in respect of the lubricant (Sodium stearyl fumarate in place of stearic acid). 16. Have you performed comparative The firm has not performed comparative dissolution studies? dissolution studies. 17. Do you have product development (R&D) The firm has dedicated product development section (R&D) section. 18. Do you have necessary equipments The firm has necessary equipment available in available in product development section product development section for development for development of sofosbuvir tablets? of sofosbuvir tablets. 19. Are the equipments in product The equipment in product development development section qualified? section are not qualified.
20. Do you have proper maintenance / The firm does not have proper re-qualification calibration / re-qualification program for program however maintenance and calibration the equipment used in PD section? programs are available for the equipment used in PD section. 21. Do you have qualified staff in product The firm has qualified staff in product development section with proper development section with reasonable knowledge and training in product knowledge in product development. development?
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22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablets. The Batch size of each batch is 165 Tables having batch no 14pd-080/A, 14PD- 080/B and 14Pd -080/C respective. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of The firm has batch manufacturing records for production of stability batches? the production of three stability batches. Each batch is of 165 tablets. During review of the manufacturing records it was found that the test/ analysis has been performed at different stages of the manufacturing of the tablets however there is no decrease in the number of the tablets irrespective of the fact that all these tests are destructive in nature. The final yield of tablets packed is 165 tablets i.e the original batch size. This irregularity show that the record is not authentic and genuine. Moreover no entry in log books for entering the activities of production at various production equipment is available .This also show gross deviation from the standard practice of GMP retarding the cross verification of production activities being undertaken. 25. Do you have protocols for stability testing The firm has protocol for stability testing of of stability batches? stability batches. 26. Do you have developed and validated the The firm has developed and validated the method for testing of stability batches? method for testing of stability batches however the method is not stability indicating which is the essential requirement of established guidelines for stability is testing. 27. Do you have method transfer studies in Not Applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The qualification of the equipment being used qualification of equipments / instruments in the manufacturing of finish drug has not being used in the test and analysis of been done however the documents related to sofosbuvir API and the finished drug? qualification of testing instruments is available. 29. Do your method of analysis stability The method of analysis for the stability indicating? studies is not stability indicating. The Chromatograms in the HPLC are not software secured, even there is no date on the chromatograms which can justify the
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minimum traceability. Hence systems traceability of the analytical record cannot be made. 30. Do your HPLC software is 21CFR The HPLC software is not 21CFR Compliant. compliant?
31. Can you show Audit Trail reports on Audit trail on the testing reports cannot be sofosbuvir testing? made.
32. Do you have some remaining quantities The firm has remaining quantities of stability of degradation products and stability batches however there is no quantity of batches? degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches kept stability testing? on stability testing for real time stability testing. 34. Do you have valid calibration status for The firm has valid calibration status for the the equipments used in sofosbuvir tablets equipment used in sofosbuvir tablets production in analysis? production and analysis.
Conclusions: Since no system traceability at any level can be made therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Sobvi (Sofosbuvir 400mg ) is not verifiable.
3. M/s Wilson Pharmaceutical, Saferon Tablets (Sofosbuvir 400 253rd Registration Islamabad mg) Board Meeting Investigation Date and Time: 10th December 2015 (Afternoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has imported 600g sofosbuvir API import of sofosbuvir API? through M/s Morgan Karachi. However no invoice for M/s Wilson and approval from DRAP could be shown to the panel. 2. What was the rationale behind selecting The rationale behind selecting the manufacturer is the particular manufacturer of API? its GMP Status only. 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard import of sofosbuvir standard and impurity and impurity standards? standard. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API API, reference standards and impurity only. standards? 5. Do you have any approval of API or The firm has GMP certificate of API manufacturer GMP certificate of API manufacturer issued by regularity authority of country of Origin. issued by regulatory authority of country of origin? 6. Do you use API manufacturer method of The firm has developed their own method for API testing? testing
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7. Do you have stability studies reports on The firm has stability studies reports on API API? provided by API manufacturer 8. If yes, whether the stability testing has The stability testing has been performed on API been performed as per SIM method and by manufacturer as per SIM method and degradation products have been degradation products have been quantified.. quantified? 9. Do you have method for quantifying the The firm is using their own method for testing the impurities in the API? API which is not capable to quantify the impurities in the API. 10. Do you have some remaining quantities The firm has some remaining quantities of the API of the API, its reference standard and only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients are import of the used excipients? available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain quality on the excipients used? parameters of the some of the excipients used. 14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of sofosbuvir tablets however there is no written and sofosbuvir tablets? authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any drug-excipient compatibility studies? compatibility studies although the composition of their tablets is different from that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has performed comparative dissolution dissolution studies? studies and their product show comparable acceptable dissolution profile. The method for analysis was spectrophotometric, therefore system traceability could not be made. Moreover, respective entries in log book for dissolution apparatus and spectrophotometer were not traceable. 17. Do you have product development (R&D) The firm does not have proper dedicated product section development (R&D) section and used general area for manufacturing of stability batches. However entries in respective area log books were partially available but without any serial indexing. 18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets? 19. Are the equipments in product The whole development work has been performed development section qualified? on equipment used for commercial production and there is no qualification of any of these equipment.
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20. Do you have proper maintenance / The firm has calibration program in place however calibration / re-qualification program for there is no such program for maintenance and re the equipment used in PD section? qualification of their any equipment in production or quality control. 21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper product development. knowledge and training in product development? 22. Have you manufactured three stability The firm has manufactured three stability batches batches for the stability studies of for the stability studies of sofosbuvir tablet with sofosbuvir tablets as required? batch number (Trial 1, Trial 2 and Trial 3) with batch size of 400 tablets each. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for fixing size of stability batches? the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of The firm has complete record of production of production of stability batches? stability batches as per their batch manufacturing record. Although firm has used manufacturing equipment of commercial area but separate log books for trial batches (compression only) were prepared instead of using general log books. For rest of processes, log books of general areas are used but without any serial indexing. 25. Do you have protocols for stability testing The firm has methods for stability testing of of stability batches? stability batches. 26. Do you have developed and validated the The firm has developed and validated the method method for testing of stability batches? of testing for testing their stability batches however the method has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in Not applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The firm does not have any documented evidence qualification of equipments / instruments confirming the qualification of equipment / being used in the test and analysis of instruments being used in the test and analysis of sofosbuvir API and the finished drug? sofosbuvir API and the finished drug. 29. Do your method of analysis stability The method of analysis for the stability studies is indicating? not stability indicating. The firm informed that chromatograph used for the analysis of stability batches is out of order and therefore no data in the chromatograph could be shown to the panel. 30. Do your HPLC software is 21CFR The HPLC software is not 21CFR Compliant as compliant? per record of the firm.
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31. Can you show Audit Trail reports on Audit trail on the testing reports cannot be sofosbuvir testing? made.
32. Do you have some remaining quantities The firm has remaining quantities of stability of degradation products and stability batches however there is no quantity of batches? degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches kept stability testing? on stability testing for real time stability testing. Panel observed that stability chamber for real time stability was set at 25C, 60%RH, which is not as per Zone IVA and thus real time stability data is not reliable. 34. Do you have valid calibration status for The firm has valid calibration status for the the equipments used in sofosbuvir tablets equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Since no stability data in the system was shown to the panel, therefore no system traceability regarding analysis at any level could be made. Therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Saferon Tablets (Sofosbuvir 400mg) is not verifiable.
4. M/s Werrick Cell-tab Tablets (Sofosbuvir 400 253rd Pharmaceutical, Islamabad mg) Registration Board Meeting Investigation Date and Time: 10th December 2015 (Afternoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has imported 600g sofosbuvir API import of sofosbuvir API? through M/s Morgan Karachi. However no invoice for M/s Werrick and approval from DRAP could be shown to the panel. 2. What was the rationale behind selecting the The rationale behind selecting the particular manufacturer of API? manufacturer is its GMP Status only. 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard and import of sofosbuvir standard and impurity impurity standards? standard. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API, reference standards and impurity API only. standards? 5. Do you have any approval of API or GMP The firm has GMP certificate of API certificate of API manufacturer issued by manufacturer issued by regularity authority of regulatory authority of country of origin? country of Origin. 6. Do you use API manufacturer method of The firm has developed their own method for testing? API testing
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7. Do you have stability studies reports on The firm has stability studies reports on API API? provided by API manufacturer 8. If yes, whether the stability testing has been The stability testing on API by manufacturer performed as per SIM method and has been performed as per SIM method and degradation products have been quantified? degradation products have been quantified.
9. Do you have method for quantifying the The firm is using their own method for testing impurities in the API? the API which is not capable to quantify the impurities in the API. 10. Do you have some remaining quantities of The firm has some remaining quantities of the the API, its reference standard and API only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients import of the used excipients? are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain quality on the excipients used? parameters of the some of the excipients used. 14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of sofosbuvir sofosbuvir tablets however there is no written tablets? and authorized protocol for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any drug- compatibility studies? excipient compatibility studies although the composition of their tablets is different from that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has performed comparative dissolution studies? dissolution studies and their product show comparable acceptable dissolution profile. The method for analysis was spectrophotometric, therefore system traceability could not be made. Moreover, respective entries in log book for dissolution apparatus and spectrophotometer were not traceable. 17. Do you have product development (R&D) The firm does not have proper dedicated section product development (R&D) section and used general area for manufacturing of stability batches. However entries in respective area log books were partially available but without any serial indexing. 18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets?
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19. Are the equipments in product development The whole development work has been section qualified? performed on equipment used for commercial production and there is no qualification of any of these equipment. 20. Do you have proper maintenance / The firm has calibration program in place calibration / re-qualification program for the however there is no such program for equipment used in PD section? maintenance and re-qualification of any equipment in production or quality control. 21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper knowledge product development. and training in product development?
22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablet with batch number (Trial 1, Trial 2 and Trial 3) with batch size of 400 tablets each. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of production The firm has complete record of production of of stability batches? stability batches as per their batch manufacturing record. Although firm has used manufacturing equipment of commercial area but separate log books for trial batches (compression only) were prepared instead of using general log books. For rest of processes, log books of general areas are used but without any serial indexing. 25. Do you have protocols for stability testing The firm has methods for stability testing of of stability batches? stability batches. 26. Do you have developed and validated the The firm has developed and validated the method for testing of stability batches? method of testing for testing their stability batches however the method has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in case Not Applicable when the method of testing being used by your firm is given by any other lab?
28. Do you have documents confirming the The firm does not have any documented qualification of equipments / instruments evidence confirming the qualification of being used in the test and analysis of equipment / instruments being used in the test sofosbuvir API and the finished drug? and analysis of sofosbuvir API and the finished drug. 29. Do your method of analysis stability The method of analysis for the stability indicating? studies is not stability indicating. The firm informed that Deputy Manager, QC has pass
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word of chromatograph used for the analysis of API and stability batches and he has left the factory due to personal emergency and therefore no data in the chromatograph could be shown to the panel. 30. Do your HPLC software is 21CFR The HPLC software is not 21CFR Compliant compliant? as per record of the firm.
31. Can you show Audit Trail reports on Audit trail on the testing reports cannot be sofosbuvir testing? made.
32. Do you have some remaining quantities of The firm has remaining quantities of degradation products and stability batches? stability batches however there is no quantity of degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches stability testing? kept on stability testing for real time stability testing. 34. Do you have valid calibration status for the The firm has valid calibration status for equipments used in sofosbuvir tablets the equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Since no stability data in the system was shown to the panel, therefore no system traceability regarding analysis at any level could be made. Therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Cell-Tab Tablets (Sofosbuvir 400mg ) is not verifiable.
5. M/s Scottmann Hepaldi Tablets (Sofosbuvir 400 253rd Pharmaceutical, Islamabad mg) Registration Board Meeting Investigation Date and Time: 10th December 2015 (Forenoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has imported 600g sofosbuvir API import of sofosbuvir API? through M/s Morgan Karachi. However no invoice and approval from DRAP could be shown to the panel. 2. What was the rationale behind selecting the The rationale behind selecting the particular manufacturer of API? manufacturer is its GMP Status only. 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard and import of sofosbuvir standard and impurity impurity standards? standard. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API, reference standards and impurity API only. standards?
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5. Do you have any approval of API or GMP The firm has GMP certificate of API certificate of API manufacturer issued by manufacturer issued by regularity authority of regulatory authority of country of origin? country of Origin. 6. Do you use API manufacturer method of The firm has developed their own method for testing? API testing 7. Do you have stability studies reports on The firm has stability studies reports on API API? provided by API manufacturer 8. If yes, whether the stability testing has been The stability testing has been performed on performed as per SIM method and API by manufacturer as per SIM method and degradation products have been quantified? degradation products have been quantified.
9. Do you have method for quantifying the The firm is using their own method for testing impurities in the API? the API which is not capable to quantify the impurities in the API. 10. Do you have some remaining quantities of The firm has some remaining quantities of the the API, its reference standard and API only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients import of the used excipients? are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain quality on the excipients used? parameters of the some of the excipients used. 14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of sofosbuvir sofosbuvir tablets however there is no written tablets? and authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any drug- compatibility studies? excipient compatibility studies although the composition of their tablets is different from that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has performed comparative dissolution studies? dissolution studies and their product show comparable acceptable dissolution profile. The method for analysis was spectrophotometric, therefore system traceability could not be made. Moreover, respective entries in log book for dissolution apparatus and spectrophotometer were not traceable. 17. Do you have product development (R&D) The firm does not have proper dedicated section product development (R&D) section and used general area for manufacturing of stability batches. However entries in respective area log books were partially available but without any serial indexing. Moreover, firm informed Minutes 256th Meeting Registration Board 150
that they have used mixer of m/s Werrick Pharmaceuticals, Islamabad. 18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets? 19. Are the equipments in product development The whole development work has been section qualified? performed on equipment used for commercial production and there is no qualification of any of these equipment. 20. Do you have proper maintenance / The firm has calibration program in place calibration / re-qualification program for the however there is no such program for equipment used in PD section? maintenance and re-qualification of any equipment in production or quality control. 21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper knowledge product development. and training in product development?
22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablet with batch number (Trial 1, Trial 2 and Trial 3) with batch size of 400 tablets each. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of production The firm has complete record of production of of stability batches? stability batches as per their batch manufacturing record. Although firm has used manufacturing equipment of commercial area but separate log books for trial batches (compression only) were prepared instead of using general log books. For rest of processes, log books of general areas are used but without any serial indexing. 25. Do you have protocols for stability testing The firm has methods for stability testing of of stability batches? stability batches. 26. Do you have developed and validated the The firm has developed and validated the method for testing of stability batches? method of testing for testing their stability batches however the method has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in case Not Applicable when the method of testing being used by your firm is given by any other lab?
28. Do you have documents confirming the The firm does not have any documented qualification of equipments / instruments evidence confirming the qualification of
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being used in the test and analysis of equipment / instruments being used in the test sofosbuvir API and the finished drug? and analysis of sofosbuvir API and the finished drug. 29. Do your method of analysis stability The method of analysis for the stability indicating? studies is not stability indicating. The firm informed that chromatograph used for the analysis of stability batches is out of order and therefore no data in the chromatograph could be shown to the panel. 30. Do your HPLC software is 21CFR The HPLC software is not 21CFR Compliant compliant? as per record of the firm.
31. Can you show Audit Trail reports on Audit trail on the testing reports cannot be sofosbuvir testing? made.
32. Do you have some remaining quantities of The firm has remaining quantities of stability degradation products and stability batches? batches. However there is no quantity of degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches kept stability testing? on stability testing for real time stability testing. 34. Do you have valid calibration status for the The firm has valid calibration status for the equipments used in sofosbuvir tablets equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Since no stability data in the system was shown to the panel, therefore no system traceability regarding analysis at any level could be made. Therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Hepaldi Tablets (Sofosbuvir 400mg) is not verifiable.
6. M/s Max Pharmaceutical, Sofavir Tablets (Sofosbuvir 400 mg) 253rd Registration Islamabad Board Meeting Investigation Date and Time: 8th December 2015 (Afternoon) Q.N Question Observation by panel o. 1. Do you have documents confirming the The firm has imported 1kg sofosbuvir API import of sofosbuvir API? through DHL. Proper tracking can be made from the available documents however no approval from DRAP has been taken. 2. What was the rationale behind selecting The rationale behind selecting the manufacturer the particular manufacturer of API? is its GMP Status only 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard import of sofosbuvir standard and impurity and impurity standards? standard.
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4. Do you have certificate of Analysis of The firm has certificate of analysis for the API the API, reference standards and only. impurity standards? 5. Do you have any approval of API or The firm has GMP certificate of API GMP certificate of API manufacturer manufacturer issued by regularity authority of issued by regulatory authority of country of Origin. country of origin? 6. Do you use API manufacturer method of The firm has used their own developed method testing? for API testing. 7. Do you have stability studies reports on The firm does not have stability studies reports API? on API. 8. If yes, whether the stability testing has No Data Available. been performed as per SIM method and degradation products have been quantified? 9. Do you have method for quantifying the The firm is using their own method for testing impurities in the API? the API which is not capable to quantify the impurities in the API.
10. Do you have some remaining quantities The firm has some remaining quantities of the of the API, its reference standard and API only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients are import of the used excipients? available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other The firm has test reports on certain quality records on the excipients used? parameters of the excipients used. 14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of sofosbuvir tablets however there is no written sofosbuvir tablets? and authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any Drug-excipient compatibility studies? compatibility studies although the composition of their tablets is different from that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has not performed comparative dissolution studies? dissolution studies. The dissolution studies performed by the firm are based on the limit of dissolution (Q=70%) which is not in compliance with any pharmacopeia general monograph or the innovator specifications. 17. Do you have product development The firm does not have proper dedicated product (R&D) section development (R&D) section.
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18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets? 19. Are the equipments in product The whole development work has been development section qualified? performed on equipment used for commercial production and there is no qualification of any of these equipment. 20. Do you have proper maintenance / The firm has calibration program in place calibration / re-qualification program for however there is no such program for the equipment used in PD section? maintenance and re-qualification of their any equipment in production or quality control. 21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper product development. knowledge and training in product development? 22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablet with batch number (15T001, 15T002 & 15T003) respectively. The batch sizes are 500, 1000 & 900 tablets respectively hence there is difference in batch sizes of all the three batches whose rationale cannot be justified. 23. What was the criteria for fixing the As per statement of the firm the criteria for batch size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies however practically the statement seems to be weak as described in Q.No.22. 24. Do you have complete record of The firm has complete record of production of production of stability batches? stability batches, however there are a lot of discrepancies regarding the number of tablets used in in-process testing and the final yield. Similarly all the testing reports do not show as to whether the product is released or not released. Furthermore no Log Book has been maintained for any equipment used in the production or quality control of these batches. 25. Do you have protocols for stability The firm has no written protocols for stability testing of stability batches? testing of stability batches. 26. Do you have developed and validated The firm has developed and validated the the method for testing of stability method of testing for testing their stability batches? batches however the method has no capability to separate and quantify the impurities in the tablets being manufactured by the firm.
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27. Do you have method transfer studies in Not Applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The firm does not have any documented qualification of equipments / evidence confirming the qualification of instruments being used in the test and equipment / instruments being used in the test analysis of sofosbuvir API and the and analysis of sofosbuvir API and the finished finished drug? drug. 29. Do your method of analysis stability The method of analysis for the stability studies is indicating? not stability indicating. The Chromatograms in the HPLC are not software secured, however there is a date on the chromatograms. The real time stability testing has been performed in a cupboard placed in the office of production in- charge hence the whole data generated is not justified and correct and any effort to justify the minimum traceability and adequacy is useless. 30. Do your HPLC software is 21CFR The HPLC software is not 21CFR Compliant compliant?
31. Can you show Audit Trail reports on Audit trail on the testing reports cannot be made. sofosbuvir testing?
32. Do you have some remaining quantities The firm has remaining quantities of stability of degradation products and stability batches however there is no quantity of batches? degradation products. The commitment batches have been placed still in the cupboard in production manager office for real time studies, which is an ambient condition and not as per Zone IVA. 33. Do you have commitment batches kept The firm has three commitment batches kept on on stability testing? stability testing for real time stability testing placed in a cupboard in production manager office, which is an ambient condition and not as per Zone IVA. 34. Do you have valid calibration status for The firm has valid calibration status for the the equipments used in sofosbuvir equipment used in sofosbuvir tablets production tablets production in analysis? and analysis however traceability to the primary standard cannot be established.
Conclusions: Since the real time data has been based on a study of batches placed in ordinary cupboard at ambient conditions and not as per Zone IVA and no system traceability at any level can be made therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Sofavir Tablets (Sofosbuvir 400mg) is not verifiable.
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7. M/s Everest Pharmaceutical, Ledisovir Tablets (Ledipasvir 90mg 253rd Islamabad + Sofosbuvir 400 mg) Registration Board Meeting Investigation Date and Time: 09th December 2015 (Afternoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has provided photocopy of import of sofosbuvir API? documents for provision of 02 kg Sofosbuvir and 500 gm of Ledispavir raw material from M/s Nimbus, Lahore and thus no approval from DRAP has been taken / provided. 2. What was the rationale behind selecting The rationale behind selecting the the particular manufacturer of API? manufacturer is its GMP Status and authorization of API manufacturer for Sofosbuvir and Ledispavir manufacturing by relevant provincial regulatory authority. 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard import of sofosbuvir and ledipasvir standard and impurity standards? and impurity standard. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API, reference standards and impurity API only. standards? 5. Do you have any approval of API or The firm has GMP certificate of API GMP certificate of API manufacturer manufacturer issued by regularity authority of issued by regulatory authority of country country of Origin. of origin? 6. Do you use API manufacturer method of The firm has used their own developed testing? method for API testing, which is a spectrophotometric method i.e. non-specific. The method for chromatographic purity has also not been used. 7. Do you have stability studies reports on The firm provided stability studies reports on API? API but real time stability data was conducted at 25C+2C/60+5 % RH, which is not relevant to the storage condition for stability studies in ZoneIVA . 8. If yes, whether the stability testing has The stability studies for API has been been performed as per SIM method and conducted on SIM with profiling of degradation products have been degradation product, however real time quantified? stability data was conducted at 25C+2C/60+5% RH, which is not relevant to the storage condition for stability studies in ZoneIVA. 9. Do you have method for quantifying the The firm is using their own impurities in the API? spectrophotometric method for testing the API which is not capable to quantify the impurities in the API.
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10. Do you have some remaining quantities The firm has some remaining quantities of the of the API, its reference standard and APIs only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients import of the used excipients? are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain quality on the excipients used? parameters of the some of the excipients used.
14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of Ledisovir tablets (Sofosbuvir 400 mg + sofosbuvir tablets? Ledispavir 90mg) tablets however there is no written and authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any Drug- compatibility studies? excipient compatibility studies as the composition of their tablets is similar to that of the innovator product (Harvoni) Tablet). 16. Have you performed comparative The firm has not performed comparative dissolution studies? dissolution studies. 17. Do you have product development (R&D) The firm does not have proper dedicated section product development (R&D) section. 18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets? 19. Are the equipment in product The whole development work has been development section qualified? performed on equipment used for commercial production and there is no qualification of any of these equipment. 20. Do you have proper maintenance / The firm has calibration program in place calibration / re-qualification program for however there is no such program for the equipment used in PD section? maintenance and re-qualification of their any equipment in production or quality control. 21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper product development. knowledge and training in product development? 22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablet, with 1st batch of 500 tablets and 02 batches of 2000 tablets each. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies.
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24. Do you have complete record of The firm has shown record / batch production of stability batches? manufacturing record of production of stability batches. 25. Do you have protocols for stability testing The firm has protocols for stability testing of of stability batches? stability batches. 26. Do you have developed and validated the The firm has developed and validated method for testing of stability batches? spectrophotometric method of testing for testing their stability batches. Since spectrophotometric method is non-specific and non-stability indicating, therefore has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in Not Applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The firm does not have any documented qualification of equipments / instruments evidence confirming the qualification of being used in the test and analysis of equipment / instruments being used in the test sofosbuvir API and the finished drug? and analysis of Sofosbuvir and Ledispavir APIs and the finished drug. 29. Do your method of analysis stability The method of analysis for the stability indicating? studies is non-stability indicating. The firm has performed analysis spectrophotometrically. System traceability of the data could not be made as the spectrophotometer has no provision for this purpose. 30. Do your HPLC software is 21CFR No HPLC has been used by the manufacturer compliant? in their analysis. 31. Can you show Audit Trail reports on Not Applicable sofosbuvir testing?
32. Do you have some remaining quantities The firm has remaining quantities of stability of degradation products and stability batches however there is no quantity of batches? degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches kept stability testing? on stability testing for real time stability testing. During the inspection, there was long and re-current breakdown of electricity with no power back up for stability chambers. Panel apprehended that data presented for registration of Ledisovir tablets (Sofosbuvir 400 mg + Ledispavir 90mg) tablets may not be reliable with same situation of power breakdown.
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34. Do you have valid calibration status for The firm has valid calibration status for the the equipments used in sofosbuvir tablets equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Since the data has been generated on non-specific, non-selective and non- stability indicating method with non-reliability of the storage condition of samples kept on stability and no system traceability regarding analysis at any level therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Ledisovir tablets (Sofosbuvir 400 mg + Ledispavir 90mg) is not verifiable.
8. M/s Everest Pharmaceutical, Sovir Tablets (Sofosbuvir 400 mg) 253rd Islamabad Registration Board Meeting Investigation Date and Time: 09th December 2015 (Afternoon). Q.No. Question Observation by panel
1. Do you have documents confirming the The firm has provided photocopy of import of sofosbuvir API? documents for provision of 02 kg Sofosbuvir raw material from M/s Nimbus, Lahore and thus no approval from DRAP has been taken / provided. 2. What was the rationale behind selecting The rationale behind selecting the the particular manufacturer of API? manufacturer is its GMP Status and authorization of API manufacturer for Sofosbuvir manufacturing by relevant provincial regulatory authority. 3. Do you have documents confirming the No documented evidence is available for the import of sofosbuvir reference standard import of sofosbuvir standard and impurity and impurity standards? standard. 4. Do you have certificate of Analysis of the The firm has certificate of analysis for the API, reference standards and impurity API only. standards? 5. Do you have any approval of API or The firm has GMP certificate of API GMP certificate of API manufacturer manufacturer issued by regularity authority of issued by regulatory authority of country country of Origin. of origin? 6. Do you use API manufacturer method of The firm has used their own developed testing? method for API testing, which is a spectrophotometric method i.e. non-specific. The method for chromatographic purity has also not been used. 7. Do you have stability studies reports on The firm provided stability studies reports on API? API but real time stability data was conducted at 25C+2C/60+5 % RH, which is not relevant to the storage condition for stability studies in ZoneIVA .
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8. If yes, whether the stability testing has the stability studies for API has been been performed as per SIM method and conducted on SIM with profiling of degradation products have been degradation product, however real time quantified? stability data was conducted at 25C+2C/60+5% RH, which is not relevant to the storage condition for stability studies in ZoneIVA 9. Do you have method for quantifying the The firm is using their own impurities in the API? spectrophotometric method for testing the API which is not capable to quantify the impurities in the API. 10. Do you have some remaining quantities The firm has some remaining quantities of the of the API, its reference standard and API only. impurities standards? 11. Have you used pharmaceutical grade The firm has used pharmaceutical grade excipients? excipients. 12. Do you have documents confirming the Import documents for some of the excipients import of the used excipients? are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. 13. Do you have test reports and other records The firm has test reports on certain quality on the excipients used? parameters of the some of the excipients used.
14. Do you have written and authorized The firm has method for manufacturing of the protocols for the development of sofosbuvir tablets however there is no written sofosbuvir tablets? and authorized protocols for the development of sofosbuvir tablets. 15. Have you performed Drug-excipient The firm has not performed any Drug- compatibility studies? excipient compatibility studies as the composition of their tablets is similar to that of the innovator product (Sovaldi Tablet). 16. Have you performed comparative The firm has performed comparative dissolution studies? dissolution studies in buffer pH 6.8. The dissolution profile is comparable to the innovator product. The traceability of the data produced could not be made as no log book for dissolution apparatus was presented by the manufacturer. 17. Do you have product development (R&D) The firm does not have proper dedicated section product development (R&D) section. 18. Do you have necessary equipments Not Applicable available in product development section for development of sofosbuvir tablets? 19. Are the equipment in product The whole development work has been development section qualified? performed on equipment used for commercial production and there is no qualification of any of these equipment.
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20. Do you have proper maintenance / The firm has calibration program in place calibration / re-qualification program for however there is no such program for the equipment used in PD section? maintenance and re-qualification of their any equipment in production or quality control. 21. Do you have qualified staff in product The firm does not have any dedicated staff for development section with proper product development. knowledge and training in product development? 22. Have you manufactured three stability The firm has manufactured three stability batches for the stability studies of batches for the stability studies of sofosbuvir sofosbuvir tablets as required? tablet, with 1st batch of 500 tablets and 02 batches of 2125 tablets each. 23. What was the criteria for fixing the batch As per statement of the firm the criteria for size of stability batches? fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing frequencies. 24. Do you have complete record of The firm has shown record / batch production of stability batches? manufacturing record of production of stability batches. 25. Do you have protocols for stability testing The firm has protocols for stability testing of of stability batches? stability batches. 26. Do you have developed and validated the The firm has developed and validated method for testing of stability batches? spectrophotometric method of testing for testing their stability batches. Since spectrophotometric method is non-specific and non-stability indicating, therefore has no capability to separate and quantify the impurities in the tablets being manufactured by the firm. 27. Do you have method transfer studies in Not Applicable case when the method of testing being used by your firm is given by any other lab? 28. Do you have documents confirming the The firm does not have any documented qualification of equipments / instruments evidence confirming the qualification of being used in the test and analysis of equipment / instruments being used in the test sofosbuvir API and the finished drug? and analysis of sofosbuvir API and the finished drug. 29. Do your method of analysis stability The method of analysis for the stability indicating? studies is non-stability indicating. The firm has performed analysis spectrophotometrically. System traceability of the data could not be made as the spectrophotometer has no provision for this purpose.
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30. Do your HPLC software is 21CFR No HPLC has been used by the manufacturer compliant? in their analysis.
31. Can you show Audit Trail reports on Not Applicable sofosbuvir testing?
32. Do you have some remaining quantities The firm has remaining quantities of stability of degradation products and stability batches however there is no quantity of batches? degradation products. 33. Do you have commitment batches kept on The firm has three commitment batches kept stability testing? on stability testing for real time stability testing. During the inspection, there was long and re-current breakdown of electricity with no power back up for stability chambers. Panel apprehended that data presented for registration of sofosbuvir tablets may not be reliable with same situation of power breakdown. 34. Do you have valid calibration status for The firm has valid calibration status for the the equipments used in sofosbuvir tablets equipment used in sofosbuvir tablets production in analysis? production and analysis however traceability to the primary standard cannot be established.
Conclusions: Since the data has been generated on non-specific, non-selective and non-stability indicating method with non-reliability of the storage condition of samples kept on stability and no system traceability regarding analysis at any level therefore, on the basis of risk based approach, the genuineness / authenticity of stability data submitted by the firm for registration of Sovir Tablets ( Sofosbuvir 400mg ) is not verifiable.
3. The Board discussed the recommendation of the panel in 255th meeting and deferred the cases for registration of Sofosbovir 400mg tablets and decided to invite manufacturers to appear before the Board to defend their cases as to why their registration application may not be rejected keeping in view the observations submitted by the investigation panel. Accordingly, letters of personal hearing have been issued to all the firms mentioned above.
Decision: Registration Board in 256th meeting heard representatives of above firms keeping in view the observations submitted by the investigation panel. Each firm was given ample time for presentation of their case. Firm wise discussion and decision is as under:
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M/s Crystollite Pharma, Islamabad. Mr.Ali Raza CEO, Zahoor Illahi Production Manager and Amir Raza Quality Control Manager represented M/s Crystollite Pharma, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 8th December, 2015 (Forenoon) to verify the genuineness of stability data for registration of Hepvir Tablets (Sofosbuvir 400 mg) particularly on following points: a. Non-provision of stability studies reports on API. b. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets. c. The firm has test reports on certain quality parameters of the some of the excipients used. d. Non-performance of comparative dissolution studies. e. Chromatograms in the HPLC are not software secured even there is no date on the chromatograms which can justify the minimum traceability hence systems traceability of the analytical record cannot be made.
Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration application of Hepvir Tablets (Sofosbuvir 400 mg). M/s Searle Company, Karachi. Mr.Anwar Jamal GM Quality Operations and Asghar Abbas Alvi GM Corporate Laison represented M/s Searle Company, Karachi. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 30th November, 2015 (Forenoon) to verify the genuineness of stability data for registration of Sobvi tablets (Sofosbuvir 400 mg) particularly on following points: a. Non-performance of comparative dissolution studies. b. The firm does not have stability studies reports on API c. The firm has batch manufacturing records for the production of three stability batches. Each batch is of 165 tablets. During review of the manufacturing records it was found that the test/ analysis has been performed at different stages of the manufacturing of the tablets however there is no decrease in the number of the tablets irrespective of the fact that all these tests are destructive in nature. The final yield of tablets packed is 165 tablets i.e the original batch size. This irregularity show that the record is not authentic and genuine. Moreover no entry in log books for entering the activities of production at various production equipment is available .This also show gross deviation from the standard practice of GMP retarding the cross verification of production activities being undertaken.
d. The Chromatograms in the HPLC are not software secured, even there is no date on the chromatograms which can justify the minimum traceability. Hence systems traceability of the analytical record cannot be made
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Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Sobvi Tablets (Sofosbuvir 400 mg).
M/s Wilson Pharmaceutical, Islamabad. Mr.Tipu Sultan Akram GM, Kashif R&D and Waqar Niazi Regulatory Manager represented M/s Wilson Pharmaceutical, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 10th December 2015 (Afternoon) to verify the genuineness of stability data for registration of Saferon tablets (Sofosbuvir 400 mg) particularly on following points: a. The firm has imported 600g sofosbuvir API through M/s Morgan Karachi. However no invoice for M/s Wilson and approval from DRAP could be shown to the panel.
b. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets.
c. The firm has test reports on certain quality parameters of the some of the excipients used.
d. The firm has performed comparative dissolution studies and their product show comparable acceptable dissolution profile. The method for analysis was spectrophotometric and system traceability could not be made. Moreover, respective entries in log book for dissolution apparatus and spectrophotometer were not traceable.
e. The firm does not have proper dedicated product development (R&D) section and used general area for manufacturing of stability batches. However entries in respective area log books were partially available but without any serial indexing.
f. The firm has complete record of production of stability batches as per their batch manufacturing record. Although firm has used manufacturing equipment of commercial area but separate log books for trial batches (compression only) were prepared instead of using general log books. For rest of processes, log books of general areas are used but without any serial indexing.
g. The firm has three commitment batches kept on stability testing for real time stability testing. Panel observed that stability chamber for real time stability was set at 25C, 60%RH, which is not as per Zone IVA and thus real time stability data is not reliable.
h. The firm informed that chromatograph used for the analysis of stability batches is out of order and therefore no data in the chromatograph could be shown to the panel.
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Representatives of firm informed that chromatograms used for analysis could not be shown at time of inspection due to system upgradation, which is a contradictory to statement given during during panel inspection. Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Saferon Tablets (Sofosbuvir 400 mg).
M/s Werrick Pharmaceutical, Islamabad. Mr.Tipu Sultan Akram GM, Muhammad Tauqeer Quality Control Manager and Waqar Niazi Regulatory Manager represented M/s Werrick Pharmaceutical, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 10th December 2015 (Afternoon) to verify the genuineness of stability data for registration of Cell-tab tablets (Sofosbuvir 400 mg) particularly on following points: a. The firm has imported 600g sofosbuvir API through M/s Morgan Karachi. However no invoice for M/s Werrick and approval from DRAP could be shown to the panel.
b. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets.
c. The firm has test reports on certain quality parameters of the some of the excipients used.
d. The firm has performed comparative dissolution studies and their product show comparable acceptable dissolution profile. The method for analysis was spectrophotometric and system traceability could not be made. Moreover, respective entries in log book for dissolution apparatus and spectrophotometer were not traceable.
e. The firm does not have proper dedicated product development (R&D) section and used general area for manufacturing of stability batches. However entries in respective area log books were partially available but without any serial indexing.
f. The firm has complete record of production of stability batches as per their batch manufacturing record. Although firm has used manufacturing equipment of commercial area but separate log books for trial batches (compression only) were prepared instead of using general log books. For rest of processes, log books of general areas are used but without any serial indexing.
g. The firm informed that Deputy Manager, QC has pass word of chromatograph used for the analysis of API and stability batches and he has left the factory due to personal emergency and therefore no data in the chromatograph could be shown to the panel.
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Representatives of firm informed that chromatograms used for analysis could not be shown at time of inspection due to system upgradation, which is a contradictory to statement given during during panel inspection. Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Cell-tab Tablets (Sofosbuvir 400 mg).
M/s Scottmann Pharmaceutical, Islamabad.
Mr.Tipu Sultan Akram GM, Tariq Mehmood Quality Control Manager and Waqar Niazi Regulatory Manager represented M/s Scottmann Pharmaceutical, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 10th December 2015 (Forenoon) to verify the genuineness of stability data for registration of Hepaldi tablets (Sofosbuvir 400 mg) particularly on following points: a. The firm has imported 600g sofosbuvir API through M/s Morgan Karachi. However no invoice and approval from DRAP could be shown to the panel.
b. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets.
c. The firm has test reports on certain quality parameters of the some of the excipients used.
d. The firm has performed comparative dissolution studies and their product show comparable acceptable dissolution profile. The method for analysis was spectrophotometric and system traceability could not be made. Moreover, respective entries in log book for dissolution apparatus and spectrophotometer were not traceable.
e. The firm does not have proper dedicated product development (R&D) section and used general area for manufacturing of stability batches. However entries in respective area log books were partially available but without any serial indexing. Moreover, firm informed that they have used mixer of m/s Werrick Pharmaceuticals, Islamabad.
f. The firm has complete record of production of stability batches as per their batch manufacturing record. Although firm has used manufacturing equipment of commercial area but separate log books for trial batches (compression only) were prepared instead of using general log books. For rest of processes, log books of general areas are used but without any serial indexing.
g. The firm informed that chromatograph used for the analysis of stability batches is out of order and therefore no data in the chromatograph could be shown to the panel.
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Representatives of firm informed that chromatograms used for analysis could not be shown at time of inspection due to system upgradation, which is a contradictory to statement given during during panel inspection. Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Hepaldi Tablets (Sofosbuvir 400 mg).
M/s Max Pharmaceutical, Islamabad.
Mr.Tahir CEO, Ayub Production Manager and Muhammad Riaz Quality Control Manager represented M/s Max Pharmaceutical, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 08th December 2015 (Afternoon) to verify the genuineness of stability data for registration of Sofavir tablets (Sofosbuvir 400 mg) particularly on following points: a. The firm does not have stability studies reports on API. b. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets.
c. The firm has test reports on certain quality parameters of the excipients used. d. The firm has not performed comparative dissolution studies. The dissolution studies performed by the firm are based on the limit of dissolution (Q=70%) which is not in compliance with any pharmacopeia general monograph or the innovator specifications.
e. The firm has complete record of production of stability batches, however there are a lot of discrepancies regarding the number of tablets used in in-process testing and the final yield. Similarly all the testing reports do not show as to whether the product is released or not released. Furthermore no Log Book has been maintained for any equipment used in the production or quality control of these batches.
f. The Chromatograms in the HPLC are not software secured, however there is a date on the chromatograms. The real time stability testing has been performed in a cupboard placed in the office of production in-charge hence the whole data generated is not justified and correct and any effort to justify the minimum traceability and adequacy is useless.
g. The firm has remaining quantities of stability batches however there is no quantity of degradation products. The commitment batches have been placed still in the cupboard in production manager office for real time studies, which is an ambient condition and not as per Zone IVA.
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Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Sofavir Tablets (Sofosbuvir 400 mg).
M/s Everest Pharmaceutical, Islamabad (Ledisovir Tablets-Ledipasvir 90mg + Sofosbuvir 400 mg).
Mr.Muhammad Usman CEO and Dr.Kamran Izhar Qureshi Director represented M/s Everest Pharmaceutical, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 09th December 2015 (Afternoon) to verify the genuineness of stability data for registration of Ledisovir Tablets (Ledipasvir 90mg + Sofosbuvir 400 mg) particularly on following points:
a. The firm has provided photocopy of documents for provision of 02 kg Sofosbuvir and 500 gm of Ledispavir raw material from M/s Nimbus, Lahore and thus no approval from DRAP has been taken / provided.
b. The firm has used their own developed method for API testing, which is a spectrophotometric method i.e. non-specific. The method for chromatographic purity has also not been used.
c. The firm provided stability studies reports on API but real time stability data was conducted at 25C+2C/60+5 % RH, which is not relevant to the storage condition for stability studies in ZoneIVA.
d. The stability studies for API has been conducted on SIM with profiling of degradation product, however real time stability data was conducted at 25C+2C/60+5% RH, which is not relevant to the storage condition for stability studies in ZoneIVA.
e. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets.
f. The firm has test reports on certain quality parameters of the some of the excipients used.
g. The firm has not performed comparative dissolution studies.
h. The firm has developed and validated spectrophotometric method of testing for testing their stability batches. Since spectrophotometric method is non-specific and non- stability indicating, therefore has no capability to separate and quantify the impurities in the tablets being manufactured by the firm.
i. The method of analysis for the stability studies is non-stability indicating. The firm has performed analysis spectrophotometrically. System traceability of the data could not be made as the spectrophotometer has no provision for this purpose.
j. No HPLC has been used by the manufacturer in their analysis.
k. The firm has three commitment batches kept on stability testing for real time stability testing. During the inspection, there was long and re-current breakdown of electricity
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with no power back up for stability chambers. Panel apprehended that data presented for registration of Ledisovir tablets (Sofosbuvir 400 mg + Ledispavir 90mg) tablets may not be reliable with same situation of power breakdown.
Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Ledisovir Tablets (Ledipasvir 90mg + Sofosbuvir 400 mg).
M/s Everest Pharmaceutical, Islamabad (Sovir Tablets Sofosbuvir 400 mg).
Mr.Muhammad Usman CEO and Dr.Kamran Izhar Qureshi Director represented M/s Everest Pharmaceutical, Islamabad. As per decision of 255th meeting Registration Board, firm was advised to defend their position regarding observations of panel inspection conducted on 09th December 2015 (Afternoon) to verify the genuineness of stability data for registration of Sovir Tablets (Sofosbuvir 400 mg) particularly on following points:
a. The firm has provided photocopy of documents for provision of 02 kg Sofosbuvir raw material from M/s Nimbus, Lahore and thus no approval from DRAP has been taken / provided.
b. The firm has used their own developed method for API testing, which is a spectrophotometric method i.e. non-specific. The method for chromatographic purity has also not been used.
c. The firm provided stability studies reports on API but real time stability data was conducted at 25C+2C/60+5 % RH, which is not relevant to the storage condition for stability studies in ZoneIVA.
d. the stability studies for API has been conducted on SIM with profiling of degradation product, however real time stability data was conducted at 25C+2C/60+5% RH, which is not relevant to the storage condition for stability studies in ZoneIVA.
e. Import documents for some of the excipients are available however some excipients are lacking for the import documents i.e. they are purchased from the local markets.
f. The firm has test reports on certain quality parameters of the some of the excipients used.
g. The firm has performed comparative dissolution studies in buffer pH 6.8. The dissolution profile is comparable to the innovator product. The traceability of the data produced could not be made as no log book for dissolution apparatus was presented by the manufacturer.
h. The firm has developed and validated spectrophotometric method of testing for testing their stability batches. Since spectrophotometric method is non-specific and non- stability indicating, therefore has no capability to separate and quantify the impurities in the tablets being manufactured by the firm.
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i. The method of analysis for the stability studies is non-stability indicating. The firm has performed analysis spectrophotometrically. System traceability of the data could not be made as the spectrophotometer has no provision for this purpose.
j. No HPLC has been used by the manufacturer in their analysis.
k. The firm has three commitment batches kept on stability testing for real time stability testing. During the inspection, there was long and re-current breakdown of electricity with no power back up for stability chambers. Panel apprehended that data presented for registration of Sovir (Sofosbuvir) 400mg tablets may not be reliable with same situation of power breakdown.
Representatives of firm could not satisfy Registration Board on above points. They also requested for re-inspection of the firm, which was not acceded to and Registration Board decided to reject registration applications of Sovir Tablets (Sofosbuvir 400 mg).
Case No. 02. Registration of Sofosbuvir tablets.
Sovaldi (Sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. The Secretary, Ministry of National Health Services, Regulations and Coordination, considering the plea of the Managing Director of M/s Ferozesons for priority registration of the drug in Pakistan and keeping in view the public health needs and public interest, was pleased to direct the Registration Board that:
“The registration applications for the drug (Sofosbuvir / Sovaldi) be processed and considered by the Registration Board on priority in its next meeting”.
Accordingly, the registration applications of Sofosbuvir, received by the Pharmaceutical Evaluation Cell, were processed / evaluated on priority basis and placed before the Board for consideration in following meetings. Orders of the board were solicited whether new applications of all such formulations continued to be placed on the agenda of the Board.
Decision: Registration Board discussed the matter and keeping in view the public health urgency and need of ensurring the provision of safe, effaccacious, quality and cost effective medicines for the treatment of this Hepatitis C, decided that Sofosbuvir and Sofosbuvir containing formulations will continue to be processed for registration on priority basis.
S/N Name and Brand Name Type of Remarks on Decision address of (Proprietary name + Form the manufacturer Dosage Form + Initial date, formulation / Applicant Strength) diary (if any) Composition Fee including Pharmacological including International Group differential status in
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Finished product fee stringent Specification Demanded drug Price / Pack regulatory size agencies / authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator 1. Biofine Sofovir 400mg Form 5 Deferred for: Pharma, Oral tablets Dairy Complete Multan Each tablet Contains: No.751 description of Sofosbuvir….400mg dated 15-09- the product. (Antiviral drug) 2015 Specifications Rs.20,000/- and analytical Rs.70000/- methods of API /28tabs and excipients. Rs.2500/Tab Fresh inspection report required. Scientifically rationale lab scale stability data as per SOP approved in 251st meeting. Water processing details. Environmental control details.
2. M/s Pharmix, Aldivir Form 5 Deferred for: Lahore Film coated tablets Dairy No. Specifications Each film coated 1451 and analytical tablet Contains: dated 13-11- methods of API Sofosbuvir…400mg 2015 and excipients. (Antiviral Agent) Rs.20,000/- Fresh Rs.30,000/- inspection /28tabs report required. (inspection report of 03.2014 provided). Scientifically rationale lab scale stability data as per SOP
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approved in 251st meeting.
3. M/s Schazoo Sofozak Form 5 Deferred for: Zaka (Pvt) Tablet Dairy No. Application is Ltd. Kalal Each film coated 245 on Form 5D Wala, Zaka tablet Contains: dated 15-12- whereas ur Rehman Sofosbuvir……400mg 2015 product is me- State, Plot (Antiviral) Rs.20,000/- too. No.1, 20km 357.14/tabs Application on Lahore form Form 5 required. Specifications and analytical methods of API and excipients. Fresh inspection report required. provided). Facility of water processing with details of specs. and analytical methods. Undertakings as per decision of 251st meeting. Scientifically rationale lab scale stability data as per SOP approved in 251st meeting.
4. M/s AJ Mirza HepCvir Form 5A Deferred for: Pharma (Pvt) Film coated tablet Dairy No. Legalized Ltd., Karachi. Each film coated 336 COPP and free tablet contains: dated 06-10- sale certificate. M/s Cipla Sofosbuvir…..400mg 2015 Sole agency Ltd. Cipla HCV NS5B Rs.100,000/- agreement. House, 1964.2//tab Stability studies Peninsula under zone IV- Business A conditions. Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400 013, India.
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Following application of M/s Getz, Karachi dated 16.4.2015 has also been received that contains Sofosbuvir 400 mg and Ledipasvir 90 mg. Application of Harvoni tablet by M/s Ferozson Risalpur for the same formulation was also approved by Registration Board in 253rd meeting.
S/N Name and Brand Name Type of Remarks on Decision address of (Proprietary name + Form the manufacturer Dosage Form + Initial date, formulation / Applicant Strength) diary (if any) Composition Fee including Pharmacological including International Group differential status in Finished product fee stringent Specification Demanded drug Price / Pack regulatory size agencies / authorities Me-too status GMP status as depicted in latest inspection report (with date) by the Evaluator 5. M/s Getz Ledifos Form 5-D Harvoni, Scientifically Pharma Film coated tablets Dairy No. FDA rationale stability (Private) Each film coated 570 approved. data required as Limited 29- tablet Contains: dated 16-04- per SOP approved 30/27, Ledipasvir…..90mg 2015 Harvoni of in 251st meeting Korangi Sofosbuvir……400mg Rs.50,000/- M/s Industrial (Direct-acting Rs.196,000/- Ferozsons, Area, antiviral) /28tabs Rislapur Karachi. Rs.7,000/- /Tab
Case No. 03. New License/Additional sections.
Evaluator IV: Salateen Waseem Philips
S/N Name and Brand Name Type of Form Remarks on the Decision address of (Proprietary name formulation (if manufacturer / + Dosage Form + Initial date, any) including Applicant Strength) diary International status in stringent Composition Fee including drug regulatory differential fee agencies / Pharmacological authorities Group Demanded
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Price / Pack size Me-too status Finished product Specification GMP status as depicted in latest inspection report (with date) by the Evaluator 6. M/s GT ED-3 Injection 1 ml Form 5 Vitamine D3 BON Approved PHARMA (PVT) Rs. 20,000/- vide 5MG/ML. Algeria, LTD. PLOT # 713 Each 1 ml glass Dy. No. 2705 France, Lithuania, b SUNDAR ampoule contains:- dated 11-12- Sri Lanka, Tunisia, INDUSTERIAL Cholecalciferol 5 2015 Vietnam ESTATE mg RAIWIND ROAD Pack size of LAHORE. (Route of 1ml x 1’s / as per Calciferol (Global) Liquid Injection Administration : IM price fixed by (General) / oral) Government ampoules & vials (SVP) granted in Vitamins D 244th meeting of analogue / Central Licensing secosteroid Board held on 28th October 2015. (BP Specification) 7. -do- G-ART Injection Form 5 In the list of Approved Rs. 20,000/- vide essential medicine Each 1ml amber Dy. No. 2712 by WHO glass ampoule dated 14-12- contains:- 2015 Artem (Hilton) Artemether 80 mg Pack size of 9Route of 1 x 6’s / as per Administration: IM) price fixed by Anti-malarial Government (Manufacture Specification) 8. -do- GT-FER Injection Form 5 MONOFER Approved Rs. 20,000/- vide (Pharmacosmos) Each 1ml glass Dy. No. 2714 UK-MHRA ampoule contains:- dated 11-12- Iron Isomaltoside 2015 MONOFER 100mg ALLMED Karachi Pack size of (Route of 1 x 5’s / as per Administration: IV) price fixed by Antianeamic Government (Manufacture Specification) 9. -do- K-LOT Injection Form 5 Konnakion MM, Approved 10mg/ml Rs. 20,000/- vide Roche (MHRA) Dy. No. 2713 Each 1ml amber dated 11-12- glass ampoule 2015 PHYTOMENDIO contains NE Phytomenadione Pack size of Haji medicine
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(Vitamin K 1) 10mg 1ml glass company ampoule type I / (Route of as per price fixed Administration: IV) by Government Antihemophilics (Manufacture Specification) 10. -do- K-LOT Injection Form 5 Vitamin K1 Approved with 2mg/ml pediatric Rs. 20,000/- vide 1mg/0.5ml the change of Dy. No. 2707 HOSPIRA brand name. Each 1ml amber dated 11-12- (USFDA) glass ampoule 2015 contains K-Lot 2mg/ml PHYTOMENADIO Pack size of (English) Reg. # NE (Vitamin K 1) 1ml glass 2mg ampoule type I / 077088 as per price fixed Route of by Government Administration: ORAL/IM/IV Antihemophilics (Manufacture Specification)
11. -do- VITRAM Vials for Form 5 Keppra-UCB Approved Injection Rs. 20,000/- vide (USFDA) Dy. No. 2711 Each 5ml glass vial dated 14-12- Eplipsa (Helix) contains 2015 Levetiracetam 500mg Pack size of 5ml x 1’s / as per Route of price fixed by Administration: IV Government Antiepileptic (Manufacture Specification) 12. -do- GT-DOL Injection Form 5 Haloperidol- Approved Rs. 20,000/- vide Mercury (MHRA) Each 1ml glass Dy. No. 2710 ampoule contains dated 11-12- Haloperidol 5 mg 2015 SERENACE Searle Route of Pack size of Administration: 1ml x 25’s / as IM per price fixed Anti-psychotic by Government (USP Specification) 13. -do- GT-CIP Infusion Form 5 Cipro I.V. Approved 100ml Rs. 20,000/- vide Bayer (USFDA) Dy. No. 2709 CIPROXIN Each 100ml glass dated 11-12- Bayer vial contains 2015 Ciprofloxacin as
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Lactate 200mg Pack size of 100ml x 1’s / as Route of per price fixed Administration: IV by Government Quinolones (Manufacture Specification) 14. -do- GT-MOX Infusion Form 5 AVELOX Approved 250ml Rs. 20,000/- vide Bayer (USFDA) Dy. No. 2708 Each 250ml glass dated 11-12- AVELOX vial contains 2015 Bayer Moxifloxacin as HCl 400mg Pack size of 250ml x 1’s / as Route of per price fixed Administration: IV by Government Quinolones (Manufacture Specification) 15. -do- LINZO Infusion Form 5 Zyvox-Pfizer Approved 100ml Rs. 20,000/- vide (USFDA) Dy. No. 2706 Each 100ml glass dated 11-12- ECASIL vial contains 2015 SAMI Linezolid 200mg Pack size of Route of 100ml x 1’s / as Administration: IV per price fixed Anticonvulsants by Government (Manufacture Specification)
16. CAPSULES Cheliron Capsules Form 5 Niferex Approved (General) granted Rs. 20,000/- vide UCB Brussels, in 244th meeting Each Capsule Dy. No. 2684 Belgium. of Central contains dated 11-12- FERRICURE Licensing Board Iron Hydroxide 2015 S.J. & G. FAZUL held on 28th polymaltose ELLAHIE (PVT) October 2015. Complex 150mg Pack size of LTD. 3 x 10’s / as per Antianemia price fixed by (Manufacture Government Specification)
17. -do- Statonil 60mg Form 5 Xenical-USA Approved Capsules Rs. 20,000/- vide (FDA) Dy. No. 2683 Each Capsule dated 11-12- OSKER contains Orlistat 2015 Genix
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(pellets) 60mg Pack size of Anti-obesity 3 x 10’s / as per (USP Specification) price fixed by Government Source of Orlistat IR pellets potency 50% -M/s Vision Pharmaceuticals, Kahuta Road, Islamabad.
18. -do- Gapre 75mg Form 5 Lyrica Approved Capsules Rs. 20,000/- vide Parke Davis, Dy. No. 2682 USA (FDA) Each Capsule dated 11-12- contains 2015 GABICA Pregabalin 75mg Getz Pack size of Anticonvulsants 2 x 7’s / as per (Manufacture price fixed by Specification) Government
19. -do- Statonil 120mg Form 5 Xenical-USA Approved Capsules Rs. 20,000/- vide (FDA) Dy. No. 2681 Each Capsule dated 11-12- OSKER contains 2015 Genix Orlistat (Pellets) 120mg Pack size of 1 x 10’s / as per Anti-obesity price fixed by (Manufacture Government Specification)
Source of Orlistat IR pellets potency 50% -M/s Vision Pharmaceuticals, Kahuta Road, Islamabad.
20. -do- Omexia Capsules Form 5 ZEGERID Deferred for Rs. 20,000/- vide USA expert opinion Each Capsule Dy. No. 2680 as per decision contains dated 11-12- Zoltar Insta of 250th Omeprazole 20mg 2015 Pharmaevo Registration Sodium bicarbonate Pack size of Board 1100mg 1 x 10’s / as per price fixed by meeting. Antacid Government (Manufacture Specification)
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21. -do- Capri 80mg Form 5 EMEND (MHRA) Approved Capsules Rs. 20,000/- vide Dy. No. 2679 APREON Each Capsule dated 11-12- Ferozsons contains 2015 Aprepitant 80mg Pack size of 1 x 2’s / as per Antiemetics price fixed by (Manufacture Government Specification)
22. -do- G.THRO 250mg Form 5 ZITHROMAX Approved Capsules Rs. 20,000/- vide Pfizer Labs USA Dy. No. 2678 Each Capsule dated 11-12- AZOMAX contains 2015 Novartis Azithromycin Pack size of Dihydrate 262.05mg 2 x 6’s / as per eq to Azithromycin price fixed by 250mg Government
Macrolides (USP Specification)
23. -do- Flucont 150mg Form 5 Diflucan Approved Capsules Rs. 20,000/- vide Pfizer USFDA Dy. No. 2677 Each Capsule dated 11-12- FLUDERM contains 2015 Nabi Qasim Fluconazole 150mg Pack size of 1 x 1’s / as per Antifungal price fixed by (Manufacture Government Specification)
24. -do- Capri 40mg Form 5 EMEND -MHRA Approved Capsules Rs. 20,000/- vide Dy. No. 2676 APREON Each Capsule dated 11-12- Ferozsons contains 2015 Aprepitant 40mg Pack size of 1 x 2’s / as per (Antiemetics) price fixed by (Manufacture Government Specification)
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25. -do- Omexia Plus Form 5 ZEGERID Deferred for Capsules Rs. 20,000/- vide USA expert opinion Dy. No. 2675 Zoltar Insta as per decision Each Capsule dated 11-12- Pharmaevo of 250th contains 2015 Registration Omeprazole 40mg Pack size of Board Sodium bicarbonate 1 x 10’s / as per 1100mg price fixed by meeting. Government Antacid (Manufacture Specification)
26. Dry Powder G-ART Dry Powder Form 5 Co-Artesiane Approved Suspension Suspension Rs. 20,000/- vide Belgium (General) granted Dy. No. 2694 in 244th meeting Each 5ml of dated 11-12- ARTEM PLUS of Central reconstituted 2015 HILTON Licensing Board suspension Contains th held on 28 Artemether 30mg Pack size of October 2015. Lumefentrine 180 1 x 60ml as per mg price fixed by Government Antimalarial (Manufacture Specification)
27. -do- G-ART Plus Dry Form 5 Co-Artesiane Approved Powder Suspension Rs. 20,000/- vide Belgium Dy. No. 2693 Each 5ml dated 11-12- ARTEM PLUS reconstituted 2015 HILTON suspension Contains Artemether 15mg Pack size of Lumefentrine 90 mg 1 x 60ml as per price fixed by Antimalarial Government (Manufacture Specification)
28. -do- MYFOSIN Dry Form 5 Deferred for Powder Suspension Rs. 20,000/- vide FOSFOMYCIN confirmation Dy. No. 2692 Efroze Each 5ml dated 11-12- of approval reconstituted 2015 status by suspension Contains Pack size of reference Fosfomycin 250mg 1 x 60ml as per regulatory price fixed by Antibiotics Government authorities. (Manufacture Specification)
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29. -do- GT-CIP 250mg Dry Form 5 CIPROXIN Registration Powder Suspension Rs. 20,000/- vide UK Board deferred Dy. No. 2691 the application Each 5ml dated 11-12- QUASH and advised to reconstituted 2015 WILSHIRE suspension Contains follow master Ciprofloxacin taste Pack size of formulation of masked granules 1 x 30ml as per 35% eq to price fixed by innovator ciprofloxacin Government brand which 250mg consist of granules of Quinolones (Manufacture ciprofoxain Specification) base and a diluent as per Source of pellets – innovator’s M/s Vision Pharmaceuticals, composition. Kahuta Road, Islamabad
30. -do- LINZO Dry Form 5 ZYVOX Approved Powder Granules for Rs. 20,000/- vide FDA Suspension Dy. No. 2690 dated 11-12- NEZOCIN Each 5ml of 2015 BROOKS reconstituted
suspension Contains Pack size of Linezolid 100mg 1 x 60ml as per price fixed by Antibiotics Government (Manufacture Specification)
31. -do- GT-CLARI 125mg Form 5 BIAXIN Approved granules for Oral Rs. 20,000/- vide USA Suspension Dy. No. 2689 dated 11-12- CLARAMED Each 5ml of 2015 NOVARTIS reconstituted suspension Contains Pack size of clarithromycin taste 1 x 60ml as per masked granules price fixed by 27.5% eq to Government Clarithromycin 125mg
Macrolide (Manufacture Specification)
Source of granules – M/s Vision Pharmaceuticals, Minutes 256th Meeting Registration Board 180
Kahuta road, Islamabad. )
32. -do- GT-CIP 500mg Dry Form 5 CIPROXIN Registration Powder Suspension Rs. 20,000/- vide (USFDA) Board deferred Dy. No. 2688 the application Each 5ml Contains dated 11-12- and advised to Ciprofloxacin taste 2015 QUASH masked granules Pack size of WILSHIRE follow master 35% eq to 1 x 60ml as per formulation of ciprofloxacin price fixed by 250mg Government innovator brand which Quinolones consist of (Manufacture granules of Specification) ciprofoxain Source of pellets – base and a M/s Vision diluent as per Pharmaceuticals, innovator’s Kahuta Road, Islamabad composition. Quinolones (Manufacture Specification)
33. -do- GT-CLARI 250mg Form 5 Clarithromycin – Approved granules for oral Rs. 20,000/- vide Sandoz (MHRA) Suspension Dy. No. 2687 dated 11-12- CLARAMED Each 5ml of 2015 NOVARTIS reconstituted suspension Contains Pack size of clarithromycin taste 1 x 60ml as per masked granules price fixed by 27.5% eq to Government Clarithromycin 250mg
Macrolide (Manufacture Specification)
Source of granules – M/s Vision Pharmaceuticals, Kahuta road, Islamabad. 34. -do- FLUCONT Dry Form 5 DIFLUCAN Approved Powder Suspension Rs. 20,000/- vide PFIZER FDA Dy. No. 2686 Each 5ml Contains dated 11-12- DIFLUCAN Fluconazole 50mg 2015
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Pfizer Antifungal Pack size of (USP Specification) 1 x 35ml as per price fixed by Government
35. -do- GT-MAX dry Form 5 ZITHROMAX Approved Powder Suspension Rs. 20,000/- vide US FDA Dy. No. 2685 Each 5ml Contains dated 11-12- AZOMAX Azithromycin taste 2015 NOVARTIS masked granules 35% eq to Pack size of Azithromycin 1 x 15ml as per 200mg price fixed by Government Source of granules – M/s Vision Pharmaceuticals, Kahuta Road, Islamabad.
Macrolide (Manufacture Specification) 36. SACHET OMEXIA PLUS Form 5 ZEGERID Deferred for (General) granted Sachet Rs. 20,000/- vide FDA USA expert opinion th in 244 meeting Dy. No. 2704 as per decision of Central Each Sachet dated 11-12- RISEK INSTA of 250th Licensing Board Contains 2015 GETZ Registration held on 28th Omeparazole 40mg Pack size of Board October 2015. Sodium Bicarbonate 1 x 10’s as per 1680mg price fixed by meeting. Government Antacid (Manufacture Specification) 37. -do- G-MONT Sachet Form 5 BNF: Singulair Approved Rs. 20,000/- vide MSD Each Sachet Dy. No. 2703 Contains dated 11-12- MYTEKA Montelukast 2015 Hilton Sodium as Montelukast 4mg Pack size of 1 x 14’s as per Leukotriene price fixed by receptor antagonist Government (Manufacture Specification)
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38. -do- GT-GUT Sachet Form 5 BNF: WHO Approved Rs. 20,000/- vide formulation Each Sachet Dy. No. 2602 OSMOLAR Contains dated 11-12- Atco Glucose anhydrous 2015 BP 6.75gm Sodium Chloride BP Pack size of 1.30gm 1 x 20’s as per Potassium Chloride price fixed by BP 0.75gm Government TriSodium Citrate dehydrate BP 1.45gm
Equivalent to Sodium 37.5mmol Chloride 32.5 mmol Potassium 10 mmol Citrate 5 mmol Glucose 37.5 mmol
Electrolytes (Manufacture Specification)
39. -do- GISPA Sachet Form 5 BNF: Fybogel Approved Rs. 20,000/- vide Reckit Benkisser Each Sachet Dy. No. 2701 (MHRA) Contains dated 11-12- HUSK-M MEBEVERINE 2015 GENIX HCl 135mg ISPAGHULLA Pack size of HUSK 3.5g 1 x 10’s as per price fixed by Antispasmodic Government (Manufacture Specification) 40. -do- MYFOSIN Sachet Form 5 MONUROL Approved Rs. 20,000/- vide Zambon Each Sachet Dy. No. 2700 Switzerland Contains dated 11-12- (USFDA) Fosfomycin 3g 2015
MONUROL Antibiotics Pack size of SCHARPER (Manufacture 1 x 1’s as per Specification) price fixed by Government 41. -do- G-SMECTA Sachet Form 5 Product is approved Approved Rs. 20,000/- vide by the French drug Each Sachet Dy. No. 2699 agency (Ipsen Contains dated 11-12- Pharma). Dioctahedral 2015 (Ref: ANSM, Smectite 3g France) Pack size of
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Antidiarrheals 1 x 30’s as per SMECTA (Manufacture price fixed by ATCO Specification) Government
42. -do- ERDO Sachet Form 5 EMA approved Approved Rs. 20,000/- vide Each Sachet Dy. No. 2698 DOSTIN Contains dated 11-12- Brooks Erdosteine 225mg 2015 Pack size of 1 x 5’s as per Antitussives price fixed by (Manufacture Government Specification)
43. -do- STRONIUM Sachet Form 5 BNF: Protelos Approved Rs. 20,000/- vide Servier (MHRA) Each Sachet Dy. No. 2797 Contains dated 11-12- ONITA Strontium Renelate 2015 Pharmevo 2g
Pack size of Bone metabolism 1 x 7’s as per (Manufacture price fixed by Specification) Government 44. -do- VIGATRIN Sachet Form 5 SABRIL-Sanofi Approved Rs. 20,000/- vide (MHRA) Each Sachet Dy. No. 2696 Contains dated 11-12- VLEP Vigabatrin 500mg 2015 Genix Pack size of Anticonvulsants 1 x 10’s as per (Manufacture SRO Specification) 45. -do- OMEXIA Sachet Form 5 ZEGERID Deferred for Rs. 20,000/- vide FDA USA expert opinion Each Sachet Dy. No. 2695 as per decision Contains dated 11-12- RISEK INSTA of 250th Omeparazole 20mg 2015 GETZ Registration Sodium Bicarbonate Pack size of Board 1680mg 1 x 10’s as per Antacid price fixed by meeting. (Manufacture Government Specification) Evaluator-I: Muhammad Ansar
46. M/s 3N-Lifemed Lifemed Bicarb Form-5 Deferred for Pharmaceuticals, Concentrate 14-12-2015 vide submission of 45 S.B, Abdullah (3NLBG-36.83X) diary No. 2718 Renacon Pharma s following:- Colony, Sargodha. After final mixing Rs.20,000 Confirmation /diluting by 35X As per SRO of me too Haemodialysis status and machines with approval by deionized water, the reference
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strength of active regulatory ingredients of part- authorities. A & part-B Finished Haemodialysis product concentrate are: specifications. Sodium……… Complete 138.0m mol/l calculations of Potassium……. the formulatin. 1.0m mol/l Calcium……… The Board further 1.5m mol/l directed to seek Magnesium…… opinion on all 0.75m mol/l dialysis concentrate Aceticacid……. applications from:- 5.0m mol/l Prof Shaheen Chloride……… Moeen, Bahria 106.25 m mol/l Medical college, Bicarbonate……35. and Head of Deptt 0m mol/l Nephrology PIMS. Glucose……….. 5.5 m mol/l Concentrate for Bicarbonate Haemodialysis
47. -do- Lifemed Bicarb Form 5 Deferred for Concentrate 14-12-2015 vide submission of (3NLBP-35X) diary No. 2716 following:- After final mixing Rs.20,000 Confirmation /diluting by 35X As per SRO Renacon Pharma of me too Haemodialysis status and machines with approval by deionized water, the reference strength of active regulatory ingredients of part- authorities. A & part-B Finished Haemodialysis product concentrate are: specifications. Sodium………….3 Complete 5.0 m mol/l calculations of Bicarbonate…….35. the formulatin. 0 m mol/l Concentrate for The Board further Bicarbonate directed to seek Haemodialysis opinion on all Require to be dialysis concentrate provided. applications from:- Prof Shaheen Moeen, Bahria Medical college, and Head of Deptt Nephrology PIMS.
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48. -do- Lifemed Bicarb Form-5 Deferred for Concentrate 14-12-2015 vide submission of (3NLBA-35X) diary No. 2715 following:- After final mixing Rs.20,000 Confirmation /diluting by 35X As per SRO Renacon Pharma of me too Haemodialysis status and machines with approval by deionized water, the reference strength of active regulatory ingredients of part- authorities. A & part-B Finished Haemodialysis product concentrate are: specifications. Sodium……… Complete 103.0 m mol/l calculations of Potassium……. the formulatin. 1.0m mol/l Calcium……… The Board further 1.5m mol/l directed to seek Magnesium…… opinion on all 0.75m mol/l dialysis concentrate Aceticacid……. applications from:- 5.0m mol/l Prof Shaheen Chloride……… Moeen, Bahria 106.25 m mol/l Medical college, Glucose……….. and Head of Deptt 5.5 m mol/l Nephrology PIMS. Concentrate for Bicarbonate Haemodialysis Require to be provided. 49. -do- Lifemed Bicarb Form-5 Require to be Deferred for Concentrate 14-12-2015 vide verified. submission of (3NLBG-36.83X) diary No. 2717 Firm has provided following:- After final mixing Rs.20,000 the reference of Confirmation /diluting by 35X As per SRO Renacon Pharma of me too Haemodialysis which require to be status and machines with verified approval by deionized water, the reference strength of active regulatory ingredients of part- authorities. A & part-B Finished Haemodialysis product concentrate are: specifications. Sodium……… Complete 140.0m mol/l calculations of Potassium……. the formulatin. 1.0m mol/l Calcium……… The Board further 1.5m mol/l directed to seek Magnesium…… opinion on all 0.75m mol/l dialysis concentrate Aceticacid……. applications from:- 5.0m mol/l Minutes 256th Meeting Registration Board 186
Chloride……… Prof Shaheen 107.25 m mol/l Moeen, Bahria Bicarbonate……36. Medical college, 0m mol/l and Head of Deptt Dextrose……….. Nephrology PIMS. 5.5 m mol/l Concentrate for Bicarbonate Haemodialysis Require to be provided.
50. -do- Lifemed Bicarb Form-5 Deferred for Concentrate 19-1-2016 vide submission of (3NLPS-35X) diary No. 409 Renacon Pharma following:- After final mixing Rs.20,000 Confirmation /diluting by 35X As per SRO of me too Haemodialysis status and machines with approval by deionized water, the reference strength of active regulatory ingredients of part- authorities. A & part-B Finished Haemodialysis product concentrate are: specifications. Sodium……… Complete 138.0m mol/l calculations of Potassium……. the formulatin. 1.0m mol/l Calcium……… The Board further 1.50 m mol/l directed to seek Magnesium…… opinion on all 0.75m mol/l dialysis concentrate Aceticacid……. applications from:- 5.0m mol/l Prof Shaheen Chloride……… Moeen, Bahria 106.25 m mol/l Medical college, Bicarbonate……35. and Head of Deptt 0m mol/l Nephrology PIMS. Glucose……….. 5.5 m mol/l Concentrate for Bicarbonate Haemodialysis Require to be provided. 51. -do- Lifemed Bicarb Form-5 Deferred for Concentrate 19-1-2016 vide submission of (3NLPG-36.83X) diary No. 410 following:- After final mixing Rs.20,000 Renacon Pharma Confirmation /diluting by 35X As per SRO of me too Haemodialysis status and machines with approval by deionized water, the reference strength of active Minutes 256th Meeting Registration Board 187
ingredients of part- regulatory A & part-B authorities. Haemodialysis Finished concentrate are: product Sodium……… specifications. 140.0m mol/l Complete Potassium……. calculations of 2.0m mol/l the formulatin. Calcium……… 2.5m mol/l The Board further Magnesium…… 1.0 directed to seek m mol/l opinion on all Aceticacid……. dialysis concentrate 4.0m mol/l applications from:- Chloride……… Prof Shaheen 105.0 m mol/l Moeen, Bahria Bicarbonate……39. Medical college, 0m mol/l and Head of Deptt Destrose……….. Nephrology PIMS. 200 mg/dl Concentrate for Bicarbonate Haemodialysis
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Additional section: (Evaluator-I: Muhammad Ansar) S/N Name and Brand Name Type of Form Remarks on the Decision address of (Proprietary name + formulation (if any) manufacturer Dosage Form + Initial date, including International / Applicant Strength) diary status in stringent drug regulatory agencies / Composition Fee including authorities differential Pharmacological fee Me-too status Group Demanded GMP status as depicted Finished product Price / Pack in latest inspection report Specification size (with date) by the Evaluator 52. M/s Genix Mipcil Injection Form 5 FDA Imipenem plus Approved Pharma (Pvt) Cilastatin 500/500 by Ltd, 44,45 B, Each Vial contains:- 10-12-2015 M/s Acs Dobfar Korangi Imipenem vide diary Creek Road, Monohydrate eq to No. 1121 Cilapen Injection 250 & Karachi Imipenem…500mg Rs50,000 500mg by M/s Bosch Cilastatin Sodium eq Beta Lactams to As per SRO (Penems) Cilastatin…..500mg non in the sterile mixture Penicillin of sodium bicarbonate as buffer.
Penems
USP Specifications 53. -do- Mipcil Injection Form 5 FDA Imipenem plus Approved Cilastatin 250/250 by Each Vial contains:- 10-12-2015 M/s Acs Dobfar Imipenem vide diary Monohydrate eq to No. 1122 Imipenem…250mg Rs50,000 Cilapen Injection 250 & Cilastatin Sodium eq 500mg by M/s Bosch to As per SRO Cilastatin…..250mg in the sterile mixture of sodium bicarbonate as buffer.
Penems
USP Specifications
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54. -do- Bianem Injection Form 5D Approval in SRA’s is not Deferred for provided the submission Each Vial contains:- 10-12-2015 of following:- Biapenem…………… vide diary Complet .300mg No. 1145 e Rs50,000 applicati Penems on on 4000/vial Form Manufacturer’s 5D. Specifications Stability data as per the guidelin es approve d by the Board in 251st meeting. 55. -do- Bactinem Injection Form 5 FDA Meropenem 500mg Approved & 1gm by M/s Hospira Each Vial contains:- 10-12-2015 Meropenem vide diary Penro 500mg & 1g by Trihydrate eq to No. 1125 M/s Bosch Pharma Meropenem buffered Rs50,000 with sodium bicarbonate………… As per SRO ….1g
Penems
USP Specifications 56. -do- Bactinem Injection Form 5 FDA Meropenem 500mg Approved & 1gm by M/s Hospira Each Vial contains:- 10-12-2015 Meropenem vide diary Penro 500mg & 1g by Trihydrate eq to No. 1124 M/s Bosch Pharma Meropenem buffered Rs50,000 with sodium bicarbonate………… As per SRO ….500mg
Penems
USP Specifications 57. -do- Ronim Injection Form 5D FDA Doripenem 250mg Deferred for & 500mg by M/s the submission Each Vial contains:- 10-12-2015 Shionogi INC of following:- Doripenem vide diary Complet Monohydrate eq to No. 1126 e
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Doripenem………… Rs50,000 applicati ….500mg on on 3700/vial Form Penems 5D. Stability Manufacturer data as Specifications per the guidelin es approve d by the Board in 251st meeting. 58. -do- Ronim Injection Form 5D FDA Doripenem 250mg Deferred for & 500mg by M/s the submission Each Vial contains:- 10-12-2015 Shionogi INC of following:- Doripenem vide diary Complet Monohydrate eq to No. 1123 e Doripenem………… Rs50,000 applicati ….250mg on on Penems 3500/vial Form Manufacturer 5D. Specifications Stability data as per the guidelin es approve d by the Board in 251st meeting. 59. -do- Ernem Injection Form 5 FDA Ertapenem 1gm by Approved M/s Merck Sharp Each Vial contains:- 10-12-2015 Ertapenem Sodium vide diary Invanz 1gm by M/s OBS eq to No. 1146 Ertapenem………… Rs50,000 …1g Penems As per PRC Manufacturer Specifications
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Case No. 03: Remaining/ Replacement applications of New Licenses/ additional sections (Evaluator I: Muhammad Ansar) Section R-II Vide letter vide No. F.6-10/2013 Reg-II dated 18-01-2016 sent the remaining applications of M/s Martin Dow Pharma, Karachi.
60. M/s Martin Dow Lorfac Capsule Form-5 FDA. Ceclor Approved Pharmaceuticals Each capsule Diary No. 38 Capsule 500mg Limited, Plot # contains:- dated 14-01- by M/s Ceph 37, Sector 19, Cefaclor 2016 INT Korangi Monohydrate eq Rs.20,000/ Local. Fyclor Industrial Area, to As per PRC capsule 500mg Karachi. Cefaclor……50 by M/s Fynk Capsule 0mg (Cephalosporin) Cephalosporin approved in USP 227th meeting of Specifications the RB. 61. -do- Lorfac Capsule Form-5 FDA. Ceclor Approved Each capsule Diary No. 41 Capsule 500mg contains:- dated 14-01- by M/s Ceph Cefaclor 2016 INT Monohydrate eq Rs.20,000/ Local. Fyclor to Cefaclor As per PRC capsule 250mg ……250mg by M/s Fynk Cephalosporin USP Specifications 62. -do- Neflex Capsule Form-5 FDA. Keflex Approved Each capsule Diary No. 37 Capsule 250 & contains:- dated 14-01- 500mg by M/s Cephalexin 2016 Shionogi INC Monohydrate eq Rs.20,000/ Local. Ceporex to As per PRC capsule 250mg Cephalexin…… by M/s GSK ..250mg Cephalosporin USP Specifications 63. -do- Neflex Capsule Form-5 FDA. Keflex Approved Each capsule Diary No. 34 Capsule 250 & contains:- dated 14-01- 500mg by M/s Cephalexin 2016 Shionogi INC Monohydrate eq Rs.20,000/ Local. Ceporex to As per PRC capsule 500mg Cephalexin…… by M/s GSK ..500mg Cephalosporin USP Specifications
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64. -do- Kefal Capsule Form-5 FDA. Velocef Approved Each capsule Diary No. 42 Capsule 250 by contains:- dated 14-01- M/s Ersana Cephradine…… 2016 Local. Cefrinex ..250mg Rs.20,000/ capsule 250mg Cephalosporin As per PRC by M/s Bosch USP Specifications 65. -do- Kefal Capsule Form-5 UK. Cefradine Approved Each capsule Diary No. 43 Capsule 500 by contains:- dated 14-01- M/s Kent Cephradine…… 2016 Pharma ..500mg Rs.20,000/ Local. Cefrinex Cephalosporin As per PRC capsule 500mg USP by M/s Bosch Specifications 66. -do- Maysa Capsule Form-5 UK. Cefadroxil Approved Each capsule Diary No. 40 Capsule 500 by contains:- dated 14-01- M/s Sandoz Cefadroxil as 2016 Local. Monohydrate.. Rs.20,000/ Biodroxil ……..500mg As per PRC capsule 500mg Cephalosporin by M/s Novartis USP Specifications 67. -do- Nucefix Form-5 FDA. Suprax Approved Capsule Diary No. 39 Capsule 400 by Each capsule dated 14-01- M/s Lupin contains:- 2016 Local. Cebosh Cefixime as Rs.20,000/ capsule 400mg trihydrate..……. As per PRC by M/s Bosch .400mg Cephalosporin Manufacturer’s Specifications
Remaining applications of M/s. Life Pharma to reach cap of 10 products
68. M/s Life Risparol 2mg Form-5 FDA. Risperdal Approved Pharmaceutical Tablet 02-12-2015 tablet 2mg by Company, 24- Each film vide diary M/s Janssen III, Industrial coated tablet no.113 Pharms. Estate, Multan. contains:- Rs.20,000. Risperidone… As per SRO Local Risperdal ….2mg Tablet 2mg by Antipsychotic M/s Janssen. USP Specifications. The firm is recommended
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for renewal as per panel inspection dated10-03- 2015 & 11-03- 2015
69. -do- Deprotine 20mg Form-5 FDA. Paxil Approved Tablet 02-12-2015 tablet 20mg as Each film vide diary base by M/s coated tablet no.113 Apotex contains:- Rs.20,000. Technologies. Paroxetine as As per SRO HCl…….20mg Local Seroxat Antidepressant Tablet 20mg by USP M/s GSK. Specifications. The firm is recommended for renewal as per panel inspection dated10-03- 2015 & 11-03- 2015
Cases of M/s Aurik Pharmaceuticals Rawat referred by Section R-III vide letter No. F.6-4/2013-Reg-III dated 16-12-2015
S/N Name and Brand Name Type of Remarks on Decision address of (Proprietary Form the manufacturer / name + Dosage formulation (if Applicant Form + Initial date, any) including Strength) diary International status in Composition Fee including stringent drug differential regulatory Pharmacologic fee agencies / al Group authorities Demanded Finished Price / Pack Me-too status product size Specification GMP status as depicted in latest inspection report (with
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date) by the Evaluator
70. M/s Aurik Gabur-100mg Form-5 US FDA. LYRICAApproved as the firm has Pharmaceuticals Capsule 16-12-2015 Capsules (25, submitted the required , Plot No.6&7 Each capsule vide diary 50, 75, 100, docuemtns pointed out Street No. S-9, contains:- no.2787 150,200, 225 during 1st evaluation. National Pregabalin……. Rs.20,000. and 300mg) Industrial Zone ..100mg As per SRO (RCCI) Rawat, Local. GABICA Rawalpindi. GABA Capsules (50, Analogue 75, 100, 150 and Manufacturer’s 300mg) Specifications. Getz
71. -do- Pext-CR Form-5 FDA. Paxil Approved as the firm has 12.5mg Tablet 14-12-2015 tablet 12.5mg as submitted the required Each SR tablet vide diary base by M/s docuemtns pointed out contains:- no.2660 Apotex during 1st evaluation. Paroxetine HCl Rs.20,000. Technologies. eq to As per SRO Paroxetine…… Local Seroxat ….12.5mg Tablet 12.5mg Antidepressant by M/s GSK. Manufacturer’s Specifications. 72. -do- Oltrus 25mg Form-5 FDA. Approved as the firm has Tablet 14-12-2015 Amlodipine & submitted the required Each DS tablet vide diary Olmesartan docuemtns pointed out contains:- no.2658 5/20mg by M/s during 1st evaluation. Amlodipine Rs.20,000. Torrent Pharma. Besylate Eq to As per SRO Amlodipine… Local Omsana …….5mg AM Tablet Olmesartan 5/20mg by M/s Medoxomil….. Hilton. …20mg Antihypertensiv e USP Specifications.
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73. -do- Mebrest-200 Form-5 UK. Colofac Approved as the firm has Capsule 14-12-2015 MR 200mg as submitted the required Each capsule vide diary modified docuemtns pointed out contains:- no.2659 release by M/s during 1st evaluation. Mebeverine Rs.20,000. BGP HCl……200mg As per SRO Colonil 200mg Antispasmodic Capsule by M/s Manufacturer’s Genome Specification Pharma
Case of M/s Winthrox Laboratories Karachi referred by Section R-II vide letter No. F.6-10/2013-Reg-II dated 01-01-2016
S/N Name and Brand Name Type of Remarks on Decision address of (Proprietary Form the manufacturer / name + Dosage formulation (if Applicant Form + Initial date, any) including Strength) diary International status in Composition Fee including stringent drug differential regulatory Pharmacologic fee agencies / al Group authorities Demanded Finished Price / Pack Me-too status product size Specification GMP status as depicted in latest inspection report (with date) by the Evaluator 74. M/s Winthrox Optiflor-T Eye Form-5 The firm has Deferred for the Laboratories Drops 26-03-2015 provided the submission of following:- (Pvt) Ltd, Plot Suspension vide diary reference of Method of No. K-219-A, Each ml of No.1905 Switzerland sterilization. S.I.T.E. Phase suspension Rs.20,000. Emefoline eye Approval status II, Super contains:- Rs.110/5ml drops by M/s by reference Highway, Fluorometholon Novartis regulatory Karachi. e USP……1mg Pharma authorities. Tetrahydrozolin Clarifications e HCl Local Femicon regarding claim of USP……0.25m Eye Drops vials instead of g 0.1/.025% by dropers in the Corticosteroid/ M/s Remington dossier. Vasoconstrictor Pharma Firm is sterilizing Manufacturer’s the product by
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Specification filteration which requires clarification as dosage form is suspension. Sterilization of container and closure system. Finished product specifications
75. -do- Optimox-D Eye Form-5 Deferred for the Drops 26-03-2015 submission of following:- Each ml of vide diary Method of sterilization. suspension No.1894 Approval status by contains:- Rs.20,000. Local Ocumox reference regulatory Moxifloxacin Rs.250/5ml D Eye Drops authorities . HCl eq to 0.1/.5% by M/s The firm is claiming Moxifloxacin Remington vials instead of USP……5mg Pharma droppers in the dossier. Dexamethasone Firm is sterilizing the Sodium product by filtration Phosphate eq to which requires Dexamethasone clarification as dosage Phosphate form is suspension. USP….……1m Sterilization of g container and closure system. Corticosteroid/ Finished product Quinolone specifications. Manufacturer’s Firm is using purified Specification water instead of distilled water in the formulation which requires justification. 76. -do- Optiline Eye Form-5 The firm has Deferred for the Drops 26-03-2015 provided the submission of following:- Each ml of vide diary reference that Method of suspension No.1906 the product is sterilization. contains:- Rs.20,000. approved by Approval status by Chloramphenico Rs.120/5ml DRAP to M/s reference regulatory l USP……5mg Novartis authorities . Dexamethasone Pharma The firm is claiming Sodium vials instead of Phosphate eq to Local dropers in the dossier. Dexamethasone Spersadexoline Firm is sterilizing the Phosphate Eye Drops by product by filteration USP….……1m M/s Novartis which requires g Pharma clarification as dosage
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Tetrahydrozolin form is suspension. HCl Sterilization of USP……0.25m container and closure g system. Corticosteroid/ Finished product vasoconstrictor/ specifications. Antibacterial Manufacturer’s Specification
Remaining applications of M/s. ICI to reach cap of 10 products
S/N Name Brand Name Type of Form Remarks on the Decision and (Proprietary name + formulation (if address Dosage Form + Initial date, any) including of Strength) diary International manufact status in stringent urer / Composition Fee including drug regulatory Applicant differential fee agencies / Pharmacological authorities Group Demanded Price / Pack size Me-too status Finished product Specification GMP status as depicted in latest inspection report (with date) by the Evaluator 77. M/s ICI Erythroprim-S Water Form 5 ______Deferred for the Pakistan Soluble Powder. 10-12-2015 vide submission of Ltd, Life Each Kg contains:- diary No. 517 ERYTHRO-TS following:- Sciences, Erythromycin Rs.20,000. POWDER by M/s Finished 45-Km, Thiocyanate……..100 Decontrolled/ Nawan product Multan gm 100gm, 250gm, specifications. Road, Trimethoprim…..20g 500gm, 1kg, Calculations in Lahore. m 5kg & 25kg salt and base Sulphadiazine as form. Sodium…100gm Proposed Antibacterial master formulation requires justification List of production equipments with GMP compliant. Potentiometer is mentioned in
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assay of trimethoprim and sulphadiazine but not present in equipment list. Complete list of technical persons involved in production and QC. On letter head scanned signature of business manager health. 78. -do- Eflosin oral Powder. Form 5 Deferred for the Each Kg contains:- 10-12-2015 vide submission of Tylosin diary No. 519 following:- Tartrate…..60gm Rs.20,000. Finished Erythromycin Decontrolled/ product Thiocyanate……40gm 100gm, 250gm, specifications Furaltadone as 500gm, 1kg, Approval status HCl…150gm 5kg & 25kg in Pakistan. Antibacterial Calculations in Finished product salt and base specifications are not form. provided. Proposed master formulation. List of production equipments with GMP compliant. Firm is claiming microbial assay method which requires confirmation of microlab. Complete list of technical persons involved in
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production and QC. On letter head scanned signature of business manager health.
79. -do- Co-Spira water soluble Form 5 Deferred for the Powder. 10-12-2015 vide submission of Each Kg contains:- diary No. 518 following:- Spiramycin Rs.20,000. Finished adipate…..75gm Decontrolled/ product Lincomycin 100gm, 250gm, specifications. HCl……25gm 500gm, 1kg, Approval status Antibacterial 5kg & 25kg in Pakistan Finished product Calculations in specifications are not salt and base provided. form are not provided. Proposed master formulation requires justification. List of production equipments with GMP compliant is not provided. Firm is claiming microbial assay method which requires confirmation of microlab. Complete list of technical persons involved in production and QC is not attached. Signatures of business manager, health
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are scanned copies.
Evaluator: Dr. Hafsa Karam Ellahie (DDC PEC-I) 80. M/s Eezoff Sachet Form 5 Zegerit by Deferred for Martin Sachet Dairy No. 1193 Santaurs INC expert opinion as Dow Each sachet contains: dated 29-12- USA per decision of Limited, Omeprazole……20mg 2015 250th Plot Sodium Rs:20,000/- Risek Insta by Registration No.37, Bicarbonate..1680mg 7’s,14’s,28’s getz pharma Board meeting. Sector (Proton Pump Inhibitor As per SRO 19, + Sodium Bicarbonate) Korangi Industrial Area Karachi- 74900
81. M/s Marfinal Sachet Form 5 Movicol by Approved Martin Sachet Dairy No. 1195 Norgine BV UK Dow Each sachet contains: dated 29-12- Movcol by Genix Limited, Polyethlene Glycol 2015 Pharma Plot (Macrogol Rs:20,000/- No.37, 3350)…13.125gm 10’s,14’s,28’s Sector Sodium As per SRO 19, Chloride....0.3507gm Korangi Sodium Bicarbonate Industrial ……....0.1785gm Area Potassium Karachi- Chloride...... 0.0466m 74900 g (Osmotically Acting Laxative) 82. M/s Eezoff Sachet Form 5 Zegerit by Deferred for Martin Sachet Dairy No. 1194 Santaurs INC expert opinion as Dow Each sachet contains: dated 29-12- USA per decision of Limited, Omeprazole……40mg 2015 250th Plot Sodium Rs:20,000/- Risek Insta by Registration No.37, Bicarbonate..1680mg 7’s,14’s,28’s getz pharma Board meeting. Sector (Proton Pump Inhibitor As per SRO 19, + Sodium Bicarbonate) Last Inspection Korangi conducted Industrial 02-02-2015 Area DML renewal Karachi- 09-02-2011 74900
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83. M/s Xelcit Dry Suspension Form 5 Biaxin by Abbvie Approved Martin Dry Powder Dairy No. 1197 USA Dow Suspension dated 29-12- Limited, Each 5ml after 2015 Klaricid by Plot reconstitutution Rs:20,000/- Abbott No.37, contains: 60ml,90ml,120 Laboratories Sector Clarithrmycin…..250 ml 19, mg As per SRO Last Inspection Korangi (J01FA09, Macrolides) conducted Industrial 02-02-2015 Area Source of Granules. DML renewal Karachi- M/s Surge 09-02-2011 74900 Laboratories, Lahore.
84. M/s Xelcit Dry Suspension Form 5 Biaxin by Abbvie Approved Martin Dry Powder Dairy No. 1196 USA Dow Suspension dated 29-12- Limited, Each 5ml after 2015 Klaricid by Plot reconstitution contains: Rs:20,000/- Abbott No.37, Clarithrmycin…..125 60ml,90ml,120 Laboratories Sector mg ml 19, (J01FA09, Macrolides) As per SRO Last Inspection Korangi conducted Industrial Source of Granules. 02-02-2015 Area M/s Surge DML renewal Karachi- Laboratories, Lahore. 09-02-2011 74900
85. M/s Jython Dry Powder Form 5 Zyvox by Approved Martin Suspension Dairy No. 1198 Pharmacia and Dow Dry Suspension dated 29-12- Upjhon Co. USA Limited, Each 5ml contains: 2015 Plot Linezolid……100mg Rs:20,000/- Nezolide by Searl No.37, (Antibiotic, 60ml,90ml,120 Sector Oxazolidinone) ml Last Inspection 19, As per SRO conducted Korangi 02-02-2015 Industrial DML renewal Area 09-02-2011 Karachi- 74900
86. M/s Kinlec Dry Suspension Form 5 Zithromax by Approved Martin Dry Powder Dairy No. 1198 Pfizer USA Dow Suspension dated 29-12- Limited, Each 5ml contains: 2015 Orzit by M/s Plot Azithromycin…….200 Rs:20,000/- Seatle Pvt No.37, mg 60ml,90ml,120 Limited Sector (Macrolide Anti- ml 19, bacterial) As per SRO Last Inspection
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Korangi conducted Industrial 02-02-2015 Area DML renewal Karachi- 09-02-2011 74900
(Evaluator II: Rana Ahsan Ul Haq Athar ADC)
Three applications of M/s Mediflow, Karachi were deferred in 251st meeting of Registration Board. Now firm has requested that these cases may be withdrawn and three new applications may be considered for registration as replacement (to reach cap of 10 products per section). Applications discussed in 251st meeting 1. Flowtol 20% IV Infusion Form-5 Deferred for confirmation of Injectable. Dy. No: 10 approval by reference Each 100ml contain: dated. 02-07- regulatory authorities Mannitol B.P….17.5gm 2015 Sorbitol B.P…..2.5gm 20000/- dated (To be withdrawn) Water for injection qs 02-07-2015 to….100ml 500ml (Osmotic Diuretic) Rs.124/- (BP specs) 2. Flow lactate D IV Infusion Form-5 Deferred for confirmation of Injectable. Dy. No: 11 approval by reference Each 100ml contain: dated. 02-07- regulatory authorities Sodium Chloride 2015 usp…0.6gm 20000/- dated (To be withdrawn) Sodium Lactate 02-07-2015 usp….0.31gm 500ml,1000ml Potassium Chloride Rs.64/- usp…0.03gm Rs.89/- Calicum Chloride usp…0.03gm Calicum Chloride 2H2O usp…5.0gm Water for injection qs to….100ml (Compound Sodium Lactate and 5% Dextrose) (USP specs) 3. Flow-Lyte M IV Infusion Form-5 Deferred for confirmation of Injectable. Dy. No: 12 approval by reference Each 100ml contain: dated. 02-07- regulatory authorities Dextrose Anhydrous 2015
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BP…5.0gm 20000/- dated (To be withdrawn) Potassium Chlorde 02-07-2015 BP…0.150gm 500ml,1000ml Sodium Chloride Rs.64/- BP…0.216gm Rs.89/- Calicum Chloride 2H2O B.P…0.022gm Sodium Acetate.3H2O B.P…0.313 Water for injection qs to….100ml (Compound Sodium Lactate and 5% Dextrose) (Specs not provided)
Fresh Applications as replacement S. No
87. Flow NS IV Form-5 Sodium Chloride Approved Infusion Dy. No: 2076 0.9% in Plastic Injectable. dated. 10-11- Container, Each 100ml 2015 Hospira, Baxter contain: 20000/- Health Care Sodium Chloride 1000ml PP USFDA BP….0.90gm Bottle with Water for injection Eurocap Sodium Chloride qs to….100ml Rs.60/- By M/s Siza (Normal Saline) Pharmaceuticals. (BP specs) 88. Flow Dex 5% IV Form-5 Baxter Health Approved. Infusion Dy. No: 2075 care Hospira Injectable. dated. 10-11- USFDA Each 100ml 2015 contain: 20000/- Pladex-5 by M/s Dextrose 1000ml Rs.62/- Otsuka Anhydrous BP..5.0gm Water for injection qs to….100ml (Carbohydrate) (BP specs) 89. Flow RL IV Form-5 Compound Approved Infusion Dy. No: 2074 Sodium Lactate Injectable. dated. 10-11- Solution for Each 100ml 2015 Infusion by M/s contain: 20000/- 1000ml Baxter Healthcare Sodium Chloride Rs.82/- ltd. UK. BP….0.6gm Sterifluid-RL by Sodium Lactate M/s FDL BP….0.32gm Potassium Chloride
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BP….0.04gm Calcium Chloride 2H2O BP…….0.027gm Water for injection qs to…….100ml (Compound Sodium Lactate) (BP specs)
Decision:- The Board acceded request of firm for withdrawl of applications at S.No. 1, 2 and 3 on firm’s request and approved the applications at S.No. 87, 88 and 89.
Case of M/s Revive Pharmakon, Lahore, 04 applications were deferred in the 254th meeting of the Registration Board due to International non availability of these products. Now the firm has applied 04 fresh applications and requested that their previous application may be rejected and fresh be considered.
Applications discussed in 254th meeting
1. M/s Revive Revasol HD Form 5 Deferred for Submitted for Pharmakon, 10 (Ringer Lactate (29.06.15) confirmation of withdrawl Km , Raiwind + Dextrose 5%) Dy. No. 4154 approval status road, Lahore. IV infusion Rs. 20000/- by reference Each 100ml Rs.84.00/1000 drug regulatory Infusion LVP contain: ml bottle w/o authority approved in Calcium set 241st meeting of Chloride New License CLB 2H2O…27mg Potassium Chloride …40mg Sodium Chloride…600 mg Sodium Lactate…310m g Dextrose anhydrous…5g m WFI…. Q.s to 100ml Isotonic volume expander, electrolyte replacement USP
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Specifications
2. -do- Revasol HD Form 5 Deferred for Submitted for withdrawl (Ringer Lactate (29.06.15) confirmation of + Dextrose 5%) Dy. No. 4148 approval status IV infusion Rs. 20000/- by reference Each 100ml Rs.59.00/500 drug regulatory contain: ml bottle w/o authority Calcium set Chloride New License 2H2O…27mg Potassium Chloride …40mg Sodium Chloride…600 mg Sodium Lactate…310m g Dextrose anhydrous…5g m WFI…. Q.s to 100ml Isotonic volume expander, electrolyte replacement USP Specifications
3. -do- Revasol H Form 5 Deferred for Submitted for withdrawl (Hartmann’s (29.06.15) confirmation of solution) IV Dy. No. 4153 approval status infusion Rs. 20000/- by reference Each 100ml Rs.56.00/500 drug regulatory contain: ml bottle authority Calcium New License Chloride 2H2O…27mg Potassium Chloride …40mg Sodium Chloride…600 mg Sodium Lactate…310m g WFI…..Q.s
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to 100ml Isotonic volume expander, electrolyte replacement B.P Specifications
4. -do- Revasol H Form 5 Deferred for Submitted for withdrawl (Hartmann’s (29.06.15) confirmation of solution) IV Dy. No. 4142 approval status infusion Rs. 20000/- by reference Each 100ml Rs.77.00/1000 drug regulatory contain: ml bottle authority Calcium New License Chloride 2H2O…27mg Potassium Chloride …40mg Sodium Chloride…600 mg Sodium Lactate…310m g WFI…. Q.s to 100ml Isotonic volume expander, electrolyte replacement B.P Specifications
Fresh Applications for registration as replacement
90. -do- Revasol HD Form 5 FDA approved Approved (Ringer Lactate (21.01.16) as Dextrose + Dextrose 5%) Dy. No. 238 5% and IV infusion Rs. 20000/- Lactated Ringer Rs.84.00/1000 in plastic bottle Each 100ml ml bottle w/o contain: set Ringolact-D Calcium New License (Otsuka) Chloride 2H2O…20mg Potassium Chloride
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…30mg Sodium Chloride…600 mg Sodium Lactate…310m g Dextrose …5gm WFI…. Q.s to 100ml
Isotonic volume expander, electrolyte replacement
USP Specifications 91. Revasol HD Form 5 FDA approved Approved (Ringer Lactate (21.01.16) as Dextrose 5% + Dextrose 5%) Dy. No. 238 and Lactated IV infusion Rs. 20000/- Ringer in plastic bottle Each 100ml Rs.59.00/500 contain: ml bottle w/o Ringolact-D Calcium set (Otsuka) Chloride 2H2O…20mg New License Potassium Chloride …30mg Sodium Chloride…600 mg Sodium Lactate…310m g Dextrose …5gm WFI…. Q.s to 100ml
Isotonic volume expander, electrolyte replacement
USP Specifications 92. Revasol H IV Form 5 MHRA. Approved infusion (21.01.16) Approved Dy. No. 238 Compound Each 100ml Rs. 20000/- Sodium Lactate contain: Solution for Calcium Rs.56.00/500 Infusion Chloride ml bottle
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2H2O…27mg New License Hartmann Potassium Solution by M/s Chloride LCPW …40mg Sodium Chloride…600 mg Sodium Lactate…320m g WFI…..Q.s to 100ml
Isotonic volume expander, electrolyte replacement
B.P Specifications 93. -do- Revasol H IV Form 5 MHRA. Approved infusion (21.01.16) Approved Dy. No. 238 Compound Each 100ml Rs. 20000/- Sodium Lactate contain: Solution for Calcium Rs.77.00/1000 Infusion Chloride ml bottle 2H2O…27mg New License Hartmann Potassium Solution by M/s Chloride LCPW …40mg Sodium Chloride…600 mg Sodium Lactate…320m g WFI…. Q.s to 100ml
Isotonic volume expander, electrolyte replacement
B.P Specifications
Decision: Registration Baord acceded to firm’s request for withdrawl of applications at S.No. 1, 2, 3 and 4 and approved applications at S.No. 90, 91, 92 and 93.
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Evaluator: Salateen waseem Philip S/N Name and Brand Name Type of Form International Decision address of (Proprietary name + Initial date, status in stringent manufacturer / Dosage Form + diary regulatory Applicant Strength) Fee including agencies Composition differential fee Pharmacological Demanded Price Me-too status Group / Pack size Finished product GMP status as Specification depicted in inspection report (dated)
94. M/s Caliph Metro-Calm M Liquid Form-5 with TGA approved and Approved Pharmaceuticals Suspension prescribed fee MHRA Approved (Pvt.) Ltd, Each 5ml of liquid 20,000/- – Pinewood Plot#17, Special suspension contains:- Dy. No. 915 dated Laboratories Industrial Zone Ibuprofen 200 mg 13-04-2015 (EPZ) Risalpur, 90ml bottle as per Brufen DS KPK NSAID SRO (Abbott) USP Specification
GMP compliant section vide inspection report dated 03-07-2015 95. -do- Tablet Califen 100mg Form 5 with Ansaid – Abbott Approved Each tablet contains prescribed fee Flurbiprofen 100mg 20,000/- Ansaid-Abbott Rs. 8000/- NSAID Dy. No. 2228 dated GMP compliant In-house specification 31-03-2010 section vide inspection report Rs. 12000/- dated 03-07-2015 Dy. No. 40 dated 08-06-2015
3 x 10’s as per SRO
Case No. 03. Deferred applications of previous meetings: (Evaluator IV: Salateen Waseem Philips)
Case No. i:- Trifon Powder of M/s Biooxime Pharma, Faisalabad
M/s Bioxime Pharmaceuticals of Faisalabad applied for registration of following drug on prescribed Form 5 which was discussed in 249th meeting of the Board as under:-
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S # Name and Brand Name Type of Form International Decision of address of (Proprietary name + Initial date, status in 249th meeting Manufacturer / Dosage form + diary. Fee stringent of RB. Applicant Strength) including regulatory differential fee agencies Me- Composition Demanded too status Pharmacologi cal Price / Pack Group Finished size product specification 1. -do- TRIFON Oral Powder Form 5 10-04- Ectonil By Approved Each 1000 gm 2015 Leads, Pharma contains. Trichlorfon Rs.20,000/- 063723 98 % / Metrifonate (Dy.No. (2523) w/w (Antiparasitic) Price Manufacturer’s Specs Decontrolled Pack Size 5,10, 20, 50,100,250,500, 1000,5000GM
Later on, it was observed in the dossier of the firm that they applied for the dosage form as an external preparation. However in the minutes of 249th meeting the product was mentioned as oral powder which is a typographical error. The application is placed before Board for reconsideration as under:-
S # Name and Brand Name Type of Form International Decision address of (Proprietary name + Initial date, status in Manufacturer / Dosage form + diary. Fee stringent Applicant Strength) including regulatory Composition Finished differential fee agencies Me- product specification Price / Pack too status size 96. -do- TRIFON Powder Form 5 10-04- Ectonil By Approved 2015 Leads, Pharma Each 1000 gm Rs.20,000/- 063723 contains. Trichlorfon (Dy.No. (2523) 98 % / Metrifonate Price w/w Decontrolled Pack Size 5,10, (Antiparasitic) 20, Manufacturer Spec 50,100,250,500, 1000,5000GM
Case No.ii. M/s. Decent Pharma, Plot # 30, Street No. SS-3, Rawat
Following application of M/s. Decent Pharma Rawat was discussed in 249th meeting of the Board as under:-
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S # Name and Brand Name Type of Form International Decision of address of (Proprietary name + Initial date, status in 249th meeting Manufacturer / Dosage form + diary. Fee stringent of RB. Applicant Strength) including regulatory Composition differential fee agencies Me- Pharmacologi cal Demanded too status Group Finished Price / Pack product specification size 97. M/s Decent Spel Injection Liquid Form 5 L.S Injection Deferred for Pharma, Plot Injection Rs.20000/- 03- 100/50mg (eq. clarification of No.30, Street Each ml Contains: 10-2014 Dy. to base) formulation No.SS-3, Spectinomycin (as No. 20 Holland whether in National sulphate) … powder or Industrial Zone ……..100mg LINCOJECT liquid form. Rawat. Lincomycin (as HCL) S INJ 100mg / …………………. Decontrolled 50mg (eq. to N.B: 50mg /100ml base) Intl. (Requirments (Antibiotic) Chempharma, of TOC Manufacture Spec’s Lhr analyzer and Liquid Particle Counter shall be observed as per decision of Registration Board)
2. Firm stated that the product composition is clearly mentioned as liquid formulation in prescribed Form 5 for registration with packing details as 100ml and 50 ml. 3. The international availability and locally existing formulation are also in liquid formulation. Decision:- Regitration Board approved product at S.No. 97. Case No.iii. M/s MALLARD PHARMACEUTICALS (PVT.) LTD, MULTAN
The product named Meloximall Injection was presented in 253rd meeting of the Board as under:- S # Name and Brand Name Type of International Decision of 249th address of (Proprietary name Form Initial status in meeting of RB. Manufacturer / + Dosage form + date, diary. stringent Applicant Strength) Fee regulatory including agencies Me- Composition differential too status Pharmacologi cal fee Group Finished Demanded product Price / Pack specification size 98. -do- Meloxmall Form 5 Metacam Deferred for Injection Rs. 20,000/- 5mg/ml, FDA clarification as vide Dy. No. approved Each ml contains 296 dated under:- Meloxicam 10 mg 29-05-2015 Meloxi-10 Internationally,
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Antibiotics (SELMORE) the product (BP Pack of available as Specification) 50 ml, 100 ml, 200 ml 5mg/ml and not as 10mg/ml.
2. Firm has submitted reply and stated that same composition they applied of 10mg/ml is available locally in Pakistan as under:- Meloxi-10 with Reg. # 049643 of M/s Selmore Pharmaceuticals (Pvt.) Ltd, Multan Road, Lahore I-FENAC with Reg. # 053985 of M/s International Pharma Labs, Lahore
3. However, firm has not provided any proof for international availability of the product with the strength 10mg/ml. Decision:- Regitration Board approved product at S.No. 98.
Case No.iv. M/s BJ Pharmaceuticals, 19 km, Mandiali Stop, Lahore.
The product of the firm named Be-Koff Syrup was presented in 237th meeting of the Board and approved with following composition:-
Each 5 ml contains Approved Ammonium Chloride …. 100 mg Sodium Citrate ……….. 58mg Chlorphenarmine maleate 2mg
Later on, firm informed that due to typographical mistake, they missed one of the active ingredient of the product i.e. menthol 1mg/5ml. Now firm has submitted revised dossiers to be considered by the Board with composition as under:- Each 5 ml contains i. Ammonium Chloride …. 100 mg ii. Sodium Citrate ……….. 58mg iii. Chlorphenarmine maleate 2mg iv. Manthol 1mg
The dossier of the proposed product has been re-evaluated and found upto date with respect to evaluation guidelines approved in 251st meeting of the Board.
Case is submitted for consideration of the Board, please.
S Name and Brand Name Type of Form International Decision # address of (Proprietary name + Initial date, status in Manufacturer / Dosage form + diary. Fee stringent Applicant Strength) including regulatory Composition differential fee agencies Me- Pharmacologi cal Demanded too status Group Finished Price / Pack
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product specification size 99. M/s BJ BE-Koff Syrup Form 5 ------Approved Pharmaceuticals, Rs. 8,000/- + 19 km, Mandiali Each 5 ml contains Rs. 12000/- Amrid -Jawa Stop, Lahore – Ammonium Chloride =20,000/- Sheikhupura 100 mg dated 22-06- Road, Lahore Sodium Citrate 2012 & 04-02- 58mg 2013
Chlorphenarmine Pack size / as maleate 2mg per SRO Manthol 1mg
Expectorant / Antihistamine (BP Specification)
Decision:- Regitration Board approved product at S.No. 99.
Case No. v:- M/s SEARLE IV SOLUTIONS (PRIVATE) LIMITED
The Registration Board in its 242nd meeting held on 25th February 2014 discussed the case of the firm for registration of Halite ISO Solution for Infusion and deferred for submission of deficiencies pointed out during evaluation. Firm has now submitted documents according to guidelines approved in 251st meeting and application is complete, therefore case is presented for consideration of the Board, Please. S/ Name and Brand Name Type of Form International status Decision N address of (Proprietary name + Initial date, diary in stringent manufacturer / Dosage Form + Strength) Fee including regulatory agencies Applicant Composition differential fee Pharmacological Group Demanded Price Me-too status Finished product / Pack size Specification GMP status as depicted in inspection report (dated)
100. -do- Halite ISO Solution for Form-5 Sterofundin ISO Approved Infusion Fast Track solution for Each 1000ml contain:- Rs.226.91per Infusion by Electrolyte mmol 500ml Rs.323.41 B.Braun Sodium 145 per 1000ml Melsungen AG Potassium 4.0 22/8/2013, 9904 34209 Melsungen, Calcium 2.5 R&I Germany Magnesium 1.0 22/8/2013 (Rs. Malate 5.0 Chloride 127 60,000/-) GMP inspection Acatate 24 report dated 16-01- Pack size 500 ml 2014
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Sodium Chloride 6.80gm / Rs. 226.91/- Potassium Chloride 0.30gm Calcium Chloride Dihydrate 1000ml / Rs. 0.37gm 323.41 Magnesium Chloride Hexahydrate 0.20gm Sodium Acetate Trihydrate 3.27gm Malic Acid 0.67gm
Plasma-Adapted Electrolytes
Case No. vi:- M/s Mafins Pharma, A-5, S.I.T.E, Superhighway Industrial Area, Karachi
The Registration Board in its 253rd meeting Deferred following application for confirmation of approval by reference regulatory authority as under:-
101. -do- Menadex – N Form 5 Dexamin – N Cream Rs. 20,000/- Cream (09-06-2015) (Geoffman) Each gram Dy. No. 297 contains Pack of Dexamethason 5 gm / Rs. 19 e Phosphate 10 13 gm / Rs. 40 mg 15 gm / Rs. 35 (Dexamethaso 20 gm / Rs 68 ne Sodium Phosphate) Neomycin 3.5 mg (as Sulfate) (USP Specification)
Now firm has submitted reply wherein they stated that the composition of the product presented in the meeting was not correct due to typographical mistake. The correct composition of the product is as under:- Each gram contains Dexamethasone Phosphate 1mg (Disodium Salt) Neomycin (as sulfate) 3500 I.U
Decision:- Registration Board deferred the case for confirmation of approval status of same formulation in reference regulatory authority.
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(Evaluator II: Rana Ahsan Ul Haq Athar ADC) Case No.vii. Deferred applications of M/s. Bio Labs Islamabad.
S/ Name and Brand Name Type of Remarks on the Decision N address of (Proprietary name + Dosage Form formulation (if manufacturer Form + Strength) any) including / Applicant Initial date, International Composition diary status in stringent drug Pharmacological Group Fee regulatory including agencies / Finished product differential authorities Specification fee Me-too status Demanded Price / Pack GMP status as size depicted in latest inspection report (with date) by the Evaluator 102. M/s Bio- BIO-Amoxy Sulfate ws Form-5 Amoxib by m/s Approved as Labs (Pvt) powder. Dy. No: Attabak the firm has Ltd. Plot Water soluble Powder. 288 (Reg. No. rectified the No.145 Each 100gm contains. Dated. 28- 071061) previous Industrial Amoxycilline as 05-2015 objection of the Baord. Triangle, Rs.20,000/ Trihydrate……15gm Kahuta Colistine - Road, Sulphate……….50MIU 100gm, Islamabad. (Both are Antibacterial 500gm, (Veterinary (Amoxycillin trihydrate is 1000gm, ) moderate-spectrum, 2kg, 3kg, bacteriolytic) 5kg/ As Bio-Labs Specs. per SRO 103. M/s Bio- BIO-Amoxy ws powder. Form-5 Me too not Deferred for Labs (Pvt) Water soluble Powder. Dy. No: available. confirmatio Ltd. Plot Each gm contains. 236 n of me too No.145 Amoxicillin Dated. 06- status. If Industrial trihydrate…..120mg 05-2015 not, then Triangle, Colistin Rs.20,000/ application Kahuta sulphate…..52.63mg - on Form Road, (Both are bacterial 100gm, 5D, Islamabad. amoxicillin trihydrate is 500gm, requisite fee moderate spectrum, 1000gm, and bacteriolytic) 2kg, 3kg, approval Bio-Labs Specs. 5kg/ As status in per SRO reference regulatory countries 104. M/s Bio- BIO-Colimox ws powder. Form-5 Me too not Deferred for Labs (Pvt) Water soluble Powder. Dy. No: available confirmatio Ltd. Plot Each 1000gm contains. 291 n of me too
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No.145 Amoxycillin Dated. 28- status. If Industrial Trihydrate…..20000mg 05-2015 not, then Triangle, Colistin Rs.20,000/ application Kahuta sulphate……2,0000,000I - on Form Road, U 100gm, 5D, Islamabad. (Antibacterial) 500gm, requisite fee Bio-Labs Specs. 1000gm, and 2kg, 3kg, approval 5kg/ As status in per SRO reference regulatory countries 105. M/s Bio- BIO-Pencitracin ws Form-5 PRO SB-Plus by Approved Labs (Pvt) powder. Dy. No: m/s Noahemis Ltd. Plot Water soluble Powder. 245 Pharmaceuticals No.145 Each 1000gm contains. Dated. 03- (Reg. No. Industrial Procaine 05-2015 028508) Triangle, penicillin…….12gm Rs.20,000/ Kahuta Streptomycin - Road, sulphate……36gm 100gm, Islamabad. Zinc 500gm, bacitracin………52gm 1000gm, Colistin sulphate…..60 2kg, 3kg, M.I.U 5kg/ As (Antibacterial) per SRO 106. M/s Bio- BIO Amoxistin ws Form-5 Amoxycol Approved Labs (Pvt) powder. Dy. No: powder by M/s Ltd. Plot Water soluble Powder. 286 M&H No.145 Each gm contains. Dated. 28- pharmaceutical Industrial Amoxicillin as 05-2015 , Lahore. Triangle, Trihydrate…..150mg Rs.20,000/ (Reg. No. Kahuta Colistin - 014540) Road, Sulphate….5000,000 I.U 100gm, Islamabad. (Antibacterial) 500gm, Bio-Labs Specs. 1000gm, 2kg, 3kg, 5kg/ As per SRO
Case No. viii. Deferred applications of M/s Espoir Pharmaceuticals PCSIR KCL, Karachi (M-254)
107. M/s Espoir Es-Fibrol Form-5 Fybogel Approved Pharmaceutic Sachet Dy. No: Mebeverine als PCSIR Each Sachet contains: 553 dated. By KCL, Mebevrine Hcl BP 13-4-2015 Reckitt Karachi. ….. 135mg Rs.20,000/- Benckiser Ispaghula Husk BP As per Healthcare …..3.5gm SRO (UK) (Antispasmodies & MHRA
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Articholiergies) Mevulak Sachet (sami) 108. M/s Espoir Montilet Sachet Form-5 Singulair Approved Pharmaceutic Sachet Dy. No: Granule By als PCSIR Each Sachet contains: 555 dated. Merck Sharp KCL, Monelukas 13-4-2015 and Dohme, Karachi. Sodium……4mg Rs.20,000/- UK (Anti-asthma As per MHRA, Leuketrienne SRO USFDA Recpton) Singulair (OBS Pharma) 109. M/s Espoir Stron Sachet Form-5 Protelos Approved Pharmaceutic Sachet Dy. No: Sachet By als PCSIR Each Sachet contains: 552 dated. LES KCL, Strontium Ranelate 13-4-2015 Laboratories Karachi. …….. 2gm Rs.20,000/- Servier, (Postmenopausal As per France osteoporosis) SRO Onita Sachet (Pharmevo)
Case No.ix. Deferred application of M/s. Vetz Pharma Kotri.
110. M/s Vetz Norzine Plus Oral Liquid Form-5 Me-too not Deferred for Pharmaceuticals, Each 100 ml contains. Dy. No: 397 provided. confirmation private Limited, Norfloxacin…….5gm dated. 19-06- Information of me too S.I.T.E Kotri Sulphamethoxypyridizine…..5gm 2015 from of status. If Sindh Trimethoprim……1gm 20000/- form-5 from not, then Oral liquid Bromhexine…..500mg+colistine dated 18-06- 14 to application Antibiotec 2015 19 not on Form 5D, (Manfacturer specs) Decontrolled provided. requisite fee Pack of and 100ml, approval 250ml, status in 500ml reference regulatory countries 111. -do- Verminil Plus Oral Liquid Form-5 Sannil-DS Approved Each 100 ml contains. Dy. No: 383 Oral Levamisole HCl…….3gm dated. 19-06- Suspension Oxyclozanide……..6gm 2015 by m/s Cobalt (sulphate) 20000/- Sanna BP……0.764gm dated 18-06- Laboratories, Selenium (Sodium)…..0.076gm 2015 Faisalabd Anthelmintic Decontrolled (Manfacturer specs) Pack of 100ml,150ml 250ml, 500ml 1liter
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(Evaluator-I Muhammad Ansar)
112. M/s Intervac Prostifas Injection Form 5 Deferred for (Pvt) Ltd, 18 Each ml contains:- 28-04-2011 submission of Km Lahore Cloprostenol Sodium diary # 210 following:- Sheikhupura B.P 263 mcg eq to R&I Copy of Challan of Road, Cloprostenol Decontrolled / The firm is differential fee of Sheikhupura. 250mcg 2ml, GMP 12000. Not provided compliant as Approval status in Manufacturer’s per inspection Pakistan. Specifications dated. Last inspection conducted within the period of 1 year. 113. -do- Intervit Plus Form 5 Deferred for Injection 28-04-2011 Firm has submission of Each 100ml diary # 222 provided the following:- contains:- Vitamin R&I reference of Copy of Challan of A….5MIU Decontrolled Uvevit plus differential fee of Vitamin D3…1MIU /100ml injection 12000. Vitamin E which require Approval status in Acetate…2gm to be verified. Pakistan. Vitamin C ….2.5gm Last inspection Vitamin B1...600mg conducted within the Vitamin B2 Last inspection period of 1 year. …100mg report is not Vitamin B6…500mg provided. Vitamin B12…5mg Nicotinamide…1gm Calcium Pantothenate..600mg Biotin…5mg Folic Acid….10mg Lysine…1mg Methionine…1mg Copper Sulphate…….10mg Zinc Sulphate…10mg Magnesium Sulphate…10mg Vitamins & Minerals Manufacturer’s Specifications
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114. -do- Amivit Plus Form 5 Deferred for Injection 28-04-2011 submission of Each ml contains:- diary # 230 following:- L-Arginine R&I Copy of Challan of HCl….1.44mg Decontrolled Last inspection differential fee of L-Cysteine /100ml report is not 12000. HCl….3.20mg provided. Approval status in L- Pakistan. Glutamine……3.20 Last inspection mg conducted within the Glycine……3.20mg period of 1 year. L- Histidine….1.32mg L- Isoleucine….3.60mg L-Leucine HCl….4.28mg L-Lysine HCl..….5.44 L- Methionine….3.20m g L- threonine…3.20mg L- Tryptophan…0.86m g L- Phenylalanine….5m g L-Valine….3.60mg Thiamine HCl….4mg Riboflavin Sodium Phosphate….0.17mg Pyridoxine HCl…0.34mg Nicotinamide …8mg Ascorbic Acid…4mg Glucose ….33mg Calcium Chloride…0.08mg Potassium Chloride….0.21mg Magnesium Chloride…0.08mg Amino acid, vitamins & electrolytes
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Manufacturer’s Specifications
115. -do- Fluxifas Injection Form 5 Deferred for Each ml contains:- 28-04-2011 submission of Flunixin as diary # 203 Loxin following:- Meglumine….50mg R&I Injection by Copy of Challan of Anti Inflammatory Decontrolled M/s Selmore differential fee of Manufacturer’s /10ml 12000. Specifications Last inspection conducted within the period of 1 year. 116. -do- Mettycoli Injection Form 5 Deferred for Each ml contains:- 28-04-2011 submission of Dimetridazole…100 diary # 224 Tycolimet following:- mg R&I Injection by Copy of Challan of Colistin Decontrolled / M/s Breeze differential fee of Sulphate…..10mg 100ml Pharma 12000. Tylosin Last inspection Tartrate….50mg conducted within the Antibiotic period of 1 year. Manufacturer’s Specifications 117. -do- Novafas Injection Form 5 Deferred for Each ml contains:- 28-04-2011 submission of Novaminsulfon…..4 diary # 205 Novamide following:- 0mg R&I Injection by Copy of Challan of Etilefrin…..0.2mg Decontrolled / M/s Guyton differential fee of Calcium 500ml Pharmaceutical 12000. Gluconate….110mg s Last inspection Magnesium conducted within the Gluconate….10mg period of 1 year. Sodium Salicylate….7mg Nicotinamide….0.3 mg Caffeine…10mg Boric Acid…10mg Antibiotic and Supplement Manufacturer’s Specifications.
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Case No. x. Deferred applications of M/s. Genome Pharma Hattar.
118. M/s Genome CALRENE 5g Form 5 Nikkin Deferred for the submission Pharmaceutic Sachet Chemiclas of following:- al Dy No. 167 Japan Stability data as per (Pvt.) Each sachet dated decision of 251st Limited, contains: 10.03.2015 Kalimate sachet meeting RB. S.I.T.E. Calcium 50000/- 5 gm (Maple 16/I, Phase polystyrene Pharma) IV, Sulfonate…….5g As per SRO/- Industrial Pack of 30’s Estate (Serum potassium Hattar level Pakistan lowering agent) (Sachet General) (Manufacturer Letter No. specs) F.3- 7/95-Lic (Vol-I) dated 07-04- 15 119. -do- NORELLA Form-5 JONICA Deferred for the submission Capsules 25mg Dy. No. 27 Capsules of of following:- Each capsule dated : 08-11- Pierre Fee Challan of Rs. contains: 10 Fabre Australia 20,000. Milnacipran……. 8000/- dated : Pty Ltd (TGA To apply on form 5-D 25 08-11-10 Appeoved) along with deficient mg 12000/- dated: fee and stability data Selective nor 17-01-14 required. epinephrine and As per SRO/ serotonin Pack of 10’s reuptake inhibitor Manufacturer 120. M/s Sitagen-M XR Form-5 Janumet XR Approved as the firm has Ferozsons 50/1000 Dy. No: 125 Tablet. MSD rectified shortcomings Laboratories Tablet. Dated. 02-03- USA observed by Registration Limited. P.O Each bi-layered 2015 Treviamet by Board. Ferozsons, film coated tablet Rs.20,000/- Getz Pharma Amangarh, contains. 14’s,28’s,30’s Karachi. Nowshera. Sitagliptin As per SRO phosphate monohydrate equivalent to Sitagliptin 50mg as immediate release layer and Metformin HCl extended release
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granules equivalent to Metformin HCl 1000mg as extended release layer.
Case No. xi:- Deferred cases of various firms. 121. M/s Bloom Tablet ALEPTAL Form 5 MHRA Approved as the firm has Pharmaceutic 30mg Rs. 20,000/- approved Tablet rectified shortcomings als (Pvt.) Ltd, Each Tablet vide Dy. No. Phenobarbital observed by Registration Plot # 30, contains 3357 dated (Actavis, UK) Board. Phase I & II, Phenobarbitone 14-01-2015 Phenobarbitone Industrial U.S.P 30mg Pack size of tablet Estate, Barbiturates 10 tablets per (Munawar Hattar. (USP strip in box of Pharma) Specification) 3 x 10’s – Tablet Price as per (Psychotropic) SRO GMP compliant vide inspection report of panel dated 27-08- 2015.
122. -do- Tablet REVEL Form 5 MHRA Approved as the firm has 1mg Rs. 20,000/- approved Tablet rectified shortcomings Each Tablet vide Dy. No. Lorazepam observed by Registration contains 3358 dated (Morningside Board. Lorazepam B.P 14-01-2015 Healthcare 1mg Pack size of Limited, UK) Benzodiazepines 10 tablets per Tenzil (Atco) (BP strip in box of Specification) 10 x 10’s – Tablet Price as per Psychotropic) SRO GMP Decontrolled compliant vide inspection report of panel dated 27-08- 2015.
123. M/s Astellas Astelexim Form-5 MHRA Approved as the firm has Pharmaceutic Injection 11-02-2011 Cefuroxime rectified shortcomings al (Pvt) Ltd, Each vial vide diary # Sodium 250mg observed by Registration 15-C contains:- 09 Rs.8000 Injection. Board. Industrial Cefuroxime as R&I &11-02- Estate Sodium eq to 2014 diary # Alfur Injection
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Hayatabad, Cefuroxime……. 166 Rs.12000 250mg by M/s Peshwar. ….250mg As per SRO Albro Pharma. Cephalosporin Priority List USP No. 857 Specifications 124. -do- Cephlex 125 dry Form-5 FDA.Duricef Approved as the firm has Suspension 20-05-2011 Suspension rectified shortcomings Each 5ml diary No 48. 125mg/5ml, observed by Registration Priority List contains Rs8000 & 250mg/5ml & Board. No. 1052 Cefadroxil 12000 dated 500mg/5ml as a Hemihydrate 11-02-2014 base. eq.to As per SRO. Davox by M/s Cefadroxil…..125 Fynk Pharma. mg. The firm is Cephalosporin GMP compliant USP as per Specifications inspection dated 24-08-2015.
125. -do- Cephlex 250 dry Form-5 FDA. Duricef Approved as the firm has Suspension 20-05-2011 Suspension rectified shortcomings Priority List Each 5ml diary No 119. 125mg/5ml, observed by Registration No. 1053 contains Rs8000 & 250mg/5ml & Board. Cefadroxil 12000 dated 500mg/5ml as a Hemihydrate 11-02-2014 base. eq.to As per SRO. Davox by M/s Cefadroxil…..250 Fynk Pharma. mg. The firm is Cephalosporin GMP compliant USP as per Specifications inspection dated 24-08-2015.
126. -do- Astaclor 50mg Form-5 Ceclor by M/s Deferred for the drops 24-03-2011 AGP Pharma. confirmation of approval Priority List Each ml when diary No 73. The firm is status by refrence regulatory No. 940 reconstituted Rs8000 & GMP compliant authorities. contains:- 12000 dated as per Cefaclor 11-02-2014 inspection dated Monohydrate As per SRO. 24-08-2015. eq.to Cefaclor…..50mg . Cephalosporin USP Specifications
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127. M/s Sind POLYMED Form-5A Approved as the firm has Medical Single Blood rectified shortcomings Stores, 13-B, Bags with Dy No: 224 observed by Registration Block 6, Anticoagulant dated 21-06- Board. P.E.C.H.S CPDA-1 Solution 11 Shahrah-e- Faisal Each 100ml 15000 dated Karachi. Anticoagulant 21-06-11 CPDA solution 85000 dated Poly USP contains: 02-04-13 Medicure Citric acid Ltd, Plot (anhydrous) 104-105, USP….0.299gm 115, Sec, Sodium Citrate Sec-59, (dihydrate) HSIDC USP….2.63gm Industrial, Monobasic Sod. Ballabgarh- Phosphate…..0.2 121004, 22gm Faridabad Dextrose Haryana (Monohydate) India. USP…3.190gm Adenine Priority List USP….0.0275gm No. 62 Water for Import Injection USP….qs to 100ml
(Surgical disposables) 128. -do- POLYMED Form-5A Approved as the firm has double Blood rectified shortcomings Priority List Bags with Dy No: 223 observed by Registration No. 63 Anticoagulant dated 21-06- Board. Import CPDA-1 Solution 11 & one transfer bag 15000 dated 21-06-11 Each 100ml 85000 dated Anticoagulant 02-04-13 CPDA solution USP contains: Citric acid (anhydrous) USP….0.299gm Sodium Citrate (dihydrate) USP….2.63gm Monobasic Sod.
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Phosphate…..0.2 22gm Dextrose (Monohydate) USP…3.190gm Adenine USP….0.0275gm Water for Injection USP….qs to 100ml
Surgical disposables 129. -do- POLYMED triple Form-5A Approved as the firm has Blood Bags with rectified shortcomings Priority List Anticoagulant Dy No: 225 observed by Registration No. 64 CPDA-1 Solution dated 21-06- Board. Import & two transfer 11 bag 15000 dated Each 100ml 21-06-11 Anticoagulant 85000 dated CPDA solution 02-04-13 USP contains: Citric acid (anhydrous) USP….0.299gm Sodium Citrate (dihydrate) USP….2.63gm Monobasic Sod. Phosphate…..0.2 22gm Dextrose (Monohydate) USP…3.190gm Adenine USP….0.0275gm Water for Injection USP….qs to 100ml
Surgical disposables
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Replies Products of M/s Pharmevo that were deferred in 248th meeting 130. M/s PharmEvo (Pvt) Ablin 50mg Capsule Form-5 Approved as the Ltd., Plot No. A-29, Capsule Rs.8000/- firm has rectified North Western Industrial Each Capsule contains: 05-04-2008 shortcomings Zone, Port Qasim, Pregabalin ....50mg observed by Karachi. (Anti depressant) Rs.12,000/- Registration Board. Manufacturers 23-04-2014 specifications Rs.200/14’s
131. M/s PharmEvo (Pvt) Ablin 75mg Capsule Form-5 Approved as the Ltd., Plot No. A-29, Capsule Rs.8000/- firm has rectified North Western Industrial Each Capsule contains: 05-04-2008 shortcomings Zone, Port Qasim, Pregabalin ....75mg observed by Karachi. (Anti depressant) Rs.12,000/- Registration Board. Manufacturers 23-04-2014 specifications Rs.250/14’s
132. M/s PharmEvo (Pvt) Ablin 100mg Capsule Form-5 Approved as the Ltd., Plot No. A-29, Capsule Rs.8000/- firm has rectified North Western Industrial Each Capsule contains: 05-04-2008 shortcomings Zone, Port Qasim, Pregabalin observed by Karachi. ……...... 100mg Rs.12,000/- Registration Board. (Anti depressant) 23-04-2014 Manufacturers specifications Rs.300/14’s LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA
GABICA Capsules (50, 75, 100, 150 and 300mg) Getz
GMP inspection report dated 20- 03-2013 provided. GMP compliance found good at time of inspection.
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133. M/s PharmEvo (Pvt) Ablin 150mg Capsule Form-5 Approved as the Ltd., Plot No. A-29, Capsule Rs.8000/- firm has rectified North Western Industrial Each Capsule contains: 05-04-2008 shortcomings Zone, Port Qasim, Pregabalin ....150mg observed by Karachi. (Anti depressant) Rs.12,000/- Registration Board. Manufacturers 23-04-2014 specifications Rs.400/14’s LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA
GABICA Capsules (50, 75, 100, 150 and 300mg) Getz
GMP inspection report dated 20- 03-2013 provided. GMP compliance found good at time of inspection.
134. M/s PharmEvo (Pvt) Ablin 300mg Capsule Form-5 Approved as the Ltd., Plot No. A-29, Capsule Rs.8000/- firm has rectified North Western Industrial Each Capsule contains: 05-04-2008 shortcomings Zone, Port Qasim, Pregabalin ....300mg observed by Karachi. (Anti depressant) Rs.12,000/- Registration Board. Manufacturers 23-04-2014 specifications Rs.725/14’s LYRICA Capsules (25, 50, 75, 100, 150,200, 225 and 300mg) US FDA
GABICA Capsules (50, 75, 100, 150 and 300mg) Getz
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Replies of the M/s Medicraft Pharmaceutical, Peshwar deferred in 252 meeting
135. M/s. Medicraft VIT.D Injection Form 5 Deferred for the Pharmaceuticals, Fast Track submission/ Peshawar Each ml Clarification/ contains:- 25/3/2013 180 rectification of Vitamin R&I following: 25/3/2013 D3…..1mcg a. Revised Form-5
Vitamin (Rs. 20,000/-) is submitted 3/10/2013 with following Rs. 40,000/- label claim: Each ml contains: Cholecalciferol..5mg eq. to 250000mg. b. Clarification is required regarding calculation of 5mg eq. to 250000IU. c. Quantity of API submitted in master formulation is not rational with label claim. d. Sterilization method/ process of finished product is not provided under Manufacturing method. e. Reference of calcitrol (1mcg/ml) injection is given under evidence of availability in reference agencies and Pakisatn.
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Replies of products of M/s Zakfas deferred in the 248th meeting of the RB
136. M/s Zakfas P.N.K Spray Form 5 Pink spray by Deferred for Pharmaceutical M/s Atzan confirmation of status (Pvt) Ltd.12km Each 100ml 12/03/2014 Pharma. of chloramphenicol in Bosan Road, contains:- Not spary dosage form Multan. Chloramphenico mentioned Rs. The inspection (Spray Section) l…..5.0gm 20000/- of the firm was Cetrimide…1.0 carried out on gm Decontrolled/ 22-02-13 by the Crystal 100ml,150ml, panel of violet…0.5mg 250ml inspectors and Dimethyl recommended Phthalate…1.0g the garnt of m additional Isopropyl sections alcohol……q.s namely: Propellant: Bolus & Dimethyl granule section ether…67ml Ointment Section (Antibiotic / Spray Section Antibacterial) Deferred for comments of Manufacturer veterinary expert committee and confirmation of me too status. Now the firm has replied the me too product 137. -do- OXYSONE Form 5 Oxycort Spray Approved as the firm Spray by M/s Star labs has rectified 12/03/2014 shortcomings Each 100ml Not observed by contains:- mentioned Rs. Registration Board. Oxytetracycline 20000/- HCl (USP).500mg Decontrolled/ Hydrocortisone 100ml,150ml, … 250ml (BP)….160mg
(Anti-bacterial and Anti- inflammatory)
ManufacturerSp ecifications
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138. -do- SULFAVET Form 5 Sulphapri by Approved as the firm Bolus M/s Prix has rectified 12/03/2014 shortcomings Each Bolus Not observed by contains:- mentioned Rs. Registration Board. Sulfadimidine 20000/- Sodium…2.5gm Decontrolled/ (Sulfonamides) 1x5,1x10, 1x50 Manufacturer
139. -do- ALBENTEX Form 5 Zoben by M/s Approved as the firm Bolus Prix has rectified 12/03/2014 shortcomings Each Bolus Not observed by contains:- mentioned Rs. Registration Board. Albendazole…1 20000/- 52mg Decontrolled/ (Anthelmintic) 1x5,1x10 1x50,1x100 Manufacturer 140. -do- DR.MAST Form 5 Genta Mast by Approved as the firm FORTE M/s Vetycare has rectified Ointment 12/03/2014 shortcomings Not observed by Each 7.5gm mentioned Rs. Registration Board. contains:- 20000/- Gentamicin Sulphate…100 Decontrolled/ mg 7.5gm,15gm, 30gm,50gm (Broad spectrum antibiotic)
Manufacturer
Replies of product of M/s Sami deferred in 254th meeting 141. M/s Sami TULOSIN MR Form 5 EMA: Flomax Deferred for Pharmaceuticals 0.4mg Capsules Rs. 20,000/- MR confirmation whether (Pvt) Ltd, Each Capsule (24-11-2014) (Boehringer) application is for Karachi, contains: vide diary # FDA: Flomax additional section or Modified 138 & 80,000 (Boehringer) otherwise. release pellets vide diary No. Tamsolin Regn. of Tamsulosin 258 dated 01- No. 050392 HCl 02-2016 (Getz)
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equivalent to New Section Grant of Tamsulosin HCl Capsule additional USP……. section – …0.4mg Capsule (General) (24- (Alpha- 06-2014) Adrenerjic VERY GOOD Blocker) The product is USP specs Deferred for source of pellets, Now the firm has applied source of pellets “M/s RA Chem Pharma Ltd, Plot # A-19/C, Road # 18, IDA, Nacharam, Hyderabad- 500076, Telangana State, India” 142. -do- FUNGONE Form 5 EMA: Diflucan Approved as the firm Remaining 50mg Capsules Rs. 8,000/- (Pfizer) has submitted required application of Each capsule (21-05-2011) Diflucan Regn. documents pointed out additional contains: vide diary # No. 011827 in previous evaluation. section Fluconazole 260 & (Pfizer) USP Rs. 12,000/- Grant of ………..50mg (29-07-2013) additional (Anti-fungal) As per latest section – SAMI’s Specs. decision taken Capsule by PAC in (General respect of Antibiotics) usual / (08-09-2014) hardship cases VERY GOOD Deferred for provision of original challan as Photocopy of differential fee 12000 is attached. Now the firm has submitted the original challan.
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143. -do- Gasicol Form-5 MHRA. Approved Remaining Suspension 21-03-2014 Gaviscon Cool application of Each 10ml vide diary # Liquid by M/s additional suspension 272 Reckitt section contains:- Rs.20,000. Benckiser Sodium As per SRO Local Gaviscon Alginate by M/s Reckitt BP….……. Benckiser …500mg Calcium Carbonate……. …160mg Sodium Bicarbonate… …..267mg
Antacid Manufacturer’s specifications 144. -do- Montika Drops Form-5 Deferred for the Routine Each ml 29-08-2011 confirmation of me too application contains:- vide diary # status and approval Montelukast as 42 Rs.8000 & status by refrenece Priority List No. Sodium eq to 29-07-2013 regulatory authorities 1415 Montelukast… Rs.12000 …4mg As per SRO
Anti-asthmatic Manufacturer’s specifications
Replies of the products of M/s Searle IV Solutions deferred in the 254th meeting.
145. M/s Searle IV Azimac Dry Form 5 FDA Zithromax Approved as the firm Solutions (Pvt) Suspension Rs. 20,000/- Suspension has submitted required Ltd, Formerly Each 5ml Dy. No. 2688 200mg/5ml as documents pointed out Mac & Rains contains:- R&I Dated base. in previous evaluation. Lahore. Azithromycin 30-09-2014 LocalAzure Dihydrate eq. to Price: 200mg/5ml by Remaining azithromycin… 165/15ml M/s Fynk applications of …200mg bottle additional Macrolide section. USP specifications 146. -do- Tacromac Gel Form 5 Deferred for the Each gram Rs. 20,000/- confirmation of me contains:- Dy. No. 2684 too status and Flurbiprofen…5 R&I Dated Local Froben approval status by 0mg 30-09-2014 Abbott refrenece regulatory
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NSAID Price: 98.67, authorities Manufacturer 226.55/20gm, specifications 50gm.
147. -do- Piroximac Gel Form 5 BNF. Feldene Approved as the firm Each gram Rs. 20,000/- Gel 0.5% has submitted required contains:- Dy. No. 2685 documents pointed out Piroxicam…5m R&I Dated Local Feldene in previous evaluation. g 30-09-2014 Topical 0.5% by M/s Pfizer NSAID Price:270/10
Manufacturer’s capsules. specifications
(DDC-PEC-I: Dr. HAFSA KARAM ELLAHIE) Applications of M/s Inshall Pharmaceutical Islamabad were deferred in 254th meeting of Registration Board due to deficiencies. Now the firm has submitted the deficiencies.
S/N Name and Brand Name Type of Remarks on the Decision address of (Proprietary name + Dosage Form formulation (if manufacturer / Form + Strength) Initial date, any) including Applicant Composition diary International Pharmacological Group Fee status in Finished product including stringent drug Specification differential regulatory fee agencies / Demanded authorities Price / Pack Me-too status size GMP status as depicted in latest inspection report (with date) by the Evaluator
148. M/s Inshal TS3 Injection. Form-5 Sulfa-T Approved Pharmaceuticals Injection Dy. No: 278 Injection by Plot No.2 Street Each ml contains: Rs.8000/- M/s Leads SS 2 national Sulfamerazine……100mg Dated 08- Pharmaceutical. industrial zone Sulfadiazine………60mg 01-2011 rawat Sulfathiazole………40mg 12,000/- Ubtech Islamabad. Trimethoprim………40mg dated Injection by Priority list No. (Antibacterial) 01-11-2013 M/s Unibiotac 87 Vetrianry Inshal Specs 50ml, company, South Decontrolled Korea 149. M/s Inshal Dexa Shell Injection. Form-5 Sulfa super Approved Pharmaceuticals Injection Dy. No: 289 injection
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Plot No.2 Street Each ml contains: Rs.8000/- 33.30% of M/s SS 2 national Sulfadimadine Dated 08- Attabak. industrial zone Sodium……..333.3mg 01-2011 rawat (Antibacterial) Rs. 12,000/- Sulfa-333 Islamabad. Inshal Specs Dated 01- Sulfadimidine Priority list No. 11-2013 33.3% Injection 98 Vetrianry 100ml by M/s Decontrolled Interchemie Werken Netherlands. 150. M/s Inshal Oxy Shell 20% Injection. Form-5 Oxy L 20 Approved Pharmaceuticals Injection Dy. No: 293 Injection of M/s Plot No.2 Street Each ml contains: Rs.8000/- Attabak. SS 2 national Oxytetracycline dated 08-01- industrial zone HCl….200mg 2011 Oxytetracycline rawat (Antibacterial, local Rs.12,000/- inj by M/s Islamabad. anesthetics) dated 01-11- Norbrooq Inc Priority list No. BP specs 2013 USA 97 Vetrianry 100ml Decontrolled 151. M/s Inshal Spyracin Injection. Form-5 Tylogenta Approved Pharmaceuticals Injection Dy. No: 279 Injection of M/s Plot No.2 Street Each ml contains: Rs.8000/- Attabak SS 2 national Gentamycin dated 08-01- Pharma. industrial zone Sulphate…25mg 2011 International rawat Tylosin Tartrate………50mg Rs.12,000/- availability not Islamabad. (Antibiotec) dated 01-11- provided. Priority list No. Inshal Specs 2013 93 Vetrianry 100ml Decontrolled 152. M/s Inshal Oxyshell 5% Injection. Form-5 Terramycin Approved Pharmaceuticals Injection Dy. No: 295 Injectable Plot No.2 Street Each ml contains: Rs.8000/- solution by M/s SS 2 national Oxytetracycline HCl…50mg dated 08-01- Ghazi brothers industrial zone (Antibictarial, BP Specs 2011 Karachi. rawat Rs.12,000/- Oxytetracycline Islamabad. dated 01-11- Hydrochloride Priority list No. 2013 Biocyl 50 by 92 Vetrianry 50ml M/s Vetpharm Decontrolled Group Ltd Dublin Ireland. 153. M/s Inshal Meloxishell Injection. Form-5 Loxicon Approved Pharmaceuticals Liquid Injection Dy. No: 286 Injection of M/s Plot No.2 Street Each ml contains: Rs.8000/- Vetcon SS 2 national Meloxicam…….10mg dated 08-01- Pharmaceuticals industrial zone (NSAID) 2011 Azad Kashmir rawat Manufacturer Specs. Rs.12,000/- Islamabad. dated 01-11- Priority list No. 2013 99 Vetrianry 50ml
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Decontrolled
154. M/s Inshal Emeria Shell Powder. Form-5 Pulmotin Water Approved Pharmaceuticals Water soluble powder Dy. No: 79 soluble powder Plot No.2 Street Each 1000g contains: Rs.8000/- of M/s Attabake SS 2 national Doxycycline HCl….200g dated 05-11- Pharma industrial zone Tylosin tartrate…….100g 2010 rawat Colistin Rs.12,000/- Islamabad. sulphate……480MIU 30g, 50g, Priority list No. Bromhexine HCl…….5g 100g, 250g, 62 Vetrianry (Anti-bacterial) 500g, 1kg, Specs not provided. 5kg, 10kg, 25kg / Decontrolled 155. M/s Inshal Ivoshell Injection. Form-5 Ivotec of M/s Approved Pharmaceuticals Liquid injection Dy. No: 280 Star Plot No.2 Street Each ml contains: Rs.8000/- Laboratories SS 2 national Ivermectin (B.P)….10mg dated 08-01- Noromectin industrial zone (Anthelmentic) 2011 1.0% w/v multi rawat Rs.12,000/- Injection by Islamabad. dated. 01- M/s Norbrook 11-2013 Laboratories Priority list No. 50ml UK 86 Vetrianry Decontrolled 156. M/s Inshal Ketoshell Injection. Form-5 Profenol Approved Pharmaceuticals Liquid injection Dy. No: 282 injection of M/s Plot No.2 Street Each ml contains: Rs.8000/- Leads Pharma SS 2 national Ketprofen……100mg dated 08-01- Anafen industrial zone (Analgesic, Anti- 2011 Injection rawat inflammatory agent) Rs.12,000/- 100mg/ml by Islamabad. dated. 01- M/s Merial Priority list No. 11-2013 Canada INC. 94 Vetrianry 50ml Canada. Decontrolled 157. M/s Inshal Coccicide Powder. Form-5 Cocisol W.D Deferred for Pharmaceuticals Water soluble powder Dy. No: 40 Powder of S.A the Plot No.2 Street Each1000gm powder Rs.8000/- International confirmation SS 2 national contains: dated 08-11- Chem Pharma. of me too industrial zone Sulphmerazine 2010 Me-too not status rawat Sodium…200g Rs.12,000/- correct as it also Islamabad. Sulphaquinoxaline Dated.30- contain Priority list No. Sodium………………25g 12-2013 Furaltadone 15 Vetrianry Pyrimethamine………25g 100g 500g HCl. Vitamin A 1kg 2.5kg, …………..15MIU 5kg / Vitamin K3…..5g Decontrolled (Coccidiocidal) Inshal Specs
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158. M/s Inshal Genta Shell 20% Injection. Form-5 Gentabak 20% Approved Pharmaceuticals Liquid Injection Dy. No: 296 of M/s Attabak Plot No.2 Street Each100ml contains: Rs.8000/- Pharma SS 2 national Gentamycin sulphate dated 08-01- industrial zone (B.P)…..20g 2011 Getion 20% rawat (Antibiotic) Rs.12,000/- injection M/s Islamabad. Inshal Specs. Dated.01- Hebei Priority list No. 11-2013 Guangrem 96 Vetrianry 100ml Pharmaceutical Decontrolled Technology Co; China 159. M/s Inshal Predni Shell Injection. Form-5 CRD super Approved Pharmaceuticals Liquid Injection Dy. No: 276 injection of M/s Plot No.2 Street Each1mll contains: Rs.8000/- Attabak. SS 2 national Tylosin Tartrate……..60mg dated 08-01- industrial zone Colistin Sulphate……10mg 2011 rawat Streptomycin Rs.12,000/- Islamabad. sulphate….100mg Dated.01- Priority list No. (Antibacteril) 11-2013 85 Vetrianry Inshal Specs. 100ml Decontrolled 160. M/s Inshal Genta Shell Plus Injection. Form-5 Gentabak Plus Approved Pharmaceuticals Liquid Injection Dy. No: 283 of M/s Attabak Plot No.2 Street Each ml contains: Rs.8000/- Pharma SS 2 national Gentamycin dated 08-01- Gentiprats industrial zone sulphate….30mg 2011 Injection by rawat Trimethoprim…………25mg Rs.12,000/- M/s Hipra Islamabad. Sulfadimadine………125mg Dated.01- Philippines Inc. Priority list No. (Antibacterial) 11-2013 Philippine 95 Vetrianry 50ml / Decontrolled 161. M/s Inshal Genta Shell Injection. Form-5 Anti CRD Approved Pharmaceuticals Liquid Injection Dy. No: 288 Injection of M/s Plot No.2 Street Each 100ml contains: Rs.8000/- Attabak Pharma SS 2 national Gentamycin sulphate…..5gm dated 08-01- industrial zone Tylosin Tartrate ……10gm 2011 rawat Colistin Rs.12,000/- Islamabad. Sulphate…….60MIU Dated.01- Priority list No. (Antibiotec) 11-2013 95 Vetrianry Manufacturer Specification. 100ml Decontrolled 162. M/s Inshal Diaprim Injection. Form-5 Trisulf Injection Approved Pharmaceuticals Liquid Injection Dy. No: 275 of M/s S.J&G Plot No.2 Street Each ml contains: Rs.8000/- Fazul Ellahe SS 2 national Trimethoprim…….80gm dated 08-01- Pvt Ltd. industrial zone Sulfadiazine……400mg 2011 rawat (Antibacterial) Rs.12,000/- A.F.S Trimsul Islamabad. Inshal specs. Dated.01- by M/s Allfarm Priority list No. 11-2013 Animal Health 91 Vetrianry 50ml Australia
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Decontrolled 163. M/s Inshal Ivoshell Super Injection. Form-5 Ivobak C Approved Pharmaceuticals Liquid Injection Dy. No: 291 Injection of M/s Plot No.2 Street Each ml contains: Rs.8000/- Attabak Pharma SS 2 national Ivermectin…..10mg dated 08-01- industrial zone Clorsolon……100mg 2011 Junyu Injection rawat (Anthelmentic) Rs.12,000/- by M/s Islamabad. Dated.01- Shandong Sky 11-2013 Color Industries Priority list No. 50ml Co; China 88 Vetrianry Decontrolled 164. M/s Inshal PD Shell Injection. Form-5 Penacort Deferred for Pharmaceuticals Liquid Injection Dy. No: 277 Injection of M/s the Plot No.2 Street Each ml contains: Rs.8000/- Selmore confirmation SS 2 national Prednisolone dated 08-01- Pharma of steroidal industrial zone Acetate….7.5mg 2011 section. rawat Dexamethamethasone Rs.12,000/- Islamabad. sodium phosphate……2.5mg Dated.01- (Corticosteroids) 11-2013 Priority list No. 50ml 90 Vetrianry Decontrolled
Case No.06. Routine Applications Muhammad Ansar 165. M/s Getz Advantec Tablet Form-5D FDA. Atacand Deferred for the Pharma, (Pvt), Each tablet 07-03-2011 HCT submission confirmation Ltd, Karachi. contains:- vide diary No. 32mg/25mg by of me too status. If not Candesartan 134 Rs.15,000 M/s Astraznaca. then differential fee of Priority list No. Cilexetil…….3 & Rs.5000 30,000. 1419 from 903 2mg dated 30-07- after swapping Hydrochlorthiaz 2013. file ide…….25mg Antihypertensiv e Manufacturer’s Specifications 166. -do- Tras Tablet Form-5 FDA. Tramadol Each tablet 03-11-2011 and Priority list No. contains:- vide diary No. Acetaminophen Approved 903 from 1419 Tramadol 460 Rs.8,000 325/37.5mg by after swapping HCL…….37.5 & Rs.12000 M/s Par file mg dated 30-07- Pharma. Paracetamol..… 2013. Local Diagesic ….325mg Extra by M/s Analgesic Wilsons Manufacturer’s Specifications
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167. -do- Ticlot Tablet Form-5D FDA. Brilinta Deferred for Stability 90mg 30-01-2012 90mg by M/s studies as per Priority list No. Each film vide diary No. Astrazeneca Registration Board’s 1139 from 1490 coated tablet 548 Rs.15,000 decision in 251st meeting. after swapping contains:- & Rs.35000 file Ticagrelor……9 dated 30-07- 0mg 2013 vide Platelet diary No. 765. aggregation Inhibitor Manufacturer’s Specification 168. -do- Artheget Junior Form-5 Artem Plus by Deferred for the DS Powder for 26-01-2012 M/s Hilton submission of following:- Priority list No. oral suspension diary No. 107 Pharma Commitment as per 1140 from 1485 Each 5ml Rs.8000 & decision of RB. after swapping contains:- Rs.12000 file Artemether…… dated 30-07- 30mg 2013 Lumefantriene ….180mg Anti-malarial Manufacturer’s Specification
Import cases:-
EVALUATOR IV S/ Name and Brand Name Type of Form International Remarks / N address of (Proprietary name + Initial date, status in stringent Observation manufacturer / Dosage Form + diary regulatory s Applicant Strength) Fee including agencies Composition differential fee Pharmacological Group Demanded Me-too status Finished product Price / Pack size Specification GMP status as depicted in inspection report (dated)
M/s Universal Enterprises, 29- Block-3, Overseas Co-operative, Housing Society Stadium Road, Karachi applied for registration on prescribed Form 5-A on 20-02-2009, for Tacogen Capsule 0.5mg and 5mg to be imported from ZHEJIANG HISUN PHARMACEUTICALS CO. LTD, China.
Now M/s Hisun Pharmaceutical Co. Ltd informed that they have terminated their exclusive agent Universal Enterprises located at 29- Block -3, Overseas Co-operative Housing Society, Karfachi for Pakistan Market.
Furthermore, Universal Enterprises agrees to co-operate in transferring the registration approval of Tacogen
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Capsules 0.5 mg to M/s Allmed Laboratories located at A-21/3, KDA Scheme 1 (EXT) Karachi, Pakistan and has no objection to the transfer of registration approval. It is submitted that M/s. Universal has not submitted application on form 5-A and fee.
169. M/s Universal Capsule Tacogen 0.5 mg Form 5-A FDA approved Enterprises, 29- Rs. 100,000/- PROGRAF Block-3, Each Capsule contains vide Dy. No. 175 (Astellas) Overseas Co- Tacrolimus 0.5 mg dated 20-02- operative, 2009 & Dy. No. Housing Immunosuppressant 936 dated 11-10- INOGRAF Society 2012 (Platinum) Stadium Road, Karachi Pack size of 10 x 5 capsule Rs. 8179
170. M/s Universal Capsule Tacogen 5 mg Form 5-A FDA approved Enterprises, 29- Rs. 100,000/- PROGRAF Block-3, Each Capsule contains vide Dy. No. 174 (Astellas) Overseas Co- Tacrolimus 5 mg dated 20-02- operative, 2009 Housing Immunosuppressant INOGRAF Society (Platinum) Stadium Road, Pack size of 10 x Karachi 5 capsule Rs. 8179 M/s Allmed Laboratories located at A- 21/3, KDA Scheme 1 (EXT) Karachi
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M/s Universal Enterprises, 29- Block-3, Overseas Co-operative, Housing Society Stadium Road, Karachi applied for registration on prescribed Form 5-A on 29-11-2010, for MONOFER 100mg/ml to be imported from M/s Pharmacosmos A/s Roervangsevj 30 DK-4300 Holbaek, Denmark.
The exporter informed that they have terminated their exclusive agent Universal Enterprises located at 29- Block -3, Overseas Co-operative Housing Society, Karfachi for Pakistan Market.
Furthermore, Universal Enterprises agrees to co-operate in transferring the registration approval of MONOFER to M/s Allmed Laboratories located at A-21/3, KDA Scheme 1 (EXT) Karachi, Pakistan and has no objection to the transfer of registration approval. It is submitted that M/s. Universal has not submitted application on form 5-A and fee.
171. M M/s MONOFER 100mg/ml MHRA approved. Firm has not Universal Solution for Injection/ Monofer of submitted Enterprises, 29- Infusion (10ml) Ampoule of 10ml Pharmacosmos, form 5-A and Block-3, UK. fee. Overseas Co- Each ml contains: operative, Iron as Iron (III) Monofer of Housing Isomaltoside 100 mg Allmed. Society Stadium Road, Iron parenteral preparation Karachi Manufacturer
The firm submitted reply with respect to above mentioned shortcomings that M/s Universal Enterprises had agreed to transfer the registration of Monofer 100mg/ml (5ml & 10 ml vial) to M/s Allmed Laboratories in October 2012 followed by the letter of termination by the manufacturer in the name of M/s Universal Enterprises; authorizing M/s Allmed Laboratories as the sole agent to register, sell and market their product monofer 100mg/ml solution for infusion in Pakistan. Furthermore, M/s Allmed Laboratories have ensured full fees submission of Rs. 100,000/- per strength for the registration of product in Pakistan and timely submission of the documents to rectify the discrepancies’ addressed by the DRAP to M/s Allmed Laboratories. Sole agency agreement dated august 2015. COPP issued on 11-07-2013 Stability data submitted 30°C & RH 65 ± 5% & 40°C±75±5%RH
Decision: - The Board deferred the case for legal opinion whether fee submitted by Universal enterprises can be considered for M/s Allmed or otherwise, because the exporter/manufacturer has cancelled the agreement with previous applicant.
172. - Importer - Oxytetravet IM Veterinary Form 5-A Oxytetracycline Deferred for M/s Samara Injection 20% Rs. 100,000/- Injection 20% - provision of
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Stores. 16-17, vide Dy. No. 156 Norbook - Ireland Legalized Qamar Market, Each 1 ml contains dated 02-03- copy of Latifabad No. Oxytetracycline (as HCl) 2011 & Dy. No. Engemycin LA Sole agency 7, Hyderabad. 200mg 2292 dated 23- 200mg/ml (MSD- agreement. Country of 12-2013 UK) GMP Import/ Antibiotics certificate Manufacturer In-house Specification Oxytetracycline of product, The Arab as Pack size of Injection 20% (Star previously Pesticides & 50ml &100ml Laboratories) Veterinary Drugs submitted amber glass Lahore Mfg. Co copy is (Mobedco) P.O bottle expired. Box 930103 1.5$ GMP Amman 11193 inspection Jordan. report of the Priority list No. manufactur 129 veterinary er conducted by the regulatory body of that country.
173. - Importer - Betamoxin Veterinary Form 5-A Amoxypen Deferred for M/s Samara Injection Rs. 100,000/- Injection – MSD provision of Stores. 16-17, vide Dy. No. 157 UK Legalized Qamar Market, Each 1 ml contains dated 02-03- copy of Latifabad No. 7, Amoxicillin (as 2011 & Dy. No. Sole agency Hyderabad. Trihydrate) 150mg 2292 dated 23- Amovet (Nawan) agreement.
12-2013 GMP Country of certificate Import/ Antibiotics of product, Manufacturer In-house Specification as The Arab Pack size of previously Pesticides & 50ml, 100ml submitted Veterinary Drugs amber glass copy is Mfg. Co bottle expired. (Mobedco) P.O 1.5$ GMP Box 930103 inspection Amman 11193 report of the Jordan. manufacturer Priority list No. conducted by 130 veterinary the regulatory body of that country.
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174. - Importer – Levofundinn Injection Form 5-A Evoxil- Beacon Deferred for M/s B.Braun Rs. 100,000/- MHRA approved provision of Pakistan (Pvt.) Each 100ml contains vide Dy. No. 44 Legalized Ltd, The Forum, Levofloxacin 500mg dated 02-02- copy of Suite 216, 2011 & Dy. No. Cravit (Hilton) Sole agency Khayaban-E- Antibiotics 330 dated 25-09- agreement.. Jami, Clifton In-house Specification 2013 Legalized Block 9, Karachi certificate of Country of Pharmaceut Import/ Pack size of ical product Manufacturer bottles 100ml./ required. B.Braun Rs 275.92 Recent Melsungen AG GMP Carl – Braun – inspection Str. 1 34 212 report of Melsungen, the Germany manufactur er Priority list No. conducted 43 import by regulatory body of that country. Status of sale of product in country of origin Real time and accelerated stability data.
Evaluator-I: Muhammad Ansar
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175. M/s Ferozsons Trinide 500mg Tablet Form-5 FDA. Alinia Tablet Approved Laboratories Each film coated tablet 17-11-2011 diary 500mg by M/s Limited, P.O contains:- No 272. Romark Ferozsons, Nitazoxanide…500mg. Rs8000 & 12000 Nitazide tablet by Amangarh, Anti-protozoal dated 25-02- M/s Helix Pharma. Nowshera, Manufacturer’s 2014 The panel has KPK. Specifications Rs.25 per tablet. recommended the grant of additional Priority list No. section tablet 1347 general as per inspection dated 27-02-2015 .
176. -do- Mezacol 400 Tablet Form-5 UK.Asacol tablet Approved Each enteric coated tablet 12-05-2011 diary 400mg as modified Priority list No. contains:- No 20. release by M/s 1035 Mesalazine……..400mg. Rs8000 & 12000 Warner Chilcott Anti-inflammatory dated 25-02- UK. Manufacturer’s 2014 Asacol tablet by Specifications Rs.380.00 per M/s Getz Pharma. 30’s tablet pack.
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Case No. 08. New Molecules
In-charge PEC: Muhammad Akhtar Abbas Khan.
S.No Name and Brand Name Type of Remarks on the Decision address of (Proprietary name + Form formulation (if manufacturer Dosage Form + any) including / Applicant Strength) Initial date, International diary status in stringent Composition drug regulatory Fee agencies / Pharmacological Group including authorities differential Finished product fee Me-too status Specification Demanded GMP status as Price / Pack depicted in latest size inspection report (with date) by the Evaluator 177. M/s Daxas 500mcg Tablets Form-5-D DALIRESP Deferred for Highnoon Each Tablet contains: Dy. No: 947 Of submission of: Laboratories Roflumilast…….500m dated 20-11- ASTRAZENEC Ltd. 17.5KM, cg 2013 A PHARMS 6 months Multan Road (Chronic obstructive 50,000/- Not USA stability data of Lahore. pulmonary disease) mentioned. 3 batches have been provided Priority list without any No. 1376 supporting evidence. At the same time firm is providing undertaking that before sale of product they will conduct stability studies. Copy of Inspection report dated 24- 09-2012 is provided. Clinical Data / Clinical trials Clinical justification.
The Board directed the frim to calrify the submission of data.
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178. M/s Racecad 10mg sachet Form-5-D Not approved in Deferred for Highnoon Each Sachet contains: FDA. submission of: Laboratories Racecadotril…….10mg Dy. No: 556 MHRA approved Firm is Ltd. 17.5KM, (Anti-diarrhel) dated 11-10- providing Multan Road 2013 undertaking that Lahore. 50,000/- before sale of Rs.1500/16’ product they Priority list s will conduct No. 2625 Rs.94/1’s stability studies. Copy of Inspection report dated 24- 09-2012 is provided. Clinical Data / Clinical trials Clinical justification
The Board directed the frim to calrify the submission of data.
179. M/s Racecad 100mg Form-5-D Not approved in Deferred for Highnoon Capsule FDA. submission of: Laboratories Each Capsule contains: Dy. No: 557 ANSM France 6 months Ltd. 17.5KM, Racecadotril…….100m dated 10-10- approved stability data of Multan Road g 2013 3 batches have Lahore. (Antidiarrhel) 50,000/- been provided Priority list Rs.1200/10’ without any No. 2626 s supporting Rs.120/1’s evidence. At the same time firm is providing undertaking that before sale of product they will conduct stability studies.
Copy of Inspection report dated 24- 09-2012 is provided. Clinical Data / Clinical trials Clinical justification.
The Board directed the Minutes 256th Meeting Registration Board 246
frim to calrify the submission of data.
180. M/s Racecad 30mg sachet Form-5-D Not approved in Deferred for Highnoon Each Sachet contains: FDA. MHRA submission of: Laboratories Racecadotril…….30mg Dy. No: 555 approved. 6 months Ltd. 17.5KM, (Antidiarrhel) dated 10-10- stability data of Multan Road 2013 3 batches have Lahore 50,000/- been provided Rs.2800/16’ without any Priority list s supporting No. 2624. Rs.175/1’s evidence. At the same time firm is providing undertaking that before sale of product they will conduct stability studies. Copy of Inspection report dated 24- 09-2012 is provided. Clinical Data / Clinical trials Clinical justification.
The Board directed the frim to calrify the submission of data.
Case No.09:- Following applications of M/s GSK were approved in 254th meeting as a new molecule and later on it was identified that these applications are not included in 1st priority list. The applications were referred to PEC as new molecule and were included in agenda during copying and pasting from the list of new molecules. Since no action has been taken so far these applications are again placed before the Board for decision.
M/s Anoro Ellipta Form-5A COPP issued on GlaxoSmithKline Dry Powder Inhaler Dy. No: dated. 06-08- Pakistan Limited Each pre-dispensed dose 693 dated 2014 35-Dockyard contains. 18-09- Road, West Umeclidinium…….62.5mcg 2014 Wharf, Karachi. Vilanterol (as 50,000/- M/s Glaxo trifenatate)…25mcg dated 18-
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Operations UK (Long acting muscarinic 09-2014 Limited, Ware antagonist (LAMA), and a Will be UK long-acting beta-2 agonist submitted (LABA) later M/s Incruse Ellipta Form-5A COPP issued on GlaxoSmithKline Dry Powder Inhaler Dy. No: dated. 28-10- Pakistan Limited Each pre-dispensed dose 234 dated 2014 35-Dockyard contains. 15-12- Road, West Umeclidinium (equivalent 2014 Wharf, Karachi. to 74.2 mcg of umecidinium 50,000/- bromide)…….62.5mcg dated 15- (Long acting muscarinic 12-2014 M/s Glaxo antagonist (LAMA) Will be Operations UK submitted Limited, Ware later UK
Decision: Registration Board discussed that as applications were considered erroneously, thus the Board decided to consider these on its turn.
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Case No.10. Import cases of M/s. Novartis Karachi
181. M/s Fentanyl Sandoz Form-5A DURAGESIC- COPP issued Deferred and Novartis 25ug/h (10.5cm2) Dy. No: 45 25 by M/s on 12 October will be Pharma Transdermal Patch dated. JANSSEN 2011. considered (Pakistan), Each transdermal 25-01-2012 PHARMS GMP certificate on its turn Limited, Patch contains: Rs.15000/- dated. 27-01- Karachi. Fentanyl 21-01-2012 2012 …...... 25ug/hour Rs.85,000/- Label (Cancer Pain/Pain dated 25-03- information in Managment) 2014 Urdu not Manufacturer Specs MRP Rs:- provided. 4227.00 / NOTE: - firm (Dermal Route) 5’s has attached request from different hospital e.g. SKMCH&RC, Lahore, Dr. Ziauddin Hospital Karachi, JPMC Karachi, PAEC MINAR Multan and from different doctors to provide alternative to Duragesic Patches (as Duragesic is short in market) for management of moderate to severe chronic pain. 182. M/s Fentanyl Sandoz Form-5A DURAGESIC- COPP issued Deferred and Novartis 50ug/h (21cm2) Dy. No: 46 25 by M/s on 12 October will be Pharma Transdermal Patch dated. JANSSEN 2011. considered (Pakistan), Each transdermal 25-01-2012 PHARMS GMP certificate on its turn Limited, Patch contains: Rs.15000/- dated. 27-01- Karachi. Fentanyl 21-01-2012 2012 …...... 50ug/hour Rs.85,000/- Label (Cancer Pain/Pain dated 25-03- information’s Managment) 2014 in Urdu not Manufacturer Specs MRP Rs:- provided. 2280.00 / NOTE:- firm (Dermal Route) 5’s has attached request from different hospital e.g.
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SKMCH&RC, Lahore, Dr. Ziauddin Hospital Karachi, JPMC Karachi, PAEC MINAR Multan and from different doctors to provide alternative to Duragesic Patches (as Duragesic is short in market) for management of moderate to severe chronic pain.
Stability of Fentanyl Sandoz by Novartis Pharma
Sandoz Business use only Page 1 of 14 3.2.p.8.1 - stability-summary - PK – 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721-
SandozTHERAPEUTIC SYSTEM, MATRIX PATCHBusiness use only 6598.00 Page 2 of 14 3.2.p.8.1 - stability-summary - PK – 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTICIntrodu SYSTEM, MATRIX PATCH 6598.00 ction The original stability study is based on the results of three batches of laminate. The corresponding FDF batches have been stored under permanent conditions (25 C/60 % relative humidity), under intermediate conditions (30 C/65% relative humidity) and under accelerate conditions (40 °C/75 % r.h.). A post-approval stability study which is based on the results of four production scale batches of laminate has been initiated in 2008. All batches were punched out to different patch sizes with one batch per patch size. These Fentanyl TDDS patches have been punched out under pharmaceutical production conditions and packed in sachets (sachet foil paper/PE/AL/PE) as applied for (please refer to 3.2.P.7).
The different strengths of the TDDS are correlated to different patch sizes. Different sizes of the patches (5.25, 10.5, 15.75, 21, 31.5 and 42 cm2) can be produced out of the same laminate by punching different sizes. Therefore, every piece of the laminate can be considered as representative for the homogenous whole laminate. Batch analysis data are provided for the
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12.5, 25, 37.5 and 100 µg/h strengths representing three batches of laminate. The 50 and 75 µg/h strengths are covered by these analysis data since the only variation is the different size of punching device. Test Parameters for Stability Program Please refer to Business use only Page 3 of 14 3.2.p.8.13.2.P.5.1.Sandoz - stability-summary - PK – 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTICTest Batches SYSTEM, MATRIX PATCH 6598.00
Batch of Batch no of batch size manufacturer dosage manufact. TDDS laminate (m²) [µg/h] Date (intermediate) FLY0013TTS FLY0007LAM 150 HEXAL AG 12.5 µg/h 04/2006 8Y0790 FLY0004PRO 3220 HEXAL AG 12.5 µg/h 11/2008 FLY0012TTS FLY0008LAM 250 HEXAL AG 25 µg/h 04/2006 8D0808 FLY0004PRO 918 HEXAL AG 12.5 µg/h 10/2008 FLY0014TTS FLY0007LAM 150 HEXAL AG 37.5 µg/h 04/2006 9B6544 FLY0007PRO 949 HEXAL AG 37.5 µg/h 04/2009 8D0816 FLY0003PRO 897 HEXAL AG 50 µg/h 10/2008 8D0826 FLY0003PRO 897 HEXAL AG 75 µg/h 10/2008 FLY0015TTS FLY0009LAM 200 HEXAL AG 100 µg/h 06/2006 8Y0784 FLY0004PRO 3220 HEXAL AG 100 µg/h 11/2008
Batch no of Batch of batch size manufact. laminate manufacturer daughter rolls (m²) date (intermediate)
FLY0002TRO FLY0008LAM 53 HEXAL AG 05/2006 FLY0004TRO FLY0009LAM 67 HEXAL AG 06/2006
Batch of batch size manufact. coating manufacturer (kg) date solution
FLY0011BSM 7.5 HEXAL AG 05/2006 Sandoz Business use only Page 4 of 14 3.2.p.8.1 - stability-summary - PK - 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00 Study Schedule
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Real Time Tests
Batch Number Strengths Packaging Storage Conditions Testing points
[°C / % r. h.] [months]
FLY0013TTS 12.5 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24, 36 8Y0790 12.5 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24 FLY0012TTS 25 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24, 36 8D0808 25 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24 FLY0014TTS 37.5 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24, 36 9B6544 37.5 µg/h sachets 25/60 0, 3, 6, 9, 12, 18 8D0816 50 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24 8D0826 75 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24 FLY0015TTS 100 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24, 36
8Y0784 100 µg/h sachets 25/60 0, 3, 6, 9, 12, 18, 24
Intermediate Tests
Batch Number Strengths Packaging Storage Conditions Testing points [°C / % r. h.] [months] FLY0013TTS 12.5 µg/h sachets 30/65 0, 3, 6, 9, 12 FLY0012TTS 25 µg/h sachets 30/65 0, 3, 6, 9, 12 FLY0014TTS 37.5 µg/h sachets 30/65 0, 3, 6, 9, 12 FLY0015TTS 100 µg/h sachets 30/65 0, 3, 6, 9, 12
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Sandoz Business use only Page 5 of 14 3.2.p.8.1 - stability-summary - PK - 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00
Intermediate Tests
Batch Number Strengths Packaging Storage Conditions Testing points [°C / % r. h.] [months]
FLY0013TTS 12.5 µg/h sachets 30/75 0, 3, 6, 9, 12, 18, 24, 36
FLY0012TTS 25 µg/h sachets 30/75 0, 3, 6, 9, 12, 18, 24, 36
FLY0014TTS 37.5 µg/h sachets 30/75 0, 3, 6, 9, 12, 18, 24, 36
FLY0015TTS 100 µg/h sachets 30/75 0, 3, 6, 9, 12, 18, 24, 36
Accelerated Tests
Batch Number Strengths Packaging Storage Conditions Testing points
[°C / % r. h.] [months]
FLY0013TTS 12.5 µg/h sachets 40/75 0, 1, 3, 6
8Y0790 12.5 µg/h sachets 40/75 0, 3, 6
FLY0012TTS 25 µg/h sachets 40/75 0, 1, 3, 6
8D0808 25 µg/h sachets 40/75 0, 3, 6
FLY0014TTS 37.5 µg/h sachets 40/75 0, 1, 3, 6
9B6544 37.5 µg/h sachets 40/75 0, 3, 6
8D0816 50 µg/h sachets 40/75 0, 3, 6
8D0826 75 µg/h sachets 40/75 0, 3, 6
FLY0015TTS 100 µg/h sachets 40/75 0, 1, 3, 6
8Y0784 100 µg/h sachets 40/75 0, 3, 6
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Sandoz Business use only Page 6 of 14 3.2.p.8.1 - stability-summary - PK - 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00
Photostability
Batch Number Strengths Packaging Storage Testing points
Conditions [hours] FLY0012TTS 25 µg/h sachets Photostability 22
withou FLY0012TTS 25 µg/h Photostability 22 t
Reference DurogesicSM 25 µg/h sachets Photostability 22 AT
Reference withou 25 µg/h DurogesicSM t Photostability 22 AT sachet
With regard to the finished product, photostability testing has been performed according to the ICH conditions given in the guideline Q1B. A light source similar to the ID65 emission standard was used (xenon lamp combined with filters having a spectral distribution from 310 to 800 nm). The samples were illuminated for 22 hours with 250 Wh/m², this corresponds to an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/m². The exposed product outside the primary packaging (sachet foil; paper/PE/AL/PE) and the product inside the primary packaging were tested. The product in the primary packaging could be seen as a dark control. At the end of the exposure period the samples were examined appearance, for assay and for purity by methods described in 3.2.P.5.2 Analytical Procedures.
Bulk stability
Batch Number Used Packaging Storage Testing points laminate Conditions
[months]
wrapped FLY0002TRO FLY0008LAM room temperature 0, 3, 6 in
wrappedPE bag FLY0004TRO FLY0009LAM room temperature 0, 3, 6 in PE bag [days]
FLY0011BSM --- closed vessel room temperature 0, 1, 3, 6
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Sandoz Business use only Page 7 of 14 3.2.p.8.1 - stability-summary - PK - 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- 6598.00 THERAPEUTICTest Protocol SYSTEM, MATRIX PATCH
25°C / 60% RH:
Timein Conditions Tests to be performed as per Control Procedure months
/ of Units crystal Dosage Dosage and Assay API Dissolution Uniformity Uniformity Appearance Appearance Related comp. Related Microb. Purity Microb. Identity API API Identity Adhesive strength
25°C / 60% RH 0 X X X X X X X X 3 X X - X - X X - 6 X X - X - X X - 9 X X - X - X X - 12 X X - X - X X X 18 X X - X - X X - 24 X X - X - X X X 36 X X - X - X X X
30°C / 65% RH:
Timein Conditions Tests to be performed as per Control Procedure months
/ of Units crystal Dosage Dosage and Assay API Dissolution Uniformity Uniformity Appearance Appearance Related comp. Related Microb. Purity Microb. Identity API API Identity Adhesive strength
30°C / 65% RH 0 X X X X X X X X 3 X X - X - X X - 6 X X - X - X X - 9 X X - X - X X - 12 X X - X - X X X
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Sandoz Business use only Page 8 of 14 3.2.p.8.1 - stability-summary - PK - 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721-
THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00 30°C / 75% RH:
Timein Conditions Tests to be performed as per Control Procedure months
/ of Units crystal Dosage Dosage and Assay API Dissolution Uniformity Uniformity Appearance Appearance Related comp. Related Microb. Purity Microb. Identity API API Identity Adhesive strength
30°C / 675% RH 0 X X X X X X X X 3 X X - X - X X - 6 X X - X - X X - 9 X X - X - X X - 12 X X - X - X X - 18 X X - X - X X - 24 X X - X - X X X 36 X X - X - X X X
40°C / 75% RH:
Timein Conditions Tests to be performed as per Control Procedure months
/ of Units crystal Dosage Dosage and Assay API Dissolution Uniformity Uniformity Appearance Appearance Related comp. Related Microb. Purity Microb. Identity API API Identity Adhesive strength
40°C / 75% RH 0 X X X X X X X X 1 X X - X - X X - 3 X X - X - X X - 6 X X - X - X X -
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Sandoz Business use only Page 9 of 14 3.2.p.8.1 - stability-summary - PK - 5 Jun-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721-
THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00 Photostability:
Timein Conditions Tests to be performed as per Control Procedure hours
of Units Dosage Dosage and Assay API Dissolution Appearance Uniformity Uniformity Related comp. Related Microb. Purity Microb. Identity API API Identity Adhesive strength
Photostability 22 X - - - - X X -
Bulk stability for daughter rolls:
Timein Conditions Tests to be performed as per Control Procedure months
/
of crystal Dosage Dosage e Adhesiv and Assay API Units and Dissolution Uniformity Uniformity Appearance Appearance Related comp. Related Microb. Microb. Purity Identity API API Identity
25°C / 60% RH 0 X X X X - X X X 3 - X - - - X X - 6 X X - X - X X -
Bulk stability for coating solution:
Timein Conditions Tests to be performed as per Control Procedure days
of
strengt h Adhesive and Assay API Dissolution Appearance Uniformity Uniformity Dosage Dosage Units Related comp. Related Microb. Purity Microb. Identity API API Identity
25°C / 60% RH 0 X - - - - X X - 1 X - - - - X X - 3 X - - - - X X - 6 X - - - - X X -
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Sandoz Business use only Page 10 of 3.2.p.8.1 - stability-summary - PK - 5 14Ju n-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- 6598.00 THERAPEUTICDiscussion and Conclusion SYSTEM, MATRIX PATCH Summary The stability study is based on the results obtained of seven batches of laminate. All batches were manufactured under comparable pharmaceutical industrial conditions. The initially stored batches were stored according to the Guideline Note for Guidance on stability testing: Stability testing of existing active substances and related finished products at 25 °C ± 2°C / 60 % ± 5 % relative humidity (r.h.), 30°C ± 2 % / 65 % ± 5 % r.h. and at 40 °C ± 2 % / 75 % ± 5 % r.h. Due to the already proven stability at intermediate conditions, batches which were stored after approval were only stored at permanent and accelerated conditions. The batches were punched out in different patch sizes. For the initially stored batches data up to 36 months (25 °C ± 2°C / 60 % ± 5 % r.h. respectively 30 °C ± 2°C / 75 % ± 5 % r.h.) and up to 12 months 30°C ± 2 % / 65 % ± 5 % r.h.) are available. For all batches stored at 25°C/60% r.h. and 30°C/75% r.h.the stability studies are ongoing up to 24 months at least. After that tests will only be carried out on a case by case decision, depending on market demands. The patches have been sealed into sachets (sachet foil of paper/PE/Aluminium/PE), please refer also to section 3.2.P.7) as intended for the product on the market. The quality of the product has been controlled by general characteristics in terms of appearance, dissolution and assay of Fentanyl as well as the test on related substances. Microbiological purity was tested at the beginning and will be tested at the end of the stability study.
Sandoz Business use only Page 11 of 3.2.p.8.1 - stability-summary - PK - 5 14Ju n-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- 6598.00 THERAPEUTICDiscussion of stability SYSTEM, results MATRIX PATCH
Storage 25 °C/60 % r.h.:
appearance The appearance of the patches showed no changes over the storage period. No crystals appeared. assay: All batches showed a good uniformity over the tested time points with exception of the laminate batch FLY0009LAM with higher values (please refer to table 04). Reason for this high mean values of the content were slightly increased weights of the laminate. The assay results show that the content did not change. The observed value differences are within the analytical variation. All Fentanyl contents reported in the stability tables are well within the specified range from 90.0 % to 110.0 %. impurities:
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In all patches one any other impurity was observed with a maximum level up to 0.13%. For the sum of impurities the same level was observed. All values reported were well within the specification limits. dissolution testing: The dissolution values for all three batches of laminate and the different sizes were very similar. All Fentanyl release rates reported in the stability tables are well within the specification limits. The listed Min and Max data show that there are only slight variations. Storage 30 °C/65 % r.h.: No differences in comparison to the storage at 25°C/60% r.h. were detected. appearance The appearance of the patches showed no changes over the storage period. assay: All batches showed a good uniformity over the tested time points with exception of the laminate batch FLY0009LAM with higher values (please refer to table 08). Reason for this high mean values of the content were slightly increased weights of the laminate. The assay results show that the content did not change. The observed value differences are within the analytical variation. All Fentanyl contents reported in the stability tables are well within the
specified range from 90.0 % to 110.0 %. Sandoz Business use only Page 12 of 3.2.p.8.1 - stability-summary - PK - 5 14Ju n-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTICimpurities: SYSTEM, MATRIX PATCH 6598.00 In all patches one any other impurity was observed with a maximum level up to 0.13%. For the sum of impurities the same level was observed. All values reported were well within the specification limits.
dissolution testing: The dissolution values for all three batches of laminate and the different sizes were very similar. All Fentanyl release rates reported in the stability tables are well within the specification limits. The listed Min and Max data show that there are only slight variations. Storage 30 °C/75 % r.h.: No differences in comparison to the storage at 30°C/65% r.h. were detected. appearance The appearance of the patches showed no changes over the storage period. assay: All batches showed a good uniformity over the tested time points with exception of the laminate batch FLY0009LAM with higher values (please refer to table 08). Reason for this high mean values of the content were slightly increased weights of the laminate. The assay results show that the content did not change. The observed value differences are within the analytical variation. All Fentanyl contents reported in the stability tables are well within the specified range from 90.0 % to 110.0 %. impurities: In all patches one any other impurity was observed with a maximum level up to 0.15%. For the sum of impurities the same level was observed. All values reported were well within the specification limits. dissolution testing:
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The dissolution values for all three batches of laminate and the different sizes were very similar. All Fentanyl release rates reported in the stability tables are well within the specification limits.
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Sandoz Business use only Page 13 of 3.2.p.8.1 - stability-summary - PK - 5 14Ju n-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721- THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00 Storage 40 °C/75 % r.h.: appearance The appearance of the patches showed no changes over the storage period. No crystals appeared. In some batches a slight decrease of the content of the active ingredient of about 3% was observed. All Fentanyl contents reported in the stability tables are within the specified range from 90.0 % to 110.0 %. impurities: In all patches one any other impurity was observed with a maximum level up to 0.14%. For the sum of impurities the same level was observed. All values reported were well within the specification limits. dissolution testing: The dissolution values for all three batches of laminate and the different sizes were very similar. All Fentanyl release rates reported in the stability tables are well within the specification limits. The listed Min and Max data show that there are only slight variations. Photostability:
After irradiation over 22 hours the content of the active ingredient decreased clearly as expected. The same results were found
for the reference product. The behaviour of both products after irradiation was the same. Sandoz Business use only Page 14 of 3.2.p.8.1 - stability-summary - PK - 5 14Ju n-08-2011 FENTANYL 100 MCG / 1 H 12.5 MCG / 1 H 25 MCG / 1 H 37.5 721-6594.00 721- MCG 6595.00 / 1 H 50 MCG / 1 H 75 MCG / 1 H TRANSDERMAL 721-6596.00 721-
THERAPEUTIC SYSTEM, MATRIX PATCH 6598.00
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Bulk stability of the laminate:
appearance: The appearance of the patches showed no changes over the storage period of 6 months. No crystals appeared. Both batches showed only slight variations during the testing periods, the values of the content of the active substance were after six months above 97 %. All Fentanyl contents reported in the stability tables are within the specified range from 90 % to 110 %. impurities: For any unspecified impurity and the sum of impurities a maximum value of 0.13 % was observed. All values reported are well within the specification limits.
dissolution testing: All Fentanyl release rates reported in the stability tables are well within the specification.
Test in changing conditions
The sample stored for one week at 5°C, then for one week at 40°C/75% r.h., then for one week at 5°C then for one week at 40°C/75% r.h. and finally for one week at 5°C is stable. No obvious changes were observed.
Expiration date statement
Taking into consideration all results described in section 3.2.P.8.3, especially the results under accelerated conditions, a shelf life of 24 months, according to ICH Guideline Q1E: Evaluation of stability data, for Fentanyl matrix patches 12.5 µg/h, 25 µg/h, 37.5 µg/h, 50 µg/h, 75 µg/h and 100 µg/h, is appropriate. No special storage condition is required. A shelf life of six months for the bulk is appropriate.
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Stability Data Muhammad Amin DDC (PEC-II)
1. M/s Novartis Pharma Karachi
Drug CaC 1000 Plus (change in packaging material) Storage Condition Accelerated: 40° ± 2°/75 ± 5 RH Real Time: 30° ± 2°/65 ± 5 RH Time Period 06 months Frequency 0, 3, 6 months Batch Size 120,000 tabs per batch No. of Batches 03 Sample Size 600 tabs per batch Meeting RB in 250th meeting decided as follows: Stability study of CAC-1000 of M/s Novartis Pharma Karachi was discussed as batch size of the product is in accordance with the primary batch defined in ICH/WHO stability guidelines. Therfore it was decided to send the complete stability data including protocol and chromatgrams to Prof. Rafi uz Zaman, Dr Amanullah, Director DTL, Quetta and Dr Saif-ur-Rehman Khattak, FGA, CDL Karachi following experts for evaluation.
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Batch No.1 Results (Accelerated Studies) Test Specs Initial results 3months 06months Appearance Light pink Complies Complies Complies speckled/ round flat tablet D.T Max.4.0 minutes 3.0 3.5 3.0 Order Of Orange Of orange Of Orange Of orange Taste Of Orange Of orange Of Orange Of orange Lod NMT 1.5% 0.92 1.04 1.25 Degradation No additional ND ND ND spots Assay of Calcium 90.0-110% 96.9 97.0 96.0 Assay of Vit-C 90.0-110% 99.1 96.9 94.2 Assay of Vit-D3 NLT 90.0-165% Validate 148.2 139.25 Assay of Vit-B6 NLT 90.0-150% Validate 110.15 95.08
Batch No.1 Results (Real Time Studies) Test Specs 3months 6months 09months Appearance Light pink Complies Complies Complies speckled/ round flat tablet D.T Max.4.0 minutes 3.0 3.0 3.0 Order Of Orange Of orange Of Orange Of orange Taste Of Orange Of orange Of Orange Of orange Lod NMT 1.5% 1.15 1.08 1.13 Degradation No additional ND ND ND spots Assay of Calcium 90.0-110% 96.9 97.78 93.67 Assay of Vit-C 90.0-110% 99.0 95.23 97.85 Assay of Vit-D3 NLT 90.0-165% 158.49 113.49 141.20 Assay of Vit-B6 NLT 90.0-150% 126.71 110.20 111.07
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Batch No. 2 Results (Accelerated Studies) Test Specs Initial results 3months 06months Appearance Light pink Complies Complies Complies speckled/ round flat tablet D.T Max.4.0 minutes 3.0 2.5 3.0 Order Of Orange Of orange Of Orange Of orange Taste Of Orange Of orange Of Orange Of orange Lod NMT 1.5% 1.01 1.13 1.19 Degradation No additional spots ND ND ND Assay of Calcium 90.0-110% 98.7 97.3 95.23 Assay of Vit-C 90.0-110% 100.03 97.01 95.60 Assay of Vit-D3 NLT 90.0-165% Validate 131.11 108.63 Assay of Vit-B6 NLT 90.0-150% Validate 115.63 101.21
Batch No. 2 Results (Real Time Studies) Test Specs 3months 6months 09months Appearance Light pink Complies Complies Complies speckled/ round flat tablet D.T Max.4.0 minutes 3.0 3.0 3.5 Order Of Orange Of orange Of Orange Of orange Taste Of Orange Of orange Of Orange Of orange Lod NMT 1.5% 0.98 1.03 0.30 Degradation No additional spots ND ND ND Assay of Calcium 90.0-110% 101.49 100.17 99.71 Assay of Vit-C 90.0-110% 101.70 99.45 98.85 Assay of Vit-D3 NLT 90.0-165% 161.73 151.11 126.80 Assay of Vit-B6 NLT 90.0-150% 122.40 114.23 119.77
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Batch No. 3 Results (Accelerated Studies) Test Specs Initial results 3months 06months Appearance Light pink Complies Complies Complies speckled/ round flat tablet D.T Max.4.0 minutes 3.0 2.5 2.5 Order Of Orange Of orange Of Orange Of orange Taste Of Orange Of orange Of Orange Of orange Lod NMT 1.5% 1.06 1.31 1.19 Degradation No additional spots ND ND ND Assay of Calcium 90.0-110% 98.1 97.2 92.18 Assay of Vit-C 90.0-110% 99.21 98.98 93.67 Assay of Vit-D3 NLT 90.0-165% Validate 132.41 99.69 Assay of Vit-B6 NLT 90.0-150% Validate 105.63 100.21
Batch No. 3. Results (Real Time Studies) Test Specs 3 months 6months 09months Appearance Light pink Complies Complies Complies speckled/ round flat tablet D.T Max.4.0 minutes 2.5 2.5 3.0 Order Of Orange Of orange Of Orange Of orange Taste Of Orange Of orange Of Orange Of orange Lod NMT 1.5% 0.83 0.96 0.98 Degradation No additional spots ND ND ND Assay of Calcium 90.0-110% 100.72 100.63 98.54 Assay of Vit-C 90.0-110% 97.45 103.51 99.97 Assay of Vit-D3 NLT 90.0-165% 164.77 155.01 133.78 Assay of Vit-B6 NLT 90.0-150% 119.40 108.23 118.77
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Comments of Experts Sr. No. Expert Comments 1. Dr. Rafiuzaman Saeedul Haq, I have gone through the stability data of CaC 1000 of M/s Member RB Novartis, Karachi. All the results for the stability relevant quality and stability characteristics comply with the specs. mentioned in the respective compendia at all stability points. The presented stability data of accelerated and interim real time stability batches is in good agreement and confirm the unaltered quality of product. Based on this data CaC 1000 Plus tablets in polypropylene tubes and polyethylene caps is sufficiently stable when packed and stored for climate zone IV-A for real time and 6 months accelerated stability and 24 months real time stability. I therefore, recommend that registration may be granted for this product. 2. Dr. Saifur Rehman Khattak, 1. The firm has changed packaging of their reg. product FGA, CDL, Karachi from tin bottle to polypropylene bottle with a child lock cap and inbuilt desiccant. 2. The stability studies have been performed as per requirements i.e. six months at accelerated condition and 24 months at real time stability conditions. 3. The stability studies have also been performed on stability indicating method. 4. The results of the study show that the product is table in the new container up to the shelf-life of two years. On the basis of the results of stability study and superiority of the new packaging in terms of less risks for the product and its user the product i.e. CaC 1000 plus Effervescent tablet is recommended to be approved in new packaging.
3. Dr. Amanullah, Member RB Keeping in view the provided data, undersigned is of the opinion to recommend the new packing of CaC 1000 PLUS tablets in plastic polypropylene tubes and polyethylene caps.
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Decision: Registration Board discussed the stability data in the light of recommendations of the experts and approved change in packaging material of CaC 1000 plus tablets.
2. PharmEvo Pvt. Ltd. Karachi
Drug Zoval Tablets (Sofosbuvir) 400 mg Sources Laurus Labs Private Limited, India.
Storage Condition Real Time: 300◦C ± 2◦C,75%±5% RH Accelerated: 40◦C ± 2◦C,75%±5% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 3, 6 months Batch Size Batch 1: 250 tab (completed with 6 months ACC & 6 month RT) Batch 2: 250 tab (completed with 6 months ACC & 6 month RT) Batch 3: 250 tab (Completed with 6 months ACC & 6 month RT)
No. of Batches 03 Sample Size 20 tablets
Meeting Deferred in 244th , 251st and 254th meeting of Registration Board
Minutes 256th Meeting Registration Board 268
Product name /Generic name Zoval 400mg tablets Batch No. 15SBV-1560-01-T /Dosage form
Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 250 Tablets (container closure system) packed in Alu Alu foil in a printed unit carton Parameters and tests As per Product Specifications (PharmEvo Specs) Mfg. Date June 2015 mentioned Short term conditions(Accelerated) 40◦C ± 2◦C,75%±5% Recommended storage RH Exp Date June 2017 condition Long term conditions 300◦C ± 2◦C,75%±5% RH Date of initiation & June 2015 (API) lot no. CSSRVSP 10010415 implementation Stability No. CN# 817
Approved by: QC Manager: ------Total Sample size (approx.) = 20
QA Manager: ------
Production Manager: ------R&D
Manager: ------
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Assessment frequency (Months) Initial 3 6 Date of Testing 13-06-2015 14-09-2015 14-12-2015 Mode of testing (F=full.) F F F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Accelerated) Appearance Yellow color oblong biconvex 40◦C ± 2◦C & 75% Complies Complies Complies shape film coated tablet plain from RH. ± 5% RH. both sides
Identification Positive for Sofosbuvir by HPLC. 40◦C ± 2◦C & 75% Retention time Retention time Retention time The retention time of the Sample RH. ± 5% RH. complies complies complies peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.
AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 914.9 mg 914.4 mg 915.2 mg WEIGHT/TAB RH. ± 5% RH.
◦ ◦ LENGTH 18.80 – 19.20 mm 40 C ± 2 C & 75% 19.14 mm 19.15mm 19.08 mm RH. ± 5% RH.
8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.13 mm 9.13 mm 9.14 mm WIDTH RH. ± 5% RH. 6.30 6.90 mm 40◦C ± 2◦C & 75% 6.38 mm 6.36mm 6.38 mm THICKNESS – RH. ± 5% RH NMT 30 mins. 40◦C ± 2◦C & 75% 3 mins. 7 mins 8 mins DISINTEGRATION RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% 91.40 % (SOFOSUBVIR ) Not less than 80% after 45 minutes RH. ± 5% RH 93.81% 91.14 % 40◦C ± 2◦C & 75% 102.33 % 99.93 % 98.84 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 400C + 20C and 75% + 5% R.H was performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.
Minutes 256th Meeting Registration Board 270
Assessment frequency (Months) Initial 3 6 Date of Testing 13-06-2015 14-09-2015 14-12-2015 Mode of testing (F=full.) F F F Tests (Physical. Acceptance Criteria Storage Conditions Chemical) (Long term)
Appearance Yellow color oblong 30◦C ± 2◦C & 75% Complies Complies Complies biconvex shape film coated RH. ± 5% RH. tablet plain from both sides
Identification Positive for Sofosbuvir 30◦C ± 2◦C & 75% Retention time Retention time Retention time by HPLC. The retention RH. ± 5% RH. complies complies complies time of the Sample peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay. AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 914.9 mg 914.9 mg 914.6 mg WEIGHT/TAB RH. ± 5% RH.
◦ ◦ LENGTH 18.80 – 19.20 mm 30 C ± 2 C & 75% 19.14 mm 19.13 mm 19.14 mm RH. ± 5% RH.
8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.13 mm 9.10 mm 9.13 mm WIDTH RH. ± 5% RH. 6.30 6.90 mm 30◦C ± 2◦C & 75% 6.38 mm 6.35 mm 6.35 mm THICKNESS – RH. ± 5% RH NMT 30 mins. 30◦C ± 2◦C & 75% 3 mins. 5 mins 8 mins DISINTEGRATION RH. ± 5% RH ◦ ◦ DISSOLUTION 30 C ± 2 C & 75% 91.40 % Not less than 80% after 45 RH. ± 5% RH 94.53 % 92.19 % (SOFOSUBVIR ) minutes 30◦C ± 2◦C & 75% 102.33 % 99.76 % 99.18 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 300C + 20C and 75% + 5% R.H was performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 9 month.
Minutes 256th Meeting Registration Board 271
1: Product Details
Product name /Generic name Zoval 400mg tablets Batch No. 15SBV-1567-02-T /Dosage form
Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 250 Tablets (container closure system) packed in Alu Alu foil in a printed unit carton Parameters and tests As per Product Specifications (PharmEvo Specs) Mfg. Date June 2015 mentioned Short term conditions(Accelerated) 40◦C ± 2◦C,75%±5% Recommended storage RH Exp Date June 2017 condition Long term conditions 300◦C ± 2◦C,75%±5% RH Date of initiation & June-2015 (API) lot no. CSSRVSP 10010415 implementation Stability No. CN# 824
Approved by: QC Manager: ------Total Sample size (approx.) = 20
QA Manager: ------
Production Manager: ------
R&D Manager: ------
Minutes 256th Meeting Registration Board 272
Assessment frequency (Months) Initial 3 6 Date of Testing 26-06-2015 28-09-2015 28-12-2015 Mode of testing (F=full.) F F F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Accelerated) Appearance Yellow color oblong biconvex 40◦C ± 2◦C & 75% Complies Complies Complies shape film coated tablet plain from RH. ± 5% RH. both sides
Identification Positive for Sofosbuvir by HPLC. 40◦C ± 2◦C & 75% Retention time Retention time Retention time The retention time of the Sample RH. ± 5% RH. complies complies complies peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.
AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 915.5 mg 915.9 mg 915.2 mg WEIGHT/TAB RH. ± 5% RH.
◦ ◦ LENGTH 18.80 – 19.20 mm 40 C ± 2 C & 75% 19.17 mm 19.11 mm 19.11 mm RH. ± 5% RH.
8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.12 mm 9.15 mm 9.14 mm WIDTH RH. ± 5% RH. 6.30 6.90 mm 40◦C ± 2◦C & 75% 6.37 mm 6.33 mm 6.35 mm THICKNESS – RH. ± 5% RH NMT 30 mins. 40◦C ± 2◦C & 75% 4 mins. 7 mins 9 mins DISINTEGRATION RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% (SOFOSUBVIR ) Not less than 80% after 45 minutes RH. ± 5% RH 92.15 % 91.58 % 91.95 % 40◦C ± 2◦C & 75% 103.15 % 99.58 % 99.06 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 400C + 20C and 75% + 5% R.H was performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.
Minutes 256th Meeting Registration Board 273
Assessment frequency (Months) Initial 3 6 Date of Testing 26-06-2015 28-09-2015 28-12-2015 Mode of testing (F=full.) F F F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Long term) Appearance Yellow color oblong biconvex 30◦C ± 2◦C & 75% Complies Complies Complies shape film coated tablet plain from RH. ± 5% RH. both sides
Identification Positive for Sofosbuvir by HPLC. 30◦C ± 2◦C & 75% Retention time Retention time Retention time The retention time of the Sample RH. ± 5% RH. complies complies complies peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay. .
AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 915.5 mg 915.3 mg 915.6 mg WEIGHT/TAB RH. ± 5% RH.
LENGTH 18.80 – 19.20 mm 30◦C ± 2◦C & 75% 19.17 mm 19.15 mm 19.17 mm RH. ± 5% RH.
8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.12 mm 9.12 mm 9.15 mm WIDTH RH. ± 5% RH. 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.37 mm 6.37 mm 6.34 mm THICKNESS RH. ± 5% RH. NMT 30 mins. 30◦C ± 2◦C & 75% 4 mins. 7 mins 8 mins DISINTEGRATION RH. ± 5% RH. DISSOLUTION 30◦C ± 2◦C & 75% (SOFOSUBVIR ) Not less than 80% after 45 minutes RH. ± 5% RH. 92.15 % 91.71 % 91.16 % 30◦C ± 2◦C & 75% 103.15 % 100.79 % 99.66 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH. Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 300C + 20C and 75% + 5% R.H was performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.
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1.0 Product details:
Product name /Genric name Zoval 400mg tablets Batch No. 15SBV-1576-03-T /Dosage form
Description of pack Yellow color oblong biconvex shape film coated tablet plain from both sides Batch Size. 250 Tablets (container closure system) packed in Alu Alu foil in a printed unit carton further packed in master shipper Parameters and tests As per Product Specifications (PharmEvo Specs) Mfg. Date July 2015 mentioned ◦ ◦ Recommended storage Short term conditions(Accelerated) 40 C ± 2 C,75%±5% Exp Date condition RH July 2017 Long term conditions 300◦C ± 2◦C,75%±5% RH Date of initiation & July- 2015 (API) lot no. CSSRVSP 10010415 implementation Stability No. CN# 830
Approved by: QC Manager: ------Total Sample size (approx.) = 20
QA Manager: ------
Production Manager: ------
R&D Manager: ------
Minutes 256th Meeting Registration Board 275
Assessment frequency (Months) Initial 3 6 Date of Testing 07-07-2015 09-10-2015 08-01-2016 Mode of testing (F=full.) F F F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Accelerated) Appearance Yellow color oblong biconvex 40◦C ± 2◦C & 75% Complies Complies Complies shape film coated tablet plain from RH. ± 5% RH. both sides
Identification Positive for Sofosbuvir by HPLC. 40◦C ± 2◦C & 75% Retention time Retention time Retention time The retention time of the Sample RH. ± 5% RH. complies complies complies peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay.
AVERAGE 915.0mg ± 5% 40◦C ± 2◦C & 75% 914.1 mg 916.2 mg 914.6 mg WEIGHT/TAB RH. ± 5% RH.
◦ ◦ LENGTH 18.80 – 19.20 mm 40 C ± 2 C & 75% 19.14 mm 19.13 mm 19.17 mm RH. ± 5% RH.
8.80 – 9.20 mm 40◦C ± 2◦C & 75% 9.11 mm 9.12 mm 9.13 mm WIDTH RH. ± 5% RH. 6.30 6.90 mm 40◦C ± 2◦C & 75% 6.35 mm 6.37 mm 6.34 mm THICKNESS – RH. ± 5% RH NMT 30 mins. 40◦C ± 2◦C & 75% 3 mins. 6 mins 8 mins DISINTEGRATION RH. ± 5% RH DISSOLUTION 40◦C ± 2◦C & 75% (SOFOSUBVIR ) Not less than 80% after 45 minutes RH. ± 5% RH 91.52 % 92.13 % 92.19 % 40◦C ± 2◦C & 75% 102.56 % 99.65 % 98.94 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 400C + 20C and 75% + 5% R.H was performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.
Minutes 256th Meeting Registration Board 276
Assessment frequency (Months) Initial 3 6 Date of Testing 07-07-2015 09-10-2015 08-01-2016 Mode of testing (F=full.) F F F Tests (Physical. Acceptance Criteria Storage Chemical) Conditions (Long term) Appearance Yellow color oblong biconvex 30◦C ± 2◦C & 75% Complies Complies Complies shape film coated tablet plain from RH. ± 5% RH. both sides
Identification Positive for Sofosbuvir by HPLC. 30◦C ± 2◦C & 75% Retention time Retention time Retention time The retention time of the Sample RH. ± 5% RH. complies complies complies peak in the chromatogram of the assay preparation corresponds to that of the standard preparation as obtained in the assay. .
AVERAGE 915.0mg ± 5% 30◦C ± 2◦C & 75% 914.1 mg 915.8 mg 915.2 mg WEIGHT/TAB RH. ± 5% RH.
LENGTH 18.80 – 19.20 mm 30◦C ± 2◦C & 75% 19.14 mm 19.16 mm 19.14 mm RH. ± 5% RH.
8.80 – 9.20 mm 30◦C ± 2◦C & 75% 9.11 mm 9.14 mm 9.16 mm WIDTH RH. ± 5% RH. 6.30 – 6.90 mm 30◦C ± 2◦C & 75% 6.35 mm 6.35 mm 6.36 mm THICKNESS RH. ± 5% RH. NMT 30 mins. 30◦C ± 2◦C & 75% 3 mins. 5 mins 6 mins DISINTEGRATION RH. ± 5% RH. DISSOLUTION 30◦C ± 2◦C & 75% (SOFOSUBVIR ) Not less than 80% after 45 minutes RH. ± 5% RH. 91.52 % 93.16 % 90.89 % 30◦C ± 2◦C & 75% 102.56 % 100.11 % 99.25 % Assay(SOFOSUBVIR ) (90.0 to 110.0) % RH. ± 5% RH. Analyst signature (after completion of every time line) Conclusion by QA (after completion of the study): Accelerated stability study at 300C + 20C and 75% + 5% R.H was performed for 6 month showed no or little change over time. No significant changes were observed in the physical and chemical characteristics of the drug product after 6 month.
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Documents / Data provided by the applicants (M/s PharmEvo, Karachi)
Sr. No. Documents to be provided Status
1. COA of API Yes 2. Approval of API by regulatory authority of Yes (Photocopy) country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. 3. Protocols followed for conduction of stability Yes study and details of tests. 4. Data of 03 batches will be supported by attested Yes respective documents like chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. Yes (ADC cleared) 6. All provided documents will be attested (name, Yes sign and stamp) for ensuring authenticity of data / documents. 7. Commitment to continue real time stability Yes study till assigned shelf life of the product.
Decision: Registration Board observed that the stability data provided by the firm is in accordance with the guidelines approved by the Board in 251st meeting. Howvever, a panel comprising Brig. (Retd.) M.H. Najmi, Member RB, Dr. Saifur Rehman Khattak, FGA, CDL, Karachi and Dr. Obaidullah, DDG Reg-I, DRAP will conduct inspection of the facility for verification of authenticity of stability data.
Minutes for 256th Meeting Registration Board 278
3. M/s Ferozsons, Nowshera
Drug Savera Tablets (Sofosbuvir) 400 mg Sources Sequent Labs Private Limited, India.
Storage Condition Real Time: 300◦C ± 2◦C,75%±5% RH Accelerated: 40◦C ± 2◦C,75%±5% RH Time Period Real Time: 6 months Accelerated: 6 months Frequency 0, 3, 6 months Batch Size Batch 1: 383 tab Batch 2: 383 tab Batch 3: 383 tab
No. of Batches 03 Sample Size NA
Meeting Deferred in 244th , 251st and 254th meeting of Registration Board
ACCELARATED STABILITY STUDY SUMMARY
Product Savera 400 mg Tablets Trial Batch No SS400-01 28 film coated tablets packed in a HDPE bottle, sealed with Description of the pack FEROZSONS logo induction seal and capped with child resistant cap. Mfg. Date May.2015 Such bottle packed in unit carton along with leaflet. Parameters and tests monitored As per In House Specifications. Expiry Date May.2017
Storage conditions 40°+ 2°C and 75 % + 5 % RH
Minutes for 256th Meeting Registration Board 279
Date of Initiation 12.05.2015 Date of completion 10.11.2015
RESULTS OF ANALYSIS TESTS SPECIFICATIONS INITIAL 1st month 3rd month 6th month
12/05/2015 09/06/2015 04/08/2015 10/11/2015
Blue, oblong, biconvex film coated tablets. One side having f and other side Description “ “ Complies Complies Complies Complies plain.
Disintegration Time NMT. 30 minutes 6 min. 5 min. 5 min. 5 min.
Dissolution NLT. 80 % should dissolved in 20 minutes 98.38 % 99.26 % 99.81 % 98.46 %
Total degradation products ≤ 0.6 % Complies N/A Complies Complies
The retention time of the major peak in the chromatogram of the assay Identification preparation corresponds to that in the chromatogram of the standard Complies Complies Complies Complies preparation, as obtained in assay.
Assay of Sofosbuvir 90 – 110 % 99.36 % 98.71 % 100.45 % 101.62 %
Conclusion: The results show that there are no significant physical or chemical changes when the product is kept at accelerated temperature of 40°+ 2°C and 75% + 5% RH for six Months.
Minutes for 256th Meeting Registration Board 280
REAL TIME STABILITY STUDY SUMMARY
Product Savera 400 mg Tablets Trial Batch No SS400-01 28 film coated tablets packed in a HDPE bottle, sealed with Description of the pack FEROZSONS logo induction seal and capped with child resistant cap. Mfg. Date May.2015 Such bottle packed in unit carton along with leaflet. Parameters and tests monitored As per In House Specifications. Expiry Date May.2017
Storage conditions 30°+ 2°C and 75 % + 5 % RH
Date of Initiation 12.05.2015 Date of completion 10.11.2015
RESULTS OF ANALYSIS TESTS SPECIFICATIONS 12th INITIAL 1st month 3rd month 6th month 9th month month
12/05/2015 09/06/2015 04/08/2015 10/11/2015
Blue, oblong, biconvex film coated tablets. One side To be To be Description Complies Complies Complies Complies having “f “ and other side plain. tested tested
To be To be Disintegration Time NMT. 30 minutes 6 min. 6 min. 4 min. 6 min. tested tested
To be To be Dissolution NLT. 80 % should dissolved in 20 minutes 98.38 % 98.38 % 99.09 % 99.36 % tested tested
Total degradation To be Complies N/A Complies Complies N/A products ≤ 0.6 % tested
The retention time of the major peak in the chromatogram of the assay preparation corresponds to To be To be Identification Complies Complies Complies Complies that in the chromatogram of the standard preparation, tested tested as obtained in assay.
Minutes for 256th Meeting Registration Board 281
100.27 100.43 To be To be Assay of Sofosbuvir 90 110 % 99.36 % 99.16 % – % % tested tested
Conclusion: The results show that there are no significant physical or chemical changes when the product is kept at 30°+ 2°C and 75% + 5% RH for six Months.
ACCELARATED STABILITY STUDY SUMMARY
Product Savera 400 mg Tablets Trial Batch No SS400-02 28 film coated tablets packed in a HDPE bottle, sealed with Description of the pack FEROZSONS logo induction seal and capped with child resistant cap. Mfg. Date May.2015 Such bottle packed in unit carton along with leaflet. Parameters and tests monitored As per In House Specifications. Expiry Date May.2017
Storage conditions 40°+ 2°C and 75 % + 5 % RH
Date of Initiation 21.05.2015 Date of completion 20.11.2015
RESULTS OF ANALYSIS TESTS SPECIFICATIONS INITIAL 1st month 3rd month 6th month
21/05/2015 18/06/2015 13/08/2015 20/11/2015
Blue, oblong, biconvex film coated tablets. One side having f and other side Description “ “ Complies Complies Complies Complies plain.
Disintegration Time NMT. 30 minutes 4 min. 6 min. 6 min. 6 min.
Dissolution NLT. 80 % should dissolved in 20 minutes 97.55 % 101.68 % 99.56 % 98.89 %
Total degradation products ≤ 0.6 % Complies N/A Complies Complies
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The retention time of the major peak in the chromatogram of the assay Identification preparation corresponds to that in the chromatogram of the standard Complies Complies Complies Complies preparation, as obtained in assay.
Assay of Sofosbuvir 90 – 110 % 98.60 % 100.04 % 98.57 % 99.92 %
Conclusion: The results show that there are no significant physical or chemical changes when the product is kept at accelerated temperature of 40°+ 2°C and 75% + 5% RH for six Months.
REAL TIME STABILITY STUDY SUMMARY
Product Savera 400 mg Tablets Trial Batch No SS400-02 28 film coated tablets packed in a HDPE bottle, sealed with Description of the pack FEROZSONS logo induction seal and capped with child resistant cap. Mfg. Date May.2015 Such bottle packed in unit carton along with leaflet. Parameters and tests monitored As per In House Specifications. Expiry Date May.2017
Storage conditions 30°+ 2°C and 75 % + 5 % RH
Date of Initiation 21.05.2015 Date of completion 20.11.2015
RESULTS OF ANALYSIS TESTS SPECIFICATIONS 12th INITIAL 1st month 3rd month 6th month 9th month month
21/05/2015 18/06/2015 13/08/2015 20/11/2015
Blue, oblong, biconvex film coated tablets. One side To be To be Description Complies Complies Complies Complies having “f “ and other side plain. tested tested
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To be To be Disintegration Time NMT. 30 minutes 4 min. 4 min. 5 min. 6 min. tested tested
101.36 To be To be Dissolution NLT. 80 % should dissolved in 20 minutes 97.55 % 99.97 % 98.07 % % tested tested
Total degradation To be Complies N/A Complies Complies N/A products ≤ 0.6 % tested
The retention time of the major peak in the chromatogram of the assay preparation corresponds to To be To be Identification Complies Complies Complies Complies that in the chromatogram of the standard preparation, tested tested as obtained in assay.
To be To be Assay of Sofosbuvir 90 110 % 98.60 % 98.79 % 99.04 % 99.80 % – tested tested
Conclusion: The results show that there are no significant physical or chemical changes when the product is kept at 30°+ 2°C and 75% + 5% RH for six Months.
ACCELARATED STABILITY STUDY SUMMARY
Product Savera 400 mg Tablets Trial Batch No SS400-03 28 film coated tablets packed in a HDPE bottle, sealed with Description of the pack FEROZSONS logo induction seal and capped with child resistant cap. Mfg. Date May.2015 Such bottle packed in unit carton along with leaflet. Parameters and tests monitored As per In House Specifications. Expiry Date May.2017
Storage conditions 40°+ 2°C and 75 % + 5 % RH
Date of Initiation 27.05.2015 Date of completion 25.11.2015
RESULTS OF ANALYSIS
Minutes for 256th Meeting Registration Board 284
TESTS SPECIFICATIONS INITIAL 1st month 3rd month 6th month
27/05/2015 24/06/2015 19/08/2015 25/11/2015
Blue, oblong, biconvex film coated tablets. One side having f and other side Description “ “ Complies Complies Complies Complies plain.
Disintegration Time NMT. 30 minutes 6 min. 6 min. 6 min. 7 min.
Dissolution NLT. 80 % should dissolved in 20 minutes 99.33 % 102.18 % 99.26 % 98.29 %
Total degradation products ≤ 0.6 % Complies N/A Complies Complies
The retention time of the major peak in the chromatogram of the assay Identification preparation corresponds to that in the chromatogram of the standard Complies Complies Complies Complies preparation, as obtained in assay.
Assay of Sofosbuvir 90 – 110 % 100.14 % 100.69 % 99.18 % 100.93 %
Conclusion: The results show that there are no significant physical or chemical changes when the product is kept at accelerated temperature of 40°+ 2°C and 75% + 5% RH for six Months.
Minutes for 256th Meeting Registration Board 285
REAL TIME STABILITY STUDY SUMMARY
Product Savera 400 mg Tablets Trial Batch No SS400-03 28 film coated tablets packed in a HDPE bottle, sealed with Description of the pack FEROZSONS logo induction seal and capped with child resistant cap. Mfg. Date May.2015 Such bottle packed in unit carton along with leaflet. Parameters and tests monitored As per In House Specifications. Expiry Date May.2017
Storage conditions 30°+ 2°C and 75 % + 5 % RH
Date of Initiation 27.05.2015 Date of completion 25.11.2015
RESULTS OF ANALYSIS TESTS SPECIFICATIONS 12th INITIAL 1st month 3rd month 6th month 9th month month
27/05/2015 24/06/2015 19/08/2015 25/11/2015
Blue, oblong, biconvex film coated tablets. One side To be To be Description Complies Complies Complies Complies having “f “ and other side plain. tested tested
To be To be Disintegration Time NMT. 30 minutes 6 min. 4 min. 7 min. 6 min. tested tested
100.33 To be To be Dissolution NLT. 80 % should dissolved in 20 minutes 99.33 % 97.93 % 99.36 % % tested tested
Total degradation To be Complies N/A Complies Complies N/A products ≤ 0.6 % tested
The retention time of the major peak in the chromatogram of the assay preparation corresponds to To be To be Identification Complies Complies Complies Complies that in the chromatogram of the standard preparation, tested tested as obtained in assay.
Minutes for 256th Meeting Registration Board 286
100.14 100.74 100.85 To be To be Assay of Sofosbuvir 90 110 % 99.53 % – % % % tested tested
Conclusion: The results show that there are no significant physical or chemical changes when the product is kept at 30°+ 2°C and 75% + 5% RH for six Months.
Documents / Data provided by the applicants (M/s Ferozsons Nowshera)
Sr. No. Documents to be provided Status
1. COA of API Yes 2. Approval of API by regulatory authority of country of origin or GMP Yes (Photocopy) certificate of API manufacturer issued by regulatory authority of country of origin. 3. Protocols followed for conduction of stability study and details of Yes tests. 4. Data of 03 batches will be supported by attested respective documents Yes like chromatograms, laboratory reports, data sheets etc. 5. Documents confirming import of API etc. No 6. All provided documents will be attested (name, sign and stamp) for Yes ensuring authenticity of data / documents. 7. Commitment to continue real time stability study till assigned shelf Yes life of the product.
Decision: Registration Board observed that the stability data provided by the firm is in accordance with the guidelines approved by the board in 251st meeting. However, a panel comprising Brig. (Retd.) M.H. Najmi, Member RB, Dr. Saifur Rehman Khattak, FGA, CDL, Karachi and Dr. Obaidullah, DDG Reg-I, DRAP will conduct inspection of the facility for verification of authenticity of stability data.
Minutes for 256th Meeting Registration Board 287
Evaluator-IV: Salateen Waseem Philip M/s ZAFA PHARMACEUTICALS LABORATORIES, KARACHI M/s Zafa Pharmaceuticals, Karachi applied for Registration of new dosage form, on prescribed Form 5-D, along with differential fee of Rs. 30,000/- with the same Brand Name Cordiclean Gel 4% (previously applied on Form 5 along with prescribed fee of Rs. 20,000/-) as per decision of 247th meeting of Registration Board held on 04th February 2015 wherein it was emphasized that “therapeutic use” of the subject drug was different as 0.2% Chlorhexidine Gel has a role in oral care whereas “7.1% Chlorhexidine Digluconate Gel (4% active Chlorhexidine)” is indicated for umbilical cord care in neonates. Therefore, all the firms shall apply for registration of 7.1% Chlorhexidine Digluconate Gel (4% active Chlorhexidine)” on Form-5D. Accordingly, the case of the firm was presented in 254th meeting of Registration Board wherein the Board deferred the case for completion of the application for following shortcomings:- Firm has provided stability data for accelerated time studies only, Real time stability data needs to be furnished by the firm. Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. Documentation confirming import of API. Commitment to continue real time stability study till assigned shelf life of the product.
The details of the submitted data are as under:-
Product name/ generic name / CORDICLEAN GEL 4% w/w dosage form Each gram contains: Chlorhexidine Batch # TR-01 Gluconate Solution BP equivalent to Chlorhexidine 4% w/w Description of Pack (Container Batch Size Trial batch closure system) 20gm aluminum tube in printed unit carton, of 100 Tubes further packed in master carton. Parameters and test mentioned Manufacturing January, BP Specification date 2014 Recommended storage conditions Short term condition (accelerated) 40c ± Expiry date January, 2C, 75 ± 5% RH. 2016 Long term condition (Real time) 30c ± 2C, 65 ± 5% RH. Date of initiation & implementation 11th January 2014 (API) Lot. No. 140501 Stability No. STB-10114
Minutes for 256th Meeting Registration Board 288
Sample taken for physical tests 22 Sample taken for chemical tests 12 Sample taken for microbiological test - Extra samples (if needed) 06 Total sample size 40 Accelerated Studies Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 1 2 24 26 6 0 Date of testing Jan-2014 Feb 2014 March 2014 April 2014 July 2014 Mode of testing, F=Full, P=Partial F P F P F F F F F F F F Tests Acceptance Storage conditions Criteria (Accelerated) Description Slightly 40°C±2°C Complies - - - Complies - Complies Complies - - Complies - yellowish &75%±5% RH viscous gel Identification The retention Complies - - - Complies - Complies Complies - - Complies - time of the sample peak in the 40°C±2°C chromatogram &75%±5% RH of the assay preparation should correspond to that of the standard preparation. pH 5.0 – 7.0 40°C±2°C 5.61 - - - 5.57 - 5.54 5.53 - - 5.53 - &75%±5% RH Assay, 95% to 105% 40°C±2°C 99.31 - - - 99.14 - 99.09 98.73 - - 98.87 - Chorhexidine of the stated &75%±5% RH amount
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Real Time Studies Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 1 2 24 26 6 0 Date of testing Jan-2014 April 2014 July 2014 Mode of testing, F=Full, P=Partial F P F P F F F F F F F F Tests Acceptance Storage conditions Criteria (Accelerated) Description Slightly 30°C±2°C Complies ------Complies - - Complies - yellowish &65%±5% RH viscous gel Identification The retention Complies - - - - - Complies Complies - - Complies - time of the sample peak in the 30°C±2°C chromatogram &65%±5% RH of the assay preparation should correspond to that of the standard preparation. pH 5.0 – 7.0 30°C±2°C 5.61 ------5.61 - - 5.59 - &65%±5% RH Assay, 95% to 105% 30°C±2°C 99.31 ------100.45 - - 99.86 - Chorhexidine of the stated &65%±5% RH amount
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Product name/ generic name / CORDICLEAN GEL 4% w/w dosage form Each gram contains: Chlorhexidine Batch # TR-02 Gluconate Solution BP equivalent to Chlorhexidine 4% w/w Description of Pack (Container Batch Size Trial batch closure system) 20gm aluminum tube in printed unit carton, of 100 Tubes further packed in master carton. Parameters and test mentioned Manufacturing January, BP Specification date 2014 Recommended storage conditions Short term condition (accelerated) 40c ± Expiry date January, 2C, 75 ± 5% RH. 2016 Long term condition (Real time) 30c ± 2C, 65 ± 5% RH. Date of initiation & implementation 11th January 2014 (API) Lot. No. 140501 Stability No. STB-20114
Sample taken for physical tests 22 Sample taken for chemical tests 12 Sample taken for microbiological test - Extra samples (if needed) 06 Total sample size 40
Accelerated Studies Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 1 2 24 26 6 0 Date of testing Jan-2014 Feb 2014 March 2014 April 2014 July 2014 Mode of testing, F=Full, P=Partial F P F P F F F F F F F F Tests Acceptance Storage conditions Criteria (Accelerated) Description Slightly 40°C±2°C Complies - - - Complies - Complies Complies - - Complies - yellowish &75%±5% RH viscous gel Identification The retention Complies - - - Complies - Complies Complies - - Complies - time of the
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sample peak in the 40°C±2°C chromatogram &75%±5% RH of the assay preparation should correspond to that of the standard preparation. pH 5.0 – 7.0 40°C±2°C 5.57 - - - 5.55 - 5.54 5.53 - - 5.52 - &75%±5% RH Assay, 95% to 105% 40°C±2°C 100.48 - - - 100.15 - 100.09 99.09 - - 98.63 - Chorhexidine of the stated &75%±5% RH amount
Real Time Studies Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 1 2 24 26 6 0 Date of testing Jan-2014 April 2014 July 2014 Mode of testing, F=Full, P=Partial F P F P F F F F F F F F Tests Acceptance Storage conditions Criteria (Accelerated) Description Slightly 30°C±2°C Complies ------Complies - - Complies - yellowish &65%±5% RH viscous gel Identification The retention Complies - - - - - Complies Complies - - Complies - time of the sample peak in the 30°C±2°C chromatogram &65%±5% RH of the assay preparation should correspond to
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that of the standard preparation. pH 5.0 – 7.0 30°C±2°C 5.57 ------5.61 - - 5.57 - &65%±5% RH Assay, 95% to 105% 30°C±2°C 100.48 ------100.25 - - 99.39 - Chorhexidine of the stated &65%±5% RH amount
Product name/ generic name / CORDICLEAN GEL 4% w/w dosage form Each gram contains: Chlorhexidine Batch # TR-03 Gluconate Solution BP equivalent to Chlorhexidine 4% w/w Description of Pack (Container Batch Size Trial batch closure system) 20gm aluminum tube in printed unit carton, of 100 Tubes further packed in master carton. Parameters and test mentioned Manufacturing January, BP Specification date 2014 Recommended storage conditions Short term condition (accelerated) 40c ± Expiry date January, 2C, 75 ± 5% RH. 2016 Long term condition (Real time) 30c ± 2C, 65 ± 5% RH. Date of initiation & implementation 11th January 2014 (API) Lot. No. 140501 Stability No. STB-30114
Sample taken for physical tests 22 Sample taken for chemical tests 12 Sample taken for microbiological test - Extra samples (if needed) 06 Total sample size 40
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Accelerated:- Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 1 2 24 26 6 0 Date of testing Jan-2014 Feb 2014 March 2014 April 2014 July 2014 Mode of testing, F=Full, P=Partial F P F P F F F F F F F F Tests Acceptance Storage conditions Criteria (Accelerated) Description Slightly 40°C±2°C Complies - - - Complies - Complies Complies - - Complies - yellowish &75%±5% RH viscous gel Identification The retention Complies - - - Complies - Complies Complies - - Complies - time of the sample peak in the 40°C±2°C chromatogram &75%±5% RH of the assay preparation should correspond to that of the standard preparation. pH 5.0 – 7.0 40°C±2°C 5.61 - - - 5.56 - 5.53 5.44 - - 5.53 - &75%±5% RH Assay, 95% to 105% 40°C±2°C 99.83 - - - 99.57 - 99.21 98.98 - - 98.94 - Chorhexidine of the stated &75%±5% RH amount
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Real Time Studies Assessment frequency (weeks) Initial 1 2 3 4 6 8 12 1 2 24 26 6 0 Date of testing Jan-2014 April 2014 July 2014 Mode of testing, F=Full, P=Partial F P F P F F F F F F F F Tests Acceptance Storage conditions Criteria (Accelerated) Description Slightly 30°C±2°C Complies ------Complies - - Complies - yellowish &65%±5% RH viscous gel Identification The retention Complies - - - - - Complies Complies - - Complies - time of the sample peak in the 30°C±2°C chromatogram &65%±5% RH of the assay preparation should correspond to that of the standard preparation. pH 5.0 – 7.0 30°C±2°C 5.61 ------5.60 - - 5.55 - &65%±5% RH Assay, 95% to 105% 30°C±2°C 99.83 ------100.69 - - 99.07 - Chlorhexidin of the stated &65%±5% RH e amount
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Decision: Registration Board observed that the stability data needs to be evaluated keeping in view characteristics of individual API/molecule. Therefore, it was decided that in future, all stability data submitted by the firms shall be evaluated by a committee comprising of Dr. Amanullah, Member Registration Board, Dr. Saif-ur-Rehman Khattak FGA, CDL, Karachi and Incharge, PEC. Recommendations of this committee shall be placed before the Board for consideration. Therefore, case was deferred and stability data was referred for evaluation of the committee.
Registration Board discussed that procedure for onsite investigation for the genuineness of submitted data shall be adopted for all registration applications of NCEs and subsequent generics of NCEs, as decided by the Board in 254th meeting. It would be appropriate that in future all such cases will be referred to panel for confirmation of data and inspectuion report along with complete case will be then placed before Registration Board for decision.
Registration Board observed that cases for stability studies have been considered alongwith set of documents including Certificate of Analysis of API; approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin etc. Aforementioned documents were considered by Registration Board as provided by the manufacturers. In case of any query / mis-declaration, applicant will be called for clarification.
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Item No.V: Cases referred by Quality Assurance & Lab Testing Division.
Case No. 01: Tyno SF Cough Syrup of M/s Reko Pharmacal, Lahore and Dextromethorphan Cough Syrup of M/s Ethical Lab. Report of PQCB.
The Secretary, Provincial Quality Control Board, (PQCB) Punjab had reported that the PQCB Board, in its meetings held on 29-12-2012 and 11-01-2013 considered the case of substandard Dextromethorphan Active Pharmaceutical Ingredients, Batch No. DMR-02-12- 029 and DMR-02-12-030 Manufactured by M/s Konduskar Laboratories (Pvt) Ltd., MIDC- India, was being used for manufacturing of Tyno SF Cough Syrup by M/s Reko Pharmacal, Lahore and Dextromethorphan Cough Syrup by M/s Ethical Labs Lahore respectively. The samples were drawn by Drug Inspector, Allama Iqbal Town, Lahore from manufacturer’s premises and the team of Provincial Health Department sealed the firm’s premises on 25-11- 2012. The Provincial Health Department de-sealed the factory on 27-11-2012 on administrative grounds. Action Taken by DRAP As per record/ information available with DRAP, the Board was apprised background of the case is as under. 1. The drugs sales outlets in Lahore were randomly checked by Federal Inspector of Drugs for availability of the said drug but no stocks were found. 2. A team of Federal Inspector of Drugs and Assistant Drug Controllers inspected the firm on the same day i.e 27-11-2012 when the company was de-sealed by the Provincial Inspector. The FID & ADC checked Production and Quality Control record of the suspected batches of Tyno SF Cough Syrup was checked. Samples of the four suspected batches of the Syrup and active raw materials used in their manufacturing were drawn for test/ analysis by the Federal Government Analyst. The available stocks of Tyno SF Cough Syrup were ordered “not to dispose off” by the FID while the active raw material was sealed by the Provincial Drug Inspector. 3. The Federal Government Analyst subsequently declared four suspected batches of Tyno SF Cough Syrup and the samples of active raw materials Dextromethorphan (Batch No. DMR-02-12-029) used in their manufacturing as of standard quality manufacturing. The provincial health authorities later furnished a sub-standard test repots of DTL Punjab in respect of the same batch Dextromethorphan raw material, imported from Konduskar Laboratories by M/s Reko, In December, 2012 another incidence was reported regarding deaths in Gujranwala due to unknown poisoning, the Punjab health authorities reported that Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Lab as suspected drugs. During further investigation it was found that the source of Dextromethorphan raw material, i.e. M/s Kundoskar India, utilized in these products was the same as that of Tyno SF Cough Syrup of M/s Reko.
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4. A joint inspection (with the provincial health authorities) of M/s Ethical Labs Lahore, whose syrup viz Dextromethorphan Cough Syrup and Cocil cough Syrup (containing Dextromethorphan) were suspected to be involved, was also carried out on 28-12-2012 and the production and quality control record was thoroughly cheeked by the inspection team. The entire stocks of suspected drugs present in the premises were order not to dispose off and 19 different samples of finished drugs and raw materials were taken for test/ analysis by the provincial inspectors. The Federal Inspector of Drugs also drew samples of suspected drugs from the firm’s premises. The reports of investigation of cause of death are awaited. The Syrup Section and suspected raw materials of the firm were sealed by the provincial drug inspectors.
5. There have been a number of news reports that all the victims were drug addicts and there is possibility that they have taken some other drugs or narcotics along with the Cough Syrup in excessive quantities. The Forensic Toxicology Analysis Report issued by Home Department, Government of Punjab, also reported Opiates, Cannabinoids, Ethanol, and other sedative/ psychotropic substances in the samples drawn from 11 victims, suggesting concomitant ingestion of narcotics and other related substances by them. 6. The test reports of the samples of finished products and raw materials used in these cough syrups, sent by Punjab Government to UK for testing, revealed that the two batches of Dextromethrophan (DMR 02- 12-029 & DMR 02/12-030) raw material imported from M/s Konduskar, India contains heavy contents of Levomethorphan (up to 22%), which is the semi finished form of Dextromethorphan. 7. While the role of Levomethorphan and other narcotics / psychotropic drugs detected in the victim’s samples is being investigated, both the Provincial Government and Drug Regulatory Authority of Pakistan has taken necessary actions to confiscate the imported raw material and finished products from the market.
The Central Licensing Board took up the matter in its 231st Meeting held on 30-01-2013, and after hearing representatives of M/s Reko Pharmacal and Ethical Labs took following decisions.
i. Import of any raw material / drug form M/s Konduskar India is banned forthwith.
ii. WHO Pakistan may be approached with the request to take up the matter with the Indian authorities through WHO India. iii. Suspension of License of Oral Liquid / Syrup Section of M/s Reko Pharmacal for one year or till completion of investigation and decision by the competent forum, whichever is earlier. iv. Suspension of License of Oral Liquid / Syrup Section of M/s Ethical Labs for one year or till completion of investigation and decision by the competent forum, whichever is earlier. v. Recommendations to the Drug Registration Board for Cancellation of Registration of Tyno SF Cough Syrup of M/s Reko Pharmacal and Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs.
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vi. Detail panel GMP inspection of the M/s Reko Pharmacal and M/s Ethical Labs
The Licensing Board further decided to take up the matter again after completion of investigation by the relevant quarters. The Central Licensing Board after review of the available details of the case noted that the matter of excessive consumption of the Cough Syrups along with narcotics and other related substances by the victims requires to be properly investigated in order to find actual cause of deaths and subsequent fixation of responsibility.
Decision:- The CLB took the following decisions. i. While endorsing the ban on import from M/s Konduskar India, the Board recommended for involving trade bodies and diplomatic channels for taking up the matter with the Indian authorities. ii. Ministry of Commerce may be approached with the recommendation that a cautious approach made may be adopted for granting Most Favored Nation (MFN) status to the India in view of the substandard imports. iii. A committee with following composition is constituted to thoroughly investigate the matter and submit its finding and recommendations to the Board on priority basis. a. Representative from DRAP b. Representative from the Government of Punjab c. Two Experts in Pharmaceutical Sciences d. Any other co-optive member the committee may require iv. Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till completion of investigation and decision by the competent forum. v. Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs till completion of investigation and decision by the competent forum.
Consideration of the Case by Registration Board Registration Board in its 237th meeting held on 26-02-2013 considered in the light of recommendation of the Secretary, Provincial Quality Control Board (PQCB), Punjab and Central Licensing Board. The Registration Board in its 237th meeting taken the following decisions. While endorsing the ban on import from M/s Konduskar India, the Board recommended for also involving trade bodies and diplomatic channels for taking up the matter with the Indian authorities. Ministry of Commerce may be approached with the recommendation that a cautious approach made may be adopted for granting Most Favored Nation (MFN) status to the India in view of the substandard imports. A committee with following composition is constituted to thoroughly investigate the matter and submit its finding and recommendations to the Board on priority basis. a. Representative from DRAP b. Representative from the Government of Punjab c. Two Experts in Pharmaceutical Sciences d. Any other co-optive member the committee may require Suspension of registration of Tyno SF Cough Syrup of M/s Reko Pharmacal till completion of investigation and decision by the competent forum.
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Suspension of registration of Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs till completion of investigation and decision by the competent forum. In consequence of the orders of DRB, following committee was constituted by CEO DRAP. S.No Name Designation 1. Syed Shaid Nasir Member Appellate Board Chairman Committee 2. Professor Dr. Bashir Ahmed Member 3. Professor Muhmmad S. Iqbal Member 4. Mr. Asim Rauf DDG, Secretary/Coordinator of the Committee 5. Dr. Saif ur Rehman Kahttak Member The above committee has sent a report for the registration board to considered the conclusion of the report is reproduce here under for kind information of DRB. The committee in its report based on to the facts, findings, review of documents, analysis of different reports and discussions based on scientific facts the committee has reached the conclusion that suspected batches of the products i.e. Tyno SF cough syrup and Dextromethorphan cough syrup manufactured by M/s. Reko Pharmacal, Lahore and M/s Ethical laboratories Lahore respectively meet the Pharmacopoeal requirements, hence, these firms cannot be held responsible for the loss of precious lives which occurred in two incidents. The deaths are attributed to overdosing of Dextromethorphan and combining of other narcotic CNS depressants/noxious substances with the Tyno SF syrup and Dextromethorphan syrup. The case along with the committee report was placed before 245th meeting of Registration Board. The Board discussed the case at length and decided as under:- “Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting”. The case was again placed before registration board in its 246th meeting who decided the case as under:- “Registration Board again decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up- coming meeting”. The Registration Board in its 246th meeting decided the case as under:- Decision:- Registration Board again decided that Mr. Jamil Anwar Member of the Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting The Director DTL Lahore Mr Jamil Anwer also the member of Registration Board informed in writing that these Firms have withdrawn their Writ Petitions at Lahore. The case was considered by the Registration Board in its 248th meeting held on 18th-19th March, 2015. 2. The Board, in view of the case background decided as under:- “Registration Board discussed the matter at length in the light of above proceedings of the case. Mr. Jamil Anwer, Director DTL Lahore showed his reservations on the report of the Committee with the following observations as under:-
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i. The panel does not have any of the members from the Government of the Punjab, Health Department. ii. The adverse reports of DTLs Punjab, Appellate laboratory NIH, Islamabad, HEJ & laboratories of UK (MHRA) has not been reflected in the panel /Committee’s report. iii. Mr. Jamil Anwer Director DTL Lahore further apprised the Board that he had been part of the proceedings in instant case when this sad incident happened and will share the factual position of the case before Registration Board. iv. Mr. Jamil Anwer Director DTL Lahore was asked by the Board to send the documentary evidences of facts of this case to Secretary Registration Board, so that same may also be incorporated.
v. The matter is deferred for next meeting of Registration Board”. The Honorable Member of the Board (Mr. Jamil Anwar Director DTL Lahore) has not furnished documentary evidences of facts of this case. Accordingly the case was submitted again for consideration/appraisal/decision of the Board in its 249th meeting held on 19-05- 2015. Decision:- “Due to paucity of time the Board deferred the case till next meeting of the Registration Board. The Case is again submitted for the appraisal of the Board. The Registration Board in its 250th meeting decided as under:- Decision: “The Board has decided and directed to QC Section to contact with Mr. Jamil Anwar to furnish documentary evidences of facts of this case.
Current Status The Honorable Member Registration Board (Mr. Jamil Anwar) has given the copies of test reports which indicate that there is not pure Dextromethorphan HBr rather a racemic mixture and also contains other Isomer in the raw material and in dosage form (syrup). The Honorable member may be requested to explain and apprised Board. The Case is submitted for the appraisal of the Board, please.
Decision of the 254th Meeting of the Registration Board “The Board deferred the case and decided to discuss the matter in the presence of Mr. Jamil Anwar who will present his report before the Registration Board”.
255th Meeting of Registration Board:- Proceedings:- Mr. Jamil Anwar, Director DTL Lahore (Member Registration Board) briefed the Board he stressed that Levomethorphan though has analgesic effect but due to its bad toxicity profile it is not registered in any country as a medicine. He informed that the presences of Levomethorphan in Racemic mixture has synergistic effect hence its Toxicity increased in Racemic mixture. He was in the view that the probably cause of death incidence due to Tyno SF cough Syrup is the presence of Racemic mixture. The presence of Racemic mixture (Dextro and Levorotatory enantiomers was confirmed in batch number 5601 by Lab reports. He informed that further investigation and studies proved that the Both firms (Ethical and Reko Pharmecal) used the material of source from M/s Konduskar Laboratories Pvt Ltd Kolapur India which was contaminated with Recemic mixture of both enantiomers of Methorphan (i.e. Levo and Dextromethorphan). He informed that WHO has also issued alert
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in the matter of death incidents in Lahore and Gujranwala due to the use of Tyno 120ml cough syrup and Dextromethorphan 120ml cough syrup which contains contaminated Dextromethorphan active pharmaceutical ingredient produced by Konduskar Lab India. Decision:- The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:- The Board decided to call both the firms (i.e. M/s Ethical and Reko Pharmacal) with the directions that the firms may appeared before the Board to defend their case as to why action should not be taken.
In light of above decision of Registration Board M/s Ethical and Recko Pharmacal call for personal hearing for defending their case.
256th Meeting of Registration Board:-
Proceedings:-
The representatives of M/s Reko Pharmacal, Mr. Mian Khalid Saleem, (Managing Director), Mr. Saeed Khalid, (Director), Mr. Akram Khatak, (Manger) and also representatives of the M/s Ethical Laboratory, Mr. Abdul Waheed Sheikh, (Director) and Mr. Haroon Dugal (Advocate) were appeared before the Board and pleaded their case. They requested to restore the registration of their products i.e Tyno SF Cough Syrup of M/s Reko Pharmacal and Dextromethorphan Cough Syrup and Cocil Syrup of M/s Ethical Labs as they were suffering a lot due to not producing these products since a long period. Their complete statement is as under:
Abstract:
1. These proceedings pertain to incidents of deaths caused due to dextromethorphan abuse by drug addicts in Shadara Town, Lahore and Gujranwala in the year 2012. Pursuant to the incidents stringent actions were taken against the firms, M/s Reko Pharmacal Private Limited and Ethical Laboratories Private Limited by the provincial and federal drug administrations for their allegedly sub-standard syrups. These actions included the suspension of registration of the Tyno Syrup, Dextromethorphan and Cocil Syrups manufactued by M/s Reko Pharmacal Private Limited and Ethical Laboratories Private Limited (the “Products”) respectively by this Honorable Board in its 237th meeting held on 26-02-2013.
2. That the order of suspension of registrations is liable to be withdrawn on, amongst others, the following grounds:
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Grounds:
Report by the Investigation Committee constituted by DRAP:
i) That an Investigation Committee (the “Committee”) was constituted by DRAP vide letter dated 10-10-2013 to investigate the matter thoroughly taking into account all aspects of the issue including scientific, technical and legal parameters. The Committee carried out detailed investigations into the whole issue, including but not limited to, carrying out physical inspection of the firms, scrutinizing the relevant data and reports and scientifically and technically. The Committee gave a detailed and through report on the alleged incident of violation of drug laws by the firms and exonerated both the companies. The conclusion drawn by the Committee is reproduced hereunder for ease of reference:
“Based on the above mentioned facts, findings, review of documents, analysis of different reports and discussions based on scientific facts, the Committee has reached the conclusion that suspected batches of the products i.e., Tyno SF Cough Syrup and Dextromethorphan Cough Syrup manufactured by M/s Reko Pharmacal, Lahore and M/s Ethical Laboratories, Lahore respectively meet the pharmacopoeal requirements, hence, these firms cannot be held responsible for the loss of precious lives which occurred in two incidents. The deaths are attributed to over dosing of dextromethorphan and combining of other narcotic CNS depressants/noxious substances with the Tyno SF Syrup and Dextromethorphan Syrup.”
In light of the foregoing positive report, it is in the interests of justice that the order of suspension of registration of the Products may very kindly be recalled and registrations may graciously be restored.
A copy of the aforesaid report is attached herewith as Annexure-A.
ii) That in its 237th meeting held on 26-02-2013 this Honorable Board was pleased to suspend the registration of the Products till the completion of investigation. The aforesaid Investigation has been completed since 17-03- 2014. However, despite a lapse of almost 2 years of a favourable report, the suspension of registration order has not been recalled which has caused colossal financial losses to both the companies.
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iii) That it is important to note that both the companies have already suffered without any fault on their part as they have faced a blacklisting/disqualification for 2 years by Government of Punjab coupled with a suspension of Drug Manufacturing License for oral liquid/syrup sections over and above the suspension of registration. Whilst, the Drug Manufacturing License for oral liquid/syrup sections was restored by the Honorable Appellate Board in its 140th Sitting held on 20-08-2013, this Honorable Board is still required to decide the issue of suspension of Products registration favourably in light of the Investigation Report.
iv) That an issue which leans heavily in favour of the aforesaid companies is that the analytical reports issued by different labs show a number of variations for different parameters of samples of API (Dextromethorphan) and finished products (Tyno-SF & Dextromethorphan). API Batch Nos. DMR 02-12-029 and DMR 02-12-030 are declared of standard quality by CDL where as DTL has declared one of Batch No. DMR 02-12-030 as sub-standard and one as of standard quality. Furthermore, the finish product batches made from API Batch Number DMR 02-12-030 are declared sub-standard by DTL, MHRA, NIH & some batches such as DMS 920, DMS 927 and DMS 928 are declared of standard quality by DTL and MHRA.
v) Furthermore, it can be ascertained from the reports and has also been confirmed by the Committee that the batch No. 5602 of finished product of Reko containing raw material from Konduskar was never released in the market and the batch No. 5601 which was allegedly held to be sub-standard on the ground that it has been manufactured from Konduskar raw material was in fact manufactured from Wockhardt raw-material declared to be of standard quality from all the testing labs (DTL, CDL & MHRA).
For more details of the discrepancies in the reports, please see the below table:
Syrup Batch no Product DTL MHRA CDL NIH Remarks Not 5601 Tyno Detected/Fail Detected standard possible DMS 931 Dextromethorphan Detected/Fail Detected standard Not
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possible Not DMS930 Dextromethorphan Detected/Fail Detected standard possible Not DMS 929 Dextromethorphan Detected/Fail Detected standard possible Same API of Not Not above DMS 920 Dextromethorphan detected/Pass detected/Pass NA NA batches Same API of Not Not above DMS 928 Dextromethorphan detected/Pass detected/Pass NA NA batches Same API of Not Not above DMS 927 Dextromethorphan detected/Pass detected/Pass NA NA batches
Comments by Director DTL, Lahore
vi) That worthy member of the Board has opined that “deaths have probably been caused due to Racemic mixture”. Kind attention of this Honorable Board is drawn to the Forensic Toxicology Analysis Reports prepared by the Punjab Forensic Science Laboratory which proves that the real cause of death is abuse of excessive quantity of dextromethorphan along with other noxious compounds by the addicts such as, ethanol, opiates, triazolam, cannabonoids, methanol, acetone etc. Furthermore, neither Levomethorphan (as none was detected in any of the autopsy reports) nor Racemic mixture of Dextro and Levorotatory enantiomers as alleged by worthy Director DTL, Lahore (ex- officio Member Registration Board) was the cause of the aforesaid deaths.
LD-50
vii) It may also be noted that according to the test reports, the maximum percentages of Levo-isomer are reported as 22.6% and 17.6% in Reko and Ethical Lab products respectively. The Levo-isomer is being blamed for deaths. However, LD-50 of Levo – Methorphan, for a man of 70kg, calculated on the basis of LD50 in rats (242 mg/kg) and mouse (145 mg/kg) will be 16.94 gm and 14.50 gm respectively, hence one will need about 350 bottles of Tyno or Dextrometharphan syrup each of 120ml to get the LD50 dose. This clearly shows that the deaths did not occur due to the presence of Levo-isomer in the products, even if the assumed reports are accepted to be true. Accordingly, the Minutes for 256th Meeting Registration Board 305
Racemic mixture cannot be blamed for the deaths by any stretch of imagination. Even otherwise, abuse of an otherwise harmless product/drug can never be attributed to the manufacturer. Not even a single complaint has been received from thousands of bottles sold throughout the country. viii) It will also be of interest to note that the Punjab Government has also got conducted acute toxicity study with reference to Tyno cough syrup from University of Veterinary and Animal Sciences Lahore. According to this study LD50 studies indicated that none of animal died when a batch of five mice was given the cough syrup at a dose of 64 times of original dose where the animals were observed critically for mortality up to 89 hours. ix) Lastly, the MHRA report never “confirmed” the presence of Racemic Mixture and was based on assumptions and an “in-house” method which was not a validated method stipulated in any leading international pharmacopeia. This fact has been admitted in the report No 13/001 of MHRA at page 49-50.
Conflict of Interest x) Even otherwise, the learned Director DTL/worthy ex-officio member of the Registration Board was conflicted in raising any opinion or providing any evidence or statement contrary to the report of Investigation Committee. Since, the sub-standard reports had been prepared by the DTL, no objection could be raised on the analysis of the reports reached by the Committee as “no one could be a judge of his own cause”. In this regard, the Honorable Appellate Board, vide order dated 20-08-2013 in its 140th sitting, has expressed its view on the raising of objections by the secretary PQCB in the same matter wherein the remarks of the secretary PQCB was expunged being in violation of the Drugs Act, 1976 and rules framed thereunder. The operative part of the said order is reproduced as under:
“Mr Muazzam Ali Khan, Secretory, PQCB, Punjab, who had made recommendations to the Central Licencing Board for cancellation of the Drug manufacturing Licence of the Appellant and was representing the Secretary, Health Department, Punjab on the Appellant Board, However, voted against the decision of the Appellate Board and stood by the recommendation given by the PQCB, Punjab in view of the reports and record available before the PQCB, Punjab. The Minutes for 256th Meeting Registration Board 306
Appellate Board, however noted participation of the Secretary PQCB, Punjab in the proceeding of the Appellate Board, which was a conflict of interest under Section 11-A of the Drugs Act, 1976 and Rule 1-A of the Drugs (Appellate Board) Rules, 1976 and ex- punched his vote.”
A copy of the aforesaid order is attached as Annexure-B.
xi) Finally, it may be noted that the firms have been suffering from financial losses of millions of rupees due to the continued suspension of the Registration and the companies are on the verge of a financial crunch that may lead to the closure of their business operations as the cough syrups are their star products. The suspension has also resulted in loss of livelihood of hundreds of employees who had been previously working in the active syrup sections in the manufacturing facilities of both the firms.
PRAYER:
In view of the foregoing submissions, it is respectfully prayed that the suspension of registration of the Tyno Syrup, Dextromethorphan and Cocil Syrups manufactued by M/s Reko Pharmacal Private Limited and Ethical Laboratories Private Limited (the “Products”) respectively by this Honorable Board in its 237th meeting held on 26-02-2013 may please be recalled in view of the favourable report by the Investigating Committee.
Decision:-
The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
The Board decided to request the Chairman PQCB (Punjab) for sending the representative (who should be well aware of the case) to apprise about the current status and assist the Honorable Board to decide the case accordingly.
Case. No.02. Supply of Substandard/Adulterated Injection Ofcil 100ml to DHQ Hospital Hafizabad (25000 vials and M/s Medisearch Pharma Pvt Ltd 5Km Raiwind Manga Road Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad.
The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad has forwarded two recommendations to DRAP as under:- i. The Federal Government Cancel the Drug Manufacturing License of M/s Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Sub-standard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore which supplied substandard Almajax 120ml Suspension to DHQ Hospital Hafizabad (35600 bottles). Minutes for 256th Meeting Registration Board 307
ii. The Federal Government Cancel the Registrations of the said drugs of M/s Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.
Brief Background The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax Suspension, and statement of the Drug Inspector observed that this is a criminal negligence on the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB) observed that there is a dire need to take quick action against the said firms to safeguard the public health at large and submitted the above mentioned recommendations. The case is placed before Registration Board for decision on the recommendations of (PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these firms as per law with the proposal that recommendations may also be send to Division of Licensing for further necessary action at their end so that public health may be saved from risk.
Decision of Registration Board:- “To get the complete investigation along with all the reports and case background from the Secretary Provincial Quality Control Board Health Department Government of Punjab Lahore through the DDG (E&M) Lahore. a. The area FID Lahore will be asked to submit the case background in writing along with all relevant reports for perusal of the Registration Board for decision. b. The Board further decided the case shall be forwarded to Directorate of Licensing for further necessary action in the light of recommendation of the Provincial Quality Control Board (PQCB) Punjab. The decision/reminders have been again conveyed to DDG (E&M) Lahore and FID Lahore the report is awaited.
The case was submitted again for consideration of the Board in its 249th meeting held on 19- 05-2015. Decision:- “Due to paucity of time the Board deferred the case till next meeting of the Registration Board”.
The Case is again submitted for the appraisal of the Board, The Registration Board in its 250th meeting decided as under:- Decision:- “The Board has decided to send reminders to DDG (E&M) Lahore and FID Lahore for the submission of the report”.
Current Status The DDG (E&M) Lahore Dr. Sheikh Akhtar Hussain, Mr. Asim Rauf FID Lahore and Syed Zia Hussnain FID Lahore, inspected the firm M/s Mediceena Pharma on 13-02-2015 and M/s Medisearch Pharma inspected on 12-01-2015 and made investigation reports”. “The DDG (E&M) Lahore Dr. Sheikh Akhtar Hussain, has submitted the investigation reports for the manufacturing units i.e. M/s Medisearch Pharma (Pvt) Ltd 5-Km Riwind Road
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Lahore and M/s Mediceena Pharma (Pvt) Ltd 27 K-m Riwind Road, Lahore. In the matter of Supply of Substandard/Adulterated Injection Ofcil 100ml to DHQ Hospital Hafizabad and M/s Medisearch Pharma Pvt Ltd 5Km Raiwind Manga Road Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad.
Investigation/Inspection Report of M/s Medisearch Pharma is submitted for perusal please. “The panel concluded in their report dated 13-02-2015 of inspection M/s. Medisearch Pharma “Firm was non-operational at the time of inspection. After detailed inspection of the firm and evaluation of documents/data submitted by the firm thereafter including BMRs, SOPs, Certificate of analysis etc has revealed certain gaps in the Quality Assurance system. Firm made observation regarding storage conditions at DHQ Hafiz Abad. Report with annexure is submitted along with enclosures for consideration of board concerned under Drugs Act 1976/DRAP Act 2012.” The DDG (E&M) Lahore Dr. Sheikh Akhtar Hussain, Mr. Asim Rauf FID Lahore and Syed Zia Hussnain FID Lahore, inspected the firm M/s Mediceena Pharma on 13-02-2015 and concluded as
Investigation/Inspection Report of M/s Medicenena Pharma is submitted for perusal please.
“The firm has developed SOPs and systems to manufacture the drug under reference. Firm has satisfactory compliance of GMP with reference to manufacturing section of drug under reference. cGMP is continuous day to day process which require consistent efforts. Storage conditions at hospital under reference may have also some impact on the product under reference as stated by the firm. Court observations are also enclosed pertaining to this case annexed at annexure at serial No.4 is submitted along with enlocsures of board concerned under Drugs Act 1976/DRAP Act 2012.”
Decision of the 254th meeting of DRB a. The Board decided to give personal hearing to both the firms. b. The Board further decided the case shall be forwarded to Directorate of Licensing for further necessary action in the light of recommendation of the Provincial Quality Control Board (PQCB) Punjab. They have been also called for personal hearing.
255th meeting of DRB Proceeding: Mr. Ch. Waris Ali, Manager Regulatory Affairs of M/s. Mediceena Pharma was appeared before the board on behalf of the firm and requested for adjournment for next date as the Chief Executive of Mediceena Pharma (Mr. Riyasat Ali Bhatti) was busy in interior of south Punjab. The Manager Operation of M/s. Medisearch was appeared and requested for adjournment for next date because he informed that he was not well versant with the case and he was directed by the management of the firm to appear as they received a day before the letter of personal hearing. The Chairman Registration Board requested the representative of PPMA to inform the firms about the seriousness of the case.
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Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under: i. “To give the last personal hearing to both firms otherwise ex-parti decision will be taken. ii. Both the firms will bring and apprise the Board regarding the case in the PQCB, Punjab and various Courts with current status”. In light of decision of Registration Board M/s Medicena and Medisearch Pharmaceuticals called for personal hearing for defending their case.
Proceedings:- The representative of M/s Mediceena Pharma, Pvt Ltd, Lahore, Mr. Riasat Ali Bhatti, and M/s Medisearch Pharma Lahore, Dr. Uzair Nagra (Managing Director) and Unaiz Ali (C.E.O) were appeared before the Board and requested to withdraw the case as they are suffering a lot due to the stoppage of production of said medicines since long period. They informed that PQCB Punjab has called them in the case after the passage of a long period.
Decision:- Registration Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
The Board decided to request the Chairman PQCB (Punjab) for sending the representative (who should be well aware of the case) to apprise about the current status and assist the Honorable Board to decide the case accordingly.
Case No.3: Manufacture and Sale of Sub-Standard Stearox 1ml Injection Batch No. H110112 M/s Guyton Pharmaceutical Lahore
The Brief about the background of the case is as under:- The samples of Stearox Injection Batch No. H110112, Mfg by M/s Guyton Pharmaceutical Lahore drawn by FID Karachi from Central Pharmacy of JPMC, Karachi on 26-02-2013, was declared Substandard vide test report No.261/2013 dated 03-04-2013 by Federal Government Analyst. The FID has identified following persons responsible in the case.. Mr. Talat Ahmad Anjum (Q.C In-charge) . Muhammad Imran Khalil (Production In-charge) As per procedure show cause notices was issued to the firm 20th February 2014 and above accused, offering opportunity of personal hearing before the Drug Registration Board. They were also called for personal hearing accordingly. The case was placed before 244th meeting of Registration Board which decided the case as under:-
“The accused of the firm were called for personal hearing, but they could not appear before the Board. The Board decided to defer the case and a final opportunity of personal hearing shall be given in next meeting of the Board” The case was again placed before 245th meeting of Registration Board wherein accused as identified by FID Lahore were also called for personal hearing accordingly. The Board decided the case as under
Decision:- Mr. Muhammad Salman Ali, Advocate High Court appeared on behalf of M/s Guyton Pharmaceutical Lahore. The Board did not accept power of Attorney on behalf of the firm. The Board decided the case as under:-
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i. The production of the injection Stearox 1ml Registration No. 040336 shall be stopped. One more opportunity of personal hearing is granted with the direction that the Management and Technical Personnel shall appear before the Board failing which the ex-parte decision shall be taken. ii. The Board further decided that the firm will recall all the marketed batches of sub-standard drugs from distribution / sale outlets / institutional supplies if any and area FID shall take report from the firm and submit a compliance report to Chairman Registration Board. iii. One more opportunity of personal hearing was granted by the Board with the direction that the Management and Technical Personnel shall appear before the Board failing which the ex-parte decision shall be taken. The case was presented before the Registration Board again in its 246th meeting on 11-12- 2014. The Board decided the case as under in the light of personal hearing of Mr. Bilal Khurshid Chief Executive of the firm:- Decision:- The Board took the following decision:- i. The area FID Mr. Abdul Rasool Shiekh to take the samples of the batch and submit the investigation report of the case again as the firm has disowned the supply of specific Batch. ii. The production of the firm in the steroidal Injectable section shall be stopped along with suspension of registration of Stearox 1ml Registration No. 040336 which had already been suspended in 245th Meeting till investigation of the case is finalized. iii. The firm will be asked to provide on stamp paper regarding their statement of disowner ship of supply of this batch. iv. The case will be submitted before the Registration Board after completing the investigation.
The undertaking on stamp paper has not submitted by the firm. Mr. Abdul Rasool Sheikh, the area FID submitted the following recommendations vide is report received on 28-01-2014:- i. The document submitted by the supplier contained some vital information including evidence of the payments made, case memos, delivery challan and more then this the authority letter given by the manufacturer to M/s Al-Amin Sukkur for institutional supply. ii. On the other hand the manufacturer not submitted the sale record that particular batch No. H110112 and other information that was sought by the under signed (FID). iii. Amid this situation the FID has recommended that both the parties may be called for personal hearing into the up-coming meeting of Registration Board so that facts may be further disclosed in front of the Board and then in the light of discussion decision may be made. The case was again submitted before 248th meeting of the Board which could not heard the case due to paucity of the time and deferred the case till next meeting of the Board. The case was submitted again for consideration of the Board in its 249th meeting held on 19- 05-2015. Decision:- “Due to paucity of time the Board deferred the case till next meeting of the Registration Board”. The Case is again submitted for the consideration of the Board, The Registration Board in its 250th meeting decided as under:- Decision:-
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“The Board has decided to call for the personal hearing both the Distributor and manufacturer, as suggested by the FID Mr. Abdul Rasool Shaikh”. In the light of decision of the Registration Board in its 250th meeting held on 08th and 09th July 2015 the distributor and manufacturer of the firm as suggested by the area FID, were called for personal hearing accordingly.
The case was presented before the Registration Board in its 251st meeting on 12 & 13th August 2015, no body was appeared from the firm and distributor in the Board meeting the Board available record and facts of the case decided as under:- Decision of 251st Meeting of RB:- The Board, deferred the case till next meeting of the Registration Board
255th meeting of DRB Proceeding: Mr. Khawaja Asad Aslam (QA Manager) M/s. Guyton Pharma appeared before and inform that the firm (M/s. Guyton Pharmaceutical) is still on its previous statement. No person was appeared from the side of distributor/supplier. Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under: i. “The Board decided to give the last opportunity to the distributor otherwise ex-parti decision will be taken against him with the charge of manufacturing and supply/sale of spurious medicines as his non appearance support the claim of the manufacturer. ii. The Board decided to call for the personal hearing both the distributor and manufacturer in the meeting”. In light of decision of Registration Board M/s M/s Guyton Pharmaceutical Lahore and distributor called for personal hearing in the meeting for defending their case.
256th Meeting of Registration Board:-
Proceedings:- The representative of M/s Guyton Pharmaceutical Lahore, Mr. Asad Aslam (QAM), was appeared before the Board and confirm the previous statement of disowning the supply of the said batch to the said distributor. The Board showed its concern about the regular appearance of manufacturer in many previous meetings and absence of distributor.
Decision:- The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
1. The Board decided to direct area FID for confirmation of existence of distributor (Al Amin Drug House Sukkr) and status of the receiving of the personal hearing letter to the distributor (Al Amin Drug House Sukkr) and send the report with clear status of distributor on urgent basis for appraisal of the Board.
2. The Board was in a view that if the distributor confirms his presence (in the light of the report of the FID) before the Board then the manufacturer will be called for personal hearing otherwise manufacturer be exempted from further personal hearing.
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Case No.04: Manufacture and Sale of Substandard Synocip 250mg Tablets Batch No. T-4019 By M/s Synchro Pharmaceuticals Lahore. No.F.3-59/2014-(QC).
The sample of Synocip 250mg Tablet Batch No. T-4019 manufactured by M/s Synchro Pharmaceutical Lahore, drawn by FID Lahore-I on 17-10-2014 from manufacturer premises were declared substandard by Federal Government Analyst vide Test report No. LHR.258/2014 dated 16-12-2014. A letter was sent to FID on 30-12-2014 and 23-01-2015 by DRAP Islamabad. An explanation letter was issued by the FID to the firm. The firm had requested Appellate Testing under Section 22(5) of Drugs Act, 1976 from Appellate Lab, NIH, Islamabad. The Appellate Laboratory also declared the sample as of Sub-standard quality vide its test report No. 01-MNHSR/2015 dated 19 March 2015. The results of the CDL and NIH on the basis of which the drug sample has been declared substandard & Misbranded are reproduced as under:-
Substandard with regard to Dissolution Test. (CDL Result) Stage-1 Tablet No. (%)age. 01. 60.23 02. 63.32 03. 54.56 04 67.09 05. 74.47 06 61.26 Limits for (Stage-1):- Each unit is not less than Q+5% i.e. 75+5=80% Stage-2 Tablet No. (%)age. 01. 91.68 02. 57.039 03. 48.57 04 65.42 05. 60.57 06 65.64 Average of 12 units = 769.849/12=64.154% Limits for (Stage-2):- Average of 12 units (S1+S2) is equal to or greater than Q (75%) and no unit is less than Q-15% (75-15=60%) Does not comply with USP 37. Remarks:- The sample is of “Sub-Standard” quality under the Drug Act 1976. Substandard with regard to Dissolution Test. (Appellate Testing Result) Dissolution Test Determined amount: 53.16% Limits: Not less than 80% of the stated amount Does not comply with USP-32. Remarks:- The sample is of “Substandard” quality on the basis of tests performed. As per procedure show cause notices were issued to the firm and accused persons of the firm offering opportunity of personal hearing before the Registration Board.. They were also called for personal hearing before the Registration Board in its 249th meeting. Decision:-
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The case was presented before the Registration Board in its 249th meeting on 19-05- 2015. The Board in the light of personal hearing of Mr. Abbas But General Manager on behalf of CEO of the firm, deliberations, available record and facts of the case decided as under:- i. Deferred the case till next meeting on the request of the representative of the firm as it was submitted that CEO of the firms is seriously ill. ii. Stopped the production of the product under reference till the decision of the case. The responsible persons of the firm was called for personal hearing. The 254th meeting of DRB The responsible persons of the firm was called for personal hearing in the meeting of 254th meeting of DRB and Mr. Abdul Marauf appeared on behalf the M/s Syncro Pharmaceuticals Pvt Ltd Lahore. Mr. Abdul Marauf informed the Board that the firm has received the personal hearing letter in last hours hence the management/CEO of the firm could not come so he (CEO of the firm) asked Mr. Abdul Marauf to request the Board for giving more chance of personal hearing in the next meeting. Decision i. The Board decided to give the last opportunity for personal hearing to all persons named in show cause notice otherwise ex-parte decision will be taken by Registration Board. ii. The Board also decided to get the recalled status and report from the area FID for the Synocip 250mg Tablets Batch No. T-4019 By M/s Synchro Pharmaceuticals Lahore. They have been also called for personal hearing.
The 255th meeting of DRB Proceeding: No person came from the firm. The request of the firm for inability to appear in the meeting and for appearance in the next meeting was presented before the Board. The firm has requested because the Chairman of the firm (Dr. Mahmood Alam) who was summoned in the meeting was died as per requesting letter of the firm. Decision: The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under: “The Board decided to give the last opportunity of personal hearing otherwise ex-parte decision will be taken against them and the firm will submit the copy of the death certificate of their Chairperson”. In light of decision of Registration Board M/s Synchro Pharmaceuticals Lahore called for personal hearing in the meeting for defending their case.
256th Meeting of Registration Board:-
Proceedings:-
The representatives of the M/s Synchro Pharmaceuticals Lahore, Mr. Shams Mahmood Sadana, (CEO), and Mr. Adnan Khan, (QAM) were appeared and defended their case. They informed the Board that they were not producing the said product as was decided by the Board.
Decision:-
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The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
The Board decided to suspended the Registration for three months and to conduct the PSI from the following panel:-
i. Director DTL Punjab, Lahore ii. Area FID
Case No.05
The case background is placed before the Board for appraisal as under:-
D. Dron M/s Epharm Adulterated & Not The Board was (Dexamethason) Laboratories, Substandard with challenged apprised about the Injection (IM/IV) Karachi. regards to Description:- background of the Finding of Lab:- case as under:- Batch No. DF.137 Colorless solution in The samples of D- clear glass ampoule. Out Dron Injection Mfg:- 06-13 of 25 ampoules (referred Batch No DF.137 EXP:- 06-15 portion of sample) one & DF-138 ampoule contain black manufactured by & particles and another M/S Epharm ampoule contains white Laboratories, fibers. Karachi were taken by FID Does not comply with Hyderabad at Description Karachi on 29-01- 2014 from Remarks:- manufacturer’s premises. The The sample is of samples were “Adulterated & declared Substandard” under the Adulterated & Drugs Act 1976. Substandard by Federal Government Analyst vide test reports Adulterated & No.KQ.60/2014 & Substandard with KQ.61/2014 dated regards to Description:- 18th February Finding of Lab:- 2014 respectively. Batch No. The FID DF.138 Clourless solution in communicated the Mfg:- 07-13 clear glass ampoule. Out test reports to the EXP:- 07-15 of 15 ampoules (referred firm vide his letter
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portion of sample) two No.05-10/2014- ampoules contain black FID-H (K) 255- (F.No.03- particles. 257 dated 19-02- 10/2014-QC) 2014. The firm in Does not comply with their reply Description mentioned about their right of Remarks:- exercise the power under subsection The sample is of (4) of Section 22 “Adulterated & of Drugs Act 1976 Substandard” under the for retesting of Drugs Act 1976. their samples from appellate lab Islamabad. As per submission of complete case by the FID, the firm’s reply was received in the office of DRAP Karachi on 08-04-2014 which was well after the expiry of time allowed under section 22(4) of the Drugs Act 1976 and hence not valid as per FID’s remarks. The FID has furnished the names of the following persons of the firm responsible for committing the offence under the law.
i. M/S Epharm Laboratories Karachi.
ii. Mr. Asad Ilyas Nainitalwala , Director,
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iii. Mr. Ahmed Nadeem Qasmi, QC Manager,
iv Dr. Mohammad Khokhar
Production Manager,
Show cause notices were issued to the firm and other accused, offering opportunity of personal hearing before the Drug Registration Board after the approval of the competent authority. They have been also called for personal hearing accordingly. The case was presented before the registration board in its 246th meeting on 11-12-2014. The Board decided the case as under in the light of personal hearing of Mr. Asad Ilyas Director of the firm and Mr. Ahmed Nadeem Qasmi QC Manager of the firm. Decision:- The Board took the following decision
i. The Board decided to
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suspended the registration of D-Dron Injection Registration No.058424 (IM/IV) for a period of three months. ii. PSI Inspection by a panel comprising of a). Director DTL Quetta and area FID will be conducted and they will submit the report to the Registration Board
In the light of above said decision of the Registration Board the PSI inspection was conducted by the panel wherein Dr. Ammanullah Khan, Director DTL, Quetta and area FID Dr. Najam us Saqib inspected the firm on 27-02-2015 and 02-03-2015 and submit the report and conclusion is as under:- “The firm has improved in sterile manufacturing facilities and recommends the recommencement of the manufacturing of the product D-Dron Injection”
256th Meeting of Registration Board:-
Proceedings:- The Directorate of QA/LT has forwarded the case for the appraisal of the Board. The worthy member of the Registration Board (Dr. Ammanullah Khan, Director DTL, Quetta) apprised the Board for the improvements made by the firm.
Decision:- The Board after detailed discussion, deliberation, considering the facts and legal provision decided as under:-
The Board allowed the recommencement of the manufacturing of the product D-Dron Injection.
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Additional Cases:
Item No.VI: Cases referred by Pharmacy Services Division.
Case No.01: Tranexamic Acid for the Treatment of Gastrointestinal Bleeding: an International Randomised, double blind placebo controlled trial “Haemorrhage Alleviation with Tranexamic Acid – Intestinal System (HALT- IT), Trial.
The case for conducting the above titled clinical trial at the following eight additional sites/centres and Principal Investigators (P.Is) was considered by the Board in its 256th meeting held on 03-02-2016.
S.# Hospital/Centre Name Principal Investigator 1. District Headquarters Hospital, Rawalpindi Dr. Haider Zaigham Baqai Raja Bazar Near Fawara Chowk, Rawalpindi. Department of Medicine 2. Benazir Bhutto Hospital, Medical Unit II Professor Mohammad Shoaib Shafi. Murree Road, Rawalpindi Department of Medicine 3. Benazir Bhutto Hospital, Medical Unit I Dr. Muhammad Ali Khalid Murree Road, Rawalpindi Department of Medicine 4. Jinnah Hospital, Medical Unit I Prof. Zafar Iqbal Chaudhri Emergency Department Department of Medicine Maulana Shaukat Ali Road Faisal Town, Lahore. 5. Liaquat National Hospital & Postgraduate Prof. Mansoor Ul Haq Medical Centre, Gastroenterology Department Gastroenterology & Hepatology Department Block No.18, Stadium Road Karachi. 6. POF Hospital, Department of Medicine, Prof. Wasim Uddin Wah Medical College Department of Medicine Wah Cantt 7. Services Hospital, Medical Unit III, Professor Muhammad Arif Nadeem Jail Road, Lahore Department of Medicine 8. Shaukat Khanum Memorial Hospital & Prof Muhammad Aasim Yusuf Research Centre. Department of Medicine. Department of Internal Medicine, 7 A Block, R 3, Johar Town Lahore.
The Board accorded the approval for extension of the trial at the above eight additional sites/centres under the strict supervision of the relevant P.Is.
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Item No.VII: Cases referred by Pharmaceutical Evaluation & Registration Division.
Case No.01 Request by M/s. Novartis Pharma, (Pvt.) Ltd, Karachi for Change Of Manufacturer/Manufacturing Site of Exafal Tablet Reg. No. 025230.
M/s. Novartis Pharma, (Pvt.) Ltd; Karachi applied for change of manufacturer/manufacturing site for their following already registered products from M/s. Beijing Novartis Pharma Ltd, China to M/s. Novartis Saglik Gida Ve Tarim Urunleri Sanayi ve Ticaret A.S. Yenisehir Mahallesi Dedepasa Cadessi N 17 34912 Kurtkoy, Istanbul, Turkey:-
S. No. Reg. No. Name of Products. 1. 025230 Exafal Tablet Each tablet contains:- Artemether …………….. 20mg Lumefantrine ………….. 120mg
The firm have deposited required fee Rs.100, 000/- and submitted following supporting documents:- i) Application o Form 5A. ii) Copies of initial registration letters & renewal status. iii) Copy of change of name of manufacturer from M/s. Parkedale Pharmaceuticals, Inc. USA to M/s. JHP Pharmaceuticals LLC, USA. iv) Original Legalized Certificate of Pharmaceutical Products (CoPP) attested by Pakistan Embassy for Exafal Tablet. v) NOC for CRF Clearance. vi) Undertaking that the formulation, specification, manufacturing process, analytical test method and shelf life have not changed.
The firm was asked to clarify that the CoPP issued by Australian TGA for proposed site was for dispersible tablet while registered drug is plain tablet and the CoPP was also for another brand name “Riamet”.
Now the management of the firm has informed that this product and the proposed manufacturing site is WHO pre-qualified and therefore, exempted from inspection as per DRAP’s import policy of December, 2013. They have also furnished legalized CoPP issued by Switzerland’s Health Authority for the same product (brand name was also changed Riamet Tablet). The firm further requested to expedite the process as they are facing an out- of-stock situation. Decision:- Since, the drug is registered for free sale in Switzerland from the same source, which is one of the reference country approved by the Registration Board, so the Board approved the change of manufacturer/manufacturing site of registered drug Exafal Tablet (Regn.
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No. 025230) from M/s. Beijing Novartis Pharma Ltd, China to M/s. Novartis Saglik Gida Ve Tarim Urunleri Sanayi ve Ticaret A.S. Yenisehir Mahallesi Dedepasa Cadessi N0 17 34912 Kurtkoy, Istanbul, Turkey on same terms and conditions.
Case No.02 Request of M/s. Martin Dow Limited, Karachi for change of title and address of company/importer on registration letter.
M/s. Martin Dow Limited, Karachi has requested for change of title and address of company/importer on registration letter of their following imported products:-
S. No. Reg. No. Name of product Name & address of New name & address importer on of importer Registration letter 1. 021099 Bon One 0.5mcg M/s. Martin Dow M/s. Martin Dow Ltd, Tablet Pharmaceuticals Plot No.37, Sector 19, Each tablet contains:- (Pakistan) Ltd., Korangi Industrial Area, Alfacalcidol…..0.5mcg 45-D Block 6, P.E.C.H.S. Karachi. Nursery, Karachi.
The firm has deposited fee Rs. 100,000/- and submitted following documents for this purpose:-
(a) Copy for change of company name/title. (b) Copy of initial registration letter. (c) Copy of last renewal submitted on 26-03-2013. (d) Copy to Drug Sale License.
Decision:- The Board approved the change of name and address of importer from M/s. Martin Dow Pharmaceuticals (Pakistan) Ltd.,45-D Block 6, P.E.C.H.S. Nursery, Karachi to M/s. Martin Dow Ltd, Plot No.37, Sector 19, Korangi Industrial Area, Karachi on same terms and conditions. However, this permission is subject to verification of storage facility at new site and authorize Chairman for approval of issuance of letter.
Case No.03. Request of M/s. Pfizer Pakistan Limited, Karachi for exemption from urdu text on the “international packs” and local printing of registration number and MRP for their registered drugs campto injection.
M/s. Pfizer Pakistan Limited, Karachi have requested to grant them exemption from Urdu Text, on the “International Packs” and permission for local printing of registration number and MRP through laser jet for their following registered imported drugs on the quantity mentioned against each.
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S. No. Reg. No. Name of Drug(s). Quantity. 1. 021128 Campto 100mg Injection 2232 units. (Irinotecan hydrochloride Trihydrate) 2. 021127 Campto 40mg Injection 648 units. (Irinotecan hydrochloride Trihydrate)
The firm has deposited fee of Rs.10,000/- and provided following documents. (i) Copy of initial registration letter. (ii) Copy of substation of name of the company from M/s. Parke Davis & Company Limited to M/s. Pfizer Pakistan Limited. (iii) Copy to CRF Clearance.
M/s. Pfizer Pakistan Limited, Karachi have submitted that Campto (Irinotecan) is an anti-cancer drug which is manufactured under strict conditions using high biotechnological processes and is used for the treatment of conditions like Advanced Colorectal Cancer, Cervical Cancer and Non-small Cell lung Carcinoma. The product is used only by specialized oncologists practicing in leading hospitals and oncology departments. Currently Pfizer Pakistan is importing product in limited quantity due to its restricted usage and it is not possible for their principal manufacturer i.e. M/s. Pfizer Perth Pty Limited, Australia to develop Pakistan Specific Packs in such a small quantity. To ensure availability of product for the treatment of incapacitating cancer patients, they requested to grant them the approval for the above given quantities to be imported in 2016 and permit them to conduct the following actions at M/s. Pfizer Pakistan Limited, Karachi premises:- i) Local printing of registration number and MRP through laser jet before releasing Campto “International packs” from their warehouse. ii) Exemption from Urdu Text on Campto “International packs”.
Decision:- Registration Board decided to grant exemption of Urdu text only on import of registered drugs Campto Injections in quantity as mentioned below subject to condition that the same shall be printed on the packs through Inkject printer (with indelible ink), at their licensed premises at B-2, S.I.T.E, Karachi, prior to marketing.
S. No. Reg. No. Name of Drug(s). Quantity. 1. 021128 Campto 100mg Injection 2232 units. (Irinotecan hydrochloride Trihydrate) 2. 021127 Campto 40mg Injection 648 units. (Irinotecan hydrochloride Trihydrate)
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Case No.04 Request of M/s. Marush (Pvt) Limited, Lahore for mentioning product license holder in the registration letter of their approved drug.
Registration Board in its 252nd meeting held on 07-08th September, 2015 has approved the registration of following imported veterinary drug in the name of M/s. Marush (Pvt) Limited, Lahore, manufactured by M/s. Univet Ltd. Tullyvin, Cootehill, County Cavan, Ireland. S.No Name of Drug (s) Composition & Decontrolled / Shelf Life Therapeutic Group. Pack Size. 1. Ubroloxin ® Intramammary 10 x 10g 12 Suspension months Each 1 injector with 10g (12ml) contains:- Cefalexin monohydrate…..200mg Kanamycin monosulfate…133mg (Corresponds to 100,000 I.U).
The application was approved subject to inspection of manufacturer abroad as per import policy, verification of storage facilities etc where applicable. The firm has deposited the differential fee and storage facility of the importer has also already been verified by the Area FID. However, the address of product license holder is not mentioned in minutes due to typographic error. The detail, as per CoPP, are as under:- Manufacturer: Product License Holder: M/s. Univet Ltd. M/s. Boehringer Ingelheim Tullyvin, Cootehill, County Vetmedica GmbH, Cavan, Ireland. Binger Straβe 173 55216 Ingelheim am Rhein, Germany.
Decision:- Registration Board approved to mention product license holder along with manufacturer in the registration letter.
Case No.05 Request of M/s. N.B. Sons (Pvt) Ltd., Lahore for correction in composition of their approved drugs.
Registration Board in its 236th and 237th meeting held on 20th November, 2012 and 26th February, 2013 constituted a sub-committee for evaluation of applications of veterinary product for ensuring completion of codal formalities. The Board further authorized its Chairman, Registration Board for taking decision on recommendations of the committee. The sub-committee in its meeting held on 25-04-2013 approved the following products of M/s. N.B. Sons (Pvt) Ltd., Lahore manufactured by M/s. Dutch Farm International B.V., The Netherlands subject to inspection of manufacturer abroad, verification
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of storage facilities as per policy. The firm, in the meantime, has also requested for correction in composition of the drugs mentioned incorrectly in minutes due to typographic mistake, as follows:- S.No. Existing composition approved by Correct composition as per dossier. Drug Registration Board. (I) (II) (III) 1. Dufacoc 200 Plus Water Soluble Dufacoc 200 Plus Water Soluble Powder Powder Each gm contains: - 1 gm contains: - Amprolium HCL……………..250mg Amprolium HCL………….250mg Sulfaquinoxaline Sodium…… 250mg Sulfaquinoxaline Sodium….250mg Mennadion Sodium Bisulfite…...5mg Mennadion Sodium Bisulfite…...5mg 2. DUFA-Ambro Water Soluble DUFA-Ambro Water Soluble Powder Powder Each gm contains: - 1mg contains: - Amoxicillin (as Trihydrate).... 200mg Amoxicillin (as Trihydrate…..200mg Colistine Sulphate…………50000 I.U Colistine Sulphate…………50000 I.U 3. DUFA-NEOGUT Water Soluble DUFA-NEOGUT Water Soluble Powder Powder Each gm contains: - 1mg contains: - Neomycin Sulphate……….. 1000mg Neomycin Sulphate……1000mg 4. Dufamox 50% Water Soluble Dufamox 50% Water Soluble Powder Powder. Each gm contains:- 1gm contains:- Amoxicillin trihydrate……….500mg Amoxicillin trihydrate……500mg 5. Dufafloxacin 20% Dufafloxacin 20% Oral 1ml contains: - Each ml contains: - Enrofloxacin……….…200mg / ml Enrofloxacin……….…200mg / ml
The firm has deposited the differential fee Rs. 85,000 x 5 = Rs.425,000/- The storage facility of the importer has also already been verified by the Area FID. Decision:- Registration Board approved the correction of composition of the above referred products as per details mentioned in column III of the table above.
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Case No.06 Inspection Report of M/s. Glenmark Generics S.A., Argentina.
Registration Board in 243rd meeting held on 08-09th May, 2014 approved registration of following drugs in the name of M/s. CCL Pharmaceuticals (Pvt) Ltd., Lahore, manufactured by M/s. Glenmark Generics S.A., Calle 9 Ing Meyer Oks No593 Parque Industrial Pilar, Buenos Aires, Argentina, subject to inspection of manufacturer abroad:- S. No. Name of Drug (s)/ Composition. Price approved by the Price Recommendatory Committee. 1. Gemmin 1gm Lyophilized Powder for Rs.8330.00/Per vial. Injection. Each vial contains:- Gemcitabine hydrochloride U.S.P equivalent to Gemcitabine……1gm. 2. Gemmin 200mg Lyophilized Powder for Rs.1675.00/Per vial. Injection. Each vial contains:- Gemcitabine hydrochloride U.S.P equivalent to Gemcitabine……200mg.
The inspection of the manufacturer abroad M/s. Glenmark Generics S.A., Calle 9 Ing Meyer Oks No593 Parque Industrial Pilar, Buenos Aires, Argentina was accordingly carried out by the nominated panel comprising Mr. Muhammad Amin, Deputy Drugs Controller (PEC), Drug Regulatory Authority of Pakistan, Islamabad and Mr. Asim Rauf, Federal Inspector of Drugs, Drug Regulatory Authority of Pakistan, Lahore. The panel of inspectors has recommended the registration of the above said products. However the inspection report indicated non compliance in few areas like stability failure investigation, maintenance of animal house etc. Clarification was sought from the panel. In response the panel stated that the firm was inspected and report was prepared on the findings/observations on the day of inspection. The availability of facilities like manufacturing, quality control and quality assurance on the day of inspection led the panel to recommend the product for registration. Had any critical observation noticed on the day of inspection the conclusion for recommendation would have not been accorded by the panel. The prices of the products have already been approved by the Price Recommendatory Committee in its 21st meeting. The storage facility of the importer has also been verified by the Area FID. Decision:- In view of clarification given by the panel and their earlier recommendations for granting registration to the drugs in question, the Board decided to allow issuance of registration letter.
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Case No.07 Request of M/s. Aims Traders, Lahore for change of local address on registration letter.
M/s. Aims Traders, Lahore have informed that the veterinary drug namely “Mastiveex-I” (Reg. No.007351) was registered at their Karachi office address i.e. M/s. Aims Traders, D-I, Razvia Society, Karachi. The firm further stated that they have shifted their office from Karachi to Lahore at new address i.e 603, Block-Q, Johar Town, Lahore. M/s. Aims Traders has, therefore, requested to approve the change of new office address for their aforesaid registered veterinary drug and issue a new registration letter at their new address. The firm has deposited the fee of Rs.100000/- and submitted following supporting documents:-
i) Copy of registration letter. ii) Copies of renewals to date. iii) Copy of Drugs Sale Licence of Johar Town Lahore. The Deputy Director General (E&M), Karachi was asked to confirm the existing address (Cosmos Plaza, Block-16, Federal ‘B’ Area, Karachi) of the firm, as it is also different from the one mentioned on the registration letter (D-I, Razvia Society, Karachi). In response the Federal Inspector of Drugs, Karachi has confirmed the present address of Cosmos Plaza.
Decision:- Registration Board approved change of name and address of importer from M/s. Aims Traders, Cosmos Plaza, Block-16, Federal ‘B’ Area, Karachi to M/s. Aims Traders, 603, Block-Q, Johar Town, Lahore on same terms and conditions subject to verification of storage facility and authorize Chairman for approval of issuance of letter.
Case No.08 Request of M/s. Novartis Pharma (Pakistan) Limited, Karachi for import of their registered drugs in international label.
Registration Board in 255th meeting approved registration of the following drugs of M/s. Novartis Pharma (Pakistan) Limited, Karachi for import, for meeting the Public Health Urgency. S.No Reg. No. Name of drug(s) & Composition 1. 080132 Syntocinon Injection 5 IU Each ampoule contains:- Synthetic Oxytocin…….5 IU (USP Specifications) 2. 080163 Methergin Solution for Injection Each 1ml contains:- Methylergometrine Hydrogen Maleate…………….…0.2mg
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(USP Specifications) 3. 080164 Oxytocin 5 I.E Haxal Injection Each ampoule contains:- Synthetic Oxytocin……5 IU (USP Specifications)
The registration letter has been issued. The firm has further informed that due to emergency situation they cannot produce localized labels for the products, and, therefore, requested to allow them to import the product in international labels. They stated to arrange re- labeling/packing as per labeling rules. Decision:- In view of public health urgency, the Board decided to allow to M/s. Novartis Pharma (Pakistan) Limited, Karachi to import above referred products in international packing. The firm, however, as per its commitment, will arrange labeling/packing as per Drugs Labeling Rules, 1976 at their license premises situated at 15th West Wharf, Karachi.
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Case No.09 Request for import of “Tamiflu 75mg Capsule” (Reg.No. 039619) In finished form By M/s. Roche Pakistan Ltd; Karachi.
M/s. Roche Pakistan Limited, Karachi has requested for change of registration status their following product to import in finished form. S. No. Reg. No. Name of Drug(s) 1. 039619 Tamiflu 75mg Capsule Each capsule contains:- Oseltamivir Phosphate 98.5mg eq. to Oseltamivir ……………75mg
Initially the product was registered in bulk import from M/s. F. Hoffmann-La Roche, Ltd; Basel- Switzerland and local repacking at M/s. Roche Pakistan Limited, Karachi. The firm has informed that they has divested their manufacturing site situated at Plot No. 39 Korangi Industrial Area to M/s. Martin Dow Pharmaceutical in June, 2010 and has ever since ceased its manufacturing operations. They have, therefore, applied for change in registration status/manufacturing site of “Tamiflu Capsule 75mg” from bulk imports to finished pack imports from their principal as per following details. Product License Holder & Exporter: M/s. F. Hoffmann-La Roche, Ltd; Basel- Switzerland, Manufacturing site: Roche S.p.A Millan, production site Segrate, Italy.
The original application/dossier claim to be submitted by the firm is not traceable in Pharmaceutical Evaluation Cell. However, as per photocopies of the application/dossier provided by the firm, they claimed to have furnished following documents:- a. Form 5-A. b. Challan fee of Rs. 50,000/- for this purpose (requisite fee is Rs. 1,00,000/- c. Copy of renewal application. d. Copy of initial letter of registration. e. CoPP issued by EMA. f. Site master file. From scrutiny of the photocopies of documents submitted by the firm, the following observations were noted:- i. The product was registered on 18-10-2005 and the firm applied for renewal of registration on 18-10-2010 i.e one day after the due date, while the fee submitted was Rs. 7500/-. ii. The application fee submitted is Rs. 50,000/- as against required fee of Rs. 1,00,000/-. iii. CoPP is not legalized and attested by Pakistan Embassy.
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Decision:- The Board observed that the drug is of vital importance for controlling the Swine / Bird Flu cases, reported to be on rise recently. In order to ensure availability of the drug for meeting the emergency requirements in treatment of Swine / Bird Flu cases, the Board decided to allow the change in a registration status of Tamiflu 75mg Capsule” (Reg. No. 039619 from bulk import (from M/s. F. Hoffmann-La Roche, Ltd; Basel- Switzerland) and local repacking (at M/s. Roche Pakistan Limited, Karachi) to import in finished form as per following details, subject to conditions mentioned thereafter;
Product License Holder & Exporter:
M/s. F. Hoffmann-La Roche, Ltd; Basel- Switzerland.
Manufacturing site:
Roche S.p.A Millan, production site Segrate, Italy.
(i) The Board observed that the provisional registration was granted on 18-10-2005, while the registration was confirmed vide a letter dated 26th December, 2005, therefore, the date of registration shall be taken from date of confirmation i.e. 26-12-2005. In view of foregoing explanation the renewal is within the validity period. (ii) The firm should provide legalized valid CoPP, updated Form-5A and other relevant documents on priority. The Board further authorized Chairman, Registration Board to issue the registration letter after receipt of required documents.
Case No.10: Request of M/s. Novartis Pharma (Pakistan) Limited, Karachi for registration of drugs, for import to meet the public health urgency.
Registration Board's attention was drawn on its decision taken in 255th meeting, regarding approval of following products of M/s. Novartis Pharma, Karachi for meeting public health urgency and also authorizing the Chairman, Registration Board for the grant of registration letter after submission of deficiencies, pointed out by the PEC in agenda of the 255th meeting. S.# Name of Manufacturer/ Name of drug(s) & Importer. Composition 1. (Product License Holder: - Syntocinon Injection 5 IU M/s. Novartis Pharma Each ampoule contains:- Schweiz AG 6343 Risch Synthetic Oxytocin…5 IU Switzerland). (Manufactured by:- M/s. Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein Switzerland). 2. -do- Methergin Solution for Injection
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Each 1ml contains:- Methylergometrine Hydrogen Maleate…0.2mg 3. (Product License Holder:- Oxytocin 5 I.E Haxal Injection M/s Hexal AG Industriestraße 5IU 25 83607 Holzkirchen Each ampoule contains:- Germany). Synthetic Oxytocin…5 IU (Manufactured by Ever Pharma Jena GmbH Otto- Schott-Straße 15 07745 Jena Germany).
The Board was informed that the PEC conveyed the deficiencies to M/s. Novartis Pharma, Karachi. The firm subsequently rectified the deficiencies and submitted the required documents. The PEC, after evaluating the response of the firm, submitted the case to the Chairman, Registration Board with recommendation for issuance of registration letters. The letters of registration for the above mentioned products was accordingly issued with the approval of Chairman, Registration Board with following additional condition. "The registration for import is being granted in order to meet public health urgency. As per undertaking given by the firm/applicant the import shall be discontinued as soon as local manufacturing of the registered drug for local manufacturing (Syntocinon Injection 5 IU, Registration No. 001582) is resumed. The firm should inform the Board before resumption of local manufacturing".
Decision:- Registration Board noted and endorsed the subsequent actions taken on its decision of 255th meeting.
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Case No.11: Grant of registration for Export purpose.
a. M/s. Pacific Pharmaceuticals (Pvt.) Ltd; Lahore M/s. Pacific Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following products for export purpose only:-
S. No Name of Products Remarks 1. Diazepam 10mg Tablet Controlled Drug Each Tablet Contains: Diazepam……10mg 2. Diazepam 5mg Tablet Controlled Drug Each Tablet Contains: Diazepam……5mg 3. Diazepam 2mg Tablet Controlled Drug Each Tablet Contains: Diazepam……2mg 4. Ethambutol 100mg Tablet The firm has submitted international Each tablet contains: availability in New Zealand and Ethambutol Hydrochloride Indonesia. BP……….100mg 5. Sodium Bicarbonate Ear Drops The firm has not submitted International Each ml Contains: Availability /Me Too Status. Sodium Bicarbonate………5% 6. Normal Saline Nasal Drops The firm has not submitted International Each ml Contains: Availability /Me Too Status. Sodium Chloride………10ml 7. Olive Oil Ear Drops The firm has not submitted International Olive Oil….10ml Availability /Me Too Status.
The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. NOC for CRF. e. Export Order from England. f. Product on Sr. 1 to 3 is Controlled drugs. The firm does not have the approval of Narcotics / Psychotropic Section from CLB.
Decision: Registration Board deferred as follows: Products at S.No. 1, 2 and 3 for confirmation of section for Narcotic Drugs and Psychotropic substances from Licensing division. Products at S.No.4-7 for confirmation of approval status in reference regulatory authorities.
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b. M/s. Life Pharmaceuticals Company (Pvt.) Ltd; Multan.
M/s. Life Pharmaceuticals Company (Pvt.) Ltd; Multan has requested for registration of following products for export purpose only:-
S. No Name of Products 1. VG Tablet Each uncoated vaginal tablet contains: Tinidazole……250mg Clotrimazole…..100mg 2. VG Plus Tablet Each uncoated vaginal tablet contains: Tinidazole……500mg Clotrimazole…..200mg
The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB. f. The firm has submitted international availability in India.
Decision: Registration Board deferred the request of the firm for confirmation of approval status in reference regulatory authorities.
c. M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore.
M/s. CCL Pharmaceuticals (Pvt.) Ltd, Lahore has requested for registration of following product for export purpose only:-
S. No Name of Products Remarks 1. Lebriva Tablet The firm has provided Each tablet contains: international Ledipasvir………90mg availability of USA Sofosbuvir………400mg and Export Order. 2. Activ AX The firm has submitted Each Tablet Contains: Export Order and gave Vitamin E…….125mg the justification for the Vitamin C…….500mg change of Vitamin A Vitamin A (as Acetate & Beta-Carotene) …… composition of in this 2.5mg Formulation is in Zinc……..7.5mg accordance with the Copper……1.0mg WHO prescribed limits Selenium…….15.0mcg Mangnaese…….. 1.5mg
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3. Active Max Tablet The firm has submitted Each film coated Tablet contains: Export Order and gave Vitamin A (As acetate & Beta the justification for the carotene)……2.5mg change of Vitamin A Vitamin B1……1.5mg composition of in this Niacin ……20mg Formulation is in Vitamin E…..30mg accordance with WHO Folic Acid……0.4mg prescribed limits Bioatin ……..30mcg Iron ……18mg Phosphorus……..100mg Megnesium……100mg Zinc…….15mg Selenium……10mcg Manganese……2.5mg Chloride……34mg Vitamin C…….60mg Vitamin B2……1.7mg Vitamin D……10mcg Vitamin B6……2mg Vitamin B12……..6mcg Pantothenic acid…….10mg Calcium…….130mg Iodine…….150mcg Copper…….2mg Chromium…..10mcg Molybdenum………..10mcg Potassium……37.5mg
The firm has submitted the following documents. a. Fee of Rs. 20000/- each product for this purpose. b. Form-5. c. Copy of GMP inspection. d. Export orders. c. NOC for CRF. e. Approval of section by CLB.
Decision: Registration Board decided as follows: Approved grant of registrations of product at S.No. 01 for export purpose only. Approved products at S.No.2 and 3 on the basis of justification provided by the firm as recorded above. Manufacturer will comply following conditions before export of drug: a. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. b. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product.
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d. M/s. English Pharmaceuticals, Lahore.
M/s. English Pharmaceuticals, Lahore has applied of following products for export purpose only:- S.No Name of Product 01. Esvordi Tablet Each film coated tablet Contains: Sofosbuvir………400mg
They have deposited application dossier, fee of Rs. 20,000/-, export order and undertaking on stamp paper and application dossier have already been evaluated.
Decision: Registration Board approved grant of registrations of above product for export purpose only. Manufacturer will comply following conditions before export of drug: b. Manufacturer will export the product after complying all the conditions as required under Drug Act, 1976 including No Objection Certificate from concerned DRAP office. Moreover, Federal Inspector of drugs will take sample from each consignment for analysis from CDL, Karachi. c. Manufacturer will also furnish export documents endorsed from custom authorities to the concerned ADC/Officer as evidence of export, in order to confirm export of the product.
Case No.12: Issuance of registration letter to of M/s. CCL Pharmaceuticals, Lahore.
Registration Board in its 215th meeting held on 05th & 06th January, 2009 approved following products of M/s. CCL Pharmaceuticals, Lahore subject to the confirmation of Atomic Absorption Spectrophotometer:- S. Name of Drug(s) Applied pack Demanded No. size price Osmin Tablets 3x10’s As Per SRO Each film coated tablet contains:- Ossein Mineral Complex…..830mg Corresponding to: Calcium……………..177.6mg Phosphorous……….82.2mg Residual Mineral Salts…24.9mg Collagen…………224.0mg Other Proteins………66.4mg Trace Element……..F1,Mg, Fe, Zn, Cu, Ni
Osmin-D Tablets 3x10’s As Per SRO Each film coated tablet contains:- Ossein Mineral Complex…..830mg Corresponding to:
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Calcium……………..177.6mg Phosphorous……….82.2mg Residual Mineral Salts…24.9mg Collagen…………224.0mg Other Proteins………66.4mg Trace Element……..F1,Mg, Fe, Zn, Cu, Ni Vitamin D as Cholecalciferol..400IU
Osmin Suspension 60ml As Per SRO Each 5ml contains:- Ossein Mineral Complex…..400mg Corresponding to: Calcium………………..85.59mg Phosphorous………….39.61mg Residual Mineral Salts…12.0mg Collagen………………107.95mg Other Proteins…………..32.0mg Trace Element……..F1,Mg, Fe, Zn, Cu, Ni
The management of the firm has furnished copy of inspection report on 2014 wherein the panel has confirmed that the firm is equipped with sufficient equipment and instruments including atomic absorption spectrophotometer and they have deposited balance fee amounting Rs. 12,000/- for this purpose on 11.11.2014. (After lapse of approximately 05years )
Decision: The request of the firm for issuance of registration letter is acceded to by Registration Board.
Case No. 13: Deferred products of M/s The Searle Company Limited Lahore.
Registration Board in 238th meeting held on 05th & 06th August, 2013 deferred following products of M/s. The Searle Company Limited Lahore for confirmation of me too status, fee, source, GMP certificate of Manufacturer, Stability Study and COA of Pellets.
S.No Name of Product Pack size Price Date of Recommendation of Submission the committee/Decision 01. Tamsin 0.4 Capsule 10’s Rs.360.0 21-06-10 Deferred for Each capsule contains:- 0 confirmation of me Tamsulosin HCl………0.4mg too status, fee, (Antagonist alpha-1 source, GMP adreorecptor in the prostate) certificate of manufacturer, Stability study and COA of pellets.
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The firm has submitted the following documents. i. Fee Rs. 80000/-. ii. Confirmation of me-too status. iii. Copy of GMP Certificate of M/s. RA Chem Pharma Limited, Plot No. A- 19/C, Road No.18, IDA, Nacharam, Hyderabad-500076, Telangana State, India iv. Stability data of pellets. v. COA of Pellets.
Decision: The request of the firm for issuance of registration letter is acceded to by Registration Board.
Case No. 14 Registration of drug applied on fast track basis.
It is submitted that various firm / new license manufacturers applied as per criteria/procedure of ten (10) products per section. In the meanwhile many firms/manufacturers had also applied registration applications on fast track basis out of queue. Some firms have the view that they may be issued registration letter applied on fast track basis separately alongwith ten products per section.
Decision: Registration Board deferred the case for deliberation in forthcoming meeting.
Case No. 15: Registration of drug in the name of Citi Pharma (Change of Title of Manufacturer.
Registration Board in its 255th meeting deferred the following products for the confirmation of the validity of Registration:- Sr. # Registration Name of Drug (s) Fee Date of Initial Date of Renewal Number Registration submitted 1 030710 Avanol cough syrup Rs. 24.07.2003 15.06.2015 Each 5 ml Contains: 20,000/ Carbinaxamin Maleate powder ………2mg Ephedrine HCl…….7mg Phalcodine………….4mg 2 030711 Asovil Cough Syrup Rs. 02.08.2003 15.06.2015 Each 5 ml Contains: 20,000/ Aminophyllin…….32mg Diphenhydramin HCl powder. 8mg Ammonium chloride……30mg Menthol…….0.98mg 3 030712 Bestonic Syrup Rs. 24.07.2003 15.06.2015 Each 5ml contains: 20,000/
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Vitamin B1……10mg Vitamin B2…….. 10mg Vitamin B6……..10mg Vitamin B12…….5mcg Calcium D Pentothenate…..3mg Vit. C……150mg Nicotinamide…….50mg Lysine Mono HCl………20mg 4 030713 Avazin 10mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Cetirizine 2HCl……… 10mg 5 030714 Askprin 75mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Aspirin………. 75mg 6 030715 Askprin 150mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Aspirin………. 150mg 7 030719 Flurip 100mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Flurbiprofen………. 100mg 8 030720 Floxcip 250mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ciprofloxacin HCl………. 250mg 9 030721 Floxcip 500mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ciprofloxacin HCl………. 500mg 10 030723 Modopine 5mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Amlodipine Besilate…. 5mg 11 030724 Modopine 10mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Amlodipine Besilate…. 10mg 12 030725 Askprol Suspension Rs. 02.08.2003 15.06.2015 Each 5ml Contains: 20,000/ Paracetamol…… 120mg 13 030726 Askprol 500mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Paracetamol…. 500mg 14 030727 Askprol C Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Paracetamol……..325mg Dextromethorphen HBr…..10mg Chloropheneramine Maleate… 1mg Vitamin-C…….50mg Pseudo Ephedrine HCl…….. 30mg 15 030729 Duotec 150mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ranitidine HCl………. 150mg 16 030730 Duotec 300mg Tablet Rs. 24.07.2003 15.06.2015 Each tablet Contains: 20,000/ Ranitidine HCl………. 300mg 17 034988 Rocoz 10mg Tablet Rs. 13.12.2004 15.06.2015
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Each tablet Contains: 20,000/ Simvastatin………. 10mg 18 034989 Rocoz 20mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Simvastatin………. 20mg 19 034990 Rocoz 40mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Simvastatin………. 40mg 20 034994 Lopec-H Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Losartan Potassium………. 50mg Hydrochlorothiazide………. 12.50mg 21 034995 Ponfab 250mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Mefanamic Acid………. 250mg 22 034996 Ponfab 500mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Mefanamic Acid………. 500mg 23 034987 Ponfab Suspension Rs. 13.12.2004 15.06.2015 Each 5ml Contains: 20,000/ Mefanamic Acid………. 50mg 24 034997 Promy 20mg Capsule Rs. 13.12.2004 15.06.2015 Each Capsule Contains: 20,000/ Omeprazole Pellets………. 20mg 25 034998 Lopec 50mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Losartan Potassium………. 50mg 26 034999 Lopec 100mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Losartan Potassium………. 100mg 27 035000 Cingol 5mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Montelukast as Sodium………. 5mg 28 035201 Cingol 10mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Montelukast as Sodium………. 10mg 29 035202 Cefask 400mg Capsule Rs. 13.12.2004 15.06.2015 Each Capsule Contains: 20,000/ Cefixime ………. 400mg 30 035203 Cefask Suspension Rs. 13.12.2004 15.06.2015 Each 5ml Contains: 20,000/ Cefixime ………. 100mg 31 034983 Diaglim 1mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 1mg 32 034984 Diaglim 2mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 2mg 33 034985 Diaglim 3mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/
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Glimipiride………. 3mg 34 034986 Diaglim 4mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Glimipiride………. 4mg 35 034991 Clopeg 75mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Clopidogril Bisulphate ………. 75mg 36 034992 Lenon 250mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Levofloxacin as Hemihydrate ….. 250mg 37 034993 Lenon 500mg Tablet Rs. 13.12.2004 15.06.2015 Each tablet Contains: 20,000/ Levofloxacin as Hemihydrate ….. 500mg 38 030728 Nimcox 100mg Tablet Rs. 02.08.2003 15.06.2015 Each tablet Contains: 20,000/ Nimesulide ….. 100mg
The Registration Board in 246th meeting approved the following SOPs for cancellation of registration from previous name of registration in new name of the firm. Registration Board deliberated on the matter and it was decided that following procedure will be adopted for these cases. “Registration will be cancelled from name of existing registration holder. The applicant will comply all requirements for grant of registration and then registration Board will decide the case for grant of registration keeping in view safety, efficacy and quality parameters”. Registration of drug when title of firm has been changed by firm and approved by Central Licensing Board (manufacturing site remains the same). Registration Board discussed that in this case registration will not be cancelled from previous name as there is no change in manufacturing site and only title of registration holder has been changed. Thus case will be processed for change of title of the firm and firm will submit following documents. a. Application on Form-5 with required fee as per relevant SRO. b. Copy of registration letter and renewal status. c. NOC for CRF clearance. d. Approval of new name / title from CLB. e. Undertaking that the formulation, API source & Specifications, manufacturing process, analytical test methods, release & shelf life specifications have not been changed.
Furthermore, the Registration Board in its 252nd meeting decided the case of Pharmawise as under:- “Registration Board discussed that decision of the Board in 164th meeting (2001) did not refer to any provision in the Drug Act, 1976 and relevant laws for payment of transfer fee for each product registered after the payment of fee for changing of title of the firm. Registration Board discussed the legal position in detail and decided as follows:
a. No fee will be charged for registration of products in new title of the firm (approved by CLB) if there is no change in management and manufacturing site of the firm. If
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the Federal Government desire to prescribe fee for each registered product with the change of the title of firm, then rules shall be amended accordingly. b. Applicant will deposit the requisite fee for registration of products in new title of the firm (approved by CLB) if there is either change in management or manufacturing site of the firm”. It is submitted that the renewal of license was granted on 28-06-2015 and they have applied for the change of title of manufacturing of the aforesaid products on 15-06- 2015. Furthermore, the renewal section informed that firm has applied for the renewal of products at Sr. 20, 21 & 26 after the date of expiry. So the registration of these 03 products are not valid and renewal of rest of the products is not confirmed till now
Decision: Registration Board deferred the request of the firm for further deliberations and confirmation of renewal status of other products except S.No. 20,21 and 26.
Case No. 16: Extension in permission for bulk manufacturing to local repacking (change of manufacturer)
Registration Board in 250th meeting deferred following application of M/s. Hyan Pharma, Lhaore for extension permission for bulk import (blister packaging) and secondary repacking by local contract repacking (secondary packaging) of following product through M/s. Genesis Pharmaceutical (Pvt.) Ltd; Lahore instead of M/s. Pulse Pharmaceuticals Lahore for the evaluation of the dossier (the firm submitted that it is not probiotic it is an enzyme)
S. Reg. Name of Drug(s) Remarks No. No. 1. 017877 Q-10 Extra The firm has deposited fee of (Normorol) Capsules Rs. 50,000/- and complete the Each capsule application dossier as per contains: approved SOPs. U ide arenone …. 30mg
Decision: Registration Board approved change in contract packaging and quality control analysis / release of Q-10 Extra, Registration No. 017877 by M/s. Genesis Pharmaceutical (Pvt.) Ltd, Lahore till 30.06.2020 in light of Rule 20A (Drugs Licensing, Registering & Advertising Rules, 1976).
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Case No. 17: Import to Local Manufacting By M/S Genesis
Registration Board in its 250th meeting deferred the following case with the following reason.
S. Name of Drug(s) Reg. No. Initial New Decision No. Manufacturer proposed at the time of manufacture registration r/remarks 1. OMP Tablet 017807 M/s. Chong Want change Registration Board Each tablet Kun Dang registered at deferred the case for contains:- Coporation their own clarification of Omeprazole ……. Seoul, Korea. premises. formulations and 20mg approval in reference regulatory authorities.
The firm has submitted the availability of 20mg Tablet in MHRA, UK and submitted Rs. 50000/- and documents as per Form-5.
Decision: Request of the firm is acceded to by the Board in the light decision taken in its 246th meeting as under:-. Cancellation of above registrations for import from M/s. Chong Kun Dang Coporation Seoul, Korea by M/s Gensis Pharmaceuticals (Pvt.) LTD 71 A, Street no 2 Cavalary Ground .Lahore cant. Grant of registration to M/s GENESIS Pharmaceuticals (Pvt.) Ltd, Plot No 25 Sundar Industrial Estate, Raiwind Road, Lahore. Case will referred to Cost & Pricing Division about MRP of the drug.
Case No. 18 Import to Local manufacturing.
M/s. The Pak Lane Pharma, Lahore Cantt. has requested for local manufacturing and packing by M/s. Neutro Pharma (Pvt.) Ltd; Lahore:- Sr. No. Name of Drug(s) Reg. No. 1. Epiglu ® 069596 Each tube of 0.1gm contains:- Ethyl-2-Cyanoacrylate 95.45mg
The firm has furnished following documents:- i. Fee of Rs. 50,000/- for this purpose. ii. Application dossier on form-5 of M/s. Neutro Pharma, Lahore. iii. NOC from importer dully attested from embassy of Pakistan in Germany. iv. Copy of initial letter of registration & renewal status. v. Contract agreement on stamp paper. vi. The firm has not provided any data related to packaging material specifications, Manufacturing method and Q.C testing method and specifications of final product even on written requests. vii. Approval of liquid sachet of the firm is not provided.
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It is submitted that the Registration Board in its 252nd meeting deliberated that case pertains to contract manufacturing and will be considered in light of Rule 20A [Drugs (L R & A) Rules, 1976]. M/s. Neutro Pharma, Lahore is a contract manufacturer and the sterilization will be performed by PARAS, Lahore which is not a licensed premises. Registration Board advised the Registration Section for provision of information for already granted permissions for sterilization from PARAS. It is submitted that all the registration section except (R-III) has informed that as per available computer record, no such permissions is granted for sterilization from PARAS while the (R-III) has informed that the section could not verify as the computer is locked. Registration Board in its 255th Meeting deferred the case for further deliberations on the legal status of the sterilization of products through PARAS.
The firm has also provided the undertaking with the following submission:-
“PARAS Sterilized empty tubes will be received at Neutro Pharma (Pvt.) Ltd., premises. These tubes will be packed with EPIGLUE in aseptic environment at Neutro Pharma (Pvt) Ltd. Sterility test would be performed at Neutro Pharma (Pvt.) Ltd, 9.5K.M Sheikhupura Road, Lahore.”
Decision: M/s Neutro Pharma, Lahore submitted that pre-sterilized empty tubes will be received from PARAS and Neutro Pharma (Pvt.) Ltd, 9.5K.M Sheikhupura Road, Lahore will perform aseptic filling at their premises and also responsible for the quality control testing of the above mentioned product. Keeping in view aforementioned submission, Registration Board permitted contract manufacturing of Epiglu, Registration No.069596, 3 gm tube from M/s Neutro Pharma, Lahore for 05 years in light of Rule 20A (Drugs Licensing, Registering & Advertising Rules, 1976).
Case No. 19 Violation of Rule 20A (Contract Manufacturing).
M/s OBS Pakistan Ltd. Karachi and M/s Pharmatec Pakistan Ltd, Karachi filed a writ petition Suit No. 3932/2015 in Islamabad High Court against the DRAP wherein they objected on the inspection report conducted on 21.10.2015 by a panel who inspected the M/s OBS for renewal of it’s DML. The panel during the inspection of the unit observed that the firm is manufacturing the hormonal sterile products (androgens and anabolic steroids) in the area for Sterile Ampoule for General Products. Therefore, the firm was directed to immediately stop the production of Hormonal products in the aforesaid area and all previous approvals for hormone production are henceforth stand cancelled till further approval by the DRAP Islamabad.
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The petition was dismissed by the Honourable Court on the grounds the cause of action has arisen at Karachi and also the impugned inspection report has been prepared and signed by the Federal Drugs Inspector who is also posted at Karachi. And no relief has been sought against the authority. The court determines that no cause of action has arisen within its territorial jurisdiction. During proceeding of the case ADC (R-II) appeared before the court and explained about the severe violation of GMP by contract manufacturer viz. M/s Pharmatec Pakistan Ltd, Karachi, Karachi. These products were granted extension in contract manufacturing by Regstration Board in 238th and 249th meetings after ascertaining the codal formalities like approval of section/manufacturing facility by Central Licensing Board ().
1. M/s M/s 002446 Sustanon 250mg Injection Dedicated OBS, Pharmatec Each ml amp contains: facility Karachi Pvt. Ltd. Testosterone Propionate…………30 mg Hormone Kar. Testosterone Phenylpropionate….60 mg Testosterone Isocarproate……….60 mg Testosterone Decanoate……….100 mg
2. -do- -do- 002444 Deca-Durabolin 100mg Inj. Dedicated Each ml ampoule contains: facility Nandrolone Decanoate………...100 mg Hormone 3. -do- -do- 002442 Deca-Durabolin 25mg Inj Dedicated Each ml ampoule contains: facility Nandrolone Decanoate………….25 mg Hormone 4. -do- -do- 002443 Deca-Durabolin 50mg Inj Dedicated Each ml ampoule contains: facility Nandrolone Decanoate………….50 mg Hormone
Decision: Registration Board deliberated that as firm has violated GMP violation, thus the Board decided to issue the show cause notice to both firms (contract manufacturer and contract giver) for cancellation of contract manufacturing approval under sub-rule rule 5.3 and 5.4 of Rule 20-A of the Drugs (Licensing, Registering & Advertising) Rules, 1976 & cancellation of registration under section 7(11) and 42 of the Drugs Act, 1976.
Case No.20: Grant of registration for export purpose – Everest Pharmaceutical, Islamabad. CEO of M/s Everest Pharma Mr. Usman appeared before Registration Board in connection with his personal hearing in the case of registration of his application for local manufacturing of drug containing “Sofosbuvir”. While during the personal hearing he raised objection on the processing of his application of the same drug applied for the export. In this regard the
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relevant section of PE & R Division informed the history of case that his application could not be processed on the following deficiencies found in the application.
i. Rs.8000/- is submitted instead of Rs.20000/- ii. Methylene chloride has been used in composition as a film coating material. Whichshould be replaced as per decision of Registration Board. iii. Two different storage temperatures have been mentioned in the dossier (25C on proposed label and 30C on form-5). iv. Outline of the manufacturing method is absent. v. Justification of specification specially about absence of dissolution test in the same. vi. NOC for CRF clearance not provided. vii. Evidence of approved section from CLB. viii. Last inspection report to verify the GMP status of the firm.
Decision: Registration Board advised to convey above shortcomings to the applicant.
Case No.21: Grant of registration (Pharmaceutical Evaluation Cell).
Evaluator II: Rana Ahsan Ul Haq
S/ Name and Brand Name Type of Remarks on the Decision N address of (Proprietary name + Form formulation (if any) manufacturer / Dosage Form + Strength) including Applicant Initial date, International status in Composition diary stringent drug regulatory agencies / Pharmacological Group Fee authorities including Finished product differential Me-too status Specification fee GMP status as Demanded depicted in latest Price / Pack inspection report size (with date) by the Evaluator 1. M/s Elite Lincomin Form-5 Lincocin by m/s Deferred for provision Pharma (pvt) Injection Dy. No: Pfizer of 9.5KM Each 2ml contains: 3697 dated. TGA. Fee Challan of Rs. Sheikhupura Lincomycin (HCl).... 19-03-2011 Olinc By M/s Bosch 12,000. Road, Lahore. 600mg Rs.8,000/- Pharmaceuticals Clarification for (Lincosamide) ------assay limit of stated BP Specs. ------amount is not as per Priority list RS. BP in some pages. No. 929 250/5x2’s Manufacturing 40/1x2’s Method. Copy of official monograph. Commitment as per 251st meeting.
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Last inspection report. Proof of FTIR and Thin layer chromatography. Gas chromatography along with flame ionization detector required as per analysis method provided by the firm.
2. Martin & Dow Valiant Tablet 320mg Form-5 Diovan (Novartis Deferred for provision Tablet Dy. No: 567 Pharmaceuticals of Priority No. Each film coated tablet dated. Corp., US) USFDA 1200 from contains: 30.04.2012 Challan of 1560 after Valsartan USP ….320mg Rs.8,000/- Diovan (Novartis Differential fee not swapping (Angiotensin II Differential Pharma Pakistan attached. antagonist) fee Challan Limited) Latest inspection (Manufacturer’s specs) is missing report within one Rs. year 1187.50/10’s Undertaking as per 1662.50/14’s 251st meeting of RB 2375.00/20’s not provided. 3325.00/28’s 3562.50/30’s 3. -do- Valiant 40mg Form-5 Diovan (Novartis Deferred for provision Priority No. Tablet Dy. No: 565 Pharmaceuticals of 1193 from Each film coated tablet dated. Corp., US) USFDA 1566 after contains: 30.04.2012 Challan of swapping Valsartan USP …. 40mg Rs.8,000/- Valtec (Tabrose) Differential fee. (Angiotensin II Differential Lastest inspection antagonist) fee Challan report (Manufacturer’s specs) is missing Undertaking as per Rs. 251st meeting of RB. 235.27/10’s 339.38/14’s 470.54/20’s 658.75/28’s 705.80/30’s 4. -do- Diatrol Plus SR Form-5 Amaryl M (Sanofi Deferred for provision Priority No. Tablet Dy. No: Aventis India) of 1452 from Each Bi-Layer film 1391 dated. 1844 after coated tablet contains: 27.08.2012 Amaryl M (Sanofi Approval status by swapping Glimepiride USP …. 1mg Rs.8,000/- Aventis) P.161 refrence regulatory Metformin Hydrochloride Differential authorities. (as sustained release) …. fee Challan Challan of 500mg is missing Differential fee not (Sulfonyl Urea + Rs. attached. Biguanides) 100.00/10’s Last inspection (Manufacturer’s specs) 200.00/20’s report is dated 300.00/30’s 26.02.2011. 600.00/60’s Undertaking as per 251st meeting of RB
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not provided.
5. -do- Diatrol Plus SR Form-5 Amaryl M (Sanofi Deferred for provision Priority No. Tablet Dy. No: Aventis India) of 1453 from Each Bi-Layer film 1397 dated. 1851 after coated tablet contains: 27.08.2012 Amaryl M (Sanofi Approval status by swapping Glimepiride USP …. 2mg Rs.8,000/- Aventis) refrence regulatory Metformin Hydrochloride Differential P.161 authorities. (as sustained release) …. fee Challan Challan of Differential 500mg is missing fee not attached. (Sulfonyl Urea + Rs. Last inspection report is Biguanides) 180.00/10’s dated 26.02.2011. (Manufacturer’s specs) 360.00/20’s Undertaking as per 251st 540.00/30’s meeting of RB not 1080.00/60’s provided.
6. -do- Xyven Form-5 Seractil (Genus Deferred for Priority No. Tablet Dy. No: 458 Pharmaceuticals UK) Reference for specs not 1456 from Each film coated tablet dated. BNF-67 provided. after contains: 20.11.2013 Challan of differential swapping Dexibuprofen …. 300mg Rs.20,000/- Dexifen (ICI fee not attached. (Propionic Acid Rs. Pakistan Limited) Last inspection report is Derivatives) 116.00/10’s p.846 dated 26.02.2011. (in house specs) 222.60/20’s Undertaking as per 251st 318.00/30’s meeting of RB not provided.
7. -do- Xyven Form-5 Seractil (Genus Deferred for Priority No. Tablet Dy. No: 459 Pharmaceuticals UK) Approval status by 1454 from Each film coated tablet dated. refrence regulatory 2727 after contains: 20.11.2013 Dexifen (ICI authorities. swapping Dexibuprofen …. 200mg Rs.20,000/- Pakistan Limited) Reference for specs not (Propionic Acid Rs. P.846 provided. Derivatives) 79.20/10’s Challan of differential (in house specs) 151.20/20’s fee not attached. 216.00/30’s Last inspection report is dated 26.02.2011. Undertaking as per 251st meeting of RB not provided.
8. -do- Xyven Form-5 Seractil (Genus Deferred for Priority No. Tablet Dy. No: 460 Pharmaceuticals UK) Reference for specs not 1455 from Each film coated tablet dated. BNF-67 provided. 2728 after contains: 20.11.2013 Challan of differential swapping Dexibuprofen …. 400mg Rs.20,000/- Dexifen (ICI fee not attached. (Propionic Acid Rs. Pakistan Limited) Last inspection report is Derivatives) 144.32/10’s p.846 dated 26.02.2011. (in house specs) 275.62/20’s Undertaking as per 251st 393.60/30’s meeting of RB not provided.
9. -do- Tri-Amvel Form-5 Exforge HCT Deferred for Priority No. Tablet Dy. No: 855 (Novartis Reference for specs not
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974 from Each film coated tablet dated. Pharmaceuticals provided. 1645 after contains: 29.05.2012 Corp. US) USFDA Challan of differential swapping Amlodipine (USP) …. Rs.8,000/- fee not attached. 5mg Differential Exforge HCT Last inspection report is Valsartan (USP) … fee Challan (Novartis Pharma dated 26.02.2011. 160mg is missing Pakistan Ltd) p.413 Undertaking as per 251st Hydrochlorothiazide USP Rs. meeting of RB not …25mg 848.21/10’s provided. (Angiotensin II 1187.50/14’s antagonist + Calcium 1696.43/20’s channel blocker + 2375.00/28’s Thiazide diuretic) 2544.64/30’s (Reference for specs not provided) 10. -do- Tri-Amvel Form-5 Exforge HCT Deferred for Priority No. Tablet Dy. No: 850 (Novartis Reference for specs not 1028 from Each film coated tablet dated. Pharmaceuticals provided. 1634 after contains: 29.05.2012 Corp. US) USFDA Challan of differential swapping Amlodipine (USP) …. Rs.8,000/- fee not attached. 10mg Differential Exforge HCT Last inspection report is Valsartan (USP) … fee Challan (Novartis Pharma dated 26.02.2011. 320mg is missing Pakistan Ltd) p.413 Undertaking as per 251st Hydrochlorothiazide USP Rs. meeting of RB not …25mg 1245.54/10’s provided. (Angiotensin II 1743.75/14’s antagonist + Calcium 2491.07/20’s channel blocker + 3487.50/28’s Thiazide diuretic) 3736.61/30’s (Reference for specs not provided) 11. -do- Tri-Amvel Form-5 Exforge HCT Deferred for Priority No. Tablet Dy. No: 854 (Novartis Reference for specs not 1027 from Each film coated tablet dated. Pharmaceuticals provided. 1633 after contains: 29.05.2012 Corp. US) USFDA Challan of differential swapping Amlodipine (USP) …. Rs.8,000/- fee not attached. 10mg Differential Exforge HCT Last inspection report is Valsartan (USP) … fee Challan (Novartis Pharma dated 26.02.2011. 160mg is missing Pakistan Ltd) p.413 Undertaking as per 251st Hydrochlorothiazide USP Rs. meeting of RB not …25mg 910.71/10’s provided. (Angiotensin II 1275.00/14’s antagonist + Calcium 1821.43/20’s channel blocker + 2550.00/28’s Thiazide diuretic) 2732.14/30’s (Reference for specs not provided) 12. -do- Tri-Amvel Form-5 Exforge HCT Deferred for Priority No. Tablet Dy. No: 851 (Novartis Reference for specs not 1006 from Each film coated tablet dated. Pharmaceuticals provided. 1636 after contains: 29.05.2012 Corp. US) USFDA Challan of differential swapping Amlodipine (USP) …. Rs.8,000/- fee not attached. 10mg Differential Exforge HCT Last inspection report is Valsartan (USP) … fee Challan (Novartis Pharma dated 26.02.2011. 160mg is missing Pakistan Ltd) p.413 Undertaking as per 251st
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Hydrochlorothiazide USP Rs. meeting of RB not …12.5mg 906.25/10’s provided. (Angiotensin II 1268.75/14’s antagonist + Calcium 1812.50/20’s channel blocker + 2537.50/28’s Thiazide diuretic) 2718.75/30’s (Reference for specs not provided) 13. -do- Tri-Amvel Form-5 Exforge HCT Deferred for Priority No. Tablet Dy. No: 852 (Novartis Reference for specs not 973 from Each film coated tablet dated. Pharmaceuticals provided. after 1637 contains: 29.05.2012 Corp. US) USFDA Challan of differential swapping Amlodipine (USP) …. Rs.8,000/- fee not attached. 5mg Differential Exforge HCT Last inspection report is Valsartan (USP) … fee Challan (Novartis Pharma dated 26.02.2011. 160mg is missing Pakistan Ltd) p.413 Undertaking as per 251st Hydrochlorothiazide USP Rs. meeting of RB not …12.5mg 843.75/10’s provided. (Angiotensin II 1181.18/14’s antagonist + Calcium 1687.50/20’s channel blocker + 2362.50/28’s Thiazide diuretic) 2531.25/30’s (Reference for specs not provided) 14. -do- Co-Valiant Form-5 Diovan HCT Deferred for Priority No. Tablet Dy. No: 570 (Novartis Confirmation of me too 1086 from Each film coated tablet dated. Pharmaceuticals status. 1560 after contains: 30.04.2012 Corp., US) USFDA Reference for specs not swapping Valsartan USP …. 320mg Rs.8,000/- provided. Hydrochlorothiazide Differential Challan of differential USP…12.5mg fee Challan fee not attached. (Angiotensin II is missing Last inspection report is antagonist + Thiazide Rs. dated 26.02.2011. diuretic) 1785.71/10’s Undertaking as per 251st (Reference for specs not 2500.00/14’s meeting of RB not provided) 3571.43/20’s provided. 5000.00/28’s Complete method of 5357.14/30’s manufacturing not provided. 15. -do- Co-Valiant Form-5 Diovan HCT Deferred for Priority No. Tablet Dy. No: 573 (Novartis Reference for specs not 1063 from Each film coated tablet dated. Pharmaceuticals provided. 1561after contains: 30.04.2012 Corp., US) USFDA Challan of differential swapping Valsartan USP …. 160mg Rs.8,000/- fee not attached. Hydrochlorothiazide Differential Co-Diovan (Novartis Last inspection report is USP… 12.5mg fee Challan Pharma pakistan dated 26.02.2011. (Angiotensin II is missing Limited) p.413 Undertaking as per 251st antagonist + Thiazide Rs. meeting of RB not diuretic) 892.66/10’s provided. (Reference for specs not 1250.00/14’s Complete method of provided) 1785.71/20’s manufacturing not 2500.00/28’s provided. 2678.57/30’s
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16. -do- Co-Valiant Form-5 Diovan HCT Deferred for Priority No. Tablet Dy. No: 572 (Novartis Reference for specs not 1085 from Each film coated tablet dated. Pharmaceuticals provided. 1565 after contains: 30.04.2012 Corp., US) USFDA Challan of differential swapping Valsartan USP …. 160mg Rs.8,000/- fee not attached. Hydrochlorothiazide Differential Co-Diovan (Novartis Last inspection report is USP… 25mg fee Challan Pharma pakistan dated 26.02.2011. (Angiotensin II is missing Limited) p.413 Undertaking as per 251st antagonist + Thiazide Rs. meeting of RB not diuretic) 901.79/10’s provided. (Reference for specs not 1262.50/14’s Complete method of provided) 1803.57/20’s manufacturing not 2525.00/28’s provided. 2705.36/30’s 17. -do- Esomax Insta 40mg Form-5 ------Deferred for Priority No. Capsules Dy. No: 849 RB has deferred the 1062 from Each capsule contains: dated. Ezocarb (Pray’s same in 250th meeting 1635 after Esomeprazole (as 29.05.2012 Pharmaceutical) for expert opinion. swapping magnesium trihydrate) Rs.8,000/- Reference for specs not USP ………... 40mg Differential provided. Sodium Bicarbonate USP fee Challan Challan of differential ………… 1100mg is missing fee not attached. (Proton pump inhibitor + Rs. Last inspection report is Antacid) 203.36/10’s dated 26.02.2011. (Reference for specs not 284.70/14’s Undertaking as per 251st provided) 406.71/20’s meeting of RB not 610.07/30’s provided.
18. -do- Esomax Insta 20mg Form-5 ------Deferred for Priority No. Capsules Dy. No: 847 RB has deferred the 1050 from Each capsule contains: dated. Ezocarb (Pray’s same in 250th meeting 1638 after Esomeprazole (as 29.05.2012 Pharmaceutical) for expert opinion. swapping magnesium trihydrate) Rs.8,000/- Reference for specs not USP ………... 20mg Differential provided. Sodium Bicarbonate USP fee Challan Challan of differential ………… 1100mg is missing fee not attached. (Proton pump inhibitor + Rs. Last inspection report is Antacid) 135.57/10’s dated 26.02.2011. (Reference for specs not 189.80/14’s Undertaking as per 251st provided) 271.14/20’s meeting of RB not 406.71/30’s provided.
19. -do- Viglip-M Form-5 Eucreas (Novartis Deferred for Priority No. Tablets Dy. No: 375 Pharmaceuticals UK Challan of differential 926 from Each film coated tablet dated. Ltd.) MHRA fee not attached. 1085 after contains: 28.05.2011 Commitment as per swapping Vildagliptin ……. 50mg Rs.8,000/- Galvus Met 251st meeting not Metformin HCl……… Differential (Novartis Pharma provided. 850mg fee Challan (PAK) Ltd) p.170 Inspection report is (Anti Hyperglycemic) is missing dated 26.02.2011. (Reference for specs not Rs. Covering letter and fee provided) 773.30/10’s Challan of Rs:8000/- is 2319.90/30’s for Viglip-M 50/1000mg.
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Reference for specs not provided. Method validation required in case of in house specs. Stability studies not as per RB guidelines. 20. -do- Tirace Form-5 Keppra (UCB Deferred for Priority No. Oral solution Dy. No: 632 Pharma Ltd.) Reference for specs not 1451 from Each ml tablet contains: dated. USFDA provided. 1455 after Levetiracetam ……. 27.12.2011 Challan of differential swapping 100mg Rs.8,000/- Lerace (Hilton fee not attached. (Antiepileptic) Differential Pharma Pvt Ltd.) Last inspection report is (Reference for specs not fee Challan p.984 dated 26.02.2011. provided) is missing Undertaking as per 251st Rs. meeting of RB not 88.40/10ml provided. 247.00/30ml Complete method of 468.00/60ml manufacturing not 936.00/120m provided. l 21. -do- Tirace Form-5 Keppra (UCB Deferred for Priority No. Tablets Dy. No: 395 Pharma Ltd.) Reference for specs not 1426 from Each film coated tablet dated. USFDA provided. 1413 after contains: 28.10.2011 Challan of differential swapping Levetiracetam ……. Rs.8,000/- Lerace (Hilton fee not attached. 250mg Differential Pharma Pvt Ltd.) Last inspection report is (Antiepileptic) fee Challan p.984 dated 26.02.2011. (Reference for specs not is missing Undertaking as per 251st provided) Rs. meeting of RB not 340.60/10’s provided. 681.20/20’s Complete method of 1021.80/30’s manufacturing not provided. 22. -do- Tirace Form-5 Keppra (UCB Deferred for Priority No. Tablets Dy. No: 517 Pharma Ltd.) Reference for specs not 1427 from Each film coated tablet dated. USFDA provided. 1412 after contains: 16.11.2011 Challan of differential swapping Levetiracetam ……. Rs.8,000/- Lerace (Hilton fee not attached. 750mg Differential Pharma Pvt Ltd.) Last inspection report is (Antiepileptic) fee Challan p.984 dated 26.02.2011. (Reference for specs not is missing Undertaking as per 251st provided) Rs. meeting of RB not 1044.00/10’s provided. 2088.00/20’s Complete method of 3132.00/30’s manufacturing not provided. 23. -do- Tirace Form-5 Keppra (UCB Deferred for Priority No. Tablets Dy. No: 397 Pharma Ltd.) Confirmation of me too 1432 from Each film coated tablet dated. USFDA status. 1411 after contains: 28.10.2011 Reference for specs not swapping Levetiracetam ……. Rs.8,000/- provided. 1000mg Differential Challan of differential (Antiepileptic) fee Challan fee not attached.
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(Reference for specs not is missing Last inspection report is provided) Rs. dated 26.02.2011. 942.50/10’s Undertaking as per 251st 1885.00/20’s meeting of RB not 2827.50/30’s provided. Complete method of manufacturing not provided. 24. M/s Hiepil 25mg Tablet Form-5 with Inspra - Pfizer Approved Highnoon fee 20,000/- (USFDA) Laboratories Each film coated tablet Dy. No: Limited, 17.5 contains: 1060 dated Macrenone-Macter km Multan Eplerenone 25mg 10-12-2013 Road, Pack size of Lahore. Steroidal 10’s Rs. (896) antimineralocorticoid - 600/- Aldosterone receptor 14’s Rs. Priority No. antagonist 800/- 896 from 20’s Rs. 2746 after Manufacture 1100/- swapping Specification
25. -do- Hiepil 50mg Tablet Form-5 with Inspra - Pfizer Approved Priority No. fee 20,000/- (USFDA) 1375 from Each tablet contains: Dy. No: 2747 after Eplerenone 50mg 1060 dated Macrenone-Macter swapping 10-12-2013 swapped Steroidal application antimineralocorticoid - Pack size of with priority Aldosterone receptor 10’s Rs. in 2011 antagonist 850/- 14’s Rs. Manufacture 1150/- Specification 20’s Rs. 1600/- 26. -do- Misar 40/10 Tablet Form-5 with TWYNSTA Approved Priority No. fee 20,000/- (USFDA) 894 from Each tablet contains: Dy. No: 2300 after Telmisartan BP 40mg 2946 dated Amtaz-getz swapping Amlodipine (as Besylate) 08-05-2013 BP 10mg Pack size of ARB blocker/ Calcium 14’s Rs. Channel Blocker 400/-
Manufacture Specification 27. -do- Misar 80/5 Tablet Form-5 with TWYNSTA Approved fee 20,000/- (USFDA) Priority No. Each tablet contains: Dy. No: 895 from Telmisartan BP 80mg 2945 dated Amtaz-getz 2299 after Amlodipine (as Besylate) 08-05-2013 swapping BP 5mg Pack size of
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ARB blocker/ Calcium 14’s Rs. Channel Blocker 530/-
Manufacture Specification 28. M/s Barrett Baritec-A Tablet 20/5mg Form-5 Azor 20/5mg Deferred for latest GMP Hodgson Tablets Dy. No: (Daiichi Sankyo) inspection report Pakistan Each tablet contains: 1301 dated. USFDA (Private) Ltd. Olmesartan Medoxomil 08.03.2013 F/423 SITE ……. 20mg Rs.20,000/- Olmedip (Shrooq Karachi. Amlodipine (besylate) Rs. 330/10’s lahore) ……… 5mg Priority No. (Angiotensin II receptor 985 from antagonist with calcium 2168 after antagonist) swapping (BH specs)
29. -do- Baritec-A Tablet 40/5mg Form-5 Azor 40/5mg Deferred for latest GMP Priority No. Tablets Dy. No: (Daiichi Sankyo) inspection report 1232 from Each tablet contains: 1303 dated. USFDA 2170 after Olmesartan Medoxomil 08.03.2013 swapping ……. 40mg Rs.20,000/- Olmedip (Shrooq Amlodipine (besylate) Rs. 550/10’s lahore) ……… 5mg (Angiotensin II receptor antagonist with calcium antagonist) (BH specs) 30. M/s Barrett Baritec-A Tablet Form-5 Azor 20/10mg Deferred for latest GMP Hodgson 20/10mg Dy. No: (Daiichi Sankyo) inspection report Pakistan Tablets 1302 dated. USFDA (Private) Ltd. Each tablet contains: 08.03.2013 F/423 SITE Olmesartan Medoxomil Rs.20,000/- Olmedip (Shrooq Karachi. ……. 20mg Rs. 350/10’s lahore) Priority No. Amlodipine (besylate) 1033 from ……… 10mg 2169 after (Angiotensin II receptor swapping antagonist with calcium antagonist) (BH specs) 31. -do Baritec-A Tablet Form-5 Azor 40/10mg Deferred for latest GMP Priority No. 40/10mg Dy. No: (Daiichi Sankyo) inspection report 1034 from Tablets 1304 dated. USFDA 2171 after Each tablet contains: 08.03.2013 swapping Olmesartan Medoxomil Rs.20,000/- Olmedip (Shrooq ……. 40mg Rs. 570/10’s lahore) Amlodipine (besylate) ……… 10mg (Angiotensin II receptor antagonist with calcium antagonist) (BH specs) 32. -do- Barresten 500mg vaginal Form-5 Mycelex-G (Bayer Deferred for latest GMP Priority No. Tablets Dy. No: Pharms) USFDA inspection report
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938 from Each tablet contains: 1216 dated. 1790 after Clotrimazole ……. 08.07.2012 Olmedip (Shrooq swapping 500mg Rs.8,000/- lahore) p.408 (Anti- fungal) 29.07.2013 (USP) 12,000/- Rs. 195/1’s
33. -do- GutSet SR 150mg Form-5 Not available in Rejected as per decision Priority No. Tablets Dy. No: 40 reference agencies. of 250th Registration 937 from Each tablet contains: dated. Board meeting as 2103 after Itopride Hydrochloride 08.01.2013 Ganaton (Abbott) formulation is not swapping …. 150mg Rs.8,000/- approved by reference (Gastrokinetic) Rs. 400/10’s drug regulatory (BH specs) agencies.
34. M/s ATCO Distalgesic 100mg/2ml Form-5 Tramadol HCL Approved with change Laboratories (IM, IV) Dy. No: injection, UK, by of name Limited, B-18 Injectable 1331 dated. M/s Brown & Burk. SITE Karachi. Each 2ml contains: 09.07.2013 Priority No. Tramadol HCl USP ……. Rs.20,000/- Tamadol by M/s 955 from 100mg Rs. 100/2ml Highnoon Pharma 2401 after (Opioid Analgesic) Ampoule swapping (Atco specification) 2mlx1’s, 2mlx5’s, 2mlx10’s 35. -do- Dioplus-H Form-5 Exforge HCT Approved Priority No. Tablet Dy. No: 255 (Novartis 797 from Each film coated tablet dated. Pharmaceuticals 1389 after contains: 18.10.2011 Corp. US) USFDA swapping Amlodipine (Besylate) Rs.8,000/- BP …. 10mg 02.08.2013 Exforge HCT Valsartan (USP) … Rs:12,000/- (Novartis Pharma 160mg Rs. 70/Tablet Pakistan Ltd) p.413 Hydrochlorothiazide USP 14’s …12.5mg (Angiotensin II antagonist + Calcium channel blocker + Thiazide diuretic) (Atco specification) 36. -do- D-All Form-5 Deferred for Priority No. Tablet Dy. No: confirmatiuon of 958 from Each chewable tablet 1445 dated. approval status by 2370 after contains: 26.07.2013 D-Max (Matrix) reference regulatory swapping Cholecalciferol (Vitamin Rs.20,000/- P.192 aythorities D3) USP …..…. 2000IU Rs. 60/Tablet (Vitamin Supplement) 10’s, 20’s, (Atco Specifications) 30’s, 60’s 37. -do- Terbiderm Lotion 1% Form-5 Deferred for Lotion Dy. No: 466 confirmatiuon of Priority No. Each ml contains: dated. approval status by 798 from Terbinafine HCl BP 26.11.2013 Cutis Topical Lotion reference regulatory
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2739 after …..…. 1% Rs.20,000/- 1% By M/s Tabros aythorities swapping (Anti-fungal) Rs. 35/ml (Atco Specifications) 10ml, 20ml, 30ml, 60ml 38. -do- Epigran Oral Suspension Form-5 Dilatin-30 (Parke Approved Oral Suspension Dy. No: 046 Davis) USFDA Priority No. Each 5ml contains: dated. 1325 Phenytoin USP …..…. 06.09.2011 Dalantin (Pfizer) 30mg Rs.8,000/- (Anti-fungal) 02.08.2013 (USP) 12,000/- Rs. 100/120ml 39. -do- Xorav 10mg Form-5 Xarelto (Byer Plc) Approved Priority Tablet Dy. No: 685 MHRA No.994 from Each film coated tablet dated. 1586 after contains: 11.05.2012 Xarelto (Byer swapping Rivaroxaban MS ..…. Rs.8,000/- Healthcare) 10mg 02.08.2013 (Antithrombic agent) 12,000/- (Atco Specs) Rs. Uses: Fibrillation, 800/Tablet Prophylaxis of deep vein 10’s, 5’s thrombosis 40. -do- Combinol ACF Form-5 Deferred for Priority syrup Dy. No: Approval status in SRAs No.956 from Each 5ml contains: 1224 dated. and Pakistan. 2375 after Acefylline piperzine MS 12.06.2013 swapping …..…. 45mg Rs.20,000/- Diphenhydramin Rs. 60/60ml HCl….8mg 120/120ml (cough and cold preparation) (Atco Specification) 41. -do- Norsaline-P Form-5 Deferred for Priority Nasal Spray Dy. No: NIL Original dossier No.976 Each ml contains: dated. Approval status by Sodium chloride 05.04.2011 reference regulatory USP…..0.9% Rs.8,000/- authorities and me too (Topical Nasal Differential status. Preparation) fee not Original fee Challan of (Atco Specification) attached Rs:8000/ not attached. Rs. 60/15ml Fee Challan of differential fee not attached. Last inspection report is dated 26.02.2011.
42. M/s Obson Oblonec Capsule 50mg Form-5 International Deferred for Pharmaceutica Capsule Dy. No: availability not Commitment as per ls, 209-S Each capsule contains: 2703 dated. confirms. 251st meeting not Industrial Diclofenac sodium (as 22-06-2011 provided by the Firm. Estate Kot enteric coated Rs.8000/- Last inspection report is Lakhpat, pellets).....50mg 22-06-2011 Phlogen by M/s dated 05-01-2009.
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Lahore. (Anti Rheumatic) Rs.12,000/- Brookes. Copy of official Priority USP Specs dated 19-12- monograph required for No.1177 2013 testing method. As per SRO / Source of pellets not 10’s provided. Form 5 is not in order as per Rule 26 (1). Details of product specs required. International availability not provided. 43. M/s Surge Sunvega 39mg Injection Form-5D Invega Sustenna Deferred for Laboratories Dy. No: Injection – Janssen Commitment as per (Private) Each 0.25ml contains: 1484 dated. (USFDA) 251st meeting not Limited, 10th Paliperidone Palmitate 27-06-2011 provided by the Firm. km, 39mg Rs.15000/- Last inspection report is Faisalabad & Dy. No. dated 30-09-2009. Road, Bikhi Route of Administration: 1122 dated Innovator brand is District, IM 04-06-2014 available in the form of Sheikhupura 35,000/- prefilled syringe but Injection (Antipsychotic) latest inspection report General In-house Specifications Pack size of required to verify firm’s (Priority 1’s/ facility. No.1204 (New molecule) Rs. 20,000/- Innovator brand have nano particle suspension Indication:-Treatment of of Paliperidone acute schizophrenia and Palmitate that dissolves maintenance of treatment slowly and clarification of schizophrenia required for the same from firm. Master formulation does not support to extended release suspension for injection. Stability studies as per 249th meeting not provided. Firm using atropine sulphate in method of manufacturing. In packing firm mentioned labeling of ampoule and vials. Firm mentioned syringe washing and filing machine in method of manufacture but in equipment list vial washing and vial filling machine mentioned. Compendial method or validation of analytical method required. 44. -do- Sunvega 234mg Injection Form-5D Invega Sustenna Deferred for Priority Dy. No: Injection – Janssen Commitment as per Minutes for 256th Meeting Registration Board 355
No.1207 Each 1.5ml contains: 1484 dated. (USFDA) 251st meeting not Paliperidone Palmitate 27-06-2011 provided by the Firm. 234mg Rs.15000/- Last inspection report is & Dy. No. dated 30-09-2009. Route of Administration: 1122 dated Innovator brand is IM 04-06-2014 available in the form of 35,000/- prefilled syringe but (Antipsychotic) latest inspection report In-house Specifications Pack size of required to verify firm’s 1’s/ facility. (New molecule) Rs. Innovator brand have 100,000/- nano particle suspension of Paliperidone Palmitate that dissolves slowly and clarification required for the same from firm. Master formulation does not support to extended release suspension for injection. Stability studies as per 249th meeting not provided. Firm using atropine sulphate in method of manufacturing. In packing firm mentioned labeling of ampoule and vials. Firm mentioned syringe washing and filing machine in method of manufacture but in equipment list vial washing and vial filling machine mentioned. Compendial method or validation of analytical method required. 45. -do- Sunvega 117mg Injection Form-5D Invega Sustenna Deferred for Priority Dy. No: Injection – Janssen Commitment as per No.1206 Each 0.75ml contains: 1489 dated. (USFDA) 251st meeting not Paliperidone Palmitate 27-06-2011 provided by the Firm. 117mg Rs.15000/- Last inspection report is & Dy. No. dated 30-09-2009. Route of Administration: 1122 dated Innovator brand is IM 04-06-2014 available in the form of 35,000/- prefilled syringe but (Antipsychotic) latest inspection report In-house Specifications Pack size of required to verify firm’s 1’s/ facility. (New molecule) Rs. 50,000/- Innovator brand have nano particle suspension of Paliperidone Minutes for 256th Meeting Registration Board 356
Palmitate that dissolves slowly and clarification required for the same from firm. Master formulation does not support to extended release suspension for injection. Stability studies as per 249th meeting not provided. Firm using atropine sulphate in method of manufacturing. In packing firm mentioned labeling of ampoule and vials. Firm mentioned syringe washing and filing machine in method of manufacture but in equipment list vial washing and vial filling machine mentioned. Compendial method or validation of analytical method required. 46. -do- Sunvega 78mg Injection Form-5D Invega Sustenna Deferred for Priority Dy. No: Injection – Janssen Commitment as per No.1205 Each 0.5ml contains: 1489 dated. (USFDA) 251st meeting not Paliperidone Palmitate 27-06-2011 provided by the Firm. 78mg Rs.15000/- Last inspection report is & Dy. No. dated 30-09-2009. Route of Administration: 1122 dated Innovator brand is IM 04-06-2014 available in the form of 35,000/- prefilled syringe but (Antipsychotic) latest inspection report In-house Specifications Pack size of required to verify firm’s 1’s/ facility. (New molecule) Rs. 30,000/- Innovator brand have nano particle suspension of Paliperidone Palmitate that dissolves slowly and clarification required for the same from firm. Master formulation does not support to extended release suspension for injection. Stability studies as per 249th meeting not provided. Firm using atropine sulphate in method of Minutes for 256th Meeting Registration Board 357
manufacturing. In packing firm mentioned labeling of ampoule and vials. Firm mentioned syringe washing and filing machine in method of manufacture but in equipment list vial washing and vial filling machine mentioned. Compendial method or validation of analytical method required. 47. -do- Sunvega 156mg Injection Form-5D Invega Sustenna Deferred for Priority Dy. No: Injection – Janssen Commitment as per No.1208 Each 1ml contains: 1489 dated. (USFDA) 251st meeting not Paliperidone Palmitate 27-06-2011 provided by the Firm. 156mg Rs.15000/- Last inspection report is & Dy. No. dated 30-09-2009. Route of Administration: 1122 dated Innovator brand is IM 04-06-2014 available in the form of Rs:35,000/- prefilled syringe but (Antipsychotic) latest inspection report In-house Specifications Pack size of required to verify firm’s 1’s/ facility. (New molecule) Rs. 65,000/- Innovator brand have nano particle suspension Indication:-Treatment of of Paliperidone acute schizophrenia and Palmitate that dissolves maintenance of treatment slowly and clarification of schizophrenia required for the same from firm. Master formulation does not support to extended release suspension for injection. Stability studies as per 249th meeting not provided. Firm using atropine sulphate in method of manufacturing. In packing firm mentioned labeling of ampoule and vials. Firm mentioned syringe washing and filing machine in method of manufacture but in equipment list vial washing and vial filling machine mentioned. Compendial method or validation of analytical Minutes for 256th Meeting Registration Board 358
method required. Evaluator-I Muhammad Ansar 48. M/s Cetrimed Tablet 10mg Form-5 MHRA. Zirtek 10mg Deferred for the Medisearch Each tablet contains:- 21-05-2011 film coated tablet. submission of Pharmacal Cetirizine 2HCl…..10mg vide diary Local Alegra 10mg following:- (Pvt) Ltd, Histamine receptor No. 5840 by M/s Tagma. Differential fee Lahore. antagonist Rs.8000 Finished product Priority Require to be provided As per SRO specifications No.997 Applications are not signed by the technical staff. Application is not as per the format of form-5. Commitment as per the decision of RB is not attached. Outline of manufacturing procedure is not attached. Inspection report conducted within the period of 1 year is not attached. Details of water treatment are not attached. 49. -do- Medisulide Tablet 100mg Form-5 i. Rejected on the Priority Each tablet contains:- 20-04-2011 grounds that the No.987 Nimesulide……..100mg vide diary Local. Nims 100mg drug has no NSAID No. 4621 by M/s Sami clinically Require to be provided Rs.8000 meaningful As per SRO advantage over other NSAIDS and that nimesulide is associated with increased risks of hepatotoxicity compared to other drugs in the class. Moreover, the combined safety profile in terms of hepatotoxicity and GI toxicity is shown as worse than some other
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alternative NSAIDS such as Diclofenac and naproxen. Hence keeping in view Risk vs benefit ratio, registration application containing Nimesulide are rejected. 250th RB meeting
50. -do- Colin Syrup Form-5 Deferred for the Priority Each 30ml contains:- 26-05-2011 submission of No.1073 Citicoline (as Citicoline vide diary following:- Sodium) …..500mg No. 404 Confirmation of me Nootropics Rs.8000 too status and Require to be provided As per SRO approval status by reference regulatory authorities Differential fee. Finished product specifications. Applications are not signed by the technical staff. Application is not as per the format of form-5. Commitment as per the decision of RB is not attached. Outline of manufacturing procedure is not attached. Inspection report conducted within the period of 1 year is not attached. Details of water treatment is not attached. 51. -do- Medival Tablet 250mg Form-5 Deferred for the Priority Each tablet contains:- 20-04-2011 submission of No.993 Divalproex vide diary Local. Epival 250mg following:- Sodium…..250mg No. 4616 by M/s Abbott. Differential fee. anticonvulsant Rs.8000 Complete Require to be provided As per SRO description of the tablet is not provided.
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Finished product specifications. Applications are not signed by the technical staff. Application is not as per the format of form-5. Commitment as per the decision of RB is not attached. Outline of manufacturing procedure is not attached. Inspection report conducted within the period of 1 year is not attached. Details of water treatment is not attached. 52. -do- Fusid Suspension Form-5 Deferred for the Priority 250mg/5ml 26-05-2011 submission of No.1074 Each 5ml contains:- vide diary Local. Lucirex following:- Fusidic Acid……..250mg No. 403 250mg Susp by M/s Differential fee. Antibacterial Rs.8000 Rex Finished Require to be provided As per SRO product specifications. Applications are not signed by the technical staff. Application is not as per the format of form-5. Commitment as per the decision of RB is not attached. Outline of manufacturing procedure is not attached. Inspection report conducted within the period of 1 year is not attached. Details of water treatment is not attached. 53. -do- Fusid Cream 2% Form-5 Deferred for the Priority Each 100gm contains:- 21-05-2011 submission of
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No.1055 Fusidic Acid…..2gm vide diary Fucidin cream by following:- Histamine receptor No. 5842 M/s Leo Differential fee. antagonist Rs.8000 Finished Require to be provided As per SRO product specifications. Applications are not signed by the technical staff. Application is not as per the format of form-5. Commitment as per the decision of RB is not attached. Outline of manufacturing procedure is not attached. Inspection report conducted within the period of 1 year is not attached. Details of water treatment is not attached. Rana Ahsan Ul Haq Ather 54. M/s Sanofi Glucantime® 1.5g/5ml Form-5A Magmony by M/s Deferred for Aventis Solution for injection Dy. No: NIL Neutro pharma. Original dossier. Pakistan Each 5ml solution for dated. Approval status by Limited. injection contains: NIL reference regulatory Priority No. Meglumine Rs.4417/5x5 authorities. 68 Import) antimoniate..... 1.5g ml As per priority list on equivalent to website the dates of fee Antimony……….0.405g are 21-09-2011 (antileshmanial) Rs.15000/- 13-05-2013 Rs.85000/- Original fee Challans not attached. Copy of Challans not endorsed/ received by statistical officer. GMP certificate valid till 30/10/2013. Firm submitted Registration COPP is not as per WHO format rather it is Certificate for Exporting Drug Products with Registered Trade Name and it is authorized for sale throughout Brazil.
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Sole agency agreement not attached. Firm has provided long term stability studies at 30 2˚C/75 5%RH that is more stringent than 65±5%RH.± Evaluator IV: Slateen Waseem Philip ± 55. M/s Tablet Zypin 5mg Form 5 with FDA approved Deferred to complete Nabiqasim prescribed Zyprexa application for Karachi Each film coated tablet fee Rs. following -do- contains 20,000/- Olanzia (Werrick) observations/shortcomin Priority No. Olanzapine 5mg Dy. No. gs:- 879 from 1427 dated Clarification needed 2460 Thiobenzodiazepine 24-07-2013 in master swapped Second generation 10’s & 30’s formulation because antipsychotics as per innovator brand is In-house specification PRC not a film coated tablet while firm claims film coated tablets. Commitment required as per decision of RB. Latest inspection report required. Firm needs to clarify for implementation of In-house finished product specification while the product is available in USP Pharmacopoeia. 56. -do- Tablet Zypin 7.5mg Form 5 with FDA approved Deferred to complete Priority No. prescribed Zyprexa application for 880 from Each film coated tablet fee Rs. following 2455 contains 20,000/- Olanzia (Werrick) shortcomings:- swapped Olanzapine 7.5mg Dy. No. Clarification needed 1427 dated in master Thiobenzodiazepine 24-07-2013 formulation because Second generation 10’s & 30’s innovator brand is antipsychotics as per not a film coated In-house specification PRC tablet while firm formulation claims film coated tablets. Commitment required as per decision of RB. Latest inspection report required. Firm needs to clarify for product specification while
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the product is available in USP Pharmacopoeia. 57. -do- Tablet Zypin 10mg Form 5 with FDA approved Deferred to complete Priority No. prescribed Zyprexa application for 881 from Each film coated tablet fee Rs. following 2456 contains 20,000/- Olanzia (Werrick) shortcomings:- swapped Olanzapine 10mg Dy. No. Clarification needed 1431 dated in master Thiobenzodiazepine 24-07-2013 formulation because Second generation 10’s & 30’s innovator brand is antipsychotics as per not a film coated In-house specification PRC tablet while firm formulation claims film coated tablets. Commitment required as per decision of RB. Latest inspection report required. Firm needs to clarify for implementation of In-house finished product specification while the product is available in USP Pharmacopoeia. 58. -do- Tablet Selar 5mg Form 5 with MHRA approved Deferred to complete Priority prescribed Eldepryl-Orion application for No.1005 from Each tablet contains fee Rs. following 2454 Selegiline (as HCl) USP 20,000/- Jumex (Sanofi) shortcomings:- swapped 5mg Dy. No. The quantity of 1433 dated active ingredient in Monoamine oxidase –B 24-07-2013 master formulation is Inhibitor 10’s & 50’s not correct (quantity In-house specification as per per tab is 10 mg). PRC Commitment required as per decision of RB. Latest inspection report required. Firm needs to clarify for implementation of In-house finished product specification while the product is available in USP Pharmacopoeia. 59. -do- Tablet Selar 10mg Form 5 with MHRA approved Deferred to complete Priority prescribed Eldepryl-Orion application for No.1360 from Each tablet contains fee Rs. following 2459 Selegiline (as HCl) USP 20,000/- Jumex (Sanofi) shortcomings:- swapped 10mg Dy. No. The quantity of 1428 dated active ingredient in
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Monoamine oxidase –B 24-07-2013 master formulation is Inhibitor 10’s & 50’s not correct. In-house specification as per Commitment PRC required as per decision of RB. Latest inspection report required. Firm has submitted accelerated stability studies data. Firm needs to clarify for implementation of In-house finished product specification while the product is available in USP Pharmacopoeia. 60. -do- Tablet Psychopine 5mg Form 5 with MHRA approved Deferred due to Priority No. prescribed Sycrest- Lundbeck- following observations:- 882 from Each siblingual tablet fee Rs. UK To apply on 2517 contains 20,000/- prescribed Form 5-D swapped Asenapine (as Dy. No. Asen (Semos) along with fee Maleate)5mg 1580 dated specified under 23-08-2013 Schedule F of the Anti-Psychotic 10’s & 30’s Drugs Act, 1976, as In-house specification as per it is not me too drug PRC in Pakistan and local availability mentioned by firm is also under review of expert committee constituted in 245th meeting of RB. To submit Stability data of both real time studies and accelerated stability studies according to guidelines provided in 251st meeting of RB.
61. -do- Tablet Psychopine 10mg Form 5 with MHRA approved Deferred due to Priority No. prescribed Sycrest- Lundbeck- following observations:- 883 from Each siblingual tablet fee Rs. UK To apply on 2516 contains 20,000/- prescribed Form 5-D swapped Asenapine (as Dy. No. Asen (Semos) along with fee Maleate)10mg 1581 dated specified under 23-08-2013 Schedule F of the Anti-Psychotic 10’s & 30’s Drugs Act, 1976, as In-house specification as per it is not me too drug PRC in Pakistan and local availability mentioned by firm is
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also under review of expert committee constituted in 245th meeting of RB. To submit Stability data of both real time studies and accelerated stability studies according to guidelines provided in 251st meeting of RB.
62. -do- Tablet Xoming 2.5mg Form 5 with MHRA approved by Approved Priority No. prescribed Actavis-UK 899 from Each film coated tablet fee Rs. 2461 contains 20,000/- Zomos (Wilshire) swapped Zolmitripan 2.5mg Dy. No. 1434 dated 5HT agonist 24-07-2013 In-house specification 3’s & 30’s as per PRC 63. -do- Tablet Xoming 5mg Form 5 with MHRA approved by Approved Priority No. prescribed Actavis-UK 886 from Each film coated tablet fee Rs. 2457 contains 20,000/- Zomos (Wilshire) swapped Zolmitripan 5mg Dy. No. 1436 dated 5HT agonist 24-07-2013 In-house specification 3’s & 30’s as per PRC 64. -do- Capsule Savol 375mg Form 5 with MHRA approved by Approved Priority No. prescribed Winthrob-UK 1363 from Each hard gelatin capsule fee Rs. swapped contains 20,000/- Rhinathol-Sanofi Carbociestine BP 375mg Dy. No. 96 dated 17-09- Expectorant 2013 In-house specification 10’s & 30’s as per PRC 65. -do- Savol Prometh Syrup Form 5 with Available in France Approved Priority No. prescribed as Rhinothiol 1361 from Each 5ml contains fee Rs. Prometh syrup - 2563 Carbocistiene BP 100mg 20,000/- Aventis swapped Promethazine HCl BP Dy. No. 93 2.5mg dated 16-09- Rhinathol-Sanofi 2013 10’s & 30’s Expectorant as per In-house specification PRC
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66. -do- Savol 5% Syrup Form 5 with MHRA approved Approved Priority No. prescribed 1362 from Each 5ml contains fee Rs. Rhinathol 5%-Sanofi 2564 Carbocistiene BP 250mg 20,000/- swapped Dy. No. 94 dated 16-09- Expectorant 2013 In-house specification 10’s & 30’s as per PRC 67. -do- Acnicot gel Form 5 with Ziana Gel-USA-FDA Approved Priority No. prescribed 1435 from Each gm contains fee Rs. Acdermin Gel -Atco 1517 Clindamycin Phosphate 8,000/- swapped 1.2 % w/w Dy. No. 315 Tretinoin USP 0.025% dated 08-02- w/w 2012 10gm & 20gm as Antibiotic/retinoid per PRC In-house specification 68. M/s The Capsule Ultragab 150mg Form 5 with FDA approved Deferred for verification Schazoo prescribed Lyrica of Challan of Rs. 8,000 Pharmaceutica Each capsule contains Rs. 8000- / l Laboratories Pregabalin 150mg Dy. No. nil Zeegap (Hilton) (Pvt.) Ltd, Manufacture dated 20-04- Kalawala, specification 2010 GMP inspection 20km Lahore (Photocopy) report of panel dated – Jaranwala Anti-eplileptic / Anti- 15-10-2015 Road, District convulsant Rs. 12000/- Sheikhupura. Dy. No. 397 dated 01-12- 2014
Pack size 2 x 7’s / Rs. 1500/-
One capsule / Rs. 107.15 Evaluator-I Muhammad Ansar 69. M/s Winthrox Zofen Syrup Form 5 BNF: Rejected for: Laboratories, 0.25mg/5ml 16-04-2015 Sanomigrane The board observed Plot No. 219- Each 5ml Contains: (Dy no. 418) Elixir Syrup that off label use of A, SITE, Pizotifen as Rs. 20,000/- 0.25mg /5ml pizotifen syrup is Super hydrogen malate As per Novartis UK appetite stimulant Highway ...0.25mg DRAP Mosegor Syrup which is not Phase-II, Serotonin and policy 0.25mg /5ml indicated in any Karachi Histamine Novartis Pharma literature. Antagonist Grant of DML by Pizotifen is Remaining Manufacture way of indicated in cluster Additional Specification formulation headache which is Section recommended not present among Deferred in (25.02.2015). children that’s why
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249. FID of Hyderabad at pizotifen is not Karachi has verified required in syrup the installation and dosage form. operational qualification of Potentiometer model No. KF787 vide inspection dated 29- 10-2015. 70. M/s Medley Ondan Tablet Form-5 FDA. Ondansetron Approved Pharmaceutica Each film coated tablet 10-11-2010 HCl 8mg as base by ls, Jhang contains:- vide diary M/s Dr Reddy Bahtar Road, Ondansetron as No. 1401 Wah Cantt. HCl…..8mg Rs.8000 07- Local Zofran tablet Rawalpindi Antiemetic 04-2015 vide bmg by M/s GSK. Priority No. USP Specifications diary 556 No.1237 Rs.12000 As per SRO 71. -do Ondan Injection Form-5 MHRA Zofran Approved Priority No. Each 4ml contains:- 10-11-2010 Injection 8mg/4ml by 560 Ondansetron as vide diary M/s Novartis HCl…..8mg No. 1412 Antiemetic Rs.8000 07- Local Zofran USP Specifications 04-2015 vide Injection 8mg by M/s diary GSK. No.1236 Rs.12000 As per SRO 72. -do- Medvepe Tablet Form-5 FDA Bendectin Approved Each film coated tablet 10-11-2010 Tablet extended Priority No. contains:- vide diary release by M/s Sanofi 557 Doxylamine No. 1406 Succinate…..10mg Rs.8000 07- Pyridoxine HCl…..10mg 04-2015 vide Antihistamine/vitamin diary Local Envepe tablet Manufacturer’s No.1235 10/10 by M/s RG Specifications Rs.12000 Pharma As per SRO 73. -do- P-Cin 200mg Tablet Form-5 Deferred for Priority No. Each film coated tablet 10-11-2010 confirmation of me too 558 contains:- vide diary status and approval Pefloxacin as No. 1408 status by reference Mesylate………...200mg Rs.8000 07- regulatory authorities. Antiemetic 04-2015 vide Manufacturer’s diary Specifications No.1238 Rs.12000 As per SRO 74. -do- Ice-15 Capsule Form-5 FDA Prevacid Approved Priority No. Each capsule contains:- 10-11-2010 capsule 15mg by M/s 559 Lansoprazole as Enteric vide diary Takeda coated Pellets eq to No. 1409 Lansoprazole…..15mg Rs.8000 07- Local. Anso capsule
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PPI 04-2015 vide 15mg by M/s USP Specifications diary Shaigan Source of Pellets M/s No.1234 Vision Pharma Kahuta Rs.12000 Triangle, Islamabad. As per SRO 75. M/s Macter Etigab Tablet Form-5-D MHRA Trobalt 50, Deferred for the International 100, 200, 300, submission of Ltd, Karachi. Each film coated tablet 02-08-2011 400mg f/c tablet following Priority No. contains:- vide diary Differential 1256 Retigabine…….50mg No. 52 fee. Rs.15000 Stability data Anti-Hyperglycemic not attached. Rs.9.7/tablet Prescribing Not provided information, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
76. -do- Etigab Tablet Form-5-D MHRA Trobalt 50, Deferred for the Priority No. 100, 200, 300, submission of 1259 Each film coated tablet 02-08-2011 400mg f/c tablet following contains:- vide diary Differential Retigabine……..300mg No. 49 fee not Rs.15000 attached. Anti-Hyperglycemic Stability data Rs.39.6/table not attached. Not provided t Prescribing informations, dosage and indications are
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not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
77. -do- Etigab Tablet Form-5-D MHRA Trobalt 50, Deferred for the Priority No. 100, 200, 300, submission of 1254 Each film coated tablet 02-08-2011 400mg f/c tablet following contains:- vide diary Differential Retigabine…..….200mg No. 45 fee not Rs.15000 attached. Anti-Hyperglycemic Stability data Rs.28.1/table not attached. Not provided t Prescribing information, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh
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inspection report not attached Details of HVAC & water treatment system not attached.
78. -do- Etigab Tablet Form-5-D MHRA Trobalt 50, Deferred for the Priority No. 100, 200, 300, submission of 1255 Each film coated tablet 02-08-2011 400mg f/c tablet following contains:- vide diary Differential Retigabine………400mg No. 50 fee not Rs.15000 attached. Anti-Hyperglycemic Stability data Rs.52.4/table not attached. Not provided t Prescribing information, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
79. -do- Etigab Tablet Form-5-D MHRA Trobalt 50, Deferred for the Priority No. 100, 200, 300, submission of 1253 Each film coated tablet 02-08-2011 400mg f/c tablet following contains:- vide diary Differential Retigabine………100mg No. 44 fee not Rs.15000 attached.
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Anti-Hyperglycemic Stability data Rs.17.3/table not attached. Not provided t Prescribing information, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
80. -do- e-Zak Tablet Form-5-D FDA Edarbi 40mg Deferred for the Priority No. & 80mg by M/s submission of 1262 Each tablet contains:- 02-08-2011 Arbor Pharma following Azilsartan as vide diary Differential Kamedoxomil eq to No. 1345 fee not Azilsartan Rs.15000 attached. Medoxomil…….80mg Stability data Rs.34/tablet not attached. Anti-Hypertensive Prescribing information, Not provided dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff.
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Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
81. -do- e-Zak Tablet Form-5-D FDA Edarbi 40mg Deferred for the Priority No. & 80mg by M/s submission of 1261 Each tablet contains:- 02-08-2011 Arbor Pharma following Azilsartan as vide diary Differential Kamedoxomil eq to No. 54 fee not Azilsartan Rs.15000 attached. Medoxomil…….40mg Stability data Rs.18/tablet not attached. Anti-Hypertensive Prescribing information, Not provided dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
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82. -do- Cyrox Tablet Form-5-D FDA Tapentadol Deferred for the 50, 75, 100mg submission of Priority No. Each immediate release 02-08-2011 Marketing Status is following 1265 tablet contains:- vide diary None (Tentative Differential Tapentadol………75mg No. 46 Approval) fee not Rs.15000 attached. Analgesic Stability data Rs.88/tablet not attached. Complete description require to be submitted in reference to innovator. Prescribing informations, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
83. -do- Cyrox Tablet Form-5-D FDA Tapentadol Deferred for the 50, 75, 100mg submission of Priority No. Each immediate release 02-08-2011 Marketing Status is following 1260 tablet contains:- vide diary None (Tentative Differential Tapentadol………50mg No. 55 Approval) fee not Rs.15000 attached. Analgesic Stability data Rs.60/tablet not attached. Not provided Complete description
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require to be submitted in reference to innovator. Prescribing informations, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
84. -do- Cyrox Tablet Form-5-D FDA Tapentadol Deferred for the Priority No. 50, 75, 100mg submission of 1257 Each immediate release 02-08-2011 Marketing Status is following tablet contains:- vide diary None (Tentative Differential Tapentadol………100mg No. 62 Approval) fee not Rs.15000 attached. Analgesic Stability data Rs.60/tablet not attached. Not provided Complete description require to be submitted in reference to innovator. Prescribing informations, dosage and indications are not attached as per
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innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
85. -do- Gliplyza Tablet Form-5-D FDA Deferred for the Saxagliptin;Metfor submission of Priority No. Each film coated tablet 02-08-2011 min HCl 5/500, following 1263 contains:- vide diary 2.5/1000, Differential Saxagliptin………2.5mg No. 56 5/1000mg by M/s fee not Metformin Rs.15000 Amneal attached. HCl….1000mg Marketing Status is Stability data Rs.30/tablet None (Tentative not attached. Anti-Diabetic Approval) Complete description require to be submitted in reference to innovator. Prescribing informations, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product
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specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
86. -do- Gliplyza Tablet Form-5-D FDA Deferred for the Saxagliptin;Metfor submission of Priority No. Each film coated tablet 02-08-2011 min HCl 5/500, following 1264 contains:- vide diary 2.5/1000, Differential Saxagliptin………5mg No. 53 5/1000mg by M/s fee not Metformin Rs.15000 Amneal attached. HCl….1000mg Marketing Status is Stability data Rs.55/tablet None (Tentative not attached. Anti-Diabetic Approval) Complete description require to be submitted in reference to innovator. Prescribing informations, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water
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treatment system not attached.
87. -do- Mactone Tablet Form-5-D FDA. Toviaz Deferred for the Priority No. extended release submission of 1314 Each extended release 29-08-2011 tablet 4mg & 8mg following tablet contains:- vide diary by M/s Pfizer. Differential Fesoterodine No. 89 fee not Fumarate..………4mg Rs.15000 attached. Stability data Rs.47.5/table not attached. Muscrinic Receptor t Complete Antagonist description require to be Not provided submitted in reference to innovator. Prescribing informations, dosage and indications are not attached as per innovator. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
88. -do- Limpat Tablet Form-5 FDA. Vimpat 150 Deferred for the Tablet by M/s UCB submission of Priority No. Each film coated tablet 02-08-2011 following 1258 contains:- vide diary Local Atcomid Differential Lacosamide………150m No. 48 100mg tablet fee not g Rs.8000 attached.
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Complete Anti-convulsant Rs.60.78/tabl description et require to be Not provided submitted in reference to innovator. Commitment as per the decision of RB not provided. Composition is not as per the innovator. Documents are not signed by the technical staff. Finished product specifications are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
Dr Hafza Karam Ellahi, DDC (PEC-II) 89. M/s Konac-M 50 Form 5 Arthrotec 50 by Deferred for the Remington Oral Tablets Dairy No. Pfizer Uk following Pharmaceutica Each tablet contains: 5856 clarification:- l Industries Diclofenac Sodium dated Cytopan by Getz There is difference (Pvt.) Ltd., 18 B.P… 50mg 29.06.2012 Pharma between composition KM, Multan Misoprostol Rs:8,000/- of API in composition Road Lahore. B.P…..200mcg Dated.30-07- of drug and active Priority No. (NSAID & Prostaglandin 2013 material 949 from E1 analogue) Rs:12,000/- 1776 after Manufacturer’s Specs 2x10’s swapping As per SRO 90. M/s Linzo Form 5 Zyvox by Pharmacia Approved Remington Oral Tablets Dairy No. and Upjohan Co. UK Pharmaceutica Each film coated tablet 5858 (need to be verified) l Industries contains: dated Ecasil by Saami (Pvt.) Ltd., 18 Linezolid……600mg 29.06.2012 Pharma KM, Multan (Antibacterial) Rs:8,000/- (need to be verified) Road Lahore. Manufacturer’s Specs Dated.30-07- Priority No. 2013
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948 from Rs:12,000/- 1770 after 2x6’s swapping As per SRO 91. M/s Linzo Form 5 Zyvox by Pharmacia Approved Remington Oral Tablets Dairy No. and Upjohan Co. UK Pharmaceutica Each film coated tablet 5855 (need to be verified) l Industries contains: dated Ecasil by Saami (Pvt.) Ltd., 18 Linezolid……400mg 29.06.2012 Pharma KM, Multan (Antibacterial) Rs:8,000/- (need to be verified) Road Lahore. Manufacturer’s Specs Dated.30-07- Priority No. 2013 947 from Rs:12,000/- 1771 after 2x6’s swapping As per SRO 92. M/s Ciof DS Form 5 Tarivid 400mg by Deferred for the Remington Oral Tablets Dairy No. Sanofi UK clarification of Pharmaceutica Each film coated tablet 3419 following:- l Industries contains: dated 21- Oflobid by Hilton There is difference (Pvt.) Ltd., 18 Ofloxacin U.S.P 052012 Pharma between composition KM, Multan …400mg Rs:8,000/- of API in composition Road Lahore. (Fluoroquinolones) Dated.30-07- of drug and active Priority No. (USP Specs) 2013 material 946 from Rs:12,000/- 2092 after 10’s swapping As per SRO 93. M/s Clariton Form 5 Biaxin by ABBVIE Approved Remington Oral Tablets Dairy No. USA Pharmaceutica Each film coated tablet 5854 l Industries contains: dated 29-06- Claricid by Abbott (Pvt.) Ltd., 18 Clarthromycin 2012 Laboratories KM, Multan USP…250mg Rs:8,000/- Road Lahore. (Antibiotic) Dated.30-07- Priority No. USP Specs 2013 843 from Rs:12,000/- 1774 after 1x10’s swapping As per SRO 94. M/s Irontose-F Form-5 Ferosoft FA by Deferred for the Unipharma Tablet Dy. No: Hilton Pharma Japan submission of (Pvt) Ltd. Each chewable tablet 1515 Commitment as per 4.5km Manga- contains. Iron-III Rs.8000/- decision of the board Raiwind Road Hydoxide Polymaltose Dated. Maltofer by Getz Lahore. Complex equivalent to 08-06-2011 Pharma Priority No. elemental Rs.12,000/- 1126 iron………….100mg Dated. Folic acid……0.35mg 31-07-2013 (Heamatonic) Rs.300/20’s (Manufacturer Specs)
95. M/s Utrahit-beta Form-5 Vrexidol by Trinity Deferred for the Unipharma Tablet Dy. No: Pharma UK submission of (Pvt) Ltd. Each tablet contains. 1515 Commitment as per 4.5km Manga- Piroxicam-beta- Rs.8000/- Pirodex by Schazoo decision of the board Raiwind Road cyclodextrin 191.2 eq. to Dated. Zaka
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Lahore. Piroxicam……20mg 08-06-2011 Priority No. (Anti-Inflammatory Rs.12,000/- 1108 Analgesic) Dated. (Manufacturer’s Specs) 31-07-2013 Rs.170/1x10 ’s 96. M/s Uviarein Form-5 Artrodar by Proter Deferred for the Unipharma Tablet Dy. No: Pharma Itlay submission of (Pvt) Ltd. Each tablet contains. 1525 (need to be verified) Commitment as per 4.5km Manga- Diacerein…….50mg Rs.8000/- Diacerein by decision of the board Raiwind Road (NSAID,s) Dated. Genome Pharma Lahore. (Manufacturer’s Specs) 08-06-2011 (need to be verified) Priority No. Rs.12,000/- 1113 Dated. 31-07-2013 Rs.270/1x10 ’s 97. M/s Unifen-100 Form-5 Brufen Suspension Deferred for the Unipharma Suspension Dy. No: by Abbott UK submission of (Pvt) Ltd. Each 5ml contains: 1517 (need to be verified) Commitment as per 4.5km Manga- Ibuprofen BP……100mg Rs.8000/- Brufen Suspension decision of the board Raiwind Road (Propionic acid) Dated. Abbot Pharma Lahore. (B.P Specs) 08-06-2011 (need to be verified) Rs.12,000/- Priority No. Dated. 1118 31-07-2013 Rs.60/120 ml 98. M/s Fidohit-S Form-5 Pepcid by Morsan Deferred for the Unipharma Suspension Dy. No: Uk submission of (Pvt) Ltd. Each 5ml contains: 1543 (need to be verified) Commitment as per 4.5km Manga- Famotidine……….10mg/ Rs.8000/- G-met by Tabros decision of the board Raiwind Road 5ml Dated. Pharma Lahore. (H2 Blocker) 08-06-2011 (need to be verified) Priority No. (Manufacturer’s Specs) Rs.12,000/- 1109 Dated. 31-07-2013 Rs.45/60 ml 99. M/s Cetrihit-S Form-5 Zyrtec Syrup by Deferred for the Unipharma Syrup Dy. No: UCH Belgium submission of (Pvt) Ltd. Each 5ml contains: 1555 (need to be verified) Commitment as per 4.5km Manga- Cetirizine Rs.8000/- Alce by decision of the board Raiwind Road USP…….5mg/5ml Dated. Dermatechno Lahore. (Antihistamine:Oxyzine 08-06-2011 Priority No. Type) Rs.12,000/- (need to be verified) 1124 (B.P Specs) Dated. 31-07-2013 Rs.80/120 ml 100. M/s Irontose Form-5 Ferrum Syrup by Deferred for the Unipharma Syrup Dy. No: Sigma Australia submission of (Pvt) Ltd. Each 5ml contains: 1514 (need to be verified)) Commitment as per 4.5km Manga- Iron-III Hydroxide Rs.8000/- Ferosoft by Hilton decision of the board Raiwind Road Polymaltose complex eq. Dated. (need to be verified) Lahore. to elemental iron… 08-06-2011 Priority No. ….50mg Rs.12,000/-
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1125 (Heamatinic) Dated. (Manufacturer’s Specs) 31-07-2013 Rs.120+/120 ml
Deferred cases of Pregabalin Evaluator II: Muhammad Ansar
101. M/s Rock Roglin Capsule Form-5 LYRICA Deferred for the Pharmaceutical 300mg 10-06-2010 Capsules 50mg, submission of following Laboratories Each capsule vide diary No. 75, 100mg, Commitment as per (Pvt), Ltd contains:- 126 Rs.8000 150mg, 300mg decision of RB is Nowshera Pregabalin…..3 & 11-12-2014 US FDA not provided. Industrial Estate 00mg vide diary No.
Risalpur. GABA 569 Rs.12,000 GABICA Last inspection Analogue As per SRO Capsules 50mg, report is not Manufacturer’s 75, 100, 150, attached Specifications 300mg Finished product Getz specifications are incomplete 102. -do- Roglin Capsule Form-5 LYRICA Deferred for the 150mg 10-06-2010 Capsules 50mg, submission of following Each capsule vide diary No. 75, 100mg, Commitment as per contains:- 127 Rs.8000 150mg, 300mg decision of RB is Pregabalin…… & 11-12-2014 US FDA not provided. …150mg vide diary No. GABA 569 Rs.12,000 GABICA Last inspection Analogue As per SRO Capsules 50mg, report is not Manufacturer’s 75, 100, 150, attached Specifications 300mg Finished product Getz specifications are incomplete 103. -do- Roglin Capsule Form-5 LYRICA Deferred for the 100mg 10-06-2010 Capsules 50mg, submission of following Each capsule vide diary No. 75, 100mg, Commitment as per contains:- 128 Rs.8000 150mg, 300mg decision of RB is Pregabalin…..1 & 11-12-2014 US FDA not provided. 00mg vide diary No. GABA 569 Rs.12,000 GABICA Last inspection Analogue As per SRO Capsules 50mg, report is not Manufacturer’s 75, 100, 150, attached Specifications 300mg Finished product Getz specifications are incomplete
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104. -do- Roglin Capsule Form-5 LYRICA Deferred for the 75mg 10-06-2010 Capsules 50mg, submission of following Each capsule vide diary No. 75, 100mg, Commitment as per contains:- 129 Rs.8000 150mg, 300mg decision of RB is Pregabalin…..7 & 11-12-2014 US FDA not provided. 5mg vide diary No. GABA 569 GABICA Last inspection Analogue Rs.12,000 Capsules 50mg, report is not Manufacturer’s As per SRO 75, 100, 150, attached Specifications 300mg Finished product Getz specifications are incomplete 105. -do- Roglin Capsule Form-5 LYRICA Deferred for the 50mg 10-06-2010 Capsules 50mg, submission of following Each capsule vide diary No. 75, 100mg, Commitment as per contains:- 130 Rs.8000 150mg, 300mg decision of RB is Pregabalin…..5 & 11-12-2014 US FDA not provided. 0mg vide diary No. GABA 569 Rs.12,000 GABICA Last inspection Analogue As per SRO Capsules 50mg, report is not Manufacturer’s 75, 100, 150, attached Specifications 300mg Finished product Getz specifications are incomplete
DEFERRED CASES OF PREVIOUS MEETINGS: Evaluator II: Salateen Waseem Philip ADVANTAN MILK - M/S BAYER PAKISTAN (PRIVATE) LIMITED, BAHRIA COMPLEX II, 4TH FLOOR, M.T. KHAN ROAD, KARACHI.
The routine case of M/s Bayer Pakistan (Private) Limited Bahria Complex II, 4th Floor, M.T Khan Road, Karachi was presented in 254th meeting of RB and decided as under:-
S/ Name and Brand Name Type of Form International Decision of 254th N address of (Proprietary name + Initial date, status in meeting of RB manufacturer / Dosage Form + diary stringent Applicant Strength) Fee including regulatory Composition differential fee agencies Pharmacological Demanded Price Group / Pack size Me-too status Finished product Specification GMP status as depicted in inspection report (dated)
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106. M/s Bayer ADVANTAN MILK Form 5-A Approved with Pakistan Rs. 100,000/- Advantan Milk condition for provision (Private) Each 1gm Advantan vide Dy. No. (Bayer,Italy) of legalized valid Limited, Bahria Milk contains 328 dated 03- marketing COPP. Complex II, 4th Methylprednisolone 06-2011 & 11- authorization floor, M.T. Aceponate 1mg 10-2012 in EEA Khan Road, (0.1%) countries Karachi. (European Glucocorticosteroid One tube of Economic Intendis cutaneous emulsion 20gm/ 750 PKR Areas) Austria, Manufacturing Belgium, S.P.A, Via E (Manufacture Bulgaria, Schering, 21, Specification) Cyprus, Czech 20090 Segrate Republic, (Milan) Italy Estonia, Finland, Germany, Greece, Hungary, Italy, Lithuania, Latvia, Luxembourg, Portugal, Romania, Slovenia.
Now firm has provided fresh COPP and GMP legalized status of the firm as under:- COPP: - issued on 25th September 2015, by Italian Medicinal Agency and certified that this medicine is authorized to be marketed and sold in Italy manufactured by BAYER HEALTHCARE MANUFACTURING S.R.L. with factory located in VIA E.SCHERING, 21 SEGRATE (MI) ITALY. (Authorization date 10/01/2014)
The name of the finished product manufacturer has been changed from Intendis Manufacturing to Bayer Healthcare Manufacturings S.R.L while company address is the same.
Decision:- The Board approved the application.
(Evaluator II: Rana Ahsan Ul Haq)
107. M/s ALLMED K-CIT Form-5 Alvesco by M/s Deferred (Private) limited, Tablet Dy. No: 5139 Takeda GMBH sundar industrial Each extended release Tablet dated. (USFDA) estate, Lahore. contains: 31-05-2012 Potassium Citrate…..10mEq Rs.8, 000/- Urocit-K by M/s (1080mg) dated. Universal (Alkalizing agent) 11-10-2012 enterprises. Manufacturer Specs Rs:12,000/ (039808) As per PRC/
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108. Jenner Claritro Dry Suspension Form 5 Approved Pharmaceuticals 125mg Dairy Date Klaricid (Pvt) Ltd. Lahore Each 5ml after reconstitution 24.08.15 Suspension By Source: 27.5% (Remaining contains : Rs: 20000.00 Pellets application of Clarithromycin : 125mg dated 18.08.15 BGP Products manufactured by:- New Liscence) (Macrolide) As per SRO Limited, UK M/s Surge 60ml MHRA Laboratories Claritek Susp. By (pvt) Faisalabad m/s (Getz) Road, Sheikhupora.
Remaining/ Replacement applications of New Licenses/ additional sections
109. M/s Sigma Gastik Capsule 50mg Form-5 Gabica 50mg by Approved Pharma, Capsule Dy. No: 361 M/s Getz pharma International Each Capsule contains: dated. (Pvt.) Ltd. Pregabalin….....50mg 17-06-2015 Karachi. (GABA Analogue) Rs.20,000/- Manufacturer Specs As per DRAP Policy / 2x5’s 2x7’s 110. M/s Sigma Gastik Capsule 75mg Form-5 Gabica 75mg by Approved Pharma, Capsule Dy. No: 361 M/s Getz pharma International Each Capsule contains: dated. (Pvt.) Ltd. Pregabalin….....75mg 17-06-2015 Karachi. (GABA Analogue) Rs.20,000/- Manufacturer Specs As per DRAP Policy / 2x5’s 2x7’s 111. M/s OBS Ostavee Form-5D Duavee By M/s Deferred for Pakistan Pvt ltd; Tablets Dy. No: 1148 Wyeth pharm clarification C-14, S.I.T.E Each modified Tablet dated. Pfizer regarding Karachi, contains: 14-12-2015 manufacturing Pakistan Conjugated estrogen…….. Rs.50,000/- requirements of (New Molecule) 0.45mg Not mentioned this product and Bazedoxifene acetate eq.to use of ascorbic Bazedoxifene ……20mg acid in formulation (Estrogen / selective estrogen as antioxidant receptor modulators) USES: Vasomotor Stability studies as Symptoms associated with per 251st meeting Menopause (Post of RB required. Menopausal Osteoprosis)
Misleading information by the firm for grant of registration on account of NEW SECTION
M/s Nortech Pharmaceuticals, 203 Sahala Industrial triangle, Kahuta Road, Islamabad has applied 6 products for new section. During evaluation it was observed that the firm was granted 10 products in 249th meeting for the same section. The firm has given misleading statement and tried to play foul with R.B.
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112. M/s Nortech Metronor Injection Form-5-A Flagyl Infusion Firm submitted the Pharmaceuticals, Injectable Dy. No: 518 (Sanofi Aventis dossiers, misleading 203 Sahala Each 100ml contains: dated. Pakistan) the evaluator and Industrial triangle, Metronidazole….....500mg 20-02-2014 RB, as they have Kahuta Road, (Amoebicide) Rs.20,000/- already got 10 Islamabad. USP Specs. As per DRAP products for this letter No: F.6- Policy / section in 249th 6/2014-Lic (M- 100ml meeting. In 249th 237) dated 14-10- meeting it was 14 discussed as Case No 07 serial No. 337 to 336. 113. M/s Nortech Levonor Injection Form-5-A Leflox Infusion Firm submitted the Pharmaceuticals, Injectable Dy. No: 517 500mg/100ml dossiers, misleading 203 Sahala Each 100ml contains: dated. (Getz the evaluator and Industrial triangle, Levofloxacin (as 20-02-2014 Pharmaceutical) RB, as they have Kahuta Road, hemihydrate)….....500mg Rs.20,000/- already got 10 Islamabad. (Quinolone Antibiotic) As per DRAP products for this letter Nortech Specs. Policy / section in 249th 100ml meeting. In 249th meeting it was discussed as Case No 07 serial No. 337 to 336. 114. M/s Nortech Moxinor Injection Form-5-A Avelon Firm submitted the Pharmaceuticals, Injectable Dy. No: 521 400mg/250ml dossiers, misleading 203 Sahala Each 250ml contains: dated. Infusion (EG the evaluator and Industrial triangle, Moxifloxacin (as HCl) 20-02-2014 Pharmaceutical) RB, as they have Kahuta Road, .....400mg Rs.20,000/- already got 10 Islamabad. (Quinolone Antibiotics) As per DRAP products for this Nortech Specs. Policy / section in 249th 100ml meeting. In 249th meeting it was discussed as Case No 07 serial No. 337 to 336. 115. -do- Cipronor Injection Form-5-A Novidate Firm submitted the Injectable Dy. No: 516 Infusion (Sami dossiers, misleading Each 100ml contains: dated. Pharma.) the evaluator and Ciprofloxacin (as 20-02-2014 RB, as they have lactate)….....200mg Rs.20,000/- already got 10 (Quinolone Antibiotics) As per DRAP products for this USP Specs. Policy / section in 249th 100ml meeting. In 249th meeting it was discussed as Case No 07 serial No. 337 to 336. 116. -do- Cipronor Injection Form-5-A Novidate Firm submitted the Injectable Dy. No: 519 Infusion (Sami dossiers, misleading Each 100ml contains: dated. Pharma.) the evaluator and Ciprofloxacin (as 20-02-2014 RB, as they have lactate)….....400mg Rs.20,000/- already got 10 (Quinolone Antibiotics) As per DRAP products for this
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USP Specs. Policy / section in 249th 100ml meeting. In 249th meeting it was discussed as Case No 07 serial No. 337 to 336. 117. -do- Oflonor Injection Form-5-A Geoflox Infusion Firm submitted the Injectable Dy. No: 520 (Geofman dossiers, misleading Each 100ml contains: dated. Pharma.) the evaluator and Ofloxacin….....200mg 20-02-2014 RB, as they have (Quinolone Antibiotics) Rs.20,000/- already got 10 Nortech Specs. As per DRAP products for this Policy / section in 249th 100ml meeting. In 249th meeting it was discussed as Case No 07 serial No. 337 to 336.
Decision: Registration Board deferred the case for confirmation of 10 products per section of the firm.
New molecule:
118. M/s Martin Dow Roswin Plus Form-5-D ------Deferred for Pharmaceuticals Tablets Dy. No: 634 Reference for specs not Limited, Korangi Each film coated tablet dated. provided. Industrial Area, contains: 27.12.2011 Challan of differential Karachi-74900 Rosuvastatin as Rs.15,000/- fee not attached. calcium ………... Differential fee Last inspection report is Priority list 10mg Challan is dated 26.02.2011. No.1846 after Fenofibrate USP … missing Undertaking as per 251st 1450 after 145mg Rs. 550.00/10’s meeting of RB not swapping (combination of HMG 1100.00/20’s provided. CoA reductase 1650.00/30’s Approval Status in SRAs inhibitor & Fibrate) not confirmed. (Reference for specs Stability studies as per not provided) 251th meeting of RB required.
119. M/s Martin Dow Roswin Plus Form-5-D ------Deferred for Pharmaceuticals Tablets Dy. No: 635 Reference for specs not Limited, Korangi Each film coated tablet dated. provided. Industrial Area, contains: 27.12.2011 Challan of differential Karachi-74900 Rosuvastatin as Rs.15,000/- fee not attached. calcium ………... 5mg Differential fee Last inspection report is Priority list Fenofibrate USP … Challan is dated 26.02.2011. No.1845 after 145mg missing Undertaking as per 251st 1453 after (combination of HMG Rs.400.00/10’s meeting of RB not swapping CoA reductase 800.00/20’s provided. inhibitor & Fibrate) 1200.00/30’s Approval Status in SRAs (Reference for specs not confirmed.
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not provided) Stability studies as per 251th meeting of RB required.
120. -do- Juvin Form-5-D ------Deferred for Priority list Tablets Dy. No: 641 Reference for specs not No.1038 after Each film coated tablet dated. provided. 1454 after contains: 27.12.2011 Challan of differential swapping Sitagliptin as phosphate Rs.15,000/- fee not attached. ……. 100mg Differential fee Last inspection report is Simvastatin……… Challan is dated 26.02.2011. 40mg missing Undertaking as per 251st (Combination of Rs. 3500.00/10’s meeting of RB not Dipeptidyl peptidase 7000.00/20’s provided. inhibitor & HMG CoA 10,500/30’s Approval Status in SRAs reductase inhibitor) not confirmed. (Reference for specs Stability studies as per not provided) 251th meeting of RB required.
121. -do- Juvin Form-5-D ------Deferred for Priority list Tablets Dy. No: 643 Reference for specs not No.1047 Each film coated tablet dated. provided. 1451after contains: 27.12.2011 Challan of differential swapping Sitagliptin as phosphate Rs.15,000/- fee not attached. ……. 100mg Differential fee Last inspection report is Simvastatin……… Challan is dated 26.02.2011. 20mg missing Undertaking as per 251st (Combination of Rs.3050.00/10’s meeting of RB not Dipeptidyl peptidase 6100.00/20’s provided. inhibitor & HMG CoA 9150/30’s Approval Status in SRAs reductase inhibitor) not confirmed. (Reference for specs Stability studies as per not provided) 251th meeting of RB required.
122. -do- Juvin Form-5-D ------Deferred for Priority list Tablets Dy. No: 644 Reference for specs not No.1048 after Each film coated tablet dated. provided. 1457 after contains: 27.12.2011 Challan of differential swapping Sitagliptin as phosphate Rs.15,000/- fee not attached. ……. 100mg Differential fee Last inspection report is Simvastatin……… Challan is dated 26.02.2011. 10mg missing Undertaking as per 251st (Combination of Rs.2620.00/10’s meeting of RB not Dipeptidyl peptidase 5240.00/20’s provided. inhibitor & HMG CoA 7860/30’s Approval Status in SRAs reductase inhibitor) not confirmed. (Reference for specs Stability studies as per not provided) 251th meeting of RB required.
123. -do- Reufin Form-5-D ------Deferred for Priority list Tablets Dy. No: 636 Reference for specs not
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No.1049 after Each film coated tablet dated. provided. 1448 after contains: 27.12.2011 Challan of differential swapping Ibuprofen ………. Rs.15,000/- fee not attached. 800mg Differential fee Last inspection report is Famotidine ……… Challan is dated 26.02.2011. 26.60mg missing Undertaking as per 251st (NSAID + H2 receptor Rs.180.00/10’s meeting of RB not antagonist) 360.00/20’s provided. (Reference for specs 540/30’s Approval Status in SRAs not provided) not confirmed. Stability studies as per 251th meeting of RB required.
124. -do- Tespral Total Form-5-D ------Deferred for Capsule Dy. No: 351 Reference for specs not Priority list Each capsule contains: dated. provided. No.822 after Pantoprazole sodium 25.06.2011 Challan of differential 1200 after sesquihydrate Rs.15,000/- fee not attached. swapping equivalent to Differential fee Last inspection report is Pantoprazole (enteric Challan is dated 26.02.2011. coated) ………. 40mg missing Undertaking as per 251st Itopride HCl ……… Rs.946.94/10’s meeting of RB not 150mg provided. (Proton pump Inhibitor Approval Status in SRAs + Prokinetic agent) not confirmed. (Reference for specs Stability studies as per not provided) 251th meeting of RB required.
125. -do- Zivaro Form-5-D ------Deferred for Priority list Tablets Dy. No: 666 Reference for specs not No.1562 after Each film coated tablet dated. provided. 1505 after contains: 16.02.2012 Challan of differential swapping Rivaroxaban ……. Rs.8,000/- fee not attached. 20mg Differential fee Last inspection report is (Anti thrombic agent) Challan is dated 26.02.2011. (Reference for specs missing Undertaking as per 251st not provided) Rs. 9680.00/5’s meeting of RB not 19360.00/10’s provided. 38720.00/20’s Approval Status in SRAs 58080/30’s not confirmed. Stability studies as per 251th meeting of RB required.
126. -do- Lanco 6/50mg Form-5-D ------Deferred for Priority list Capsules Dy. No: 669 Reference for specs not No.1510 after Each capsule contains: dated. provided. 1506 after Olenzapine (USP) 16.02.2012 Challan of differential swapping ……. 6mg Rs.8,000/- fee not attached. Fluoxetine HCl Differential fee Last inspection report is …….50mg Challan is dated 26.02.2011. (combination of missing Undertaking as per 251st
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atypical antipsychotic Rs. 253.50/10’s meeting of RB not & Selective serotonin 507.00/20’s provided. reuptake Inhibitor) 760.50/30’s Approval Status in SRAs (Reference for specs not confirmed. not provided) Stability studies as per 251th meeting of RB required.
127. M/s ATCO Alodip H Form-5-D Amturnide Deferred for Laboratories 300/10/12.5mg Dy. No: 489 (Novartis) Stability studies as per Limited, B-18 Tablet dated. USFDA 251th meeting of RB SITE Karachi. Each film coated tablet 31.03.2011 required. contains: Rs.15,000/- Priority list Aliskiren as 02.08.2013 No.2375 from (hemifumarate) Rs:35,000/- 959 after MS……… 300mg Rs. 3010/14’s swapping Hydrochlorothiazide 6020/28’s USP … 12.5mg Amlodipine (besylate)…..10mg (Cardiovascular drugs) (Atco specification) 128. -do- Rashfree Cream Form-5-D Sudo Crem Deferred for Priority list Cream Dy. No: 213 antiseptic healing Approval in SRAs not No.1051 Each gm contains: dated. cream Forest Lab confirms. Zinc Oxide BP …..…. 18.05.2011 MHRA. Stability studies as per 15.25% Rs.15,000/- 251th meeting required. (Dermal Preparation) 02.08.2013 (Atco Specifications) 35,000/- Rs. 100/15gm 660/100gm 129. -do- Canaflo 100mg Form-5-D Invokana (Janssen Deferred for Priority list No. Tablet Dy. No: 1336 Cilag) USFDA, Stability studies as per 799 from 2409 Each film coated tablet dated. MHRA 251st th meeting required. after swapping contains: 09.07.2013 Canagliflozin (as Rs.50,000/- hemihydrate) MS..…. Rs. 250/Tablet 100mg 7’s, 14’s & 28’s (Anti-diabetic) (Atco Specs) Uses: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 130. -do- Canaflo 300mg Form-5-D Invokana (Janssen Deferred for Priority list No. Tablet Dy. No: 1447 Cilag) USFDA, Stability studies as per 872 from 2467 Each film coated tablet dated. MHRA 251st meeting required. after swapping contains: 26.07.2013 Canagliflozin (as Rs.50,000/- hemihydrate) MS..…. Rs. 550/Tablet 300mg 7’s, 14’s & 28’s (Anti-diabetic) (Atco Specs)
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Uses: adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus 131. -do- Retig 100mg Form-5-D Trobalt (GSK Deferred for Priority list No. Tablet Dy. No: 71 UK) MHRA Stability studies as per 1327 Each film coated tablet dated. 251st meeting required. contains: 08.09.2011 Retigabine MS ..…. Rs.15,000/- 100mg 02.08.2013 (Anti-epileptic) 35,000/- (Atco Specs) Rs. 85/Tablet Uses: adjunctive 10’s, 14’s & 30’s treatment of partial onset seizures 132. -do- Retig 300mg Form-5-D Trobalt (GSK Deferred for Priority list No. Tablet Dy. No: 125 UK) MHRA Stability studies as per 1357 Each film coated tablet dated. 251st meeting required. contains: 21.09.2011 Retigabine MS ..…. Rs.15,000/- 300mg 02.08.2013 (Anti-epileptic) 35,000/- (Atco Specs) Rs. 200/Tablet Uses: adjunctive 10’s, 14’s & 30’s treatment of partial onset seizures 133. -do- Agrel Form-5-D Brilinta Deferred for Priority list No. Tablet Dy. No: 1130 (Astrazeneca LP) Stability studies as per 898 from 1769 Each film coated tablet dated. USFDA 251st meeting required. after swapping contains: 28.06.2012 Ticagrelor MS ..…. Rs.15,000/- 90mg 02.08.2013 (Cyclopentyltri- 35,000/- azolopyrimidine) Rs. 1200/Tablet (Atco Specs) 14’s & 28’s Uses: reduces the rate of thrombic cardiovascular events in patients acute coronary syndrome 134. -do- Acdermin Cream Form-5-D Treclin 30 (Meda Deferred for Priority list No. Topical Cream Dy. No: 916 Pharmaceuticals) Stability studies as per 1679 Each gm contains: dated. MHRA 251st meeting required. Clindamycin phosphate 07.06.2012 USP eq. Clindamycin Rs.15,000/- …..…. 1.0% 02.08.2013 Tretinoin 35,000/- Rs. 350/20gm
USP……….0.025% (Anti Acne Preparation) (Atco Specifications)
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135. M/s Pfizer Inlyta Form-5-A Inlyta Pfizer USA. Approved Pakistan Limited Film coated tablet Dy. No: 168 12 Dockyard Each tablet contains dated. EMA approved Road, West Axitinib……1mg 27-09-2013 Wharf, Karachi. (Selective tyrosine Rs.50,000/- EMA conducted kinase inhibitor) Not provided inspection of the Manfacturer and 28 tablet firm for approval responsible for of the said product batch release: New Molecule M/s Pfizer Manufacturing Deutschland Gmbh Betriebsstatte Freiburg Mooswaldallee1 79090 Freiburg Germany.
Marketing authorization Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, UK (152) Import
Priority list No.152 import
136. M/s Pfizer Inlyta Form-5-A Inlyta Pfizer USA. Approved Pakistan Limited Film coated tablet Dy. No: 167 12 Dockyard Each tablet contains dated. EMA approved Road, West Axitinib……5mg 27-09-2013 Wharf, Karachi. (Selective tyrosine Rs.50,000/- EMA conducted kinase inhibitor) Not provide inspection of the Manfacturer and Not provided firm for approval responsible for New Molecule of the said product batch release: M/s Pfizer Manufacturing Deutschland Gmbh Betriebsstatte Freiburg Mooswaldallee1 79090 Freiburg Germany.
Marketing authorization Holder: Pfizer Limited, Ramsgate Road, Minutes for 256th Meeting Registration Board 392
Sandwich, Kent CT13 9NJ, UK (153) Import
Priority list No.153 import
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ITEM IV:- ADDITIONAL SECTION EVALUATOR IV: Salateen Waseem Philip
S/N Name and Brand Name Type of Form International Decision address of (Proprietary name + Initial date, status in stringent manufacture Dosage Form + diary regulatory r / Applicant Strength) Fee including agencies Composition differential fee Pharmacological Demanded Me-too status Group Price / Pack size Finished product GMP status as Specification depicted in inspection report (dated)
137. M/s Gallop G-Metro IV Infusion Form-5 MHRA. Approved Water Science Dy. No: 3474 Metronidazole 404, Sundar Each 100ml contains:- dated.18-05- 500mg/100ml IV Industrial Metronidazole..500mg 2015 Rs.20,000/- infusion by M/s Estate Lahore Rs.80/100ml Baxter Anti Protozoal LDPE bottle B.P specifications Local Flagyl infusion by M/s Sanofi 138. - -do- G-Sol IV Infusion Form-5 FDA. Dextrose Approved - Dy. No: 3466 25% 250mg/ml by Each 100ml contains:- Dated.18-05- M/s Hospira Dextrose 2015 Rs.20,000/- anhydrous….25gm Rs.1200/100x25 Local. Pladex-25
ml infusion by M/s (Caloric Solution) BP Specifications Otsuka 139. - -do- G-Cipro IV Infusion Form-5 MHRA. Approved Dy. No: 3452 Ciprofloxacin Each 100ml contains:- dated.18-05- 2mg/ml solution Ciprofloxacin as lactate 2015 Rs.20,000/- for infusion by 200mg Rs.350/100ml M/s Hospira
LDPE Bottles (Quinolone) B.P Specifications Local.Ciproxin by M/s Bayer
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140. -do- G-H2O Injection Form-5 Dy. No: 3462 Approved Water for Injection dated. 18-05- 2015 Rs.20,000/- Sterile irrigating Rs.600/100x5ml Solution
USP Specifications
141. -do- G-Levo IV Infusion Form-5 BNF. Tavanic Approved Dy. No: 3468 500mg/100ml by Each 100ml contains:- dated. 18-05- M/s Sanofi Levofloxacin…500mg 2015 Rs.20,000/- Rs.350/100ml Local Leflox (Quinolone) 500mg, 750mg by Manufacturer’s Specifications M/s Getz 142. -do- G-Levo IV Infusion Form-5 Deferred for Dy. No: 3460 confirmation of Each 100ml contains dated. Local Leflox approval status of Levofloxacin…750mg 18-05-2015 500mg, 750mg by same dosage in (Quinolone) Rs.20,000/- M/s Getz reference
regulatory Rs.700/- 100ml authorities. 143. -do- G-Nebu Sol IV Form-5 MHRA. Deferred for Infusion Dy. No: 3461 Ipratropium confirmation of Each 2ml contains:- dated.18-05- 500mcg/2ml me too in LDPE Ipratropium 2015 Rs.20,000/- Nebulizer Solution packing in same Bromide… 0.5218mg Rs.400/5x2ml strength eq to Ipratropium 0.5mg Anticholinergic B.P Specifications
144. -do- G-Aero Sol IV Form-5 Deferred for Infusion Dy. No: 3456 confirmation of Each 2ml contains:- dated. me too status and Beclomethasone 18-05-2015 approval status of Diproponate…0.8mg Rs.20,000/- same dosage form (Corticosteroid) Rs.400/- in reference Manufacturer’s 5x2ml regulatory Specifications authority.
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ITEM IV:- Routine cases.
EVALUATOR IV S/N Name and Brand Name Type of Form International Decision address of (Proprietary name + Initial date, status in stringent manufacturer / Dosage Form + diary regulatory Applicant Strength) Fee including agencies Composition differential fee Pharmacological Group Demanded Me-too status Finished product Price / Pack size Specification GMP status as depicted in inspection report (dated)
154. M/s MBL Peadisol 500ml Oral Form 5-A International Deferred for Pharma, Plot # Solution Rs. 8000/- vide availability not completion of B-77/A, Hub Dy. No. 96 dated given application for Industrial Each 500ml contains 11-02-2011 following Trading Estate, Sodium Chloride USP Pedialyte abbott shortcomings/obs ervations:- Balauchistan 1.75gm Latest Trisodium Citrate Pack size of inspection Priority list Dihydrate USP 1.45gm 500ml report required No.865 Potassium chloride USP Rs. 44/- Commitment 0.75gm required as per Glucose anhydrous USP decision of 10.0gm 251st meeting of RB. Antidiarrhoeals Proof for USP Specification differential fee of Rs. 12000/-
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155. -do- Tablet Polymazol-F Form 5 Maltofer Tablet – Deferred for Rs. 8000/- vide Vifor Australia completion of Priority list Each tablet contains Dy. No. 645 application for No.910 Iron (III) hydroxide dated 15-03- Ferrum FA - following polymaltose complex 2011 Pharmevo shortcomings/obs ervations equivalent to elemental Complete
Iron … 100 mg description of Folic acid 0.35mg Pack size of 1 x dosage form 10’s required i.e. Rs. 75/- film coated/ Haematinic core tablet / USP Specification chewable tablet / enteric coated tablet etc. Latest inspection report required Commitment required as per decision of 251st meeting of RB. Proff of differential fee of Rs. 12000/-
156. -do- Carolin oral Syrup Form 5 International Deferred for Rs. 8000/- vide availability not completion of Priority list Each 5ml contains Dy. No. 256 provided application for No.1061 Ammonium Chloride BP dated 23-05- following 100 mg 2011 Semo-cof (Semos) shortcomings/obs ervations Chlorpheniramine Latest Maleate BP 2mg inspection Ephedrine HCl BP 7mg Pack size of report required 60ml Rs. 20/- Commitment Antihistamine / 120ml Rs. required as per Bronchodilator 40/- decision of Firm’s Specification 450 ml Rs. 251st meeting 100/- of RB. Differential fee of Rs. 12000/- Reference of finished product specification required
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157. M/s Noa Hemis Quinox Cream 4% Form 5 Valeant –USA Approved Pharmaceuticals Rs. 20000/- & , Plot # 154, Each gram contains 12000/- vide Revaquin Sector 23, Hydroquinone 40mg Dy. No. 256 (Dermagen) Korangi dated 23-05- Industrial Area, Anti Hyperpigmentation, 2011 & 10-04- GMP compliant Karachi Melasma 2014 section vide USP specification inspection report of Priority list panel dated 02-02- No.1348 Pack size of 2015. 15gm Rs. 260/-
158. -do- Quinox Cream 2% Form 5 TGA approved Approved Rs. 20000/- vide Priority list Each gram contains Dy. No. 256 Revaquin No.1349 Hydroquinone 20mg dated 23-05- (Dermagen) 2011 & 10-04- Anti Hyperpigmentation, 2014 GMP compliant Melasma section vide USP specification inspection report of Pack size of panel dated 02-02- 15gm Rs. 2015. 260/-
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159. -do- Acrotin gel Form 5 MHRA approved Approved Rs. 20000/- vide Isotrexin gel Priority list Each gram contains Dy. No. 256 No.1344 Erthromycin 20mg dated 23-05- Isotretinoin 0.5mg 2011 & 10-04- 2014 Isotrexin – GSK Antibacterial agent Firm’s specification GMP compliant Pack size of section vide 10gm Rs. inspection report of 230/- panel dated 02-02- 2015.
160. -do- Calpril Ointment Form 5 MHRA approved Approved Rs. 20000/- vide product of Sndoz Priority list Each gram contains Dy. No. 163 No.1337 Calcipotriol 50 mcg dated 17-09- 2011& 10-04- Vitamin D analogue 2014 Isotrexin – GSK Firm’s specification GMP compliant section vide Pack size of inspection report of 10gm Rs. panel dated 02-02- 980/- 2015. 30gm Rs. 950/-
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161. -do- Dicamin Gel 1% Form 5 MHRA approved Approved Rs. 20000/- vide product of Sndoz Priority list Each gram contains Dy. No. 169 No.1345 Diclofenac Sodium (as dated 17-09- Diclofenac Diethyl 2011 & & 10-04- Voltral-Sandoz Ammonium salt) 10mg 2014 GMP compliant NSAID section vide BP Specification inspection report of Pack size of panel dated 02-02- 5gm Rs. 40/- 2015. 15gm Rs. 95/-
162. -do- Calpril – B Ointment Form 5 Deferred for Rs. 20000/- vide completion of Priority list Each gram contains Dy. No. 177 application w.r.t No.1332 Calcipotriol 50 mcg dated 17-09- following Betamethasone 0.05mg 2011 & 10-04- shortcomings:- 2014 To provide approval status Vitamin D / of same corticosteroid formulation in Firms specifications GMP compliant reference Pack size of section vide regulatory 10gm Rs. inspection report of authorities. 850/- panel dated 02-02- To furnish 30gm Rs. 2015. master 900/- formulation with amount of base as well as salt per unit dose and per batch. Official monographs/ reference pharmacopeia required for active and inactive ingredient in the master formulation. Reference of finished product specification alongwith procedure of
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analysis.
163. -do- Aczimus Ointment Form 5 MHRA approved Deferred for Rs. 20000/- vide protopic (Astellas) confirmation of Priority list Each gram contains Dy. No. 166 manufacturing No.1342 Tacrolimus 0.3 mg dated 17-09- requirement 2011 & 10-04- Tacroderm (Sante) Immunosuppressant 2014 Firms specifications
GMP compliant Pack size of section vide 10gm Rs. inspection report of 275/- panel dated 02-02- 2015.
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164. -do- Clinac Gel Form 5 MHRA approved Approved Rs. 20000/- vide Dalacin Priority list Each gram contains Dy. No. 167 No.1331 Clindamycin Phosphate dated 17-09- 20mg 2011 & & 10-04- Dalacin –Pfizer 2014 Anti acne USP specifications GMP compliant section vide Pack size of inspection report of 10gm Rs. panel dated 02-02- 145/- 2015.
165. -do- Adapzic Cream Form 5 Deferred for Priority list Rs. 20000/- vide completion of No.1338 Each 100 gram contains Dy. No. 162 Clear (Saffron) application w.r.t Adapalene ……… dated 17-09- following shortcomings:- Azelaiic Acid …….. 2011 & 10-04- 2014 To furnish approval status Anti acne of same dosage Firms specifications form in GMP compliant reference Pack size of section vide regulatory 15gm Rs. inspection report of authorities. 160/- panel dated 02-02- To submit 2015. complete dosage form along with quantities of salt and base in master formulation per unit dose and per batch. To furnish master formulation with amount of base as well as salt per unit dose and per batch. Official monographs/ reference pharmacopeia required for active and
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inactive ingredient in the master formulation. Reference of finished product specification alongwith procedure of analysis.
166. -do- Tablet Flexibon Form 5 Deferred for Rs. 20000/- vide completion of Priority list Each tablet contains Dy. No. 168 application w.r.t No.1335 Diclofenac Sodium 50mg dated 17-09- GMP compliant following Misoprostol 200 mcg 2011 & 10-04- section vide shortcomings:- 2014 inspection report of To furnish approval status Anti acne panel dated 02-02- of same dosage Firms specifications 2015. form in reference Pack size of regulatory 20’s Rs. 350/- authorities. To submit complete dosage form along with quantities of salt and base in master formulation per unit dose and per batch. To furnish master formulation with amount of base as well as salt per unit dose and per batch. Official monographs/ reference pharmacopeia required for active and
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inactive ingredient in the master formulation. Reference of finished product specification alongwith procedure of analysis.
167. -do- Tablet Gabamin Form 5 Deferred for Rs. 20000/- vide completion of Priority list Each tablet contains Dy. No. 164 Gabmin (Pharmix) application w.r.t No.1340 Gabapentin 300 mg dated 17-09- following Mecobalamin 500mcg 2011 shortcomings:- To furnish approval status Co-enzyme Vitamin B12 GMP compliant of same dosage Firms specifications Pack size of section vide form in 14’s Rs. 160/- inspection report of reference panel dated 02-02- regulatory 2015. authorities. To furnish master formulation with amount of base as well as salt per unit dose and per batch. Official monographs/ reference pharmacopeia required for active and inactive ingredient in the master formulation. Reference of finished product specification alongwith procedure of analysis.
168. -do- Tablet Stamux 20mg Form 5 Deferred for Rs. 20000/- vide completion of Priority list Each tablet contains Dy. No. 165 Gabmin (Pharmix) application w.r.t
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No.1341 Pantoprazole 20mg dated 17-09- following 2011 & 10-04- shortcomings:- Proton Pump Inhibitor 2014 GMP compliant To provide Firms specifications section vide complete inspection report of description of panel dated 02-02- dosage form either film Pack size of 2015. coated / enteric 14’s Rs. 335/- coated etc. To provide quantity of salt as well as base per dose and batch size. Official monographs/ reference pharmacopeia required for active and inactive ingredient in the master formulation. Reference of finished product specification alongwith procedure of analysis.
169. -do- Tablet Migrip 50 mg Form 5 Imigran Radis – Deferred for Rs. 20000/- vide GSK (MHRA) confirmation of Priority list Each film coated Dy. No. 160 me too status No.1346 dispersable tablet dated 17-09- contains 2011 & 10-04- Sumatripan (as succinate) 2014 50 mg Pack size of 5HT agonist 6’s Rs. 525/- Firms specifications
170. -do- Tablet Migrip 100 mg Form 5 Imigran Radis – Deferred for Rs. 20000/- vide GSK (MHRA) confirmation of Priority list Each film coated Dy. No. 160 me too status No.1339 dispersable tablet dated 17-09- contains 2011 & 10-04- Sumatripan (as succinate) 2014 100 mg
5HT agonist Firms specifications
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Pack size of 6’s Rs. 525/-
171. -do- Tablet Ureax 40mg Form 5 FDA approved Approved Rs. 20000/- vide Priority list Each film coated tablet Dy. No. 173 No.1334 contains dated 17-09- Ulora – helix Febuxostat 40 mg 2011 & 10-04- 2014 Inhibitor of Xanthine Oxidase Pack size of Firms specifications 2 x 10 Rs. 540/- 3 x 10 Rs. 750/-
172. -do- Tablet Ureax 80mg Form 5 FDA approved Approved Rs. 20000/- vide Priority list Each film coated tablet Dy. No. 173 No.1333 contains dated 17-09- Ulora – helix Febuxostat 80 mg 2011 & 10-04- 2014 Inhibitor of Xanthine Pack size of Oxidase 2 x 10 Rs. Firms specifications 540/- 3 x 10 Rs. 750/-
173. -do- Tablet Diarip Form 5 Eurartism –MHRA Approved Rs. 8000/- vide approved Priority list Each film coated tablet Dy. No. 175 No.1343 contains dated 17-09- Antimal-Rapid - Dihydroartemisinin 40 mg 2011 & 10-04- Pharmevo Piperaquine 320 mg 2014 Pack size of Antimalarial 2 x 8 Rs. Firms specifications 760/-
174. -do- Tablet Visera Form 5 Vesicare –MHRA Approved Rs. 8000/- vide approved Priority list Each film coated tablet Dy. No. 172 No.1336 contains dated 17-09- Fenaso – Highnoon Solifenacin succinate 10mg 2011 & 10-04- 2014 Muscuranic acetylcholine Pack size of receptor antagonist 10’s Rs. Firms specifications 1600/-
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EVALUATOR NO. II , RANA AHSAN
S/N Name and Brand Name Type of Form Reason for Decision address of (Proprietary name + Dosage Form which Deferred. manufacturer / + Strength) Initial date, Applicant diary Composition Fee including Pharmacological Group differential fee
Finished product Specification Demanded Price / Pack size
175. M/s AGP Dexigesic 400mg Form-5 Seractil (Genus Deferred for (Private) Tablet Dy. No: 667 Pharmaceuticals providing: Limited, B-23 Each film coated tablet contains: dated. UK) BNF-67 Commitment as SITE Area Dexibuprofen …. 400mg 12.03.2011 per 251st Karachi. (Propionic Acid Derivatives) Rs.8,000/- Dexifen (ICI meeting of RB (Reference of specs not provided) 02.08.1013 Pakistan not provided. Priority list RS.12,000/- Limited) p.846 Inspection No.915 As per PAC report is dated 10’s,20’s, 7th and 9th July Rs.345/30’s 2010. Reference of finished goods specs not provided. 176. -do- Dexigesic 200mg Form-5 Deferred for Tablet Dy. No: 175 providing: Priority list Each film coated tablet contains: dated. Dexifen (ICI Approval in No.916 Dexibuprofen …. 200mg 12.03.2011 Pakistan SRAs not (Propionic Acid Derivatives) Rs.8,000/- Limited) p.846 confirms. (Reference of specs not provided) 02.08.1013 Commitment as RS.12,000/- per 251st As per PAC meeting of RB 10’s,20’s, not provided. 30’s Inspection report is dated 7th and 9th July 2010. Reference of finished goods specs not provided. 177. -do- Nervit 500mcg IM/IV Form-5 Methycobal Deferred for Injection Dy. No: 175 (Eisai, Japan) providing: Priority list Each 1ml ampoule contains: Dated. Commitment as No.1036 Mecobalamin …. 500mcg 07.05.2011 Methycobal per 251st (Vit. B12 Coenzyme) Rs.8,000/- (Hilton) meeting of RB (Reference of specs not provided) 02.08.1013 not provided. RS.12,000/- Inspection Rs.483/10x1ml report is dated Ampoule 7th and 9th July
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2010. Reference of finished goods specs not provided. 178. -do- Doxiproct Plus Ointment Form-5-D Deferred for Ointment Dy. No: 334 providing: Priority list Each gm contains: Dated. Commitment as No.819 Calcium Dobesilate …. 40mg 21.01.2011 per 251st Lidocaine HCl……..20mg 15,000/- meeting of RB Dexamethazone Acetate……250mg 02.08.1013 not provided. (Topical Anti Haemorrhoidal) RS.35,000/- Inspection (Reference of specs not provided) Rs.240/10gm report is dated 7th and 9th July 2010. Reference of finished goods specs not provided. Quantities in master formulation need justification. Approval status in reference SRAs not confirm. Stability studies as per 251th meeting of RB required. 179. M/s OBS Xifadote 550mg Form-5 Xifaxan (Salix Deferred for Pakistan (Pvt) Tablet Dy. No: 231 Pharms) USFDA providing: Ltd, C14 SITE Each film coated tablet contains: Dated. Commitment as Karachi. Rifaximin B.P……..550mg 11.10.2013 Nimixa (Getz) per 251st (Antibacterial) Rs.20,000/- meeting of RB Priority list (not provided) Rs.572.94/- not provided. No.1216 from 10’s, Inspection 2649 after report is dated swapping 11.02.2013. Reference of specification required. 180. M/s OBS Xifadote 200mg Form-5 Deferred for Pakistan (Pvt) Tablet Dy. No: 232 providing: Ltd, C14 SITE Each film coated tablet contains: Dated. Commitment as Karachi. Rifaximin B.P……..200mg 11.10.2013 per 251st (Antibacterial) Rs.20,000/- meeting of RB Priority list (not provided) Rs.197.54/- not provided. No.1217 from 10’s, Inspection 2651 after report is dated swapping 11.02.2013. Reference of
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specification required. 181. M/s OBS Corvaf 5/145mg Tablet Form-5D Deferred for Pakistan (Pvt) Tablet Dy. No: 142 providing: Ltd, C14 SITE Each film coated tablet contains: Dated. Commitment as Karachi. Rosuvastatin ….5mg 23.09.2013 per 251st (as Rosuvastatin calcium 5.21mg is Rs.50,000/- meeting of RB Priority list equivalent to 5mg of Rosuvastatin) Rs.350/- not provided. No.1404 from Fenofibrate………..145mg 10’s, Inspection 2596 after (Anti Hyperlipidemic) report is dated swapping (in house specs) 11.02.2013. Reference of specification required. Approval status in SRAs not confirms. Stability studies as per 249th meeting required. 182. M/s OBS Corvaf 10/145mg Tablet Form-5D Deferred for Pakistan (Pvt) Tablet Dy. No: 143 providing: Ltd, C14 SITE Each film coated tablet contains: Dated. Commitment as Karachi. Rosuvastatin ….10mg 23.09.2013 per 251st (as Rosuvastatin calcium 10.42mg is Rs.50,000/- meeting of RB Priority list equivalent to 10mg of Rosuvastatin) Rs.500/- not provided. No.1405 from Fenofibrate………..145mg 10’s, Inspection 2597 after (Anti Hyperlipidemic) report is dated swapping (in house specs) 11.02.2013. Reference of specification required. Approval status in SRAs not confirms. Stability studies as per 249th meeting required. 183. M/s Swiss Spasno 80/80mg Form-5 Deferred for Pharmaceuticals Tablet Dy. No: 243 providing: (pvt) Ltd, A/159 Each coated tablet contains: Dated. Spasfon Approval in SITE Karachi. Hydrated Phloroglucinol ….80mg 21.05.2011 (Himont) SRAs not Trimethylphloroglucinol..…80mg Rs.8,000/- confirms. Priority list (Antispasmodic & Anticholinergic) Differential fee Commitment as No.1059 (Reference for specs not provided) Challan not per 251st attached. meeting not As per PRC provided. 30’s. Quantities of API in master formulation need justification.
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Copy of monograph for polyvinyl acetate/ alcohol required. Method of manufacturing not correct. Color of coating material not provided. Reference for specs required. 184. -do- Roplex Form-5 Deferred for Syrup Dy. No: 58 providing: Priority list Each 5ml syrup contains: Dated. Approval in No.964 Iron (III) Hydroxide Polymaltose 04.04.2011 Acefer (saffron) SRAs not Complex eq. to elemental iron Rs.8,000/- confirms. …………… 50mg Differential fee Commitment as (Erythropoietics (Haematinics)) Challan not per 251st (Reference for specs not provided) attached. meeting not As per PRC provided. 60ml, 120ml Calculation on the basis of salt not provided in master formulation. Fir is using ascorbic acid as (excepient) preservative. Which flavor firm is using not mentioned in master formulation. Reference monograph of API required to know either it is Ferric Hydroxide or polymaltose complex or Ferric Oxide polymaltose complex. Specs reference required. 185. M/s Medisure Sablin Form-5 LYRICA Deferred for Laboratories Capsule Dy. No: 31 Capsules 50mg providing: Pakistan (pvt) Each Capsule contains: Dated. US FDA Duplicate Ltd. A-115, pregabalin …………… 50mg 30.07.2011 Dossier SITE, Karachi. (antiepileptic) Rs.8,000/- GABICA Commitment as Minutes for 256th Meeting Registration Board 410
(Specs not provided) 31.03.2014 Capsules 50mg per 251st Priority list Rs.12,000/- Getz meeting not No.1278 As per PRC provided by the 14’s Firm. Last inspection report of 23- 10-2013 provided. Finished product specs and testing method required. Copy of form 5 and other documents attached except fee challans. Equipment shown in the list is for tablets and dry powder suspension. Original fee Challan for Rs.8000/- not attached. 186. -do- Sablin Form-5 LYRICA Deferred for Capsule Dy. No: 29 Capsules 75mg providing: Priority list Each Capsule contains: Dated. US FDA Commitment as No.1275 pregabalin …………… 75mg 02.08.2011 per 251st (antiepileptic) Rs.8,000/- GABICA meeting not (Specs not provided) 31.03.2014 Capsules 75mg provided by the Rs.12,000/- Getz Firm. As per SRO Last inspection 14’s report of 23- 10-2013 provided. Finished product specs and testing method required. Copy of form 5 and other documents attached except fee challans. Equipment shown in the list is for tablets and dry powder suspension. Minutes for 256th Meeting Registration Board 411
187. -do- Sablin Form-5 LYRICA Deferred for Capsule Dy. No: 33 Capsules 100mg providing: Priority list Each Capsule contains: Dated. US FDA Commitment as No.1276 pregabalin …………… 100mg 02.08.2011 per 251st (antiepileptic) Rs.8,000/- GABICA meeting not (Specs not provided) 31.03.2014 Capsules 100mg provided by the Rs.12,000/- Getz Firm. As per SRO Last inspection 14’s report of 23- 10-2013 provided. Finished product specs and testing method required. Copy of form 5 and other documents attached except fee challans. Equipment shown in the list is for tablets and dry powder suspension. Page 27 to 30 missing from dossier. 188. -do- Sablin Form-5 LYRICA Deferred for Capsule Dy. No: 33 Capsules 150mg providing: Priority list Each Capsule contains: Dated. US FDA Commitment as No.1277 pregabalin …………… 150mg 02.08.2011 per 251st (antiepileptic) Rs.8,000/- GABICA meeting not (Specs not provided) 31.03.2014 Capsules 150mg provided by the Rs.12,000/- Getz Firm. As per SRO Last inspection 14’s report of 23- 10-2013 provided. Finished product specs and testing method required. Copy of form 5 and other documents attached except fee challans. Equipment shown in the list is for tablets and dry Minutes for 256th Meeting Registration Board 412
powder suspension. 189. -do- Sablin Form-5 LYRICA Deferred for Capsule Dy. No: 30 Capsules 300mg providing: Priority list Each Capsule contains: Dated. US FDA Commitment as No.1274 pregabalin …………… 300mg 02.08.2011 per 251st (antiepileptic) Rs.8,000/- GABICA meeting not (Specs not provided) 31.03.2014 Capsules 300mg provided by the Rs.12,000/- Getz Firm. As per SRO Last inspection 14’s report of 23- 10-2013 provided. Finished product specs and testing method required. Copy of form 5 and other documents attached except fee challans. Equipment shown in the list is for tablets and dry powder suspension. 190. M/s Zafa Zampi-Sul 1500mg Form-5 Ampicillin/ Deferred for Pharmaceutical Injection Dy. No: 650 Sulbactam providing: Laboratories Each vial contains: Dated. (Antibiotics SA) Commitment as (Private) Ltd, Ampicillin Sodium eq. to Ampicillin 15.03.2011 US FDA per 251st B-10, SITE …………… 1000mg Rs.8,000/- meeting not Karachi. Sulbactam sodium eq. to Differential fee Sulbarax provided by the sulbactam……………….500mg not attached. (Mediceena) Firm. Priority list (Semisynthetic penicillins) As per SRO Last inspection No.913 (USP Specs) 1’s report of 06- 01-2010 provided. Clarification required regarding weighing and mixing of material in sterile area. List of equipment of penicillin injection section required. Copy of reference Minutes for 256th Meeting Registration Board 413
monograph required. Differential fee not attached. 191. M/s ATCO Dioplus-H Form-5 Exforge HCT Deferred for Laboratories Tablet Dy. No: 257 (Novartis providing: Limited, B-18 Each film coated tablet contains: dated. Pharmaceuticals Commitment as SITE Karachi. Amlodipine (Besylate) BP …. 5mg 18.10.2011 Corp. US) per 251st Valsartan (USP) … 160mg Rs.8,000/- USFDA meeting not Priority list No. Hydrochlorothiazide USP …12.5mg Differential fee provided by the 795 from 1394 (Angiotensin II antagonist + Challan not Exforge HCT Firm. after swapping Calcium channel blocker + Thiazide attached (Novartis Pharma Differential fee diuretic) Rs. 65/Tablet Pakistan Ltd) not attached. (Atco specification) 14’s p.413 Stability studies as per 251th meeting of RB required.
192. -do- Alodip H 300/10/12.5mg Form-5-D Amturnide Deferred for Tablet Dy. No: 491 (Novartis) providing: Priority list No. Each film coated tablet contains: dated. USFDA Stability 959 Aliskiren as (hemifumarate) 31.03.2011 studies as per MS……… 300mg Rs.15,000/- 251th meeting Hydrochlorothiazide USP … 25mg Differential fee of RB required. Amlodipine (besylate)…..5mg Challan not Commitment as (Cardiovascular drugs) attached per 251st (Atco specification) Rs. 3010/14’s meeting not 6020/28’s provided by the Firm. Differential fee not attached.
193. -do- Retig 200mg Form-5-D Trobalt (GSK Deferred for Priority list No. Tablet Dy. No: 188 UK) MHRA providing: 1358 Each film coated tablet contains: dated. Stability Retigabine MS ..…. 200mg 23.09.2011 studies as per (Anti-epileptic) Rs.15,000/- 249th meeting (Atco Specs) Differential fee required. Uses: adjunctive treatment of partial Challan not Commitment as onset seizures attached per 251st Rs. 85/Tablet meeting not 10’s, 14’s & provided by the 30’s Firm. Differential fee not attached.
194. -do- Rofl Form-5-D Daxas (Takeeda, Deferred for Tablet Dy. No: 48 Uk) MHRA providing: Priority list No. Each film coated tablet contains: dated. Stability 1324 Roflumilast MS ..…. 500mcg 07.09.2011 studies as per (Anti asthma & COPD) Rs.15,000/- 249th meeting (Atco Specs) Differential fee required. Uses: treatment of COPD associated Challan not Commitment as with chronic chronic bronchitis in attached per 251st
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adults Rs. 600/Tablet meeting not 1200/14’s provided by the 2400/28’s Firm. Differential fee not attached.
195. -do- Viglip Form-5 Galvus 50mg Commitment as Tablet Dy. No: 353 (Novartis) per 251st Priority list No. Each tablet contains: dated. MHRA meeting not 1072 Vildagliptin MS ..…. 100mg 26.05.2011 provided by the (Antidiabetic) Rs.8,000/- Galvus 50mg Firm. (Atco Specs) Differential fee Tablets Differential fee Challan not (Novartis) not attached. attached Approval of Rs. 1600/14’s Applied strength in Pakistan and SRAs not confirm. 196. M/s Pakistan Candia 8mg Form-5 Atacand Commitment as pharmaceutical Tablet Dy. No: 1058 (Astrazaneeca) per 251st Products pvt ltd. Each tablet contains: dated. USFDA meeting not D-122 SITE, Candesartan Cilexitil ..…. 8mg 30.04.2011 provided by the Karachi. (Antihypertensive) Rs.8,000/- Advant (Getz) Firm. (Specs reference not provided ) Differential fee Last inspection Priority list No. Challan not report of 28- 1017 attached 02-2011 Rs. 10.71/Tablet provided. 14’s Differential fee not attached. Testing method along with specs reference required. 197. -do- Candia 16mg Form-5 Atacand Commitment as Priority list No. Tablet Dy. No: 1059 (Astrazaneeca) per 251st 1016 Each tablet contains: dated. USFDA meeting not Candesartan Cilexitil ..…. 16mg 30.04.2011 provided by the (Antihypertensive) Rs.8,000/- Advant (Getz) Firm. (Specs reference not provided ) Differential fee Last inspection Challan not report of 28- attached 02-2011 Rs. 16.07/Tablet provided. 28’s Differential fee not attached. Testing method along with specs reference required. 198. -do- Alfa-One 1µg Form-5 Alfacalcidol 1 Approval of Tablet Dy. No: 1249 microgram tablet dosage Priority list No. Each tablet contains: dated. capsule form in SRAs 1044 Alfacalcidol...…. 1µg 16.05.2011 (AmdiPharm not confirms. (Vitamin D Analogue) Rs.8,000/- Mercury) MHRA Commitment as
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(Specs reference not provided ) Differential fee per 251st Challan not Alfa-D meeting not attached (Platinum) provided by the Rs. 26/Tablet Firm. 10’s Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. 199. -do- Zairl 20mg Form-5 Prinivil (Merk) In FDA and Tablet Dy. No: 1463 USFDA MHRA it is Priority list No. Each tablet contains: dated. Lisinopril (as 1106 Lisinopril Dihydrate ..…. 20mg 30.05.2011 Lisna (Zafa) Dihydrate) (Antihypertensive) Rs.8,000/- 20mg. (Specs reference not provided ) Differential fee Quantity of Challan not active in master attached formulation Rs. needs 296.96/Tablet justification. 14’s Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. In identification firm is using IR but they have not mentioned FTIR in QC equipment list. 200. -do- Zairl 10mg Form-5 Prinivil (Merk) In FDA and Tablet Dy. No: 1465 USFDA MHRA it is Priority list No. Each tablet contains: dated. Lisinopril (as 1104 Lisinopril Dihydrate ..…. 10mg 30.05.2011 Lisna (Zafa) Dihydrate) (Antihypertensive) Rs.8,000/- 10mg. (Specs reference not provided ) Differential fee Quantity of Challan not active in master attached formulation Rs. needs Minutes for 256th Meeting Registration Board 416
150.17/Tablet justification. 14’s Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. In identification firm is using IR but they have not mentioned FTIR in QC equipment list. 201. -do- Zairl 5mg Form-5 Prinivil In FDA and Tablet Dy. No: 1466 (AstraZaneeca) MHRA it is Priority list No. Each tablet contains: dated. USFDA, MHRA Lisinopril (as 1103 Lisinopril Dihydrate ..…. 5mg 30.05.2011 Dihydrate) (Antihypertensive) Rs.8,000/- Lisna (Zafa) 5mg. (Specs reference not provided ) Differential fee Quantity of Challan not active in master attached formulation Rs. 76.53/Tablet needs 14’s justification. Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. In identification firm is using IR but they have not mentioned FTIR in QC equipment list. Minutes for 256th Meeting Registration Board 417
202. -do- Vastec 10mg Form-5 Crestor (Merk) It exist in the Tablet Dy. No: 987 USFDA form of Priority list No. Each tablet contains: dated. Rosuvastatin 1001 Rosuvastatin ..…. 10mg 23.04.2011 Crestat (CCL) calcium salt. (Lipid-Lowering agent) Rs.8,000/- Quantity of (Specs reference not provided ) Differential fee active in master Challan not formulation attached needs Rs. 24.00/Tablet justification. 10’s Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. In identification firm is using IR but they have not mentioned FTIR in QC equipment list. 203. -do- Vastec 5mg Form-5 Crestor (Merk) It exist in the Tablet Dy. No: 985 USFDA form of Priority list No. Each tablet contains: dated. Rosuvastatin 1000 Rosuvastatin ..…. 5mg 23.04.2011 Crestat (CCL) calcium salt. (Lipid-Lowering agent) Rs.8,000/- Quantity of (Specs reference not provided ) Differential fee active in master Challan not formulation attached needs Rs. 12.00/Tablet justification. 10’s Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. Minutes for 256th Meeting Registration Board 418
In identification firm is using IR but they have not mentioned FTIR in QC equipment list. 204. -do- Co-Zairl 20mg Form-5 Prinzide (Merk) In FDA and Tablet Dy. No: 1464 USFDA MHRA it is Priority list No. Each tablet contains: dated. Lisinopril (as 1105 Lisinopril Dihydrate ..…. 20mg 30.05.2011 Co-Lispril Dihydrate). Hydrochlorothiazide…..12.5mg Rs.8,000/- (Werrick) Quantity of (Antihypertensive) Differential fee active in master (Specs reference not provided ) Challan not formulation attached needs Rs. 554/Tablet justification. 28’s Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- 02-2011 provided. Differential fee not attached. Testing method along with specs reference required. In identification firm is using IR but they have not mentioned FTIR in QC equipment list. 205. -do- Zolot-S 75/75mg Form-5 Approval status Tablet Dy. No: 1065 in reference Priority list No. Each enteric coated tablet contains: dated. Norplat-S SRAs not 1015 Clopidogrel Hydrogen Phosphate 30.04.2011 (Scilife) confirm. ..…. 75mg Rs.8,000/- Confirmation Aspirine………....75mg Differential fee of (Antiplatelet) Challan not manufacturing (Specs reference not provided ) attached facility for Rs. 14.50/Tablet double core 10’s Table required. Commitment as per 251st meeting not provided by the Firm. Last inspection report of 28- Minutes for 256th Meeting Registration Board 419
02-2011 provided. Differential fee not attached. Label claim not correct. Justification for the quantity of active required.
Deferred Cases
206. M/s. Shrooq Maxlum IM Form 5 Not confirmed Case was Deferred Pharmacetuicals Injection in Stringent in 245th meeting in (Pvt) Ltd., 21- Each ml contains:- 31-3-2014 (611) DRA,s the light of Km Ferozepur Artemether….80mg Rs.20,000/ recommendations Road, Lahore. (Antimalarial) Artem (Hilton) by Malaria Control Additional Programm. (Manufacturer’s Spec.s) As Per SRO/1ml Sections granted vide letter No. RB has approved F.6-2/2013-Lic the same in 252nd (M-233) dated meeting. 07-04-2014 1.Injection The Board appoved (General) the application. Ampoules 2. Vial Infusion
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Deferred Case of M/s Bajwa Sons Following products of M/s Bajwa Sons, 129 Circular Road, Lohari Lahore are deferred in the 246th and 251st meetings of Registration Board due to below mentioned reasons. The firm has submitted documents in this respect. Detailed evaluation is written below:- S/N Name and Brand Name Type of Reason for which Descion address of (Proprietary name + Dosage Form Deferred. manufacturer / Form + Strength) Applicant Initial date, Composition diary
Pharmacological Group Fee including differential Finished product fee Specification Demanded Price / Pack size 207. Applicant Famous Brand Single Blood Form-5A Product was a. Firm has M/s Bajwa Sons, Bags Deferred in 251st submitted 129 Circular Dy No: Not meeting for COPP on Road, Lohari provided submission of firm’s letter Lahore Each 100ml of CPDA (Citrate following: head, which Phosphate Dextrose Adenine 15000/- dated need Manufacturer Solution, Anticoagulant) 08-10-10 1. COPP with clarification. Shanghai contains: complete b. Single page Transfusion Citric acid Rs 150/ Blood presentation of stability report Technology Co. monohydrate……0.299g Bag of 250ml applied product. is submitted in Ltd. Sodium citrate Rs 150/ Blood 2. Stability data which the firm Add: No.500 dihydrate…………2.63g Bag of 450ml with details of informed that You Dong Road, Sodium biphosphate Rs 160/ Blood physical 12 samples Minhang, monohydrate……0.222g Bag of 500ml chemical and with Shanghai, Dextrose biological test. anticoagulants 201100, P.R of monohydrate……..3.19g 3. Packaging of year 2002 China Adenine……….0.0275g material and 21 Water for Injection….Qs specifications. samples of blood bags in Disposable 2005 tested. And the samples qualified the physical, chemical, biological tests. c. Packaging material specifications are not submitted
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208. Applicant Famous Brand Double Blood Form-5A Product was a. Firm has M/s Bajwa Sons, Bags Deferred in 251st submitted 129 Circular Dy No: 29 meeting for COPP on Road, Lohari Each 100ml of CPDA (Citrate dated 08-10- submission of firm’s letter Lahore Phosphate Dextrose Adenine 10 following: head, which Solution, Anticoagulant) need Manufacturer contains: 15000/- dated 1. COPP with clarification. Shanghai Citric acid 08-10-10 complete b. Single page Transfusion monohydrate……0.299g presentation of stability report Technology Co. Sodium citrate Rs 300/ Blood applied product. is submitted in Ltd. dihydrate…………2.63g Bag of 450ml 2. Stability data which the firm Add: No.500 Sodium biphosphate Rs 315/ Blood with details of informed that You Dong Road, monohydrate……0.222g Bag of 500ml physical 12 samples Minhang, Dextrose chemical and with Shanghai, monohydrate……..3.19g biological test. anticoagulants 201100, P.R of Adenine……….0.0275g 3. Packaging of year 2002 China Water for Injection….Qs material and 21 specifications. samples of Disposable blood bags in 2005 tested. And the samples qualified the physical, chemical, biological tests. c. Packaging material specifications are not submitted
209. Applicant Famous Brand triple Blood Form-5A Product was a. Firm has M/s Bajwa Sons, Bags Deferred in 251st submitted 129 Circular Dy No: Not meeting for COPP on Road, Lohari Each 100ml of CPD (Citrate provided submission of firm’s letter Lahore Phosphate Dextrose Solution, following: head, which Anticoagulant) contains: 15000/- dated need Manufacturer Citric acid 08-10-10 1. COPP with clarification. Shanghai monohydrate……0.299g complete b. Single page Transfusion Sodium citrate Rs 510/ Blood presentation of stability report Technology Co. dihydrate…………2.63g Bag of 450ml applied product. is submitted in Ltd. Sodium biphosphate Rs 525/ Blood 2. Stability data which the firm Add: No.500 monohydrate……0.222g Bag of 500ml with details of informed that You Dong Road, Dextrose physical 12 samples Minhang, monohydrate……..3.19g chemical and with Shanghai, Water for Injection….Qs to biological test. anticoagulants 201100, P.R of 100ml 3. Packaging of year 2002 China material and 21 Each 100ml of SAGM (Saline specifications. samples of Adenine Glucose Mannitol, blood bags in Red Blood Cell Preservative) 2005 tested. contains: And the Dextrose samples Minutes for 256th Meeting Registration Board 422
monohydrate…..0.900g qualified the Sodium chloride…..0.877g physical, Adenine…….0.0169g chemical, D-Mannitol…….0.525g biological Water for Injection….qs to tests. 100ml c. Packaging material Disposable specifications are not submitted
210. Applicant Famous Brand Quadruple Form-5A Product was a. Firm has M/s Bajwa Sons, Double Blood Bags Deferred in 251st submitted 129 Circular Dy No: Not meeting for COPP on Road, Lohari Each 100ml of CPD (Citrate provided submission of firm’s letter Lahore Phosphate Dextrose Solution, following: head, which Anticoagulant) contains: 15000/- dated need Manufacturer Citric acid 08-10-10 1. COPP with clarification. Shanghai monohydrate……0.299g complete b. Single page Transfusion Sodium citrate Rs 440/ Blood presentation of stability report Technology Co. dihydrate…………2.63g Bag of 450ml applied product. is submitted in Ltd. Sodium biphosphate Rs 445/ Blood 2. Stability data which the firm Add: No.500 monohydrate……0.222g Bag of 500ml with details of informed that You Dong Road, Dextrose physical 12 samples Minhang, monohydrate……..3.19g chemical and with Shanghai, Water for Injection….Qs to biological test. anticoagulants 201100, P.R of 100ml 3. Packaging of year 2002 China material and 21 Each 100ml of SAGM (Saline specifications. samples of Adenine Glucose Mannitol, blood bags in Red Blood Cell Preservative) 2005 tested. contains: And the Dextrose samples monohydrate…..0.900g qualified the Sodium chloride…..0.877g physical, Adenine…….0.0169g chemical, D-Mannitol…….0.525g biological Water for Injection….qs to tests. 100ml c. Packaging material Disposable specifications are not submitted
Decision: Deferred for presentation of dossiers in the next board meeting.
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ITEM VI :- EVALUATOR I , MUHAMMAD ANSAR
S/N Name and Brand Name Type of Form International Decision address of (Proprietary Initial date, status in manufacturer / name + diary stringent Applicant Dosage Form Fee including regulatory + Strength) differential fee agencies Composition Demanded Pharmacologi Price / Pack Me-too status cal Group size Finished GMP status as product depicted in Specification inspection report (dated)
213. M/s Macter Limpat Tablet Form-5 FDA. Vimpat Deferred for the International Ltd, 100 Tablet by submission of Karachi. Each film 27-02-2011 vide M/s UCB following:- coated tablet diary No. 37 Differential contains:- Rs.8000 Priority list No. Local fee not Lacosamide… 1270 Atcomid attached. ……100mg Rs.40/tablet 100mg tablet Complete Anti-convulsant description require to Not provided be submitted in reference to innovator. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Dosage and indications are not as per the innovator. Manufactur ing method is not complete. Documents are not signed by Minutes for 256th Meeting Registration Board 424
the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 214. -do- Limpat Tablet Form-5 FDA. Vimpat Deferred for the 50 Tablet by submission of Priority list No. Each film 27-07-2011 vide M/s UCB following:- 1267 coated tablet diary No. Differential contains:- Rs.8000 Local fee not Lacosamide… Atcomid attached. ……50mg Rs.24/tablet 50mg tablet Complete Anti-convulsant description require to Not provided be submitted in reference to innovator. Dosage and indications are not as per the innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the
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innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 215. -do- Limpat Injection Form-5 FDA. Vimpat Deferred for the 200mg/20ml submission of Priority list No. Each vial 27-02-2011 vide Solution IV following:- 1268 contains:- diary No. 43 by M/s UCB Differential Rs.8000 Lacosamide… fee not
……200mg Require to be Rs.40/tablet attached. Anti-convulsant submitted. Complete description Not provided require to be submitted in reference to innovator. Dosage and indications are not as per the innovator. Manufactur ing method is not complete. Local availability having same
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dosage form require to be submitted. Description of dosage form is incomplete Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 216. -do- Mebrin Form-5 UK. Colofac Deferred for the Capsule 02-08-2011 MR 200mg as submission of Priority list No. Each capsule vide diary modified following:- 1273 contains:- no.35 Rs.8,000. release by M/s Differential Mebeverine 23/tablet which BGP fee not HCl as is not as per attached. extended applied Colonil 200mg Calculation release formulation Capsule by M/s s as base pellets……200 Genome not mg Pharma provided. Antispasmodic Minutes for 256th Meeting Registration Board 427
Require to be Complete submitted description require to be submitted in reference to innovator. Demended price of the firm is not as per formulation . Source of pellets is not provided by the firm. Dosage and indications are not as per the innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh
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inspection report not attached Details of HVAC & water treatment system not attached 217. -do- Paramac Form-5 FDA. Deferred for the Infusion 24-08-2011 Acetaminophen submission of Priority list No. Each 100ml vide diary 100ml/1gm by following:- 1359 contains:- no.198 M/s Fersenius Differential Paracetamol… Rs.8,000. Kabi fee not .……1gm Rs. 80/Pack. attached. Analgesic & Falgan by M/s Dosage and Antipyretic Bosch Pharma indications Require to be are not as submitted per the innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Section approval require to be submitted. Finished product specificatio ns are not provided.
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Fresh inspection report not attached Details of HVAC & water treatment system not attached 218. -do- Netz Tablet Form-5 FDA. Starlix Deferred for the Each film 02-08-2011 60mg by M/s submission of Priority list No. coated tablet vide diary Novartis following:- 1271 contains:- no.34 Rs.8,000. Differential Nateglinide… 12.5/tablet. Require to be fee not ……60mg submitted. attached. Antidiabetic Complete Require to be description submitted require to be submitted in reference to innovator. Local availability require to be submitted. Dosage and indications are not as per the innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not
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signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached. 219. -do- Ramol plus Form-5 FDA. Tramadol Deferred for the Tablet 02-08-2011 and submission of Priority list No. Each film vide diary No. Acetaminophen following:- 1266 coated tablet 38 Rs.8,000. 325/37.5mg by Differential contains:- Rs.10/tablet M/s Par fee not Tramadol Pharma. attached. HCL…….37.5 Local Diagesic Calculation mg Extra by M/s s as base Paracetamol.. Wilsons not …….325mg provided. Analgesic Complete Require to be description submitted. require to be submitted in reference to innovator. Demended price of the firm is not as per formulation . Dosage and indications are not as per the innovator. Manufactur
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ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 220. -do- Cadla plus Form-5 Require to be Deferred for the Tablet provided submission of Priority list No. 02-08-2011 vide following:- 1283 Each tablet diary No. 63 Require to be Differential contains:- Rs.8000 submitted fee not Alfacalcidol… attached. ……0.25mcg Rs.20/tablet Calcium Complete Carbonate description ….250mg require to be Bone submitted Development in reference Promoter to innovator. Not provided Commitme
nt as per the
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decision of RB not attached Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached.
221. -do- Mucotec Form-5 Require to be Deferred for the Capsule submitted. submission of Priority list No. 02-08-2011 vide following:- 1284 Each capsule diary No.61 Local Erdos Differential contains:- Rs.8000 150mg fee not Erdosteine…… Capsule by attached. …150mg Rs.6.75/capsule M/s Platinum Internationa Mucolytic l Agent availability require to Not provided be submitted. Dosage and indications are not as per the innovator. Manufactur ing method is not
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complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 222. -do- Mucotec Form-5 MHRA. Deferred for the Capsule Erdotin submission of Priority list No. 02-08-2011 vide 300mg by M/s following:- 1279 Each capsule diary No.60 Galen Differential contains:- Rs.8000 Local Require fee not Erdosteine…… to be attached. …300mg Rs.13.5/capsule submitted. Local Mucolytic availability Agent require to be Not provided submitted. Dosage and indications are not as per the innovator. Manufactur ing method
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is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 223. -do- Mucotec Form-5 Require to be Deferred for the Priority list No. Suspension submitted submission of 1269 02-08-2011 vide Local Erdos following:- Each 5ml diary No.39 Suspension Differential contains:- Rs.8000 175mg by M/s fee not Erdosteine…… Platinum attached. …175mg Rs.135/pack of 100ml Interational Mucolytic availability Agent require to be Not provided submitted. Dosage and indications are not as per the innovator. Manufactur
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ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 224. -do- Vetz-Met Tablet Form-5 Require to be Deferred for the submitted. submission of Priority list No. Each film 29-08-2011 vide Galvus Met following:- 1318 coated tablet diary No.92 50/500, Differential contains:- Rs.8000 50/850, fee not Vildagliptin… &50/1000mg attached. ……50mg Rs.27.66/tablet Metformin by M/s Local HCl….500mg Novartis. availability require to Anti-diabetic be submitted. Not provided Dosage and indications are not as per the innovator.
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Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 225. -do- Vetz-Met Tablet Form-5 MHRA. Deferred for the Priority list No. Eucrease submission of 1316 Each film 29-08-2011 vide 50/850mg by following:- coated tablet diary No.90 M/s Novartis Differential contains:- Rs.8000 Galvus Met fee not Vildagliptin… 50/500, attached. ……50mg Rs.27.86/tablet Metformin 50/850, Local HCl….850mg &50/1000mg availability by M/s require to Anti-diabetic Novartis. be submitted. Not provided Dosage and indications are not as per the
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innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 226. -do- Zopic Tablet Form-5 FDA. Lunesta Deferred for the 1, 2, 3mg by submission of Priority list No. Each film 2-08-2011 vide M/s Sunovion following:- 1282 coated tablet diary No.58 Clonexa 1, 2, Differential contains:- Rs.8000 3mg by M/s fee not Eszopiclone… Atco. attached. ……3mg Rs.22/tablet Local Hypnotic agent availability require to Not provided be submitted. Dosage and indications are not as
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per the innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 227. -do- Zopic Tablet Form-5 FDA. Lunesta Deferred for the 1, 2, 3mg by submission of Priority list No. Each film 2-08-2011 vide M/s Sunovion following:- 1281 coated tablet diary No.59 Clonexa 1, 2, Differential contains:- Rs.8000 3mg by M/s fee not Eszopiclone… Atco. attached. ……2mg Rs.14.3/tablet Local Hypnotic agent availability require to Not provided be submitted. Dosage and indications
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are not as per the innovator. Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Compositio n is not as per the innovator. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 228. M/s Rasco AZ-KO 500mg Form-5 Require to be Deferred for the Pharma, Lahore. Capsule submitted. submission of 2-11-2010 vide Alide Capsule following:- Priority list No. Each capsule diary No.1132 500mg by M/s Differential 494 contains:- Rs.8000 Pharmix. fee not Azithromycin as As per SRO. attached. dihydrate..…… internationa …500mg l availability Antibiotic require to be Not provided submitted.
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Manufactur ing method is not complete. Commitme nt as per the decision of RB not provided. Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Fresh inspection report not attached Details of HVAC & water treatment system not attached 229. M/s Irza Pharma, Irzaflox Infusion Form-5 MHRA. Deferred for the Lahore. Tarivid submission of Priority list No. Each 100ml 28-05-2011 vide Infusion following:- 1097 contains:- diary No.622 2mg/ml by Differential Ofloxacin Rs.8000 M/s Sanofi fee not
HCl..………200 Curitol mg As per SRO. attached. Infusion by Manufactur Antibiotic 200mg by M/s ing method Standpharm. is not Not provided provided. Calculation s in salt and base are not provided. Commitme nt as per the decision of RB not provided.
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Documents are not signed by the technical staff. Finished product specificatio ns are not provided. Firm is claiming for the use of RO water. In the testing firm is claiming specificatio ns of I- Cobal instead of Irzaflox. Fresh inspection report not attached Details of HVAC & water treatment system not attached
Meeting ended with a vote of thanks to and from the chair. End of Document *************************************************************************
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