Proposed Agenda / Working Paper for 238Th Meeting of Registration Board

MINUTES OF 239th MEETING OF DRUGS REGISTRATION BOARD HELD ON 12th September, 2013

239th meeting of the Drugs Registration Board was held on 12th September, 2013 in the Committee Room, Minitrsy of National Health Regulation Service & Coordination Division, Local Government Building, G-5, Islamabad. The meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation & Registration Division. The meeting started with the recitation of Holy Verses. The meeting was attended by the following:- 1. Prof.Dr.Rafi-uz-Zaman Saeed-ul-Haq. Dean, Member University of Lahore, Islamabad 2. Lt General (R) Karamat Ahmed Karamat. Member

3. Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean, Member Basic Sciences Division, Foundation Medical University, Rawalpindi.

4. Mr. A.Q. Javed Iqbal, Chief Pharmacist, PIMS, Member Islamabad. awalpindi. 5. Dr. Muhammad Arshad, President, Pakistan Veterinary Member Medical Council

6. Dr. Muhammad Khalid Khan Member Director Drugs Testing Laboratory Government of Khyber Pakhtoonkhwa, Peshawar.

7. Muhammad Jamil Anwar Member Director Drugs Testing Laboratory Government of Punjab, Lahore.

8. Dr.Amanullah Khan Member Director Drugs Testing Laboratory Government of Baluchistan, Quetta 9. Sheikh Muhammad Idress Member Director Drugs Testing Laboratory Government of Sind, Karachi 10. Dr.Noor Muhammad Shah Member Director Medical Devices and Medicated Cosmetics, DRAP

11. Abdul Samad Khan representing Director, Biological Member Drug, DRAP

12. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member

Mr.Akhter Abbas Khan (DDG R.II), Mr.Muhammad Arif (DDC R.I), Mr. Babar Khan (DDC R.III), Dr. Tariq Siddique (DDC R.IV), Ms. Sara Mehreen (ADC R.I) and Mr. Atiq-ul-Bari (ADC R.V) assisted Secretary of the Board with agenda. Dr. Kaiser Waheed & Mr. Hammayun Kabir, Dr.Farid Khan and Dr.M.Qasim Awan attended the meeting as observer on behalf of PPMA, Pharma Beauru and PVPMA respectively.

2 Item No I: Confirmation of minutes 238th meeting Registration Board. 238th meeting of Registration Board was held on 5th-6th August, 2013 and minutes were accordingly circulated to all members through e-mail. Only 3 members confirmed the minutes while observations of Dr. Khalid Khan, Director, DTL, Peshawar are as follows: The minutes of 238th RB meeting held on 5-6 Aug. 2013 are approved subject to partial modifications i.e. 1. In Agenda item 2. Extension in contract manufacturing cases i.e. line extension/general products/ associated company/ sister concern cases were rejected rather than deferred. 2. Panel inspection should be conducted by the board members to the premises and manufacturing facilities of contract givers. 3. Agenda Item delegation of Board power to Chairman, the powers mentioned in serial v, xii, xv, xvi, xvii, xviii,, and xix should be remained with Board rather delegated to Chairman. v. Increase/ decrease in shelf life of finished drug. xii. Renewal of registered drugs. xv. Change in the packing design/packaging components/ change in label, carton/ change in shape, colour of Capsule, Tablets and shape of blister/ aluminum foil. xvi. Change of brand names of registered drugs. xvii. Change of formulation of already registered drug / grant of registration for improving Safety, efficacy & quality as per recommendations of WHO / International Agencies. xviii. Transfer of registration from one manufacturer/importer to another manufacture/importer. xix. Constitution of panel of experts for inspections

4. For medical devices specifications and testing methods. a committee should be constituted to formulate specifications and testing method procedures according to our country need in best interest of public at large. Decision: The Board discussed above mentioned observations of the member and after detailed discussion decided as follows: Cases which were not covered in Contract Manufacturing Policy were deferred, as said policy is under consideration by the Policy Board.

3 Panel of inspectors would inspect the manufacturing premesis for grant of new contract manufacturing permissions, if required by the Board. Chairman, Registration Board would continue to decide cases mentioned at point 3. However, all cases which require evaluation of technical data will be referred to panel of experts including atleast one member of Registration Board. The Chairman, Registration Board will decide the case keeping in view recommendation of experts. However, Dr.Khalid Khan maintained his view point. Dr.Noor Muhammad Shah, Director MD & MC apprised the Board that draft Medical Devices Rules, 2013 have already been sent to provincial governments and also posted / uploaded on DRAP’s website for comments. He also requested all members of the Board to give inputs on draft regulations at the earliest.

4 Item No II: Grant of Registration (Local manufacturing). Applications for registration (July-September, 2010 & fast track) were forwarded to officers of DRAP. As per review, following applications were found complete. Registration-I. Fast track applications for registration (Locally manufactured drugs me-too)

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision Applicant Size Life 1. M/s. Baariq Furosebar Water Soluble Powder Decontrolled 02 Approved Pharmaceuticals, Each 1000gm contains:- 100gm years Raiwind Road, Furosemide…………….20gm 250gm Lahore. Potassium Chloride……. 4gm 500gm Calcium Carbonate…….45gm 1000gm Magnesium Sulphate…..1gm 2500gm (Diuretic, Electrolytes).

2. M/s. Baariq Electrobar-C Water Soluble Decontrolled 02 Deferred for PSI Pharmaceuticals, Powder 100gm years by panel Raiwind Road, Each gm contains:- 250gm comprising of Lahore. Aspirin………………..200mg 500gm Area FID and Vitamin C…………….600mg 1000gm Director DTL, Sodium Chloride………35mg 2500gm Lahore. Sodium Citrate………….7mg (Vitamin, Electrolytes, NSAID).

3. M/s. Baariq Colibar Oral Liquid Decontrolled 02 Approved Pharmaceuticals, Each 1000ml contains:- 100ml years Raiwind Road, Colistine 500ml Lahore. Sulphate……..2,000,000,000 IU 1000ml (Antibiotic). 4. M/s. Elegance Flurotin Liquid Decontrolled 02 Approved Pharmaceuticals, Each ml contains 10ml years Chak Belli, Pandori Florfenicol ….200mg 20ml Road, Rawalpindi. (Anti-bacterial) 50ml 100ml 150 ml 200ml 250ml 500ml 1Lit

5 5. M/s. Elegance Ecotin-M Powder Decontrolled 02 Approved Pharmaceuticals, Each 100g contain 100gm years Chak Belli, Pandori Enrofloxacin HCl……10 % 250gm Road, Rawalpindi. Colistin Sulphate……..3 % 500gm Amantadine HCl……..4 % 1Kg (Anti-Biotic) 5Kg 10Kg 25Kg 6. M/s. Elegance Poly Quin Liquid Decontrolled 02 Approved Pharmaceuticals, Each 100ml contains 10ml years Chak Belli, Pandori Enrofloxacin………10 g 20ml Road, Rawalpindi. Colistin Sulphate….48 MIU 50ml (Anti-Biotic) 100ml 150 ml 200ml 250ml 500ml 1Lit 7. M/s. D-Maarson Bella Flush Powder Decontrolled 02 Approved Pharmaceuticals, Each 100g contains:- 100g years Rawat, Islamabad. Furosemide………………2gm 250g Belladonna Extract……..0.2gm 500g (Diuretic, Anti-spasmodic). 1Kg 5Kg 10Kg

8. M/s. Nawal BELLA RAFT Powder Decontrolled 02 Approved Pharmaceuticals, Each 100g contains:- 100g years Small Industrial Furosemide…………….2gm 250g Estate Taxila. Belladonna Extract…..0.2gm 500g (Diuretic, Anti-spasmodic). 1Kg 5Kg 10Kg

9. M/s. Leads Virox TD Powder Decontrolled 02 Approved Pharma (Pvt) Ltd., Each Kg contains:- 100gm years Islamabad. Doxycycline HCI………200gm 250gm Tylosin Tartrate………..100gm 500gm Amantadine HCI…………40gm 1Kg Colistin Sulphate……...500MIU 5Kg Bromhexine HCL…………5gm 25Kg (Antibiotic). 10. M/s. Leads Amandx Powder Decontrolled 02 Approved Pharma (Pvt) Ltd., Each 1000gm contains:- 100gm years Islamabad. Doxycycline HCI…..….20% 250gm Tylosin Tartrate ……....10% 500gm Amantadine HCI……...4.5% 1Kg (Antibiotic). 5Kg 25Kg 11. M/s. Decent Nortrim-S Oral Liquid Decontrolled 02 Approved

6 Pharma, Rawat, Each ml contains:- 30ml years Islamabad. Norfloxacin ……………….10% 50ml Sulphamethoxypyridazine...15% 100ml Trimethoprim……………..03% 500ml (Antibacterial). 1 Liter 2.5 Liter 5 Liter 10 Liter

LOCALLY MANUFACTURED VETERINARY DRUGS FOR THE MONTH OF NOVEMBER & DECEMBER, 2010.

Registration Board thoroughly discussed the following cases and decided the cases as mentioned against each.

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision Applicant Size Life 1. M/s. Inshal Nilza Shell Super Suspension Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 100ml years Industries, Rawat, Oxyclozanide…………….3.0% 150ml Islamabad. Levamisole Hcl…………..1.5% 250ml Cobalt Chloride (6H20).0.075% 450ml Sodium Selenite ……...0.035% 500ml (Anthalmintic). 1000ml 2.5 Liter

2. M/s. Inshal Clobenda Shell Suspension Decontrolled 02 Approved Pharmaceutical Each ml of suspension 30ml years Industries, Rawat, Albendazole……….2.5% 50ml Islamabad. Closantel…………..0.5% 100ml (Anthalmintic). 250ml 450ml 500ml 1000ml 2.5 Liter

3. M/s. Inshal Oxfashell Suspension Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 30ml years Industries, Rawat, Oxfendazole………2.265% 50ml Islamabad. (Anthalmintic). 100ml 250ml 450ml 500ml 1000ml 2.5 Liter

7 4. M/s. Inshal Levashell 1.5 Suspension Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 50ml years Industries, Rawat, Levamisole HCI…1.5% 100ml Islamabad. (Anthalmintic). 150ml 250ml 450ml 500ml 1000ml 2.5 Liter

5. M/s. Inshal Tol Shell Liquid Decontrolled 02 Approved Pharmaceutical Each ml contains:- 30ml years Industries, Rawat, Doxycycline HCI……..200mg 50ml Islamabad. Tylosin Tartrate……….100mg 100ml Colistin Sulphate….450000 IU 250ml Bromhexine HCI………4mg 500ml (Antibacterial, Anti-Viral). 1 Liter 5 Liter 10 Liter 25 Liter

6. M/s. Inshal Mentho Flush Oral Liquid Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 30ml years Industries, Rawat, Sorbitol……………….140mg 50ml Islamabad. 1,2Propane Diol………60mg 100ml Magnesium Sulphate 250ml (6H20)………………..40mg 500ml Potassium Chloride……20g 1 Liter Sodium Propionate……3g 5 Liter (Anti fungal, Antimicrobial). 10 Liter

7. M/s. Inshal Albashell 10 Suspension Decontrolled 02 Deferred for Pharmaceutical Each 100ml contains:- 30ml years application on Industries, Rawat, Albendazole USP………..10% 50ml Form 5 D Islamabad. Cobalt Chloride 100ml along with (6H20)………………….0.05% 250ml revised Fee Sodium Selenite………..0.07% 450ml and expert (Anthalmintic). 500ml views of 1000ml following; 2.5 Liter a. Dr. M Ashraf, UVAS b. Head of Pharmacol ogy Deptt. UAF Dr. M. Arshad, Member DRB 8. M/s. Inshal Trizo Shell Liquid Decontrolled 02 Deferred for

8 Pharmaceutical Each 100ml contains:- 50ml years confirmation Industries, Rawat, Trimethoprim……………..8.0g 100ml of use as Islamabad. Sulfadiazine Na Sodium….40g 200ml bronchodilator (Antibacterial, Coccidial, 250ml Bronchodilator). 500ml 1 Liter 2.5 Liter 25 Liter 9. M/s. Inshal Immunufur E Liquid Decontrolled 02 Deferred for Pharmaceutical Each 1000ml contains:- 100ml years application on Industries, Rawat, Sodium Selenite…….150mg 250ml Form 5 D Islamabad. Vitamin E………..…10,000mg 500ml along with Choline……………..50,000mg 1 Liter revised Fee Vitamin C………….35,000mg 5 Liter and expert Zinc sulphate….…..…4500mg 10 Liter views of Biotin……………..…100mg 25 Liter following; Sorbitol………….….50,000mg c. Dr. M (Immune boster, Multi Vitamin). Ashraf, UVAS d. Head of Pharmacol ogy Deptt. UAF Dr. M. Arshad, Member DRB 10. M/s. Inshal Silymar 2% Liquid Decontrolled 02 Deferred for Pharmaceutical Each ml contains:- 100ml years application on Industries, Rawat, Silymarin……….20mg 150ml Form 5 D Islamabad. Sorbitol………….50mg 250ml along with (Hepatoprotective). 500ml revised Fee 1 Liter and expert 2.5 Liter views of following; e. Dr. M Ashraf, UVAS f. Head of Pharmacol ogy Deptt. UAF Dr. M. Arshad, Member DRB 11. M/s. Inshal Cyper Shell Liquid Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 50ml years Industries, Rawat, Enrofloxacin………...10g 100ml Islamabad. Colistin Sulphate……50MIU 150ml (Antibiotic). 250ml 500ml 1 Liter

9 2.5 Liter 12. M/s. Inshal Sulfadine Liquid Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 50ml years Industries, Rawat, Enrofloxacin…………...10g 100ml Islamabad. Colistin Sulphate………3.5g 150ml Amantadine HCI……….4.0g 250ml (Antibiotic). 500ml 1 Liter 2 Liter 2.5 Liter

13. M/s. Inshal Bromo Shell Liquid Decontrolled 02 Approved Pharmaceutical Each 100ml contains:- 100ml years Industries, Rawat, Bromhexine HCI……..05g 500ml Islamabad. (Bronchodilator). 1 Liter

14. M/s. Inshal Asper Shell Water Soluble Powder Decontrolled 02 Deferred, for Pharmaceutical Each 1000g contains:- 30g years PSI by panel Industries, Rawat, Vitamin C……………..…200g 50g comprising of Islamabad. Acetyl Salicylic Acid…….67g 100g Area FID and (NSAIDS + Supplement). 250g A.Q.Javed 500g Iqbal Member 1 Kg RB. 5 Kg 10Kg 15. M/s. Inshal Amento Water Soluble Powder Decontrolled 02 Approved Pharmaceutical Each 100g powder contains:- 100g years Industries, Rawat, Enrofloxacin HCI……..10% 250g Islamabad. Amantadine HCI………4% 500g Colistin Sulphate………3% 1 Kg (Antibacterial, Antiviral). 5 Kg 10Kg 25Kg

16. M/s. Inshal Adekshell Water Soluble Powder Decontrolled 02 Deferred, for Pharmaceutical Each 1000g contains:- 30g years PSI by panel Industries, Rawat, Vitamin A……………..20 MIU 50g comprising of Islamabad. Vitamin D……………...2 MIU 100g Area FID and Vitamin E……………....6g 250g A.Q.Javed Vitamin K3……………..5g 500g Iqbal Member (Multivitamins). 1 Kg RB. 5 Kg 10Kg

17. M/s. Inshal Shelldox Water Soluble Powder Decontrolled 02 Approved Pharmaceutical Each 1000gm contains:- 100g years Industries, Rawat, Doxycycline HCI…………400g 250g Islamabad. Tylosin Tartrate…………..200g 500g (Antibacterial, Anti-viral). 1 Kg

10 5 Kg 10Kg

18. M/s. Inshal OXY NEO 10/10 Water Soluble Decontrolled 03 Approved Pharmaceutical Powder 30g years Industries, Rawat, Each 100g contains:- 50g Islamabad. Neomycin Sulphate……..10g 100g Oxytetracycline HCI…….10g 125g (Anti-infective, Antibacterial). 250g 500g 1 Kg 5 Kg

19. M/s. Inshal Levashell 15 Powder Decontrolled 02 Approved Pharmaceutical Each 100gm contains:- 30g years Industries, Rawat, Levamisole HCI……….15% 50g Islamabad. (Anthalmintic). 100g 250g 500g 1 Kg 5 Kg 10Kg

20. M/s. Inshal Tifo Shell Powder Decontrolled 02 Approved Pharmaceutical Each 100gm contains:- 30g years Industries, Rawat, Trichlorfon…………98% 50g Islamabad. (Antiparasites, Anti Helminths). 100g 500g 1 Kg 2.5Kg 5 Kg 10Kg 25Kg

21. M/s. Inshal Pipra Shell Water Soluble Powder Decontrolled 02 Approved, Pharmaceutical Each 1000g contains:- 100g years with brand Industries, Rawat, Piprazine Citrate………..1000g 250g name change Islamabad. (Anthelmintics). 500g 1 Kg 5 Kg 10Kg 22. M/s. Inshal Enrodine Plus Water Soluble Decontrolled 02 Approved, Pharmaceutical Powder 100g years with brand Industries, Rawat, Each 1000g contains:- 250g name change Islamabad. Enrofloxacin………..100g 500g Amantadine HCI……40g 1 Kg Colistin Sulphate……35g 5 Kg (Antibacterial, Anti-viral). 10Kg

11 23. M/s. Inshal Sulpha Plus Water Soluble Powder Decontrolled 02 Approved Pharmaceutical Each 100gm powder contains:- 100g years Industries, Rawat, Enrofloxacin………….10% 250g Islamabad. Amantadine HCI………4% 500g Colistin Sulphate………4% 1 Kg (Antibacterial, Anti-Viral). 5 Kg 10 Kg 25 Kg

24. M/s. Inshal Amino Flush Water Soluble Decontrolled 02 Approved Pharmaceutical Powder 100g years Industries, Rawat, Each 100g contains:- 250g Islamabad. Ammonium Chloride………45g 500g Sodium Sulphate…………..25g 1 Kg Magnesium Sulphate 5 Kg 7H2O...... 25g 10Kg (Aminoacid, Multi-Vitamin, Expectorant).

25. M/s. Inshal Reno Shell Water Soluble Powder Decontrolled 02 Deferred for Pharmaceutical Each 100g contains:- 30g years application on Industries, Rawat, Methanamine…………90g 50g Form 5 D Islamabad. Sorbitol………………..5g 100g along with (Aminoacid, Multi-Vitamin, 250g revised Fee Expectorant). 500g, and expert 1 Kg views of 5 Kg following; 10Kg g. Dr. M Ashraf, UVAS h. Head of Pharmacol ogy Deptt. UAF Dr. M. Arshad, Member DRB 26. M/s. Inshal Vita Shell Water Soluble Powder Decontrolled 02 Approved Pharmaceutical Each 1000gm powder contains:- 30g years Industries, Rawat, Vitamin C………………200g 50g Islamabad. Acetylecylicic Acid…….67g 100g Potassium Chloride……..3g 250g Sodium Citrate………….7g 500g (NSAIDs + Suppliment). 1 Kg 5 Kg 10Kg 25Kg

27. M/s. Inshal Coxishell Water Soluble Powder Decontrolled 02 Approved

12 Pharmaceutical Each 1000g powder contains:- 30g years Industries, Rawat, Doxycycline HCI………..200g 50g Islamabad. Tylosin Tartrate………….100g 100g Bromhexine………………5g 250g (Antibacterial, Anti-Viral). 500g 1 Kg 5 Kg 10Kg 25Kg

28. M/s. Inshal Amproshell 60% Water Soluble Decontrolled 02 Approved Pharmaceutical Powder 100g years Industries, Rawat, Each 100gm powder contains:- 500g Islamabad. Amprolium Hcl………60gm 1 Kg Coccididal).

29. M/s. Inshal Tetra Shell 20 Water Soluble Decontrolled 02 Approved Pharmaceutical Powder 30g years Industries, Rawat, Each 1000g contains:- 50g Islamabad. Chlortetracycline HCI……..200gm 100g (Anti-infective, Antibacterial, 150g Tetracycline). 200g 250g 500g 1 Kg

30. M/s. Inshal Tilco Shell Water Soluble Powder Decontrolled 02 Deferred for Pharmaceutical Each 1000g contains:- 30g years application on Industries, Rawat, Tilmicosin Phosphate…….10% 50g Form 5 D Islamabad. (Anti-infective, Antibacterial). 100g along with 500g revised Fee 1 Kg and expert 2.5Kg views of 5Kg following; 10Kg i. Dr. M 25Kg Ashraf, UVAS j. Head of Pharmacol ogy Deptt. UAF Dr. M. Arshad, Member DRB 31. M/s. Inshal Doxyline Water Soluble Powder Decontrolled 02 Approved Pharmaceutical Each 1000gm powder contains:- 30g years Industries, Rawat, Doxycycline HCI………200g 50g Islamabad. Tylosin Tartrate………..100g 100g Colistin Sulphate…….450MIU 250g

13 Bromhexine HCI…….….4g 500g (Antibacterial, Anti-Viral). 1 Kg 5 Kg 10 Kg 25Kg

32. M/s. Prix Pri-Dimidine 33.3% Injection Decontrolled 02 Approved Pharmaceutica Each ml injection contains:- 100ml years (Pvt) Ltd Lahore. Sulphadimidine 500ml Sodium……………….333.3mg (Sulphonamide).

33. M/s. Prix Pri-Calcifort injection Decontrolled 02 Deferred for Pharmaceutica Each 100 ml injectable solution 50ml years application on (Pvt) Ltd Lahore. contains:- 100ml Form 5 D Calcium gluconate………20g 250ml along with Toldimphos sodium…….400mg 500ml revised Fee Magnesium sodium…….334mg and expert Baric acid………………..2.4g views of Sorbitol………………….5g following; (MineralsCalcium/Phosphrous/Ma k. Dr. M gnesium and Sugar) Ashraf, UVAS l. Head of Pharmacol ogy Deptt. UAF Dr. M. Arshad, Member DRB 34. M/s. Prix PRI-Dolocam 7.5 Injection Decontrolled 02 Approved Pharmaceutica Each ml contains:- 5 x 10ml years (Pvt) Ltd Lahore. Meloxicam………7.5mg 25ml (NSAID) 50ml 100ml

35. M/s. Prix Pri-Deflame 5 Injection Decontrolled 02 Approved Pharmaceutica Each ml injection 5x 10ml years (Pvt) Ltd Lahore. contains: - 20ml Flunixin Meglumine…..50mg 50ml (Nsaid) 100ml

36. M/s. Epoch Escour Oral Suspension Decontrolled 2 years Approved Pharmaceuticals, Each ml contains:- 100ml Karachi. Sulphadiazine BP……35.50mg 500ml Sulphadimidine BP…28.40mg Neomycin Sulphate BP1.80mg Hysoine Methylbromide…….0.040mg Pectin USP…………7.1mg Kaolin BP……………103.3mg Vitamin B1 BP………0.150mg Vitamin B2 BP………0.220mg (Antibiotic, Anti-Toxins, antispasmodic and Vitamins).

37. M/s. Epoch Epotizer Injection Decontrolled 18 Approved Pharmaceuticals, Each 3ml contains:- 50ml months Karachi. Thiamine HCI (Vitamin 100ml B1)…………………..100mg Pyridoxine Hydrochloride (Vitamin B6)…………………100mg Cyanocobalamin (Vitamin B12)…………………500mcg (Vitamins).

15 Registration-II. Registration Applications of July, 2010.

S.No. Name of Name of drug(s) & Proposed Demanded Date of Decision firm(s) Composition Pack size Price application, Diary No. & Form 1. M/s Barret DiaSet Plus Tablet As per As per 28-7-2010 Approved Hodgson, Each tablet contains: PRC PRC Dy.No.1433 Karachi Pioglitazone ……15 mg Form-5 Metformin Rs.8000/- Hydrochloride…...850 mg Rs.12,000/- (Antidiabetic agent) 21-5-2013 2. M/s Nabi 01/07/2010 Approved Qasim Reliefal 6 Plus Suspension Dy. No. 1273 Karachi Each 5ml contains: 60ml As per Form 5 Paracetamol BP……….250mg 450ml PRC Rs. 8000/- (analgesic & antipyretic) Rs.12,000/1 14-5-2013 3. M/s Bosch Bentocin 30mg Injection 5’s Rs.75/- 22-07-2010 Deferred Pharmaceut Each vial contains: 10’s Rs.150/- Dy.No.1388 being icals, Kar. Pentazocin As Form-5 Controlled lactate…………...…30 mg Rs.8000/- Drug (Narcotic analgesic, post Rs.12,000/- operative pain) 20-5-2013 4. M/s Barrett Ivabar 7.5mg Tablet 10’s Rs.1950/- 10/07/2013 Deferred for Hodgson Each tablet contains: 14’s Rs.2730/- Dy. No. 691 i.submission of Karachi Ivabradine Hydrochloride eq. 28’s Rs.5460/- Form 5D remaining fee. to Ivabradine……...7.5mg 56’s Rs.10,920/- Rs. 60,000/- ii. (Anti anginal, anti heart Fast track Confirmation for approval by failure) application USFDA, EMA, regulatory body of Japan or Australia. iii. Expert opinion byBrig. M.H.Najmi, Dr.Shahid Nawaz, PIMS Dr.Ghulam Haider, Shifa International 5. -do- Ivabar 5mg Tablet 10’s Rs.1740/- 10/07/2013 -Do- Each tablet contains: 14’s Rs.2436/- Dy. No. 690

16 Ivabradine Hydrochloride eq. 28’s Rs.4872/- Form 5D to Ivabradine………...5mg 56’s Rs.9744/- Rs. 60,000/- (Anti anginal, anti heart Fast track failure) application

6. M/s Clogrel Plus Tablet 10x2’s As per 01/07/2013 Deferred for Pharmatec Each film coated tablet PRC Dy. No. 683 product Pakistan contains: Form 5 specifi Pvt. Ltd. Aspirin (enteric coated Rs. 60,000/- inspection for Kar. pellets)………………..75 mg Fast track confirmation Clopidogrel (as Clopidogrel application of Bisulphate USP)……..75 mg manufacturin (Anticoagulant/ antiplatelet) g & QC facility by area FID & Director DTL, Karachi

Registration Applications of August, 2010.

S.No. Name of Name of drug(s) & Proposed Demanded Date of Comments firm(s) Composition Pack size Price application, Diary No. & Form 7. M/s Nabi Letol Tablet 10’s & As per 11-08-2010 Deferred for Qasim Each film coated tablet 20’s PRC Dy.No.1553 i.submission of Karachi contains: Form-5 application on Labetalol Rs.8000/- Form5D. ii. Hydrochloride …200mg Rs.12,000/- Confirmation for approval by (Beta Blockers) 14-5-2013 USFDA, EMA, regulatory body of Japan or Australia. iii. Expert opinion by Brig. M.H.Najmi, Dr.Shahid Nawaz, PIMS Dr.Ghulam Haider, Shifa International 8. -do- Loprot Plus Capsule 7’s As per 03-08-2010 Referred to Each capsule contains:- 10’s PRC Dy.No.1530 review Omeprazole ……..20mg 14’s Form-5 committee Sodium Bicarbonate .1100mg Rs.8000

17 (Anti Ulcerant) Rs.12,000/ 14-5-2013 9. -do- Letol Tablet 10’s & As per 11-08-2010 Deferred for Each film coated tablet 20’s PRC Dy.No.1554 i.submission of contains: Form-5 application on Labetalol Rs.8000/- Form5D. ii. Hydrochloride USP…300mg Rs.12,000/1 Confirmation for approval by (Beta Blockers) 14-5-2013 USFDA, EMA, regulatory body of Japan or Australia. iii. Expert opinion byBrig. M.H.Najmi, Dr.Shahid Nawaz, PIMS Dr.Ghulam Haider, Shifa International 10 -do- Misotec tablet 10’s & 30 As per 17-08-2010 Approved Each tablet contains: PRC Dy.No.1578 Misoprostol…100mcg Form-5 Mfg.Specs.NQ Rs.8000/- (Prostaglandin Analogue) Rs.12,000/1 14-5-2013 11 -do- Misotec tablet 3 &10’s As per 17-08-2010 Approved Each tablet contains: PRC Dy.No.1577 Misoprostol…200mcg Form-5 Mfg.Specs.NQ Rs.8000/- (Prostaglandin Analogue) Rs.12,000/1 14-5-2013 12 -do- Tensel 5mg Tab. 14’s As Per 10-08-2010 Approved Each tablet contains: PAC 1540 Nebivolol HCI equivalent to Form-5 Nebivolol…….5mg Rs.8000/- (Anti-hypertensive) Rs.12,000/1 14-5-2013 13 -do- Letol Tablet 20’s As per 11-08-2010 Approved Each film coated tablet PRC Dy.No.1556 contains: Form-5 Labetalol Rs.8000/- Hydrochloride ….…100 mg Rs.12,000/1 (Beta Blockers) 14-5-2013

Applications for Fast Track Registration

S.No. Name of Name of drug(s) & Proposed Demanded Date of Comments firm(s) Composition Pack size Price application, Diary No. & Form 14 M/s Indus Dyclo Plus 2ml Inj. 5’s Rs.140/- 13-05-2013 Approved. Pharma Each 2ml contains: 10’s 280/- Dy.No.367 Only IM Karachi Diclofenac Sodium ..75 mg 20’s Rs.560/- Form-5 route of Lignocaine Rs.60,000/- administratio Hydrochloride……..20mg n approved (Non Steroidal Anti- Inflammatory) 15 -do- I-Flor 250mg Schet 10’s Rs.480/- 13-05-2013 Referred to Each sachet contains: Dy.No.366 H&OTC Saccharomyces Form-5 Division Boulardii………….250 mg Rs.60,000/- being (Anti diarrheal) probiotics 16 M/S. GSK Panadol sinus Caplets 100’s Rs.300/- 24-07-2013 Deferred for Pakistan Each Caplet contains:- Dy.No.1047 submission of Ltd. Paracetamol……. 500 mg Form-5 application on Karachi. Phenylephrine HCl. 5.00mg Rs,60,000/- Form5D & (Cold Preparation) remaining fee.

17 M/s Sante Cipromax 250mg Tablet 10’s As per 14-05-2013 Approved. Pvt. Ltd, Each tablet contains: PRC Dy.No.371 The Board Karachi Ciprofloxacin HCl eq. to Form-5 advised to Ciprofloxacin……..250 mg Rs.60,000/- change brand (Fluoroquinolone) name. 18 M/s Sepride Tablet 10’s As per 20-05-2013 Approved Medisure Each tablet contains: 50’s PRC Dy.No.498 Lab. Kar. Cinitapride…….….1 mg Form-5 (Antiemetic) Rs.60,000/- 19 -do- Dexiprofen Tablet 10’s As per 20-05-2013 Approved Each tablet contains: 30’s PRC Dy.No.496 Dexibuprofen…….300 mg Form-5 (Analgesic agent) Rs.60,000/- 20 -do- Dexiprofen Tablet 10’s As per 20-05-2013 Approved Each tablet contains: 30’s PRC Dy.No.497 Dexibuprofen…..400 mg Form-5 (Analgesic agent) Rs.60,000/- 21 M/s S.J & Berica 60mg Tablet 14’s Rs.600/- 29-04-2013 Approved G, Karachi Each film coated tablet 273 contains: Form-5 Etoricoxib…….…60 mg Rs.20,000/- (NSAID) Rs.40,000/- 20-05-2013

19 22 -do- Acenac 150mg Injection 5x1ml Rs.200/- 20-05-2013 Approved Each ml contains: 273 Aceclofenac…….150 mg Form-5 (Non-Steroidal Anti Rs.20,000/- inflammatory drug) Rs.40,000/- 20-05-2013 23 M/s Sami D3 Injection As per As per 20-05-2013 Approved. Pharmaceuti Each ml contains: PRC PRC 518 The Board cals, Kar. Cholecalciferol …...5 mg Form-5 advised to (200,000 IU) Rs.60,000/- change brand (Vitamin D3) name. 24 M/s Helix Azil 40mg Tablet 10’s As per 20-05-2013 Deferred for i. Pharma kar. Each tablet contains: 30’s PRC 515 Confirmation Azilsartan kamedoxomil Form-5D for approval by eq.to Azilsartan Rs.60,000/- USFDA, medoxomil……..40 mg Rs.90,000/- EMA, regulatory (Anti Hypertensive) 24-07-2013 body of Japan or Australia. iii. Expert opinion byBrig. M.H.Najmi, Dr.Shahid Nawaz, PIMS Dr.Ghulam Haider, Shifa International 25 -do- Azil 80mg Tablet 10’s As per 20-05-2013 -Do- Each tablet contains: 30’s PRC 514 Azilsartan kamedoxomil Form-5D eq.to Azilsartan Rs.60,000/- medoxomil………80 mg Rs.90,000/- (Anti Hypertensive) 24-07-2013 26 -do- Azil 20mg Tablet 10’s As per 20-05-2013 -Do- Each tablet contains: 30’s PRC 513 Azilsartan kamedoxomil Form-5D eq.to Azilsartan Rs.60,000/- medoxomil………20 mg Rs.90,000/- (Anti Hypertensive) 24-07-2013 27 M/s Tramorhage 250mg 20’s Rs.154/- 20-05-2013 Approved Mediate Capsule 502 Pharmaceuti Each capsule contains: Form-5 cals, kar Tranexamic acid...250 mg Rs.20,000/- Rs.40,000/- 23-5-2013 28 -do- Tramorhage 500mg 20’s Rs.310/- 20-05-2013 Approved Capsule 501

20 Each capsule contains: Form-5 Tranexamic acid…..500 mg Rs.20,000/- Rs.40,000/- 23-5-2013 29 -do- Medeiron-S Injection 5mlx5’s Rs.1250/- 20-05-2013 Approved. 20mg/ml Injection 500 The Board Each ml contains: Form-5 advised to Iron sucrose…….…20 mg Rs.20,000/- change brand name. 30 M/s Maple Losaan 25mg Tablet 20’s As per 21-05-2013 Approved Pharma. Each tablet contains: PRC 526 Kar. Losartan Potassium...25 mg Form-5 (Anti hypertensive) Rs.60,000/- 31 -do- Ciprozee 750mg Tablet 10’s As per 21-05-2013 Approved Each tablet contains: PRC 525 Ciprofloxacin (as Form-5 Hydrochloride)……750 mg Rs.60,000/- (Fluoroquinolone Antibiotic) 32 M/s Opal Febutab 80mg Tablet 10’s As per 04-06-2013 Approved Lab. Each film coated tablet 20’s PRC Dy.No.631 Karachi contains: 30’s Form-5 Febusostat…………..80 mg Rs.60,000/- (Xanthine Oxidase Inhibitor) 33 M/s Helix Lacosa 200mg Tablet 14’s As per 17-06-2013 Approved Pharma Each film coated tablet PRC Dy.No.664 Karachi contains: Form-5 Lacosamide……….200 mg Rs.60,000/- (Anti epileptic/ Anti- Convulsant) 34 -do- Lacosa 100mg Tablet 14’s As per 17-06-2013 Approved Each film coated tablet PRC Dy.No.663 contains: Form-5 Lacosamide……….100 mg Rs.60,000/- (Anti epileptic/ Anti- Convulsant) 35 -do- Lacosa 50mg Tablet 14’s As per 17-06-2013 Approved Each film coated tablet PRC Dy.No.665 contains: Form-5 Lacosamide……….50 mg Rs.60,000/- (Anti epileptic/ Anti- Convulsant) 36 -do- Rozerem Tablet 10’s As per 04-06-2013 Deferred for i. Each film coated tablet 30’s PRC Dy.No.633 Confirmation contains: Form-5D for approval by

21 Ramelteon………..8 mg Rs.150,000/- USFDA, (Hypnotics) EMA, regulatory body of Japan or Australia. iii. Expert opinion by Brig. M.H.Najmi, Dr.Rizwan Taj, PIMS Dr.Saleem Jehangeer, MH Rawalpindi 37 M/s Alptec 0.5mg Tablet 3x10’s As per 03-06-2013 Deferred Pharmatec Each tablet contains: PRC Dy.No.616 being Pak. Alprazolam ………..0.5 mg Form-5 controlled Karachi (Anxiolytic) Rs.60,000/- Drug 38 -do- Reltus Forte Cough 120ml As per 07-06-2013 Deferred Expectorant PRC Dy.No.640 being Each 5ml contains: Form-5 controlled Ammonium Rs.60,000/- Drug chloride……….100mg Ephedrine Hydrochloride……7 mg Chlorpheniramine maleate…………..2 mg (Cpigj ex[ectprant) 39 M/s Sanofi Aprovasc 300/10mg Tablet 28’s Rs.2212/- 04-06-2013 Deferred for i. Aventis, Each tablet contains: Dy.No.630 Confirmation Karachi Irbesartan……….300 mg Form-5D for approval by Amlodipine besylate.14 mg Rs.150,000/- USFDA, eq. to amlodipine…10 mg EMA, regulatory (Alntihypertensive, body of Japan angiotensin II receptor or Australia. ii. antagonist) Expert opinion by Brig. M.H.Najmi, Dr.Shahid Nawaz, PIMS Dr.Ghulam Haider, Shifa International 40 -do- Aprovasc 150/10mg Tablet 28’s Rs.2620.8/- 04-06-2013 -Do- Each tablet contains: Dy.No.624 Irbesartan……….150 mg Form-5D Amlodipine besylate.14 mg Rs.150,000/- eq. to amlodipine…10 mg

22 (Alntihypertensive, angiotensin II receptor antagonist) 41 -do- Aprovasc 150/5mg Tablet 28’s Rs.1456/- 04-06-2013 -Do- Each tablet contains: Dy.No.631 Irbesartan……….150 mg Form-5D Amlodipine besylate.7 mg Rs.150,000/- eq. to amlodipine……5 mg (Alntihypertensive, angiotensin II receptor antagonist) 42 -do- Aprovasc 300/5mg Tablet 28’s Rs.2114/- 04-06-2013 -Do- Each tablet contains: Dy.No.628 Irbesartan……….300 mg Form-5D Amlodipine besylate.7 mg Rs.150,000/- eq. to amlodipine……5 mg (Alntihypertensive, angiotensin II receptor antagonist) 43 M/s Abbott Rondec E Syrup 60ml Rs.60/- 07-06-2013 Deferred for i. Laboratorie Each 5ml contains: 120ml Rs.120/- Dy.No.639 Confirmation s, kar. Salbutamol………….2 mg Form-5D for approval by Guaifenesin ……..200 mg Rs.150,000/- USFDA, Bromhexine HCl…….4mg EMA, regulatory (Expectorant with body of Japan bronchodilator cough or Australia. ii. syrup) Expert opinion by Brig. Aslam Khan, Dr.Rehana Kausar, PIMS Head, Dept of Chest Diseases, Shaikh Zayed Hospital, Lahore

44 M/s Barrett Megaklar DS Suspension 60ml Rs.450/- 27-06-2013 Deferred for Hodgson 250mg/ml Dy.No.675 confirmation Pak. Kar. Each 5ml contains: Form-5 whether Clarithromycin*…250mg Rs.60,000/- powder or (Antibacterial and granules Antibiotic)

23 Item No.III Miscellaneous Cases:

Registration-I

Case No:01 Transfer of Registration of Drugs from M/s. Pakistan Business International, Karachi to M/s. Zenith International, Karachi.

M/s. Zenith International, Karachi have requested for transfer of registration of the following registered Surgical Sutures from the name of previous agent M/s. Pakistan Business International, Karachi to their name for import and approved the change of manufacturer’s name of the products from M/s. Shandong Shanxian Medical Suture Materials Co. Ltd. China to M/s. Shandong Sinorgmed Co. Ltd., China:-

S. No. Reg. No. Name of Products. 1. 031371 PLAIN CATGUT (Plain Catgut Surgical Sutures). 2. 031372 CHROMIC CATGUT (Chromic Catgut Surgical Sutures). 3. 031373 POLYGLYCOLIC ACID (Synthetic Absorbable Sutures). 4. 031374 SILK BRAIDED (Silk Braided Surgical Sutures). 5. 043055 Black Monofilament Nylon Surgical Suture. 6. 043056 Blue Polypropylene Surgical Suture. 7. 043057 Green Braided Polyester Surgical Suture.

The firm has deposited the fee Rs.15000 x 7 = Rs.105000/- and submitted following supporting documents:- i. No objection certificate to transfer the registration in the name of M/s. Zenith International, Karachi from the manufacturer abroad M/s. Shandong Sinorgmed Co. Ltd., China. ii. Manufacturer declaration regarding termination of their previous agency. iii. Manufacturer declaration of change in company name. iv. Certificate from Heze Food and Drug Administration of Peoples Republic of China certifying the change in company name.

No Objection Certificate of the former agent M/s. Pakistan Business International, Karachi was not provided. M/s. Pakistan Business International, Karachi was asked either to submit their NOC in this regard or provide their fresh agency agreement (if any) with the manufacturer abroad. They have informed that they do have strong objection in transferring the said drugs to other applicant/company without their consent and shall be

24 furnishing fresh Agency Agreement and relevant documents as soon as they receive. However the principals abroad M/s. Shandong Sinorgmed Co. Ltd., China have meanwhile confirmed that they have appointed M/s. Zenith International, Karachi as their sole agent for all their products and have terminated their agency with M/s. Pakistan Business International, Karachi. Show Cause Notices were issued to M/s. Pakistan Business International, Karachi two times for cancellation of registration of said drugs from their name. In response they have requested to grant them an appointment to appear in person to explain the details. They have also informed that they already pursue the matter with Wafaqi Mohtasib (Ombudsman’s) Secretariat Regional Office Karachi to counter the challenges and forward copies of proceedings as and when required by this office.

M/s Zenith International, Karachi have submitted relevant documents from manufacturer abroad that are not endorsed by Pakistan embassy in China.

Accordingly, M/s. Pakistan Business International, Karachi was called for personal hearing before the Drug Registration Board in its 237th meeting held on 26-02- 2013.

In response, M/s. Pakistan Business International, Karachi have submitted that the letter for personal hearing received too late leaving no time, not even a single day to move / attend the scheduled hearing before Drug Registration Board on 26th February, 2013.

The Drug Registration Board in its 237th meeting held on 26-02-2013 and also placed in 238th meeting held on August 5-6, 2013 the board considered and deferred the case and decided to issue final show cause notice to call the firm for personal hearing in next board’s meeting. Decision: The representative of the firm Mian Abdul Jabbar CEO appeared before the Board and informed that his firm i.e. M/s. Pakistan Business International, Karachi is still authorized agent of M/s. Shandong Sinorgmed Co. Ltd., China for above referred products and requested for two week time for submission of legalized New Sole agency agreement from M/s. Shandong Sinorgmed Co. Ltd., China. The Board

25 after detailed deliberations allowed him to submit the same within 15 days for further actions on the request of M/s. Zenith International, Karachi.

Case No:02. Re-registration of BONEFOS Capsules (REG. NO.013031). On the request of M/s. Medipharm (Private) Limited, Karachi the Drug Registration Board in its 236th meeting held on 20th November, 2012 de-registered their drug “Bonefos Capsules (Disodium Clodronate 400mg) (Reg. No. 013466)” due to non- available business with immediate effect. Now M/s. Medipharm (Private) Limited, Karachi have informed that they have two presentations of Bonefos Capsules, registered with DRAP Bonefos Capsules, 1x 100’s pack and Bonefos Capsules, 1x30’s pack. They have pointed out that they applied for withdrawal / discontinue one of the above mentioned presentations i.e., Bonefos Capsules, 1x100’s pack, with the intention to continue with the sale of Bonefos Capsules 1x30’s. Unintentionally wrong registration number was mentioned which was corrected in subsequent clarification letter.

Now surprisingly, they have received the letter with the subject, “de-registration of drug” in which there are two main confusions:-

i) The registration number (013466) mentioned is not of Bonefos capsules, but of another unrelated product. ii) The letter does mention Bonefos Capsule but confusingly does not mention the de-registration presentation, i.e., Bonefos Capsules, 1x100’s pack. While they had clearly mentioned the desired pack size in their request letter.

They have stopped further sales of Bonefos Capsules. To avoid any further confusion, they have requested:-

i) Please confirm withdrawal / discontinuation of Bonefos Capsules 1x100’s presentation. ii) Please confirm continued registration of Bonefos Capsules 1x30’s pack size having Registration No.013031 so that it can continue to be marketed.

26 The firm has submitted that Bonefos is used on long term basis, in life threatening cancers, so to avoid any inconvenience to the patients already on Bonefos Capsules requested to treats this matter at the earliest.

Decision: The Board after detailed discussion accepted the request of the firm for re- registration of Bonefos Capsules (Registration No. 013031) in pack size of 30’s on same terms and conditions.

Case No:03. APPEAL FILED BY M/S. FINE TRADERS INTERNATIONAL AGAINST THE DECISION OF REGISTRATION BOARD REGARDING REJECTION OF REGISTRATION APPLICATION OF NEOCLOXIN POWDER.

The Drug Registration Board in its 210th meeting held on 26th – 27th October, 2007 considered and rejected the application of “Neocloxin Powder” applied by M/s. Fine Traders International Faisalabad for import from M/s. Agrar Holland BV Holland due to irrational formulation. Against the decision of Drug Registration Board M/s. Fine Traders International Faisalabad filed an appeal before the Drugs Appellate Board. The Drugs Appellate Board in its 138th meeting held on 13-01-2010 considered and passed orders on the appeal preferred by the firm against the decision of the Drug Registration Board regarding rejection of their application for grant of registration due to the reason as follows: - Name of Drug (s) & Composition. Orders Passed by the Drugs Appellate Board. Neocloxin Powder After hearing to arguments of the appellant and Each gm contains: - the basis of decision by the respondent i.e. the Oxytetracycline HCl 100mg. Registration Board as stated by its secretary and Neomycin Sulphate 50mg. taking into consideration all the relevant pros and Chloramphenicol 100mg. cons of the matter, the Board decided to remand the case back to the Registration Board for getting expert evaluation of this formulation from University of Veterinary and Health Sciences, Lahore and also to verify its formulation in other countries and to decide the matter on merit accordingly.

27 The Drug Registration Board in its 226th meeting held on 20th & 21st July 2010 considered and decided that the instructions of the Drugs Appellate Board be processed accordingly. As per decision of the Drug Registration Board in its 226th meeting held on 20th & 21st July 2010 case was referred to Prof. Dr. Muhammad Nawaz, Vice Chancellor, University of Veterinary and Health Sciences, Lahore for their detailed views/expert opinion and recommendations on the matter. The views/expert opinion of Prof. Dr. Muhammad Nawaz is not received so far.

Decision: The Board discussed the matter in detail. Dr. Arshad, Member DRB also recommended that chloramphenicol containing formulation should be banned in veterinary drugs. Thus the Board rejected the request of the firm. The Board further decided to issue cuase notices to all manufactures / importers of veterinary drugs for de-registration of all chloramphenicol containing products.

Case No:04. Correction in Composition of Solvasole Forte Injection.

M/s. Mylab (Private) Limited, Bahawalpur have requested for correction of composition of their registered veterinary drug “Solvasol Forte Injection (Reg. No.075602)” that one of the ingredient “Etilefrine 10mg/ml” is written by mistake in the registration application instead of “Etilefrine 0.2mg/ml”. They have therefore requested for correction of composition of the product as follows. M/s. Mylab (Private) Limited, Bahawalpur have deposited required fee Rs.20000/-:-

Incorrect composition Correct composition Solvasol Forte Injection. Solvasol Forte Injection. Each ml contains:- Each ml contains:- Novaminsulfon …………….. .40mg. Novaminsulfon …………….. .40mg. Etilefrin…………………….10mg. Etilefrin……………………0.2mg. Calcium Gluconate …………100mg. Calcium Gluconate …………100mg. Magnesium Gluconate ……… 10mg. Magnesium Gluconate ……… 10mg. Sodium Salicylate …………… 7mg. Sodium Salicylate …………… 7mg. Nicotinamide ………………… 0.3mg. Nicotinamide ………………… 0.3mg. Caffeine………………………. 10mg. Caffeine………………………. 10mg.

28 Boric acid………………………10mg. Boric acid………………………10mg.

The firm have further requested that the above composition is already registered and is a Mee-Too product. They have given the following references of already registered products:-

S. No. Name of Manufacturer. Name of Product. Reg. No. 1. M/s. Nawan Laboratories, Karachi Nevit Forte Injection 058987 2. M/s. Selmore Pharmaceuticals, Lahore Aminox Injection 029663 3. M/s. Star Laboratories, Lahore Novastar Injection 035134 4. M/s. Zakfas Pharma, Multan Novafon 052325

Keeping in view of above submitted documents request of the firm for correction of composition of the drug “Solvasol Forte Injection (Reg. No.075602)” may be considered for approval please. Decision: Request of the firm was approved by the Board . Case No:05. Change of Manufacturing Site of Tarceva Tablets.

M/s. Roche Pakistan Limited, Karachi have requested to approve the change of manufacturing site of their following registered imported drugs from M/s. F. Hoffmann- La Roche Ltd., Basel, Switzerland to M/s. Roche S.p.A., Segrate (Milano), Italy:-

S. No. Reg. No. Name of Drug (s). 1. 043002 Tarceva 100mg Tablets. Each film-coated tablet contains:- Erlotinib hydrochloride corresponding to 100mg of Erlotinib.

2. 043003 Tarceva 150mg Tablets. Each film-coated tablet contains:- Erlotinib hydrochloride corresponding to 150mg of Erlotinib.

29 M/s. Roche Pakistan Limited, Karachi has deposited required fee submitted following supporting documents:- i) Copy of initial registration letter. ii) Copy of change of manufacturing site. iii) Copy of last renewal of drugs. iv) Original COPP of drugs issued by EMA. M/s. Roche Pakistan Limited, Karachi was advised to confirm about status of Tarceva 25mg Tablets (Reg. No.043001) whether it will be supplied from previous manufacturing site. In response, M/s. Roche Pakistan Limited, Karachi have submitted that “Tarceva 25mg Tablets” strength is not prescribed by specialist doctors, which leaves it with no place in the market; therefore they do not intend to continue marketing this strength. Keeping in view the submitted documents request of the firm for change of manufacturing site from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s. Roche S.p.A., Segrate (Milano), Italy is submitted for consideration of the Drug Registration Board. Decision: The Board after discussion approved the change in manufacturing site of Tarceva tablets from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s. Roche S.p.A., Segrate (Milano), Italy. However the Board advised to provide site master file of new manufacturing site and authorized its Chairman to accord approval for issuance of letter.

Case No:06. Change of Manufacturing Site of Integrilin Injections.

M/s. Schering-Plough Pakistan (Pvt) Limited, Karachi have requested to approve the change of manufacturing site of their following registered imported drugs from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia SPA, Ferentino, Italy, while the Labeling, Secondary Packaging and Batch release site of the finished products remain the same i.e. M/s. Schering-Plough Labo N.V., Belgium:-

S. No. Reg. No. Name of Drugs. 1. 033145 Integrilin 0.75mg/ml Injection.

30 2. 033146 Integrilin 2.0mg/ml Injection.

They have deposited required fee and submitted following documents in support of their request:- i) Original declaration letter from their parent company M/s. Schering- Plough Corporation, USA affecting this change requirement. ii) Patheon’s GMP and Manufacturing Certificates duly notarized and legalized in original by Pakistan embassy, Rome, Italy. iii) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from Italy for Integrilin 0.75mg/ml Injection. iv) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from Italy for Integrilin 2.0mg/ml Injection. v) FDA approval of Integrilin 0.75mg/ml &2.0mg/ml in US. vi) Notarized Merck letter confirming availability of Integrilin in US from the manufacturing site Patheon Italia S.p.A. Ferentino, Italy. vii) Legalized and Notarized FDA approval of Integrilin with the source of supply Patheon Italia S.p.A in US.

The Registration of the drug is valid till 16th December 2013 as change in the name of manufacturing site was approved on 17th December 2008. Keeping in view the submitted documents request of the firm for change of manufacturing site from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia SPA, Ferentino, Italy is submitted for consideration of the Drug Registration Board.

Decision: The Board approved the change in manufacturing site of Integrilin Injection from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia SPA, Ferentino, Italy, while the labeling, secondary packaging and batch release site of the finished products remain the same i.e. M/s. Schering-Plough Labo N.V., Belgium. However the Board advised to provide site master file of new manufacturing site and authorized its Chairman to accord approval for issuance of letter.

31 Case No: 07. Transfer of Registration of Imported Drugs and Change of manufacturing site.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of registration of the under-mentioned registered imported drugs from the name of previous importer M/s. Highnoon Laboratories Ltd., Lahore to their name as due to an International Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been acquired by the Abbott group since February 15, 2010: -

S# Reg. Name of Drugs. Existing Name of New Name of No. Manufacturer. Manufacturer. 1. 018552 Physiotens 0.2mg M/s. Eli Lilly S.A., Manufactured by: M/s. Tablets. Spain. Rottendrof Pharma GmbH, Germany. Packed by: - M/s. Abbott Healthcare SAS, France. 2. 018551 Physiotens 0.3mg -do- -do- Tablets.

3. 018550 Physiotens 0.4mg -do- -do- Tablets.

They have deposited required fee and submitted following supporting documents: - i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore. ii) Copy of the acknowledgement of last renewal of registration of the products applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore. iii) Copies of acknowledgement of receipt issued by the German National authority BfArM & a notification submitted by the Solvay to the Germany authority for the change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany. iv) Copy of NOC for CRF.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi was advised to provide the

32 proof of approval of the “Physiotens tablets” from EMA, US FDA, Japan & WHO form the same source, the product is not approved from any of these regulatory bodies and as per Import Policy the inspection of the source is required before transfer. The case is submitted for consideration of the Drug Registration Board.

Decision: The Board approved transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories (Pakistan) Ltd. Karachi alongwith the change in manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master file of both sites and panel will inspect the manufacturing sites as well to comply the provisions of import policy. The Board authorized its chairman to accord approval for issuance of letter after compliance of aforementioned provisions.

Case No:08. Change of Manufacturing Site of Clozaril Tablets.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the change of manufacturing site of their following registered imported drugs from M/s. Novartis Pharmaceuticals, Horsham, Great Britain to M/s. Norartis Urunleri, Kurtkoy, Istanbul, Turkey:-

S. No. Reg. No. Name of Drug (s). 1. 016329 Clozaril Tablets 25mg. 2. 016330 Clozaril Tablets 100mg.

They have deposited required fee and submitted following supporting documents:-

i) Copy of registration letter. ii) Original legalized GMP Certificate of new manufacturing site. iii) Copy of evidence of approval of Clozaril Tablets by FDA. iv) Copy of evidence of approval of Clozaril Tablets by EMEA. v) Copy of GMP Certificate of new site issued by MHRA. vi) Copy of NOC for CRF.

33 vii) Original legalized GMP Certificate issued by Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom. viii) Original legalized CPP issued by Ministry of Health, Republic of Turkey as an evidence of approval in the country of origin. ix) Copies of the acknowledgement of last renewal of registration of the products. x) Copy of transfer of registration from M/s. Sandoz (Pakistan) Limited, Karachi to M/s. Novartis Pharma (Pakistan) Limited, Karachi. M/s. Novartis Pharma (Pakistan) Limited, Karachi have further submitted that they will be importing these products from M/s. Novartis Pharma Stein AG, Switzerland till they receive products from new manufacturing site.

M/s. Novartis Pharma (Pakistan) Limited, Karachi was advised to provide legalized / notarized documents for approval of the “Clozaril tablets” from EMA, US FDA, Japan & WHO form the same source. In reply the firm has provided legalized Certificate of Pharmaceutical Product (CPP) of Australia from Australian Government, Department of Health and Ageing, Therapeutic Goods Administration (TGA) as the proof of approval of the “Clozaril tablets” manufactured by to M/s. Norartis Urunleri, Kurtkoy, Istanbul, Turkey.

Decision: Registration Board approved change in manufacturing site of Clozaril Tablets from M/s. Novartis Pharmaceuticals, Horsham, Great Britain to M/s. Norartis Urunleri, Kurtkoy, Istanbul, Turkey. However, the Board advised to deposit remaining fee and provide site master file of manufacturing site. The Board authorized its chairman to accord approval for issuance of letter after compliance of aforementioned provisions.

Case No:09. Change of Manufacturing Site of Eloxatin Injetcion.

M/s. Sanofi-Aventis Pakistan Limited, Karachi have requested to approve the change of manufacturing site of their following registered imported drugs from M/s. Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to M/s. Sanofi- Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany :- S. No. Reg. No. Name of Products. 1. 044890 Eloxatin 50mg/10ml Concentrate for Solution for Infusion.

34 Each ml contains:- Oxaliplatin …………… 5mg.

2. 044891 Eloxatin 100mg/20ml Concentrate for Solution for Infusion. Each ml contains:- Oxaliplatin …………… 5mg.

They have deposited required fee and submitted following supporting documents:- i) Copies of Registration Documents. ii) Original Legalized Certificate of Pharmaceutical Products. iii) Original Legalized GMP Certificate. iv) Original Legalized Manufacturing Authorization.

M/s. Sanofi-Aventis Pakistan Limited, Karachi was advised to provide legalized / notarized documents for approval of the “Eloxatin Injection” from EMA, US FDA, Japan & WHO form the same source. In response the firm has submitted a letter addressed to Director Registration, Drug Regulatory Authority of Pakistan, Islamabad regarding confirmation of registration and approval “Eloxatin Injection” from M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany. Keeping in view the submitted documents request of the firm for change of manufacturing site of the products from M/s. Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany is submitted for consideration of the Drug Registration Board. Decision: The Board approved the change in manufacturing site of above products from M/s. Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany. However, the Board advised to provide site master file of new manufacturing site and authorized its chairman to accord approval for issuance of letter after compliance of aforementioned provision.

35 Registration-II

Case No.10 Permission for bulk import and local repacking – Telfast D tablets (Reg. No: 023617).

Registration Board in its 215th meeting deferred request of M/s Aventis, Karachi for extension in bulk import and local repacking of Telfast- D Tablet (Reg. No.023617) for five years, for clarification from the firm for plan of local manufacturing of Telfast- D Tablet. Last permission for extension for bulk import and local repacking of subject item was granted by the Chairman, Registration Board for two years which is up to 29th August, 2009. Firm submitted an undertaking to establish their own facilities for manufacturing of Telfast-D Tablets within this period. Permission was subject to no further extension in future. Later on firm submitted that Telfast-D Tablet is manufactured at Sanofi-aventis Pharmaceuticals Inc. USA and involves sophisticated unique technology that enables slow release of pseudoephedrine using a tan-wax matric in these bi-layered tablets. This also follows strict analytical procedures and quality tests to maintain specification standards and safety precautions to be taken during its manufacturing and analysis. Due to these facts, this site is responsible for supply bulk tablet to all sanofi-aventis subsidiaries across the world to be imported in bulk followed by local repacking at local units. The Registration Board in its 223rd meeting discussed the case and advised firm to transfer technology as committed previously and must develop facility for manufacturing of Telfast-D Tablet. If firm is still interested for import, then they should brief the Registration Board.

In the Registration Board’s 224th meeting dated 21st & 22nd April, 2010 Mr.Muhammad Amjad, Director Technical, Sanofi Aventis appeared before the board and presented that Telfast-D Tablet cannot be manufactured in Pakistan due to low sale volume and safety concern in manufacturing of fexofenadine and pseudoephedrine combination. The board considered firm’s view about safety concern in manufacturing of fexofenadine and discussed that firm is presently manufacturing fexofenadine tablets and firm has already taken safety measures in its manufacturing. However in order to avoid scarcity of product in market, it was decided to extended bulk import and local repacking permission of Telfast- D Tablet (Reg. No.023617). Permission was valid till August

36 2011. The board also advised firm to transfer technology as committed previously and must develop facility for manufacturing of Telfast-D Tablet. No further extension will be granted after this permission. The Board after detailed discussion deferred the case for personal hearing in next Registration Board.

Now firm has requested for further extension in the permission for bulk import and local repacking of Telfast-D Tablets and have deposited fee amounting to Rs.100,000/- for the purpose.

Decision: Mr.Muhammad Idress incharge QA and Mr.Jaffar Zaida, Regulatory Officer, SITE appeared before the Board and presented that initially M/s Sanofi Aventis, Karachi was granted registration for finished import from M/s Sanofi Aventis, Kansas, USA and later on permitted for bulk import and local repacking at their manufacturing site. As per directions of Registration Board they have tried to make arrangements for local manufacturing of the product but their principal did not agree to the proposal as M/s Sanofi Aventis, Arkansas, USA is the only site of M/s Sanofi Aventis for providing Telfast-D tablets across the globe.

Registration Board discussed and decided to permit M/s Sanofi Aventis, Karachi for import of Telfast-D tablet from M/s Sanofi Aventis, Kansas, USA in tablet form and then further processing to finished form in M/s Sanofi-Aventis, Karachi for 02 years time. However, the Board advised firm to provide legalized COPP of the source and authorized its chairman to accord approval for issuance of regsirtation letter.The Board further advised the firm to apprise them about future strategy for transfer of technology to Pakistan in 02 months time.

Case No:11: Use of packaging materials with old address.

M/s Novartis Pharma (Pakistan) Ltd, West Wharf, Karachi was granted permission for bulk import and local repacking of their Amoxi-Clav range of products at M/s CSH Pharmaceuticals, Lahore. They have now informed that they have imported bulk stocks with repackaging address of 15, West Wharf Road, Karachi instead of CSH Pharmaceuticals, Lahore due to error which was caused to due to some misunderstanding. S. Reg. No. Name of drug(s) Quantity Value in

37 No. rupees 1. 031354 Amoxi-Clav Injection 1.2gm 980,273 116,652,463 2. 031355 Amoxi-Clav 375mg Tablet 743,492 52,044,426 3. 031356 Amoxi-Clav 625mg Tablet 2,554,843 196,722,880 4. 031357 Amoxi-Clav 1gm Tablet 417,131 43,798,734 5. 031353 Amoxi-Clav Injection 600mg 72,000 6,847,920 6. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension 732,132 51,351,738 60ml 7. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension 69,048 6,503,631 100ml 8. 031359 Amoxi-Clav 312.5mg/5ml Dry Suspension 921,024 83,500,036 60ml 9. 031359 Amoxi-Clav 312.5mg/5ml Dry 90,000 12,136,500 Suspension100ml Total 6,579,942 569,558,329

Firm has requested that they may be allowed to repack the above mentioned quantities at M/s CSH Pharmaceuticals; Lahore mentioning the address of M/s Novartis Pharma (Pakistan) Ltd, 15, West Wharf Road, Karachi and bulk manufacturer address will remain same i.e Sandoz Kundl, Austria. Decision: Dr.Farid Khan, representative Pharma Beauru presented samples of Amoxi-Clav 375mg Tablet onwhich old address has been blocked but new address was yet to print. The Board discussed the matter in detail and advised the firm to present samples of all drugs with blocked old address and printed new address for its consideration.

Case No.12 Deferred Drugs.

a. M/s Healthtek Pharma, Karachi – 2SUM 500mg Injection Registration Board in 237th meeting deferred following application of M/s Healthtek Pharma, Karachi Name of drug(s) & Proposed Demanded Date of Decision Composition Pack size Price application, Diary No. & Form 2SUM 500mg Injection As per As per PRC 07-09-2012 Deferred for Each vial contains: PRC 1551 submission of Cefoperazone as sodium Form-5 application on ……………...250 mg Rs.8000/- form5D with

38 Sulbactam as sodium Rs.52,000/- balance fee ……………..250 mg 27-1-2013

Later on scrutiny of record reveals that this formulation is already registered in favour of M/s Global Pharma, Islamabad under brand name of Toxibid Injection, Reg. No.049233. Decision: The Board approved above product for registration for M/s Healthtek Pharma, Karachi b. Pharmatec Pakistan (Pvt.) Ltd, Karachi Following product of M/s Pharmatec Pakistan, Karachi was deferred in 237th meeting for review the case after submission of balance fee, GMP of source, COA and stability data by the Expert Committee of Registration Board.

Name of Drug & Composition Pack size Demanded MRP Prazol 40mg Capsule 14’s As per PRC Each capsule contains: Omeprazole……………..40 mg (Anti peptic ulcerants)

Now the firm has requisite information as under:- i) Omeprazole Pellets will be purchased from M/s Vision Pharma, Islamabad ii) GMP Certificate of M/s Vision Pharma, Islamabad iii) Certificate of Analysis iv) Stability data (for Zone IV. Both accelerated i.e 400C / 75% RH and long term studies i.e 300C / 65% RH) Decision: The Board approved above product for registration for M/s Pharmatec Pakistan, Karachi.

c. M/s OBS Pakistan, Karachi The Registration Board in 237th meeting deferred following application of M/s OBS Pakistan, Karachi Name of drug(s) & Proposed Demanded Date of Decision Composition Pack size Price application, Diary No. & Form C-Yalta 20mg Capsules 10’s Rs. 400.00 14-12-2010 The Sub Committee

39 Each capsule contains:- Dy.No.2168 decided to review the Duloxetine HCL……….20 Form-5 cases after mg Rs.8000/- submission of (Antidepressants) Rs.52,000/- balance fee, GMP of 06-2-2013 source of pellets, COA and stability data C-Yalta 60mg Capsules 10’s Rs. 1200.00 14-12-2010 -do- Each capsule contains:- Dy.No.2170 Duloxetine HCL……….60 Form-5 mg Rs.8000/- (Antidepressants) Rs.52,000/- 06-2-2013 C-Yalta 30mg Capsules 10’s Rs. 600.00 14-12-2010 -do- Each capsule contains:- Dy.No.2173 Duloxetine Form-5 HCL………..30 mg Rs.8000/- (Antidepressants) Rs.52,000/- 06-2-2013

M/s OBS Pakistan, Karachi has now furnished the following documents:- i) GMP Certificate of API source M/s Spansules Formulation, India

ii) Certificate of Analysis

iii) Stability study data on accelerated and real time study of API

iv) Remaining fee Rs.240,000/- for each product for the purpose.

Decision: The Board approved above product for registration for M/s OBS Pakistan, Karachi. d. Correction cases: i. M/s Sami Pharmaceuticals (Pvt.) Ltd, Karachi

M/s Sami Pharma, Karachi has requested for change of drug profile from plain to extended release formulation for their already registered drug i.e ITP 150mg Tablet, Reg. No.075852 containing Itopride HCl ….150mg. Firm has submitted that as the innovator M/s Abbott Lab’s product Ganaton OD is available as extended release tablet, hence they would like to market their product as extended release tablet. Firm has furnished following document / information to support their request:-

i) Form-5 ii) Comparative study of Dissolution profile with innovator

40 iii) Method of analysis iv) Stability summary v) Fee Rs.20,000/- for the purpose. Decision: The Board discussed firms’s request and reviewed documents submitted by the firm and then approved their request for change of drug profile from plain to extended release formulation for their already registered drug i.e ITP 150mg Tablet, Reg. No.075852 containing Itopride HCl 150mg.

ii. Pharmatec Pharmaceuticals, Karachi.

The Registration Board in 236th meeting approved the following registration of M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi and accordingly registration letter was issued. Now the firm has pointed out some typographical mistakes in the said registration letter. Details are as under:- S. Existing Name & Composition Reg. No. Correct name & Composition No. 1 Fenzitec Depot Injection 073773 Fenzitec Depot Injection Each ml contains:- Each ml contains:- Fluphenazine Decanoate …25mg Fluphenazine Decanoate …25mg (Manufacturer’s Specification) (Manufacturer’s Specification) Pack Size : 1mlx1’s Pack Size : 5’s x1ml MRP : Rs.100.00 MRP : Rs.215.00 Pack Size : 1mlx10’s MRP : Rs.1000.00

Firm has stated that they have applied aforementioned product with demanded pack and MRP as mentioned in last column, as evidence firm has furnished Form-5. Firm has requested for issuance of correction letter. Decision: The Board agreed to the firm’s request and referred matter to Drug Pricing Committee for fixation of MRP of Fluphenazine Decanoate …25mg/ml in pack sizes of 1’s and 10’s.

41 Registration-III Case No.13 M/s Saibins Pharmaceuticals, Islamabad

The Registration Board in its 237th meeting referred the following product of M/s Saibins Pharmaceuticals, Islamabad to a Committee comprising of following members. The Board further decided that the recommendations of committee will be submitted to the Chairman, Registration Board for decision & Ten (10) products per section policy will be followed for new License / Section in accordance with the priority as given by the firm:-

1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of the Committee). 2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam University, Islamabad (Member Registration Board) 3. DDG (Reg-II)

The recommendations of the above committee which were approved by the Chairman Registration Board are reproduced in the last column as below:- S. Brand Name / Label Demande Demanded Date of Previous No. Claim d Pack Price Submission Decision Size M-237 1. Muscide 4mg Capsules 10’s As Per 21-01-2013 Deferred Each capsule contains:- Dy.No.996 for Thicolchicoside ……4mg SRO Fee confirmation (Anti-rheumatics (anti- Rs.20,000 of registration

inflammatory agents). status in

international and national market.

Now, the firm has submitted information that the above formulation is registered in Grece, France, Italy, Poland, Portugal, Turkey & India. The applicant has also provided the evidence of registration of above formulation in Pakistan of M/s Searle with brand name Muscoril 4mg Cap & Inj. Other locally registered brands are Myoron (M/s Angelini) & Thiolax (M/s SJ & G Fazul Ellahi). They have therefore requested to register above formulation in their name. Decision: The Registration Board after thorough deliberation decided to refer the case to the review committee for review of formulation.

42 Case No.14: M/s Winilton Pharmaceuticals (Pvt) Ltd, Rawat

The Registration Board in its 237th meeting referred the following products of M/s Winilton Pharmaceuticals (Pvt) Ltd, Rawat to a Committee comprising of following members. The Board further decided that the recommendations of committee will be submitted to the Chairman, Registration Board for decision & Ten (10) products per section policy will be followed for new License / Section in accordance with the priority as given by the firm:- 1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of the Committee). 2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam University, Islamabad (Member Registration Board) 3. DDG (Reg-II)

The recommendations of the above committee which were approved by the Chairman Registration Board are reproduced in the last column as below:-

S. Brand Name / Label Demande Demanded Previous Decision No. Claim d Pack Price M-237 Size 2. Kastwin 10mg Dispersible 14’s As Per SRO Deferred Tabs. Fee for confirmation of Each Dispersible tablet Rs.60,000 me-too status. contains:- Montelukast ………… 10mg (Respiratory System) 3. Fenacwin 75mg Dispersible 2x10’s As Per SRO Deferred Tabs. for confirmation of Each Dispersible tablet Fee me-too status. contains:- Rs.60,000 Diclofenac Potassium…..75mg (Anti-Rheumatics, Systemic)

Now the firm has clarified that due to typographical mistake the products at Sl.No.2 & 3 have been applied as dispersible while in actual fact the dosage form of product at Sl.No.2 is chewable tablets and for product at sl.No.3 is plain tablets instead of dispersible tablet. The firm has therefore, requested for issuance of registration of above product in chewable dosage form for Sl.No.2 and in Plain Tablets for Sl.No.3.

43 Decision: The Registration Board deferred the above applications for submission of complete registration dossier on Form-5 with clarification of dosage forms of drugs.

Case No.15. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi

The Registration Board in its 237th meeting referred the following product of M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi to a Committee comprising of following members. The Board further decided that the recommendations of committee will be submitted to the Chairman, Registration Board for decision & Ten (10) products per section policy will be followed for new License / Section in accordance with the priority as given by the firm:-

4. Mark Injection 1’s As Per 19-12-2011 Deferred Each ampoule (5ml) SRO for confirmation contains:- Fee of formulation Zoledronic Acid as Rs.60,000 whether it is Dry Monohydrate………..4mg Powder or (Bisphosphonic Acid) Liquid Ampoule.

The firm actually applied in Liquid Ampoule. Due to this reason the committee recommended to defer the request of firm 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 has therefore requested to issue the registration of above product in Vial.

Decision: The Registration Board deferred the above registration application for product specific inspection for verification of manufacturing and quality control facility and the data / information submitted in the registration dossier by A.Q. Javed Iqbal (Member, Registration Board) and Director DTL, Peshawar and area FID.

Case No.16. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha

The Registration Board in its 223rd meeting deferred the following products firm M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column as below:- S. Brand Name / Label Claim Demande Demanded Previous Decision No. d Pack Price M-223 Size 1 Triphenamol Tablets 100’s Rs.350.00 Deferred Each tablet contains:- Fee Rs.20,000 Orphenadrine Citrate………35mg Paracetamol………..450mg (Manufacturer Specifications) 2 Tricidol Tablets 0.5mcg 10’s Rs.145.00 Deferred Each film coated tablet contains:- Fee Rs.20,000 Alfacalcidol BP…………0.5mcg (USP Specifications) 3 Trivelox 400mg Tablets 5’s Rs.460.00 Deferred Each film coated tablet contains:- Fee Rs.20,000 Moxifloxacin (as HCl)……400mg

4 Trigesic 550mg Tablets 20’s Rs.180.00 Deferred Each film coated tablet contains:- Fee Rs.20,000 Naproxen Sodium……….550mg (Manufacturer Specifications) 5 Trinolol Tablets 50mg 20’s Rs.110.00 Deferred Each film coated tablet contains:- Fee Rs.20,000 Atenolol USP……….50mg (USP Specifications) 6 Tribastin Tablets 10mg 10’s Rs.100.00 Deferred Each film coated tablet contains:- Fee Rs.20,000 Esbastine BP………….10mg 7 Trizadine Tablets 2mg 10’s Rs.102.00 Deferred Each film coated tablet contains:- Fee Rs.20,000 Tizanidine (as HCl) …………2mg (USP Specifications)

Now the firm has submitted that in 2010 the Registration Board in its 223rd meeting granted five products per section to the new licensees and deferred the remaining product

45 as per policy. Now three years have passed it is therefore requested to grant the registration above remaining product in their name. The firm has submitted an inspection report dated 11-01-2011 which verifies the GMP status bearing the words “Firm was GMP compliant at the time of inspection”. Decision: The Registration Board deferred the above registration applications for the evaluation of the registration dossiers. For Alfacalcidol tablet, product specific inspection will be carried out by Director DTL, Lahore and area FID for confirmation of manufacturing and quality control facilities.

Case No.17. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha

The Registration Board in its 226th meeting deferred the following products of M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column as below:- S. Brand Name / Label Claim Demanded Demanded Previous Decision No. Pack Size Price M-226 1 Gerdnil 40mg Capsule 14’s Rs.300.00 Deferred for toll Each capsule contains:- Fee Policy Esomeprazole as Magnesium Rs.20,000 enteric coated (Pellets) Eq. to Esomeprazole……..40mg (Product Complies to Manufacturer Specifications) 2 Prelin 75mg Capsules 14’s Rs.800.00 Deferred for toll Each capsule contains:- Fee Policy Pregabalin……..75mg Rs.20,000 3 Prelin 150mg Capsules 14’s Rs.1200.00 Deferred for toll Each capsule contains:- Fee Policy Pregabalin………….150mg Rs.20,000 (Manufacturer Specifications) 4 Azotri Capsule 6’s Rs.500.00 Deferred for toll Each capsule contains:- Fee Policy Azithromycin (as Rs.20,000 diyhydrate)…..250mg (Manufacturer Specifications) 5 Omegab 20mg Capsule 14’s Rs.475.00 Deferred for toll Each capsule contains:- Fee Policy Omeprazole as enteric Rs.20,000 coated Pellets.……20mg (Manufacturer Specifications)

46 6 Trigab 100mg Capsules 10’s Rs.85.00 Deferred for toll Each capsule contains:- Fee Policy Gabapentin USP…….100mg Rs.20,000 (Manufacturer Specifications) 7 Trigab 300mg Capsules 10’s Rs.220.00 Deferred for toll Each capsule contains:- Fee Policy Gabapentin USP…….300mg Rs.20,000 (Manufacturer Specifications) 8 Hematose –F Syrup 60ml Rs.80.00 Deferred for toll Each 5ml contains:- Fee Policy Iron (III) Hydroxide Rs.20,000 Polymaltose Complex Eq. to Elemental Iron………………….50mg Folic Acid BP….….0.43mg

Now, the firm has informed that they have developed their own facility of Capsule (General) and Dry Powder Suspension (General) sections. The firm has therefore requested that the above mentioned products which were initially applied on contract manufacturing may please be registered in their own name. For product at S.No19 (Iron Polymaltose Syrup) the firm has clarified that the dosage form is Dry Powder Suspension. In support of this, the firm has stated that they have already been granted Registration of Iron Polymaltose formulation plain in Dry Powder Suspension Reg.No.063300 (Brand name Trifer). The firm also provided the reference of already registered same formulations in Dry Suspension of following firms: 1. M/s Pharmedic (Brand Biofer Suspension). 2. M/s Trison Labs. (Brand Trifer Suspension)

Decision: The Registration Board deferred the above registration applications for the evaluation of the registration dossiers.

Case No.18. M/s Medley Pharmaceuticals Wah Cantt

The Registration Board in its 234th meeting approved the following products of M/s Medley Pharmaceuticals Wah Cantt in the same strength i.e. 20mg. S.No Name and Composition of Pack Demanded Previous . Product size Price Decision M-234

47 1 Esowel Capsules 20mg 2x7’s As Per SRO Approved Each Capsule Contains: Esomeprazole (Pellets)….20mg (Antipeptic Ulcerant)

2 Esowel Capsules 20mg 2x7’s As Per SRO Approved Each Capsule Contains: Esomeprazole (Pellets)….20mg (Antipeptic Ulcerant)

At the time of issuing registration letter, the firm pointed out that, they actually applied the above products with two different strengths as under:-

S.No Name and Composition of Pack Demanded Decision . Product size Price 1 Esowel Capsules 20mg 2x7’s As Per SRO Approved Each Capsule Contains: Esomeprazole (Pellets)….20mg (Antipeptic Ulcerant)

2 Esowel Capsules 40mg 2x7’s As Per SRO Approved Each Capsule Contains: Esomeprazole (Pellets)….40mg (Antipeptic Ulcerant)

The firm has deposited the fee of Rs.20,000/= for each product. The request of firm has been verified from the dossiers. Actually due to typographic mistake the same strength has been return in the agenda of Registration Board meeting. The firm has therefore requested to please issue the registration of above formulation in 40mg. The registration of above formulation in 20mg has been already issued to firm. Decision: The Registration Board has approved request of firm.

Case No. 19. M/s Kanel Pharma, Gujranwala.

Registration Board in its 236th meeting approved the following product of M/s Kanel Pharma, Gujranwala. The decision of the Registration Board is mentioned in last column as under:-

S.No Name and Composition of Pack Demanded Previous

48 . Product size Price Decision M-236 1 Paroxin 12.5mg Capsules 30’s As Per SRO Approved Each capsule contains:- subject to Paroxetine as HCl ………… Fee compliance of 12.5mg Rs.20,000/= following:- (Antidepressant) 1. GMP Certificate of Source. 2. COA Certificate of Analysis. 3. Stability studies.

At the time of issuance of Registration letter, the firm informed that Paroxetine is not available in Pellets or / Capsules dosage form & they actually, applied erroneously for capsule dosage form. The firm has now requested to please change/correct the dosage form as tablet. The firm has deposited Rs.5000/= in support of their request previously the applicant had deposited Rs.15000/= for above product in capsule dosage form, at the time of application before meeting of Registration Board. The firm has also requested to adjust their already deposited fee of Rs.15,000/= for the instant request. Decision: Registration Board has approved request of firm.

Case No.20. M/s Miracle Pharmaceuticals (Pvt) Ltd, Rawat

Registration Board in its 235th meeting deferred the following products of M/s Miracle Pharmaceuticals (Pvt) Ltd, Rawat, with the conditions as mentioned in the second last column against each product as under:- S.N Name and Composition of Previous Information o. Product Decision submitted by the M-235 firm. 1 Clomin Tablets Deferred for The firm has submitted Each film coated tablet contains:- rectification of that: following 1. They will use methanol Clomiphene Citrate …… 50mg observation in the as coating material instead (Antioestrogen) dossier in the of Methylene chloride. dossier:- 1. Methyline Chloride should be replaced with some other suitable film coating material

2 Dimet DS Tablets Deferred for The firm has submitted Each film coated tablet contains:- rectification of that: following 1. They will use methanol Diloxanide Furoate observation in the as coating material instead (USP)..500mg dossier in the o Methylene chloride. Metronidazole (USP)…… dossier:- 2. Dissolution test has 400mg 1. Methyline been submitted by the (Nitroimidazole, Amoebicide) Chloride should be firm alongwith finished replaced with some specifications of products. other suitable film coating material 2. Dissolution test is absent in finished product specification.

3 Marither Forte Deferred for The firm has submitted Each tablet contains:- rectification of that:- following 1. Dissolution test has Artemether ……… 80mg observation in the been submitted by the Lumefantrin ……. 480mg dossier:- firm alongwith finished (Synthetic Anti-Malarial derived 1. Dissolution test specifications of product. from Artemisinin synthetic is absent in finished Recemic Flourene Mixture) product specification.

4 Irovit Capsules Deferred for -do- Each capsule contains:- rectification of following Iron III hydroxide polymaltose observation in the complex eq. to Elemental dossier:- Iron……………. 100mg 1. Dissolution test Folic Acid ……. 0.35mg is absent in finished (Haematinic) product specification.

Now the firm has fulfilled all the formalities as per decision of Registration Board. The firm therefore requested to grant the registration of above in their name.

Decision: Registration Board after thorough deliberation approved products at Sl. No.2 (Diloxanide Furoate + Metronidazole) & 3 (Artemether + Lumefantrin). While the products at Sl.No.1 & 4 have been deferred by the Registration Board for product specific inspection for confirmation of manufacturing and quality control facilities by A.Q. Javed Iqbal (Member, Registration Board) and Director, DTL, Peshawar and area FID. Brand name of product at S.No.1 will be changed.

50 Case No.21. M/s Global Pharmaceutical, Islamabad

Registration Board in its 229th meeting approved the following product of M/s Global Pharmaceutical, Islamabad. The decision of the Registration Board is mentioned in last column as under:-

S.No. Name and Composition of Pack size Demanded Previous Product Price Decision M-229 5. Tamsol-D Tablets 10’s As Per SRO Approved Each film coated tablet Fee contains:- Rs.8,000/= Tamsulosin Hydrochloride …0.4mg (as modified – release tablets) Dutasteride………………0.5mg

Accordingly the Registration was granted to the firm on 11th September, 2012. Later on, it was identified that the above formulation does not exist in tablet dosage form internationally or locally. However, it is available in capsule dosage form. The case is submitted for reconsideration of formulation by the Registration Board. Decision: Registration Board after considering the technical opinion by its members decided to ask the manufacturer to appear before Registration Board for presentation of his opinion regarding efficacy of the above drug formulation. The Board further ordered that till final decision, the registration of above product would remain suspended under section 7(11) (ad) of Drug Act, 1976.

Case No.22. M/s Warafana Pharmaceutical, Islamabad.

Registration Board in its 235th & 237 meeting deferred the following products of M/s Warafana Pharmaceutical, Islamabad. The decision of the Registration Board is mentioned in last column as under:-

S.No. Name and Composition of Pack Demande Previous Decision Product size d Price M-235th & 237th 1 Clari-250 Tablets 1x10’s As Per Deferred for Each tablet contains:- SRO rectification of Clarithromycin ……250mg following observation

51 (Macrolide Antibiotic) Fee in the dossier:- Rs.8000 1. Methylene Choloride should be replaced with some Balance other suitable film fee coating materal. Rs.12000/ = 2 Fusifit-B Cream 1’s As Per Deferred Each gm contains:- SRO for confirmation of Fusidic Acid ……..2.0% w/w Fee steroidal section Betamethasone as Valerate Rs.60,000 and me-too status. (BP)……………. 0.1% w/w (Anti-Inflammatory & Anti- Pruritic Effects).

3 Fusifit-H Cream 1’s As Per SRO -do- Each gm contains:- Fusidic Acid ……..…..20mg Fee Hydrocortisone Acetate Rs.60,000 BP..10mg (Anti-Inflammatory & Anti- Pruritic Effects).

Now the firm has submitted that they have replaced Methylene Choloride with water base film coated material FC 4-H for the product at Sl.No.30 (Clarithromycin 250mg Tablet). For the products at Sl.No.31&32 the firm has submitted the proof / approval of steroidal section for cream. The firm has requested for issuance of registration of above products.

Decision: The Registration Board has approved request of firm.

52 Registration-IV

Case No. 23. M/s. Saaaf Pharmaceuticals, Risalpur

The Drugs Registration Board in its 237th meeting held on 26-02-2013 had deferred the following products of M/s. Saaaf Pharmaceuticals, Risalpur for rectification of shortcoming of the following products.-

S.N Name of Pack Demande o manufactu Name of drugs (s) Decision size d MRP rer 1. Deferred for P.S.I & GMP Varisaf Tablets 229th Meeting M/s. Saaaf Each tablet contains:- 22.1.2011. As Per Pharmaceutica Mebeverine 3x10’s Fee paid, SRO ls, Risalpur HCl……200 mg confirmation of (Antispasmodic) formulation. 237th 26.02.2013

2. Deferred for P.S.I & GMP XL Tablets 229th Meeting Each film coated tablet 22.1.2011. contains:- As Per -do- 10’s Fee paid, Linezolid……..600 SRO confirmation of mg formulation. (Antibiotic) 237th 26.02.2013

3. Deferred for XL Dry Powder P.S.I & GMP Suspension 229th Meeting Each 5 ml contains:- 22.1.2011. As Per -do- Linezolid ……..100 60 ml Fee paid, SRO mg confirmation of (Antibiotic) formulation. 237th 26.02.2013

The firm paid the differential fee. The management could not rectify the relevant shortcomings in comparison of the brand leader (Mebeverine HCl 200mg/ Colofac Cap of Abbott Lab); Linezolid Film coated tablet: Incorrect M.O.T. and dissolution profile not submitted; Linezolid Dry Powder Suspension M.O.T. incorrect, Master formulation is

53 ambiguous. The management requested to grant the registration of above mentioned products.

Decsion: Registration Board decided to conduct product specific inspection by Director DTL, DDG (E&M) and ADC, Peshawar, Peshawar for above products. Moreover, firm will be advised to complete registration applications.

Case No. 24. Deferred Drug

The Drugs Registration Board in its 237th meeting held on 26th February, 2013 had been deferred the following application due to shortcomings in application dossiers:-

S.No. Name of Firms Name of Drugs /label AU Price Date Remarks Claim 1. M/s. Novae Xiben 200 mg Capsule 10’s As 25- SDS > FDA limit Pharmaceuticals, Each capsule contains:- 20’s Per 1- To be deferred Hattar Celecoxib…….200 mg SRO 2013 General Tablets (NSAID) General Capsules Dry Powder Suspension General 2. -do- Macrozith 250 mg 6’s As -do- Principally Film Coated Capsule 10’s Per Tablet Each capsule contains:- SRO Master Formulation does Azithromycin dihydrate not conform with film ≡ Azithromycin ……250 coated tablet mg Uniform decision is (Macrolide) required about existing dosage form of Capsule Azithromycin

3. -do- Voxipro 250 mg Dry 60 ml As -do- Master formulation Powder Suspension Per MOP Each 5 ml contains:- SRO Inconformity Ciprofloxacin MOT Hydrochloride To be deferred. ≡ Ciprofloxacin …..250 mg (Quinolone) (Mfg Spec)

54 4. -do Arthen Dry Powder 30 ml As -do- SDS > FDA limit Suspension 60 ml Per To be deferred Each 5 ml contains:- SRO Artemether……..15 mg Lumefantrine…..90 mg (Antimalarial)

5. -do- Leoflox 125 mg Dry 60 ml As -do- Label claim Powder Suspension Per MOT’ Each 5 ml contains:- SRO Incorrect Levofloxacin To deferred. hemihydrates ≡ Levofloxacin ………..125 mg (Quinolone)

6. -do- Zason 10 mg Dry Powder 60 ml As -do- Master formulation Suspension Per ambiguous /incorrect. Each 5 ml contains:- SRO Deferred for Zinc Sulphate monohydrate ≡ Zinc (element)………10 mg (Antidiarrhoeal & Zinc Supplement) 7. -do- Bevexin 20 mg Tablets 2x10’s As -do- Master formulation Each tablet contains:- Per MOT +Specification Piroxicam β-Cyclodextrin. SRO Deferred. ≡ Piroxicam………….20 mg (NSAID) 8. -do- Leoflox Tablets 250 mg 1x10’s As -do- Film coated Each film coated tablet Per Wrong label claim contains:- SRO Wrong specification. Levofloxacin Hemihydrate Incorrect DIT ≡ Levofloxacin ……..250 Chromatographic mg condition not mentioned (Quinolone) Deferred for 9. -do- Leoflox Tablets 500 mg 1x10’s As -do- Incorrect Specification Each film coated tablet Per Incorrect MOP/MOT contains:- SRO Signature of QCM/PM Levofloxacin Hemihydrate Deferred. ≡ Levofloxacin…………500 mg (Quinolone)

10. -do- Voxipro 250 mg Tablets 10’s As -do- Specification Each film coated tablet Per MOP contains:- SRO MOT Ciprofloxacin Master formulation Hydrochloride To be deferred ≡ Ciprofloxacin …….250 mg

11. -do- Voxipro 500 mg Tablets 10’s As -do- Incorrect Each film coated tablet Per Specification/MOP/MOT contains:- SRO Finished Ciprofloxacin Signature of QCM/PM Hydrochloride deferred ≡ Ciprofloxacin……… .500 mg (Quinolone) (B.P.)

12. -do- Moxigrat 400 mg Tablets 1x5’s As -do- SDS is more than FDA Each film coated tablet 1x10’s Per limits contains:- SRO MOT/MOP Moxifloxacin HCl Specification incorrect Moxifloxacin ……….400 Deferred. mg (Quinolone) 13. -do- Arthen DS Tablets 1x8’s As -do- Master formulation Each tablet contains:- Per Subject to correction Artemether……..40 mg SRO for. Lumefantrine…..240 mg (Antimalarial)

14. -do- Montigrat Tablets 10 mg 14’s As -do- MOP coating procedure Each film coated tablet 2x10’s Per is mentioned contains:- SRO Coating material has not Montelukast Sodium been mentioned ≡Montelukast …..….10 MOT is not correct. mg To be deferred. (Leukotriene Receptor Antagonist)

15. -do- Novaefen 100 mg Tablets 3X10’S As -do- Product Specification Each film coated tablet Per MOP/MOT do not contains:- SRO conform Flurbiprofen....100 mg To be deferred. (NSAID)

16. -do- Painclay 75 mg Tablets 1x10’s As -do- Spec/MOT/MOP are Each enteric coated tablet 2x10’s Per contradicting contains:- 3x10’s SRO To be deferred. Diclofenac Potassium…75 mg (NSAID) 17. -do- Painclay 100 mg Tablets 1x10’s As -do- Spec/MOT/MOP are Each enteric coated tablet 2x10’s Per contradicting contains:- 3x10’s SRO To be deferred. Diclofenac Potassium..100 mg (NSAID)

Now the firm has rectified shortcomings upto S.No.16. But the master formulations (S.No. 17) of tablet Diclofenac potassium does100mg not conform with the internationally available dosage forms.

Decision: Registration Board approved products at S.No.1-16 while product at S.No.17 deferred for confirmation of international availability.

Case No. 25. M/s. Hizat Pharmaceuticals, Peshawar

The Drugs Registration Board in its 237th meeting held on 26-02-2013 had deferred the following products for rectification of shortcoming:-

Submission Esoprazol capsule of differential Each delayed release fee capsule contains:- M/s. Hizat and Esomeprazole enteric Pharmaceuticals, 10’s Rs.159.00 confirmation coated pellets Peshawar of ≡Esomeprazole……...40 formulation. mg Pellet’s fee (Proton Pump Inhibitor) unpaid Submission Lanzprazole Capsule of differential Each Delayed Release fee and Capsule contains:- confirmation -do- Lansoprazole enteric coated 10’s Rs.160.00 of pellets formulation. ≡ Lansoprazole……30 mg Pellet’s fee (Proton Pump Inhibitor) unpaid

57 The firm had rectified relevant shortcoming and paid differential fee mentioning Vision Pharmaceutical as the source of pellets of Esomeprazole (22.5% w/w) and Lansoprazole (8.5% w/w) .The firm requested to grant the registration of above mentioned products.

Decision: Request of firm was approved by the Board.

Case No.26 Navegal Labs, Hattar

The Drugs Registration Board in its 237th meeting held on 26-02-2013 had deferred the following products of M/s. Navegal Labs Hattar for submission of complete method of manufacturing and studies regarding dissolution/release of the following drug:-

S. Manufacturer Name of the Drug Pack Demanded Decision No. size Price Navegal Labs Movez SR Capsule 1x10 Rs.8.5/capsule. Deferred in Hattar 100 mg. view of Each Capsule strength and Contains:- uniform Diclofenac Sodium policy. Fee Sustained Release/ paid Coated Pellets ≡ Diclofenac sodium…100 mg.

It is pointed out that sustained release coated pellets of Diclofenac Sodium 100mg are manufactured by M/s. Vision Pharmaceuticals, Islamabad which can be approved subject to submission of Specification of product, GMP, Certificate of Analysis and Stability data for zone IV. Fee is paid according to local manufacturer.

Decision: Request of firm was approved with source of pellets will be M/s. Vision Pharmaceuticals, Islamabad.

Case No. 27. M/s Alen Pharmaceutical (Pvt) Ltd, Risalpur.

Drug Registration Board in its 237th meeting had deferred the following products of M/s. Alen Pharmaceuticals (Pvt.) Ltd; Risalpur subject to the confirmation of formulation.

S.No Manufacturer Name of Drugs A/Unit Price Remarks

58 1. M/s Alen Mitex Tablets. 1’s Rs. Confirmation Pharmaceutical Each film coated tablet 100.00 of (Pvt) Ltd, contains:- formulation. Risalpur Ivermectin BP………6 Total fee mg. paid

The firm had rectified relevant shortcoming and paid differential fee. The firm had requested to grant the registration of above mentioned products

Decision: Request of firm was approved by the Registration Board.

Case No.28 M/s. Aries Pharmaceuticals, Peshawar.

M/s. Aries Pharmaceuticals, Peshawar has requested for registration of the following drugs:-

1. M/s. Aries Levocap Capsules 250 10’s Rs.260.00 - Fee paid, Pharmaceuticals, mg do- deferred for Peshawar Each capsule contains:- uniform 1.Tab General Levofloxacin decision. 2. Capsule Gen Hemihydrate 3.Tab Psycho ≡ Levofloxacin ….250 mg (Quinolone)

2. -do- Levocap Capsules 500 10’s Rs.520.00 - Fee paid, mg do- deferred for Each capsule contains:- uniform Levofloxacin decision. Hemihydrate ≡ Levofloxacin ….500 mg (Quinolone)

3. -do- Pranax 1 mg Tablets 3x10’s Rs.369.00 - As per policy Each tablet contains:- do- on Alprazolam…….1 mg psychotropic/ (Antidepressant) narcotics. Fee paid. Deferred. 4. -do- Pranax 2 mg Tablets 3x10’s Rs.738.00 - As per policy on Each tablet contains:- do- psychotropic/ Alprazolam…….2 mg narcotics. Fee

59 paid. Deferred

These drugs were considered in 237th meeting of Registration Board decision mentioned against each. Now the firm has stated that Pranax 0.5mg (Alprazolam0.5 mg) is already registered with the firm where as Pranax 1 mg & 2 mg are the additional strengths of Alprazolam which are requested to be registered. Levofloxacin 250 mg/500 mg Capsules have been registered with many manufacturer therefore the firm requested to approve registration of the Levofloxacin 250 mg/500 mg in the form of Capsules. Levofloxacin in the form of Capsule (dosage form) has to be decided uniformly.

Decision: The Board referred products at S.No.1 & 2 to review committee for evaluation and recommendation. Products at S.No. 3 & 4 were deferred being controlled drug.

Case No.29. M/s. Libra Pharma (Pvt.) Ltd; Peshawar

The Drug Registration Board in its 195th meeting had approved the following products of M/s. Libra Pharma (Pvt.) Ltd; Peshawar subject to installation & verification of HVAC system and segregated section. It is submitted that the ingredients and strength of some products were typed incorrectly which were approved accordingly.

S.No Name of drug with Name of drug with Pack Demande Decision incorrect formulation correct size d MRP formulation/strength 1 Cryptosad Tablets Cryptosad Tablets 21’s Rs.240.0 Approved Each tablet contains:- Each sugar coated 0 subject to Cyproterone acetate tablet contains:- installatio …...2mg Cyproterone acetate n and Ethinyloestroadioe….35 …… 2 mg verificati mg Ethinyloestradiol . on of …..35 mcg HVAC System and Segregate d section. 2 U-Dine 100 mg Tablets U-Dine 100 mg 14’s Rs.1600. -do- Each tablet contains:- Tablets 00

60 Lamivudine……..100 Each film coated mg tablet contains:- (Anti-retroviral) Lamivudine……..10 0 mg (Anti-retroviral) 3 Osteocol Oinetment Osteocol Ointment 1x10’ Rs.275.0 Approved Each tablet contains:- Each gm contains:- s 0 Tacalcitol……….2mcg Tacalcitol (Antipsoriasis / Vitamin monohydrate ≡ Tacalcitol.…. 2 mcg 4 Diploprate Cream Diploprate Cream 5gm Rs.21.20 Approved Each gam contains:- Each gm contains:- subject to Diflucortolone Diflucortolone installatio valeate...0.001gm valerate.…1 mg n and Chlorquinalolol..….0.01 Chlorquinaldol…… verificati 0gm …. 10 mg on of HVAC System and Segregate d section

The firm has furnished copy of inspection report wherein FID, Peshawar has reported that the firm has installed HVAC and has requested to grant the registration of above mentioned product. The Licensing Section confirmed that the firm got approval of Hormonal Tablets Section as segregated with HVAC but Hormonal Ointment/Cream Section is not present in record of licensing unit. The firm has deposited remaining fee amounting Rs. 12000/- for each formulation and furnished copy of inspection report and has requested to grant the registration of above mentioned products. It is worthwhile to mention that Tacalcitol monohydrate equivalent to Tacalcitol is available in the form of Ointment/Lotion (Curatoderm Ointment/Lotion) but the strength is 4 mcg/gm in both dosage form instead of 2 mcg/gm as mentioned in the application dossier. . Decision: Registration Board approved products at S.No.1 &2 and advised to review the registration dossiers before issuance of registration letter and authorized its Chairman to grant approval for issuance of registration letter. Products at S.No3 & 4 were deferred for confirmation of steroidal section for cream and ointment. As

61 Tacalcitol is available only in 4 mcg/gm thus referred to review committee for review. Case No.30 Extension in contract manufacturing permissions.

The following drugs of M/s. Navegal Laboratories, Hattar for toll manufacturing extension were left over due to oversight. The firm had deposited the Rs.8000/- each on 29th September, 2010 and remaining fee of Rs. 42000/- each on 9th April, 2013.

1. 045442 M/s. Toll Uneek 250mg Dy. Cephalospori Navegal manufactured by Injection No.2873 n Pharmaceuti M/s. Welmark Each vial contains:- Form-not cals, Hattar Pharma, Hattar Ceftriaxone (as Rs.42000/- Sodium)……..250mg Rs.8000/- (USP Specification) dated 29- 09-2010 2. 053219 -do- -do- Uneek 500mg Dy. Cephalospori Injection No.2873 n Each vial contains:- Form-not Ceftriaxone (as Rs.42000/- Sodium)……..500mg Rs.8000/- (USP Specification) dated 29- 09-2010 3. 045441 -do- -do- Uneek 1gm Injection Dy. Cephalospori Each vial contains:- No.2873 n Ceftriaxone (as Form-not Sodium)……..1gm Rs.42000/- (USP Specification) Rs.8000/- dated 29- 09-2010 4. 045443 -do- -do- Sobeta 2gm Injection Dy. Cephalospori Each vial contains:- No.2873 n Cefoperazone (as Form-not Sodium) ….....1gm Rs.42000/- Sulbactam (as Rs.8000/- Sodium)…1gm dated 29- (USP Specification) 09-2010 5. 045444 -do- -do- Sobeta 1gm Injection Dy. Cephalospori Each vial contains:- No.2873 n Cefoperazone (as Form-not Sodium) ….....0.5 gm Rs.42000/- Sulbactam (as Rs.8000/- Sodium)……..0.5 gm dated 29- (USP Specification) 09-2010

62 6. 045438 -do- -do- Effo 500mg Injection Dy. Cephalospori Each vial contains:- No.2873 n Cefepime HCl with Form-not L-arginine Rs.42000/- ≡Cefepime Rs.8000/- …….500mg dated 29- (USP Specification) 09-2010

Decision: Request for extension in contract manufacturing acceded till 30.06.2015.

Case No.31. M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar

M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar has applied for registration of following drugs for the purpose on export only:- S. No. Name of Drug(s) Remarks 1. Phenomed 30 mg Tablet The relevant documents and Each tablet contains:- total fee received, Phenobarbiton ……..……. 30 mg Approved subject to the concurrence of Narcotic Control Department /Board. 2. Dipam 5 mg Tablet -do- Each tablet contains:- Diazepam …………….. 5 mg

The firm has submitted following documents:- i. Application on Form-5. ii. Fee of Rs. 20000/- for each formulation.

The firm possesses the relevant facility to manufacture the above mentioned products. This case was discussed in the 237th meeting or Registration Board. The decision of the Board is mentioned against each. Decision: Committee on allocation of controlled Drug has already conveyed that Registration Board may take decision according to its rules. Thus Board approved firm’s request. Matter regarding allocation of quota will be dealt by Committee on allocation of controlled Drug accordingly.

Case No.32. M/s. Shaheen Pharmaceuticals, Swat

63 The Drug Registration Board in its 235th meeting had deferred the following products of M/s. Shaheen Pharmaceuticals, Swat subject for deletion of Methylene Chloride from the formulation.

1. M/s. Shaheen Finas-M 1mg 3x10’ As -do- Deferred due to Pharmaceutical Tablets s Per Methylene s, Swat Each tablet SRO Chloride. 1. Tab General contains:- 2.Tab Antibiotic Finasteride 3.Cap General ………..1mg 4.Dry Powder (5-alpha reductase Susp (Ceph) inhibitor) 2. -do- Paroxet 10mg 3x10’ As -do- Deferred due to Tablets s Per Methylene Each tablet SRO Chloride. contains:- Paroxetin (as HCl).10mg (Antidepressant)

3. -do- Paroxet Plus 20mg 3x10’ As -do- Deferred due to Tablets s Per Methylene Each tablet SRO Chloride. contains:- Paroxetin (as HCl).20mg (Antidepressant)

4. -do- Nomide 20mg 3x10’ As -do- Deferred due to Tablets s Per Methylene Each tablet SRO Chloride. contains:- Leflunomide……2 0mg (Anti-rheumatic systemic)

Now the firm has rectified the shortcoming of the formulation. The firm had requested to grant them the registration of above mentioned products

Decision: Registration Board approved firm’s request. Registration-V

Case No. 33. Transfer of Registration of contract manufacturer from Contract Donor.

M/s Allmed (Private) Ltd. Lahore (Formerly M/s Ever Green Pharmaceuticals (Pvt.) Ltd. Lahore) have requested for transfer of registration of following product manufactured by them on contract basis for M/s. Ontech Corporation, B-154 Block-13-D/2 Gulshan-e- Iqbal, Karachi to their name. S. No. Reg. No. Name of Drug with Composition 1. 041199 Norepine Injectable Each 4ml contains:- Noradrenaline tartarate…8mg

It is submitted that the product was initially registered for import in the name of M/s. Ontech Corporation, Karachi for finished import. Later on the product was transferred from import to local toll manufacturing by M/s Allmed (Private) Ltd. Lahore (formerly M/s. Evergreen Lahore). Registration Board in 237th meeting has already delegated the power of transfer of registration from one manufacturer/importer to another manufacturer/importer to its Chairman. However in this case the contract manufacturer is applying for transfer of registration from contract giver. The firm has also applied for extension of contract manufacturing for the said product and has submitted the following for transfer of registration:- 1. Fee challan of Rs.20,000/- 2. Form-5 3. N.O.C on transfer from M/s Ontech Corporation, Karachi. 4. Import Registration letter in the name of M/s. Ontech Corporation, Karachi. 5. Copy of earlier toll permission letter.

Decision: Registration Board deferred the request of the firm for following: Confirmation whether transfer of registration is permissible under contract manufacturing policy or otherwise. Verification of testing facility by Director DTL, Lahore and area FID.

Case No.34. M/s. Paradise Pharmaceuticals, Lahore

65 M/s. Paradise Pharmaceuticals, Lahore was granted the registration of following product:- S. No. Name of Drug(s) Reg. No. 1. Ampride Syrup 071546 Each 5ml contains:- Ammonium Chloride ……………… 100mg

The firm has requested that this product in not according to products being marketed locally. They have therefore, requested to change the formulation as under:- Ampride Syrup Each 5ml contains:- Chlorpeniramine Maleate ………..… 2mg Ammonium Chloride ……………… 100mg They have deposited fee of Rs. 20000/- for this purpose and furnished application dossier on Form-5. It is submitted that the firm has attached the outer packing of British Pharma which contains Sodium Citrate also in addition of Chlorpeniramine Maleate 2mg & Ammonium Chloride 100mg. However, according to the firm Sodium Citrate is not an active ingredient and has been included in in-active ingredients. US FDA also mentioned Sodium Citrate as inactive ingredient in syrup dosage form Decision: The request of the firm was acceded to. Case No. 35 M/s. Medipak Ltd; Lahore The Drugs Registration Board in its 222nd meeting had deferred the following product of M/s. Medipak Ltd; Lahore for review committee. Initially the case was discussed in 141st meeting of the Drug Registration Board and was deferred for price comparison and subsequently again deferred in 213th meeting of DRB for getting clarification from the firm regarding the use of the formulation:- Medisol Solution Each liter contains:- Citric acid (Anhydrous)...... 7.30gm Sodium Citrate (Dihydrate)…22.00gm Dextrose (Monohydrate).24.50gm Water for Injection....Q.S (Anticoagulant Solution)

66 The firm has informed that the pricing section has approved the price of the subject product in 19th meeting of Price Recommendatory Committee held on 26-12-2006 and has requested for grant of registration of above mentioned product. The firm has deposited fee of Rs. 15000/- in addition to Rs.5000/- and has not submitted new form-5.

Decision: The Registration Board deferred the case for submission of new dossier, applicable fee for the product and expert opinion by Brig. Qaiser, AFIC.

Case No. 36 M/s. CCL Pharma Lahore.

Following application of M/s. CCL Pharma Lahore was deferred in sub/expert committee meeting 237th of Drug Registration Board due to inadequate fee for fast track and different formulation from originator. The originator formulation is as following (Duodart / Jalyn capsule by GSK):- Each Capsule contains the following:

• One dutasteride oblong, opaque, dull-yellow soft gelatin capsule, containing 0.5 mg of dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-di-glycerides of caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. • Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin hydrochloride and the inactive ingredients: methacrylic acid copolymer dispersion, microcrystalline cellulose, talc, and triethyl citrate.

S.No Name of the drugs with Pack Proposed Date of Recomme composition Size Price Submission ndations of Committe. 1. BPH Capsules 10’s As per 15-6-2011 Deferred. Each capsule contains:- brand Fee.8000 Dutasteride….0.5mg leader Fast track Tamsulosin….0.4mg fee submission Fee.52000 21-2-2013

The firm has submitted fee of Rs. 300,000/- and has submitted that competitor formulation is immediate release dutasteride pellets in soft gel capsule filled in hard gelatin capsule along with sustained release tamsulosin pellets, which has no technical

67 advantage but a novelty. But in their formulation they are using a blend of immediate release dutasteride pellets along with sustained release tamsulosin pellets filled in hard gelating capsule. They have submitted 2 reference products of india Tamlocept D Capsule by Lupin Ltd. (Pinnacle Pharmaceuticals, India) and Tamdura Capsule by Sun Pharmaceutical industries Ltd. India. Containing Dutasteride IR + Tamsulosin SR pellets. They have submitted comparative dissolution profile with Duodart capsules. Decision: The Registration Board deferred the case for evaluation by the review committee.

Case No. 37. Cases of 237th meeting Registration Board

Following applications (Fast track) were considered in 237th meeting and subsequently in me-too committee on 08-03-2013 subject to differential fee. Now differential fee have been paid for following applications.

S.No Name of Firm Name of the drugs with composition Pack Proposed Previous Remarks Size Price Decision 1. M/s Saffron Noctis Capsule 14’s Rs 300/- Approved Rs.2,40,000/- Pharmaceutica Each capsule contains:- subject to + Fee ls Faisalabad Omeprazole…40mg Source deposited GMP Rs.60,000/- certificate, GMP COA and certificate of stability M/s study of Metrochem pellets. API Pvt. Ltd., India.,CoA, 2. M/s. English Terol 4mg SR Capsules 3×10’s Rs.2300/- Deferred for Detrusitol Pharmacutical Each capsule contains:- confirmatio Capsule SR 4 s Industries, Tolterodine HCl equiv. to n of mg (Pfizer) Lahore Tolterodine SR…4mg me-too Comparative status and Dissolution comparative profile with dissolution originator. profile with originator 3. M/s. English Urimax 0.4 mg Capsule 3×10’s Rs.1100/- Approved Rs.240, 000/ Pharmacutical Each capsule contains:- subject to has been s Industries, Tamsulosin HCl equiv to remaining deposited,

68 Lahore Tamsulosin…0.4mg fee of GMP (Alpha-1-adrenergic blocker) Rs.240, certificate of 000/ (in source, COA case of and stability import of studies of pellets),GM pellets. P certificate of source, COA and stability studies of pellets. 4. M/s. English K-Cit Tablets 3×10’s Rs.650/- Deferred for Urocit K of Pharmacutical Each tablet contains:- confirmatio Universal s Industries, Potassium Citrate…10 mEq n of me-too (Allmed Lahore status. Pharma) 5. M/s. English Dutride-T Capsules 30’s Rs. Deferred Fee submitted. Pharmacutical Each capsule contains:- 2700/- Firm wants to s Industries, Dutasteride …….0.5mg fill in pellets. Lahore Tamsulosin Hydrochloride….0.4mg 6. M/s. English Ucholin 10mg Tablet 60’s Rs.1500/- 06-02-2013 Deferred for Pharmacutical Each tablet contains:- confirmation of s Industries, Bethanechol Chloride equiv. to me-too status. Lahore Bethanechol …..10mg

Decision: Registration Board decided as follows: Approved products at S.No.1 and 3. Product at S.No.2 deferred for verification of complete formulation with originator (Detrusitol Capsule SR 4 mg by Pfizer) and Comparative Dissolution profile with originator. Product at S.No.4 deferred for Product Specific Inspection by Director DTL Lahore, Director DTL, Quetta and Area FID. Product at S.No.5. The firm has submitted a separate application for tablet dosage form. The DRB deferred the case for evaluation by review committee. Product at S.No.6 deferred for expert opinion by Gen.Dr. Tassawar Husain, Dr. Falak Sher Bhatti, Nescom., Prof. Shoaib Shafi, RMC.

69 Case No. 38. M/s. Medipak Ltd; Lahore The Drugs Registration Board in its 201st meeting had rejected the following product of M/s. Medipak Ltd; Lahore as the cGMP condition of the section was not good:- Medisol ½+5% Infusion. 500ml As per Rejected as the Each 1000ml contains:- Policy CGMP condition Dextrose of the section is Monohyrate……….55gm. not good. Sodium Chloride….4.5gm. (BP)

The firm submitted application in Drug Appellate Board and the Drug Appellate Board in its 135th sitting held on 123-11-2008 decided and accepted the appeal to grant them the registration of above mentioned product. Decision: The Registration Board deferred case for product specific and GMP inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore; DDG E&M, Lahore and Area FID.

Case No: 39 M/s. Medipak Ltd; Lahore

M/s Medipak Limited, Lahore has requested that their product “Moxidex Eye Drops” was included in Agenda of 229th DRB meeting, but they said product was written under the name of M/s Vega Pharma Lahore by mistake and the product was deferred for GMP & Product specific Inspection. They have submitted that their Eye Drop section is already approved and GMP inspection report dated 11-02-10 submitted. They have submitted copy of registration dossier. Decision: The Registration Board deferred case for product specific and GMP inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore; DDG E&M, Lahore and Area FID..

Case No.40. M/s. Medisave Pharmaceuticals, Lahore.

M/s. Medisave Pharmaceuticals, Lahore has requested for registration of following drugs for export purpose only:-

70 S.No Name of the products with composition

1. Flusave Tablets Each Tablet contains:- Triprolidine HCl B.P……… 2.5mg Pseudoephedrine HCl B.P …...60mg 2. Sorefix-P Tablets Each Tablet contains: Pseudoephedrine ……36mg Triprolidine….1.5mg Paracetamol……..300mg 3. Sorefix-DX Tablets Each Tablet contains: Pseudoephedrine ……..90mg Triprolidine……2.5mg Clemastine as hydrogen fumarate…..1mg 4. Sorefix Tablets Pseudoephedrine ……….60mg Triprolidine …………2.5mg

The firm submitted the following documents. i. Fee i.e. Rs.20000/-for the each products. ii. Copy of form 5 iii. Copy of export order from Hong Kong. Registration Board in its 237th meeting referred the case to committee on controlled drugs, Narcotic Control Division for its recommendation and authorized Chairman Registration Board to take decision for the grant of export registration or otherwise in light of recommendation of the committee and submission of differential fee. Committee of the allocation of controlled drugs in its 11th meeting held on 6th May, 2013 decided that Registration Board may consider the registration of Controlled Drugs for export and local manufacturing in the light of relevant Act and rules and the Committee on the allocation of controlled drugs will consider matter for allocation of Controlled Drugs in the light of relevant laws and rules after registration.

Decision: Committee on allocation of controlled Drug has already conveyed that Registration Board may take decision according to its rules. Thus Board approved firm’s request. Matter regarding allocation of quota will be dealt by Committee on allocation of controlled Drug accordingly.

71 Case No. 41. M/s. Highnoon Laboratories Ltd Lahore. Following products of M/s. Highnoon Laboratories Ltd Lahore were deferred for expert opinion. Two experts gave their recommendations while the opinion of 3rd expert was awaited. The Drug Registration Board in its 237th meeting referred these products for expert opinion to Brig. (R).Prof. Dr. Muzammil Hasan Najmi after submission of differential fee. Now opinion of all experts has received as under:-

Name of Products MRP/ Name of Expert Comments by the Brig. (R).Prof. Dr. Pack expert Muzammil Hasan Size. Najmi Pidogrel-CAP 75 Rs.215.0 Prof.Dr. As this product is This is a combination of Each capsule contains:- 0/10’s Mahmood Ahmad already manufactured by clopidogrel with enteric Clopidogrel (as Faculty of the same company under coated aspirin pallets in bisulphate) ……75mg pharmacy and Re. No. 038902 in tablet capsule form. A Aspirin (as enteric alternative form and according to combination of coated pellets) 75mg medicine, the available literature clopidogrel with aspirin The Islamia and stability data without enteric coating University of provided both the is already being Bahawalpur strengths of pidogrel are marketed by the same stable and retain its manufacturer and some efficacy in combination other companies. The in capsule form. two drugs in Therefore, the pidogrel- combination are platelet Cap 75mg & pidogrel- inhibitors acting by Cap 150mg may be independent different registered. mechanisms. These are used in treatment and prophylaxis of thromboembolic disorders. However their use in the form of a fixed dose combination is not approved by FDA of USA. In the formulation under review, aspirin has been replaced with enteric coated aspirin and the dosage form has been changed from tablet to capsule. Dissolution profile of the new

72 dosage form has been submitted by the manufacturer which shows satisfactory pattern of dissolution. In view of the registration and availability of combinations of clopidogrel and aspirin in Pakistan, Pidogrel- CAP 75 is recommended for registration.

Pidogrel-CAP 150 Rs.225.0 Brig Syed M. Preparations are Each capsule contains:- 0/10’s Imran Majeed considered suitable for Clopidogrel (as registrations. bisulphate) ……75mg Aspirin (as enteric coated pallets) 150mg Dr. Iqbal The products are Saifullah Head of recommended for Cardiology PIMS registration. Islamabad Loprin-AT Capsules Rs.300.0 Prof.Dr.Muhamm This combination of It is a combination of Each capsule contains:- 0/10’s ad Ishaq Karachi Atorvastatin and Asprin Atorvastatin with enteric Atorvastatin (as Institute of Heart can be used for CAD coated aspirin. calcium trihydrat) Diseases Karachi patients and potential Atorvastatin is an ………….10mg patients. Both drugs as inhibitor of HMG Co A Aspirin (as enteric individual molecules are Reductase enzyme and coated pallets) established sherapeutic helps to lower …………… 75mg agents as lipid lowering cholesterol level in and antiplatlets. The patients of dyslipidemia advantages of while aspirin is an combination include Antiplatelet drug used to beeter compliance at treat and prevent reduced cost. However thromboembolism. being fixed combination While the two drugs the side effects can be may be required to be difficuit to as ses. The used together in several only major country patients, their having this combination availability in a fixed is India as such there are dose combination is not no reasons against this supported by the formulation to be made scientific literature.

73 available in Pakistan. Such combination is not approved by FDA of USA and European Medicines Agency. Loprin-AT is therefore NOT RECOMMENDED for registration.

Dr. Iqbal Additive effect of Saifullah antiplatelet therapy and Head of cholesterol lowering Cardiology PIMS agent has been proved in Islamabad reducing cardiovascular events. Combination of these two agents reduces the risk of cardiovascular mortality in non-diabetic patients with known IHD as well as coronary artery disease diabetics. Combination of asprin and Atorvastatin is widely used in Pakistan. Fixed dose combination will also provide better patient compliance. Loprin AT is recommended for registration. Syed Khalid Aspirin has been used as Saeed Bukhari very effective WHO Country antiplatelet therapy in advisor/NPO cardiovascular diseases, Essential while Atorvastatin is medicines antihyperlipidemic and Pakistan used to lower cholesterol levels. Combination of these two agents reduces the risks of cardiovascular mortality in non diabetic patients with known IHD as well coronary artery disease diabetics.

74 Fixed dose combination of these tow agents is available in other countries. Loprin-At Capsule which is a combination of atorvastatin and enteric coated aspirin pallets will offer the benefit of combined aspirin with statin therapy. Aspirin is present as enteric coated pellets therefore it will avoid aspirin related GI side effects leading to cost effective therapy. Aspirin is present as enteric coated pallets therefore it will avoid aspirin related GI side effects leading to costeffectiveness; it will definitely increase better patient compliance. So product may be recommended for registration with positive opinion.

Nebizide 10 Tablet Rs.735.0 Prof.Dr.Muhamm Nebivolol is a novel Each tablet contains:- 0/14’s ad Ishaq Karachi cardioselective beta Nebivolol (as Institute of Heart blocker being used as an HCl)…..10mg Diseases Karachi effective Hydrochlorthiazide….1 Antihypertensive. It’s 2.5mg unse in Heart failure is not recommended so far. The molecule is FDA approved bot separately and in combination. Recommend the availability of this product for our hypertensive patints. Fised dose combination of these two products

75 are already available in other ountries. Nebizide 5 Tablet Rs.385.0 -do- Both strength are This is a combination of Each tablet contains:- 0/14’s recommended Nebivolol with Nebivolol (as Hydrochlorothiazide. HCl)…..5mg Nebivolol is a beta Hydrochlorthiazide….1 blocker with high degree 2.5mg of selectivity for beta 1 receptors and additional vasodilator property. Like other beta blockers, it is used for treatment of hypertension and other cardiovascular diseases. Hydrochlorothiazide is a diuretic which is also useful in hypertension. Studies have been reported in scientific literature showing a synergistic action of the two drugs in hypertension. Many other beta blockers are also available in combination with thiazide diuretics. Nebizide 5 mg and 10 mg is therefore, recommended for registration. Syed Khalid Nebivolol is a beta Saeed Bukhari blocking drug used for WHO Country hypertension while advisor/NPO hydrochlorothiazide is Essential antidiuretic which is medicines also used as Pakistan antihypertensive. Combination of Nebivolol and Hydrochlorothiazide has been evaluated in large scale clinical trials. Nebivolol and HCTZ is and effective and well

76 tolerated therapeutic strategy for management of hypertension including diabetic and elderly patients. Combination of these two products called Nebizide is fixed dose which is bioequivalent to the two agents administered concomitantly. This combination is useful as monotherapy nonresponders and for those who required rapid BP control to prevent end organ damage. Post marketing surveillance studies published so far has shown that drug is effective and well tolerated therapeutic strategy in clinical trials. SO product may be recommended for registration with positive opinion.

Decision: The Board decided following:

Pidogrel-CAP 75: Deferred for the confirmation of approval of formulation by USFDA, EMA, TGA, and Japan. Pidogrel-CAP 150: Deferred for the confirmation of approval of formulation by USFDA, EMA, TGA, and Japan. Loprin-AT Capsules: Deferred, as the formulation is not approved by US- FDA, EMA, TGA, Japan. Nebizide 10 Tablet: Deferred for the confirmation of approval of formulation by FDA, EMA, TGA, and Japan Nebizide 5 Tablet: Deferred for the confirmation of approval of formulation by FDA, EMA, TGA, and Japan

Case No. 42. M/s. Shrooq Pharma Lahore.

77 M/s. Shrooq Pharma Lahore applied for following applications. These were considered in 235th meeting of Drug Registration Board Held On 18th September 2012 and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC after completion of files. The meeting of the subcommittee was held on 08-11-2012 but complete dossiers were not received at that time. Now the firm has submitted differential fee and duplicate dossiers (photocopies) of these products and has requested for the registration of these products.

S Name of Name of the Pack Size Proposed Decision in the Remarks .No Firm drugs with Price 235th meeting. composition 1. M/s. Isono Tablets 10’s As Per Approved subject Me-too status of Shrooq 10mg SRO to the submission 10mg tablets not Pharma Each tablet of duplicate files confirmed. S.No Lahore contains:- and completion of 14 of form 5 not March, Isotretinon…..1 registration correct. 2010 0mg dossier and Dissolution test (Dermatologica recommendations method not l) of the committee provided. comprising of Prof. Rafi-Uz- Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the firm.

2. -do- Isono Tablets 10’s As Per -do- S.No 14 of form 5 20mg SRO not correct. Each tablet Dissolution test contains:- method not Isotretinon…..2 provided. 0mg (Dermatologica

78 l)

3. -do- Micin-T Lotion 30ml - do -do- The firm has no Each ml external liquid contains:- preparation Clindamycin section; however (phosphate)…. oral liquid and 10mg semi solid sections (antifungal) are present.

4. -do- Lumart-Forte 6’s -do- -do- No comments Dispersible Tablets Each tablet contains:- Artemether ….80mg Lumefantrin…. 480mg (anti Malarial)

5. -do- Benz-C Lotion 30ml As Per Approved subject Confirmation of Each ml SRO to the submission me-too status? contains:- of duplicate files S.No 13 of Form 5 Clindamycin and completion of not correct (Clycin (phosphate)… registration Plus Lotion not ….10mg dossier and found). The firm Benzyl recommendations has no external peroxide….50 of the committee liquid preparation mg comprising of section; however (Antifungal Prof. Rafi-Uz- oral liquid and and Zaman, member semi solid sections dermatological) Registration are present. Board, Secretary Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the firm.

79 6. -do- Duaba Sachet 10’s - do - -do- Saccharin sodium Each sachet 3.5g per sachet= contains:- 50%. Strontium ranelate….2.00 g

7. -do- Clerox Liquid 60ml As per -do- The firm has no Each 5ml SRO external liquid contains;- preparation Ciclopirox section; however Olamine….1.5 oral liquid and % semi solid sections (Anti-fungal) are present. Me- too status not confirmed. Stieprox by stiefel not found in Pharmaguide, however pricing minutes mention it with Salycilic acid which is not present in this formulation. 8. -do- Medison 5g As per Approved subject The firm has no Cream SRO to the submission semi solid Each gram of duplicate files steroidal section. contains:- and completion of Raw material Mometasone registration specifications not Furoate……… dossier and provided. 0.1% recommendations (Corticosteroid of the committee s) comprising of Prof. Rafi-Uz- Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the

80 firm.

9. -do- Sugrel Tablets 10’s Rs.1275.0 Approved subject S.No 13 of Form 5 Each tablet 20’s 0 to the submission not filled. contains:- Rs.2550.0 of duplicate files Prasugrel 0 and completion of Hydrochloride registration …………….5 dossier and mg recommendations (Platelet of the committee aggregation comprising of inhibitor) Prof. Rafi-Uz- Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the firm.

10. -do- Sugrel Tablets 10’s Rs.640.00 Deferred for S.No 13 of Form 5 Each tablet 20’s Rs.1280.0 confirmation of not filled. contains:- 0 formulation, Me-too status not Prasugrel submission of confirmed in 2.5 Hydrochloride duplicate file and mg strength. …………….2. completion of 5mg registration (Platelet dossier. aggregation inhibitor) 11. -do- Scabease 10’s As per Approved subject Tablets SRO to the submission Each tablet of duplicate files contains:- and completion of Ivermectin…… registration ……….6mg dossier and (Anti-parasitic recommendations and Anti- of the committee scabietic) comprising of Prof. Rafi-Uz- Zaman, member

81 Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the firm.

12. -do- Lite Orange 10’s Rs.196.00 -do-/ and also Formulation is Sachet subject to WHO according to Each sachet formulation. WHO. contains:- Saccharin sodium Sodium 3.5g per citrate……… sachet=14.28% …..2.9 Sodium Chloride…… ……..2.6g Potassium chloride……… .1.5g Dextrose monohydrate… ……….13.50g (Electrolyte)

13. -do- Lumart 16’s As per Approved subject Confirmation of Dispersible SRO to the submission me-too status in Tablets of duplicate files Dispersible form. Each tablet and completion of contains:- registration Artemether… dossier and ………20mg recommendations Lumefantrine of the committee …………..120 comprising of mg Prof. Rafi-Uz- (Anti-Malarial) Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and

82 concerned DDC. Five products per section will be granted on the priority list of the firm.

Decision: The Board decided following: Isono Tablets 10mg: Deferred for confirmation of Me-too status of 10mg tablets, submission of new complete signed form 5 and dissolution test method. Isono Tablets 20mg: Approved. However the Board advised to submit new complete signed Form 5 and dissolution test method. Micin-T Lotion: Rejected as the firm has no external liquid preparation section. Lumart-Forte Dispersible Tablets: Approved. Benz-C Lotion: Rejected as the firm has no external liquid preparation section. Duaba Sachet: Deferred for clarification of master formula and change of inactive ingredients according to FDA limits. Clerox Liquid: Rejected as the firm has no external liquid preparation section. Medison Cream: Deferred till decision of semi solid steroidal products in semi solid general section by licensing section and submission of raw material specifications. Sugrel Tablets 5mg: Approved. However the Board advised to submit new complete and signed form 5. Sugrel Tablets 2.5 mg: Deferred for confirmation of me-too status in 2.5 mg strength and submission of new complete and signed form 5. Scabease Tablets: Approved. The firm shall propose other brand names which do not resemble with already registered brands. Lite Orange Sachet: Deferred for clarification of master formula and change of inactive ingredients according to FDA limits. Lumart Dispersible Tablets: Deferred for confirmation of Me-too status in dispersible form.

Case No. 43. M/s Pacific Pharma, Lahore.

Following application of M/s Pacific Pharma, Lahore was rejected in 189th Meeting of the Registration Board because the experts did not recommend the product for registration.

83 The firm got registration of the product for export purpose and applied for transfer of registration from export to local manufacturing on 02-07-2010 on form-5D. Now the firm has submitted the differential fee and requested for the registration of the product because according to them the product is registered in countries like Germany, Italy, Belgium, Spain, Greece, and Portugal. Name of Name of the drugs with Pack Size Proposed Price Date of Remarks Firm composition Submission M/s Pacific Exituss Syrup 60ml Rs. 195/- 02-07-2010 Form-5 D , Pharma, Each 5 ml contains:- 120ml Rs.390/- (Rs. 8000/- New Lahore. Levodropropizine…30mg +Rs.15000/- application. (Anti-tussive) +Rs.27000/-)

Decision: Registration Board deferred the case for confirmation of availability of formulation in USFDA, EMA, Australia or Japan.

Case No.44. M/s Rasco Pharma, Lahore.

Director (Quality Control) has informed that M/s Rasco Pharma, Lahore has manufactured Nil-Gesic Tablets which is counterfeit of Wilgesic Tablets manufactured by M/s Wislon Pharmaceuticals, Islamabad. He has directed the DDG (E&M) Lahore to inspect the premises and to rectify the counterfeit packing and has requested the Drug Registration Board for cancellation of registration of counterfeit Nilgesic manufactured by M/s Rasco Pharma, Lahore. In this regard the FID Lahore-II has inspected the premises of the firm and he has observed that no stock of packing of counterfeit “Nil-Gesic Tablet” was found in the premises. Meanwhile M/s. Rasco Pharma, Lahore has requested for change of packing design of counterfeit “Nil-Gesic Tablet” and has submitted following documents:- i. Undertaking that all of their current and future production will be packed in new design of carton & Aluminum foil. ii. Undertaking that their product “Nilgesic Tablet” with existing packing material/design is not available in the market and has been withdrawn from the market and there is no case pending/under process in any Court of Pakistan and the firm has also undertake that their proposed packing design does not resemble with already available drugs. iii. Prescribed fee of Rs. 5000/- for the purpose.

84 Later on the firm was asked to why they have change the packing design without prior approval of the Drug Regulatory Authority of Pakistan. As per reply of the firm and FID report the firm was manufacturing the said drug in its original approved packing, but on the demand of marketing department they manufactured only three batches of the product without approval from DRAP. According to the firm as soon as they came to know about the resemblance, they stopped manufacturing and have requested to change the design again to its original approved packing and have tender apology for this act. Decision: The Drug Registration Board decided to approve the packing design and directed to change the name of the product immediately. The Board also decided to issue warning to the firm and advised to be careful in future.

Case No.45. M/s. Mediways International, Lahore.

The Drug Registration Board in its following meetings had deferred the following products of M/s. Mediways International, Lahore as mentioned in relevant column for each product. The firm has deposited remaining fee of Rs. 12000/- for each product and provided copy of inspection report dated 19-06-2013 in which the panel has verified that the firm has installed HVAC in the manufacturing area of the premises. They have requested to grant them the registration of these products.

Brand Name/Label claim Demande Demand Decision of Remarks d Pack ed Price Board size Coftus Syrup 5ml Rs.2.25 Deferred Formulation Each 5ml contains:- (M-223) contains Dextromethorphan HBr Pseudoephe BP…..10mg drine Pseudoephedrine HCl BP…….30mg Chloropheniramine Maleate BP...... 2mg

Flucof Syrup 5ml Rs.2.50.0 Deferred Formulation Each 5ml contains:- 60ml 0 (M-223) contains Paracetamol B.P 120ml Rs.30.00 Pseudoephe …………....325mg Rs.60.00 drine Dextromethorphan HBr

85 B.P….10mg Pseudoephedrine HCl B.P……30mg Chloropheniramine as maleate…..1mg (analgesic)

Vomax Suspension. 60ml Rs.2.50/ Deferred till the firm has Each 5ml Contains:- 5ml. the installed Domperidone B.P………5mg. installation HVAC of HVAC. (M-201) Certex Syrup. 60ml. Rs.3.08/ -do- the firm has Each 5ml Contains:- 5ml. (M-201) installed Cetirizine HCl B.P eq. to HVAC Cetirizine base……….5mg.

Neurotone Syrup 5ml Rs.15.42 Deferred for The firm has Each 5ml contains:- 120ml Rs.370.0 Licensing installed Piracetam ………………1.0gm 0 section’s HVAC. The comments molecule is on under requirement review. of HVAC in Syrup section. (M-225) Nu-Fer Syrup 60ml Rs.6.60 -do- The firm has Each 5ml contains:- 120ml per 5ml installed Iron (III) Hydroxide Polymaltose HVAC. Complex Eq. to elemental Iron…………..…..50mg Folic Acid………...0.35mg

Decision: Registration Board decided as follows: Coftus Syrup: Deferred till decision on controlled drugs. Flucof Syrup: Deferred till decision on controlled drugs. Vomax Suspension: Approved. Certex Syrup: Approved. Neurotone Syrup: Deferred for review committee as the formulation is under review.

86 Nu-Fer Syrup: Deferred for product specific inspection by Director DTL, Lahore, DDG E&M, Lahore and Area FID

Case No. 46. M/s. English Pharmaceutical Industries Lahore.

M/s. English Pharmaceutical Industries Lahore applied for following applications. These were considered in 235th meeting of Drug Registration Board Held On 18th September 2012 and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC after completion of files. The meeting of the subcommittee was held on 08-11-2012 but complete dossiers were not received at that time. Now the firm has submitted differential fee and new dossiers of these products and has requested for the registration of these products.

S Name of Name of the drugs Pack Proposed Decision in the 235th .No Firm with composition Size Price meeting. 1 M/s. Zital 20mg Tablet 10’s As per Approved subject to the English Each tablet S.R.O submission of duplicate Pharma contains:- files and completion of Lahore. Escitalopram (as registration dossier and oxalate)….20mg recommendations of the committee comprising of Prof. Rafi-Uz-Zaman, member Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the firm.

2 -do- X-Ron 15mg Tablets 10’s -do- Approved subject to the Each tablet submission of duplicate contains:- files and completion of Mirtazapin….15mg registration dossier and recommendations of the committee comprising of Prof. Rafi-Uz-Zaman, member Registration Board, Secretary

87 Registration Board, DDG (Reg) and concerned DDC. Five products per section will be granted on the priority list of the firm.

3 -do- X-Ron 30mg Tablets 10’s -do- -do- Each tablet contains:- Mirtazapin….30mg

Decision: Registration Board approved above products for registration. Brand name of Zital tablets will be changed.

Case No.47. Extension in Contract Manufacturing

S.No Applicant Contract Reg. No. Name of Drug (s) & Date of Category manufacturer Composition application, and Form. 1. M/s. Feroza M/s. 024050 Ferophin injection IM 26-08- Dedicated International Medisave Each vial contains:- 2013 section Pharma Pharma Ceftriaxone sodium Rs.50000/- Lahore Lahore eq.to Form 5 Ceftriaxone…..250mg (anti-Biotic) 2. -do- -do- 024051 Ferophin injection IM 26-08- Dedicated Each vial contains:- 2013 section Ceftriaxone sodium Rs.50000/- eq.to Form 5 Ceftriaxone…..500mg (anti-Biotic) 3. -do- -do- 024055 Ferophin injection IV 26-08- Dedicated Each vial contains:- 2013 section Ceftriaxone sodium Rs.50000/- eq.to Form 5 Ceftriaxone…..1gm (anti-Biotic) 4. -do- -do- 024054 Ferophin injection IV 26-08- Dedicated Each vial contains:- 2013 section Ceftriaxone sodium Rs.50000/- eq.to Form 5 Ceftriaxone…..500mg (anti-Biotic) 5. M/s. Allmed M/s. 045001 Ivoryzone 1gm 12-8-2013 Dedicated (Pvt) Ltd, Medisave Injection Rs.50000/- section (formall Pharma Each vial contains:- Form 5

88 M/s. Lahore Ceftriaxone (as Evergreen sodium)….1gm Pharma Lahore 6. -do- -do- 045014 Rutex 400mg Caspule 12-8-2013 Dedicated Each capsule Rs.50000/- section contains:- Form 5 Cefixime……400mg

7. -do- -do- 045013 Rutex 100mg Dry 12-8-2013 Dedicated Suspension Rs.50000/- section Each 5ml contains:- Form 5 Cefixime……100mg 8. -do- -do- 044491 Greenec 2gm Injection 12-8-2013 Dedicated Each vial contains:- Rs.50000/- section Cefoperazone (as Form 5 sodium)…..1.0gm Sulbactam (as sodium)….1.0gm 9. -do- -do- 045002 Ivoryzone 500mg 12-8-2013 Dedicated Injection Rs.50000/- section Each vial contains:- Form 5 Ceftriaxone (as sodium)….500mg 10. -do- -do- 044493 Puna 1.0gm Injection 12-8-2013 Dedicated Each vial contains:- Rs.50000/- section Cefepime (as Form 5 HCl)…..1.0gm 11. -do- -do- 044490 Greenec 1gm Injection 12-8-2013 Dedicated Each vial contains:- Rs.50000/- section Cefoperazone (as Form 5 sodium)…..500mg Sulbactam (as sodium)….500mg 12. -do- -do- 044493 Puna 500mg Injection 12-8-2013 Dedicated Each vial contains:- Rs.50000/- section Cefepime (as Form 5 HCl)…..500mg 13. -do- -do- 045003 Ivoryzone 250mg 12-8-2013 Dedicated Injection Rs.50000/- section Each vial contains:- Form 5 Ceftriaxone (as sodium)….250mg

Decision: Registration Board extended above products till 30.06.2015. The Board advised the firms to select either IM or IV for products at S.No. 5, 9 and 13.

89 Item No.IV New Section-New License-Anomly cases:

Registration-II a. M/S, City Pharmaceuticals, Karachi Capsule (General)

231st RB meeting: 05

S.No. Name of drug(s) & Proposed Demanded Date of Decision Composition Pack size Price application, Diary No. & Form 1 Orex-500mg Capsule As per As per PRC 27-03-2013 Approved Each capsule contains: PRC Dy.No.191 However the Cefadroxil………500 mg Form-5 Registration (Anti bacterial/Antibiotic) Rs.20,000/- Board advised the registration sections to again review the Registration Dossiers before issuance of Registration letters

Suspension (Cephalosporin)

231st RB meeting: 04 S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Orex-250mg Dry Suspension As per As per PRC 27-03-2013 Approved Each 5ml contains: PRC Dy.No.190 However the Cefadroxil………250 mg Form-5 Registration (Anti bacterial/Antibiotic) Rs.20,000/- Board advised the registration sections to again review the Registration Dossiers before issuance of Registration

90 letters 2 Orex-125mg Dry Suspension As per As per PRC 27-03-2013 -Do- Each 5ml contains: PRC Dy.No.189 Cefadroxil……125 mg Form-5 (Anti bacterial/Antibiotic) Rs.20,000/-

b. M/S, Kaizen Pharmaceuticals, Karachi. Dry Powder Suspension Section.

235th RB meeting: 05 236th RB meeting: 04 S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Proart Dry Suspension 30ml As per PRC 08-11-2012 Deferred for Each 5ml contains: 40ml Dy.No.1766 me too staus Dihydroartemisinin..15mg 60ml -A & Piperaquine 80ml Form-5 confirmatio phosphate……..…120 mg Rs.20,000/- n of WHO (Anti malarial) approved formulation

c. M/s, Reign Pharmaceuticals PCSIR-KLC (Pvt.) Ltd, Karachi

Tablet (General). 235th RB meeting: 05

S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Montikol 10mg Tablet As per As per PRC 21-05-2013 Approved Each tablet contains: PRC Dy.No.528 However the Montelukast Form-5 Registration Sodium………….10 mg Rs.20,000/- Board (Is oral leukotriene advised the registration receptor antagonist) sections to again review the Registration Dossiers before issuance of Registration letters 2 Spastol Tablet As per As per PRC 21-05-2013 Deferred for Each tablet contains: PRC Dy.No.529 review

91 Phloroglucinol ……80 mg Form-5 committee Trimethylphloroglucinol… Rs.20,000/- consideration …………………..80 mg (Antispasmodic)

Capsule (General) 235th RB meeting: 05

S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Fluben 100mg Capsule As per As per PRC 21-05-2013 Approved Each capsule contains: PRC Dy.No.531 However the Flurbiprofen……100 mg Form-5 Registration (NSAID) Rs.20,000/- Board advised the registration sections to again review the Registration Dossiers before issuance of Registration letters 2 Omzol 40mg Capsule As per As per PRC 21-05-2013 -Do- Each capsule contains: PRC Dy.No.532 Omeprazole……..40 mg Form-5 (Proton pump inhibitor) Rs.20,000/-

3 Omzol 20mg Capsule As per As per PRC 21-05-2013 -Do- Each capsule contains: PRC Dy.No.530 Omeprazole……..20 mg Form-5 (Proton pump inhibitor) Rs.20,000/-

Dry Powder (Suspension)

235th RB meeting: 05

S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Fosfon 250mg/5ml oral As per As per PRC 21-05-2013 Approved Suspension PRC Dy.No.533 However the

92 Each 5ml contains: Form-5 Registration Fosfomycin Rs.20,000/- Board Sodium………….250 mg advised the (Broad Spectrum registration Antibiotic of macrolide sections to again review group) the Registration Dossiers before issuance of Registration letters 2 Renflox 250mg/5ml Dry As per As per PRC 21-05-2013 -Do- Powder Suspension PRC Dy.No.535 Each 5ml contains: Form-5 Ciprofloxacin ….250 mg Rs.20,000/- (Antibiotic) 3 Zinkid 20mg/5ml Susp. As per As per PRC 21-05-2013 -Do- Each 5ml contains: PRC Dy.No.534 Zinc Sulphate ……20 mg Form-5 (Astringent (for zinc Rs.20,000/- deficiency)

Sachet Section. 235th RB meeting: 03

S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Lotrol Low Osmolarity As per As per PRC 21-05-2013 Deferred for Sachet PRC Dy.No.540 confirmatio Each sachet contains: Form-5 n of WHO Sodium chloride….1.3g Rs.20,000/- approved Potassium Chloride..0.75g formula Trisodium Citrate Dihydrate…….1.45 g Glucose anhydrous…6.75g Eq. to sodium 37.5mmol, Potassium10.00mmol, chloride 32.5mmol, citrate 5.00mmol, Glucose 37.5mmol. (Low-Osmolarity

93 electrolytes/ORS) 2 Fem-C Plus Sachet As per As per PRC 21-05-2013 Referred to Each sachet contains: PRC Dy.No.539 review Calcium Gluconate..587mg Form-5 committee Calcium carbonate..327mg Rs.20,000/- for Calcium lactate…422 mg evaluation Asc orbic acid….500 mg Cyanocobalamin..250 mcg Folic acid…………1 mg

Liquid Syrup. 235th RB meeting: 02

S.No. Name of drug(s) & Proposed Demanded Date of Remarks Composition Pack size Price application, Diary No. & Form 1 Anafe-F Syrup As per As per PRC 21-05-2013 Deferred for Each 15ml contains: PRC Dy.No.527 confirmation Iron Protein Succinylate Form-5 of me too 800mg eq. to elemental Rs.20,000/- status Iron ………….40 mg Folic acid………..2.5 mg (Anaemia, Haematinic) 2 DuMol Syrup As per As per PRC 21-05-2013 Approved. Each 5ml contains: PRC Dy.No.536 The Board Paracetamol…….120 mg Form-5 advised to (Analgesic and antipyretic) Rs.20,000/- change brand name. The Registration Board also advised the registration sections to again review the Registration Dossiers before issuance of Registration letters 3 Irofer-F Syrup As per As per PRC 21-05-2013 Deferred for Each 5ml contains: PRC Dy.No.541 PSI by Iron (III) Hydroxide Form-5 Director polymaltose complex eq.t o Rs.20,000/- DTL, Karachi and

94 elemental iron …..50mg area FID Folic acid………0.35 mg (For iron deficiency anemia, haematinic) 4 Irol-F Syrup As per As per PRC 21-05-2013 Deferred for Each 5ml contains: PRC Dy.No.538 confirmation Iron Polysacharide Form-5 of me too complex eq.t o elemental Rs.20,000/- status and Iron ………..100 mg PSI by Director Folic Acid………..0.35 mg DTL, (For iron deficiency Karachi and anemia, haematinic) area FID 5 Nuprin 100mg Suspension As per As per PRC 21-05-2013 Each 5ml contains: PRC Dy.No.537 Approved Ibuprofen………100 mg Form-5 (Analgesic and antipyretic Rs.20,000/- NSAID)

Registration-V

S. No Name of Name of the drugs with composition Pack Proposed Date of Decsion Firm Size Price Submission 1. M/s. Simz Diclosim-75mg Tablets 10’s As Per 18-7-2013 Deferred Pharma Each tablet contains:- SRO 20000/- for Lahore Diclofenac Potassium ….75mg submission (analgesic) of Raw material specificatio ns and latest GMP Inspection report. 2. -do- Simfexo 60mg Tablets 10’s -do- 18-7-2013 -Do- Each tablet contins:- 20000/- Fexofenadine HCl….60mg (anti allergic)

3. -do- Simfexo 120mg Tablets 10’s -do- 18-7-2013 -Do- Each tablet contins:- 20000/- Fexofenadine HCl….120mg (anti allergic)

4. -do- Simfexo 180mg Tablets 10’s -do- 18-7-2013 -Do- Each tablet contins:- 20000/-

95 Fexofenadine HCl….180mg (anti allergic)

5. -do- Zithosim 500mg Tablets 6’s -do- 18-7-2013 -Do- Each tablet contains:- 20000/- Azithromycin as dihydrate…500mg (macrolide antibacterial)

6. -do- Diclosim 100mg SR Tablets 10’s -do- 18-7-2013 -Do- Each tablet contains:- 20000/- Diclofenac potassium….100mg (analgesic) 7. -do- Simclar 250mg Tablets 10’s -do- 18-7-2013 -Do- Each tablet contains:- 20000/- Clarithromycin….250mg (antibiotic)

8. -do- Simclar 500mg Tablets 10’s -do- 18-7-2013 -Do- Each tablet contains:- 20000/- Clarithromycin…..500mg (antibiotic) 9. -do- Omepza 40mg Capsule 14’s -do- 18-7-2013 -Do- Each capsule contains:- 20000/- Omeprazole enteric coated Pellets…..40mg (proton pump inhibitor)

10. -do- Fansimz 80-480mg Tablets 7’s -do- 18-7-2013 -Do- Each tablet contains:- 20000/- Artemether….80mg Lumefentrine….480mg (anti malarial)

11. -do- Fansimz 15/90mg Dry 60ml -do- 18-7-2013 -Do- Suspension 20000/- Each 5ml contains:- Artemether…15mg Lumefentrine…90mg (anti malarial)

12. M/s. Amrosal Syrup 60ml As Per 22-5-2013 Deferred Novartana Each 5ml contains:- SRO Rs.20000/- for confirmati

96 Pharma Ambroxol as HCl……15mg on of me Lahore Salbutmol…..1gm too status, Guaphenesin…..50mg Submissio n of Menthol….1mg correct signed application on form 5 and raw materials and finished product specificati ons. 13. -do- Acnov 20mg Capsule 10’s -do- 22-5-2013 Deferred Each capsule contains:- Rs.20000/- for Isotretinoin…..20mg Submissio n of

correct signed application on form 5 and raw materials and finished product specificati ons. 14. -do- Acnov 10mg Capsule 10’s -do- 22-5-2013 Deferred Each capsule contains:- Rs.20000/- for Isotretinoin…..10mg Submissio n of correct signed application on form 5 and raw materials and finished product specificati

97 ons. 15. -do- Vantrin Suspension 60ml -do- 22-5-2013 Deferred Each 5ml contains:- Rs.20000/- for Artemether……15mg Submissio Lumefantrine….90mg n of correct signed application on form 5, verificatio n of product for dry suspension as formulatio n contains water and raw materials and finished product specificati ons. 16. -do- Irofer Syrup 120ml -do- 22-5-2013 Deferred Each 15ml contains:- Rs.20000/- for Iron protein succinylate Submissio complex 800mg equivalent to n of 40mg elemental iron correct signed application on form 5 and raw materials and finished product specificati ons.

98 17. -do- Prebalin 75mg Capsule 10’s -do- 22-5-2013 Deferred Each capsule contains:- Rs.20000/- for Pregabalin….75mg Submissio n of correct signed application on form 5, raw materials and finished product specificati ons and decision of review committee. 18. -do- Prebalin 150mg Capsule 10’s -do- 22-5-2013 Deferred Each capsule contains:- Rs.20000/- for Pregabalin….150mg Submissio n of correct signed application on form 5, raw materials and finished product specificati ons and decision of review committee. 19. -do- Orthin 50mg Capsule 10’s -do- 22-5-2013 Deferred Each capule contains:- Rs.20000/- for Diacerein….50mg Submissio n of

99 correct signed application on form 5, raw materials and finished product specificati ons and decision of review committee. 20. -do- Amrosal Syrup 60ml -do- 22-5-2013 Duplicate Each 5ml contains:- Rs.20000/- entry Ambroxol as HCl……15mg Salbutamol….1mg Guaphenesin….50mg Menthol….1mg

21. -do- Olit Capsule 30’s As Per 1-8-2013 Deferred Each capsule contains:- SRO Rs.20000/- for Orlistat…..120mg Submissio n of

GMP Certificate of pellets manufactu rer, Certificate of Analysis and stability studies of pellets.

22. -do- Irofol Syrup 120ml -do- 1-8-2013 -Do- Each 5ml contains:- Rs.20000/- Iron (III) Hydroxide polymaltose complex….50mg

100 Folic Acid…..0.35mg

23. -do- Tamo Capsule 20’s -do- 1-8-2013 Deferred Each capsule contains:- Rs.20000/- for Tamsulosin HCl…….0.4mg Submissio n of GMP Certificate of pellets manufactu rer, Certificate of Analysis and stability studies of pellets.

24. -do- Amrosal Syrup 120ml -do- 21-7-2013 Duplicate Each 5ml contains:- Rs.20000/- entry Ambroxol as HCl……15mg Salbutamol BP……1mg Guaphenesin BP…..50mg Menthol BP….1mg

101 Item No. V. Quality Control cases

Case No.01: Deferred Cases

Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

1. Pamectin Drench M/s. Nawan Substandard in Not challenged Samples drawn from manufacturer’s premises on Laboratories respect of Assay 25-02-2013 by FID Karachi-III. The firm could not Batch NO. (Pvt) Ltd., for Ivermectin: provide any valid justification for non conformance V026/PMC/H/23 Animal of the product, in question, with the specifications.

(Levermectin) Health Show Cause Notice, for cancellation / suspension Division Percentage: 44.8% of registration / prosecution, was issued on 04-05- (F. No. 3-16/2013- Karachi. 2013. Accused Licensee namely Naseer Ahmed QC) Limits: 90.0 % to Awan, Muhammad Akram Rana, Mohammad 110.0% Does not Younus and the Firm / their Representative were comply with called for personal hearing before 238th DRB manufacturer’s meeting held on 06-08-2013, specifications. Since no one appeared on behalf of the accused/firm before the 238th meeting of the Board so the Board deferred the case to give final opportunity of the personal hearing to the firm/accused. The Board, in the same meeting, further decided to stop production of Pamectin Drench till final decision by the Board.

During proceeding of the 239th meeting, the Board was informed that the orders for stoppage of the production of Pamactin Drench, taken in its 238th

102 Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

meeting, could not be conveyed as the approval of minutes was not received in time from members.

Mr. Ahsan Naseer Awan, Director, Nawan Laboratories, appeared on behalf of the firm and stated that, as per their investigation, mal functioning of mixer lead to improper mixing resulting in low percentage of active drug in certain portions of the mixture. He further informed that problem has been rectified and the sub-standard product has been recalled.

Decision:-

The Board in view of the personal hearing and available record of the case decided as under:-

Production of Pamectian Drench be stopped till further orders

Inspection of the firm by the following panel in order to indentify the problems and confirm the actions taken by the firm:-

Director, DTL Quetta,

DDG, (E&M) Karachi.

Area FID.

103 Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

2. Hydrogen Peroxide M/s. Substandard in Not challenged Samples drawn from JPMC, Karachi on 09- Solution Batch No. Karachi respect of Acidity 07-2012 by FID Karachi-III. The firm could not 840 Pharmaceuti & Assay for provide any valid justification for non conformance cal Hydrogen of the product in question with the specifications. (F. No. 3-21/2012- Laboratories Peroxide: Show Cause Notices, for cancellation / suspension Q.C) , Karachi of registration / prosecution, were issued on 07-05-

2013. Accused Licensee namely Muhammad Saleh Assay Memon, Mrs. Amina Mehboob Ali, Mrs. Farida Qureshi and the Firm / their representative, were Determined: called for personal hearing before 238th DRB 3.402%w/v meeting held on 06-08-2013.

The case was deferred by the Board in its 238th Limits: 5.0%w/v to meeting on request of Mr. M. Shaban, Regional 7.0%w/v. Manager, KPL. The Board, in the same meeting, further decided to stop production of Hydrogen Does not comply Peroxide till final decision by the Board. with BP 2011 During proceeding of 239th DRB meeting, The Board was informed that the orders for stoppage of the production of Hydrogen Peroxide, taken in its 238th meeting, could not be conveyed as the approval of minutes was not received in time from members.

Mr. Muhammad Shaban, Manager Quality Assurance, appeared on behalf of the firm and

104 Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

submitted a written reply. As per the reply the firm claimed to have recalled and replaced the sub- standard stocks from the JPMC. The firm further pointed out that a sample of the same batch, drawn by FID from distributor of the firm, has been declared of standard Quality by CDL. The firm’s representative also referred to their request for appellate testing made vide letter dated 10-09- 2012, which, as per photocopy submitted by the firm, was received at DRAP Karachi office on 11- 09-2012.

With regards to the standard report of the same batch issue by the CDL, the Board noted that, the Federal Government Analyst, in this report, has stated that quality of the bottle and sharpness, visibility and colour of the labels text of the sample was different from the one declared sub- standard vide its earlier report. The Board However, observed that appellate testing request of the firm appears to be with in time as per documents / evidence of the receipt submitted by the firm.

Decision:-

The Board, in view of the personal hearing and

105 Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

available record of the case, decided as under:-

Production of Hydrogen Peroxide be stopped till further orders

The Board’s portion of the sample (Hydrogen peroxide Batch No 840) already drawn from JPMC, Karachi will be sent for appellate testing.

3. Carded Absorbent M/s Sub-Standard:- in Sub-Standard:- in Samples drawn from M/s Pharmex Fair Price Drug Cotton Wool, National respect of respect of Store, JPMC, Karachi on 16-08-2012 by FID-III Absorbent description:- description Karachi. The Appellate Lab, to which Sample was Batch No. 4555-C, Cotton Mills sent on firm’s request, also declared the sample sub- Not well carded White cotton, free Co, Karachi standard. Show Cause Notice, issued on 05-07-2013 F.No.3-20/2012-QC cotton, not from pieces of to the accused namely Mr.Kashif Iftikahr C.E.O, bleached to a good thread, leaf, shell Mr. Zahid Hussain I/C Q.C, Mr. Ilyas Khan, I/C white, it is free and foreign matter. Production and the Firm. The Accused Licensee / from leaf shells & It do not offer Representative were called for personal hearing foreign mater, it appreciable before 238th DRB meeting held on 06-08-2013. does not offer any résistance when appreciable pulled and shed Since no one appeared on behalf of the resistance when heavy dust when accused/firm before the 238th meeting of the Board, pulled and it does gently shaken. The so the Board deferred the case to give final not shed any staple length of fiber opportunity of the personal hearing to the appreciable is less than 08mm. firm/accused. The Board, in the same meeting,

106 Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

quantity of fiber (Does not comply further decided to stop production of Carded matter when gently with revised Absorbent Cotton Wool till final decision by the shaken. specification which Board. states that the cotton th Does not comply wool should be well During proceeding of the 239 meeting, the Board with the carded, should have was informed that the orders for stoppage of the description a staple length of not production of Carded Absorbent Cotton Wool, th PC.1973 less than 08mm, taken in its 238 meeting, could not be conveyed as should be bleached the approval of minutes was not received in time to a good white and from members. be odorless, should Mr. Raziuddin Ahmed, Manager and Mr. Ilyas be free from pieces Khan, represented, National Absorbent Cotton of thread and Mills/accused, and stated that the report of CDL reasonable free from and Appellate Lab’s are contradictory. leaf, shell and foreign matter The Board observed that the report of Appellate should offer Lab is conclusive evidence of the facts stated appreciable therein under Section 22(5) of Drugs Act 1976. resistance when pulled and should Decision:- not shed any The Board in view of the personal hearing and appreciable quantity available record of the case decided as under:- of dust when gently shaken. Suspension of Registration of Carded Absorbent Cotton Wool for three months

Inspection of the firm by the following panel

107 Sr. Name of Drugs Firm CDL Report Appellate Testing Details/Decision #

for reporting on GMP Compliance:- Director, DTL Quetta, DDG, (E&M) Karachi. Area FID.

Case No.02. NEW CASES

Sr. Name of Drugs Firm CDL Report Appellate Testing Detail / Decision No

1. (i). Normal Saline M/s Marion Sub- Standard:- Not Challenged Samples drawn from manufacturer’s premises Injection (0.9% Laboratories on 19-03-2012 by ADC Karachi from Assay for sodium Sodium Chloride) , Karachi consignment meant for export. Batch No. 0105235 Chloride: The firm could not provide any valid Determined F. No. 3-15/2012- justification for non conformance of the amount/100ml: DDC-QC-II products in question, with the specifications. 1.023gm Show Cause Notice were issued on 07-08-

Sated amount 2013 to the accused namely Mr. Saboor, /100ml: 0.9gm Director, Syed Asghar Afaque, Assistant Production manger and the Firm / through its Percentage: C.E.O. 113.67% Accused Licensee and accused were called Limits: 95.0% to for personal hearing 105.0% Does not

108 comply Mr. Imran Saboor represented M/s Marion Laboratories and informed that his father S.M Saboor, the Director of the firm, is seriously ill. He stated that the samples were drawn from the 16 batches of various drugs but only 04 samples were declared sub-standard. However, on instructions of the DRAP authorities, they recalled all the batches, including the one declared standard, from the market. He further claimed that their production was suspended due to sub-standard manufacturing. However, The DRAP authorities later allowed resumption of production after confirming that the firm has made required improvements.

The Board noted that the firm failed to give any valid justification for sub-standard manufacturing. The Board also considered the recommendations of the Central Licensing Board given its 232nd meeting held on 29-30th July, 2013 regarding Cancellation/ suspension of registration of Marivel-5 Injections for sub- standard export to Rawanda. (Case 03 (b) of Miscellaneous Cases of the Agenda). It was also noted that the Drug Manufacturing License of the firm has been suspended for six months by the Central Licensing Board.

109 Decision:-

The Board in view of the personal hearing and available record of the case decided to cancel registration of Normal Saline Injection.

(ii). Normal Saline M/s Marrion Sub- Standard:- Not Challenge Samples drawn from manufacturer’s premises Injection (0.9% Laboratories on 19-03-2012 by ADC Karachi from Assay for sodium Sodium Chloride) , Karachi consignment meant for export. Chloride: Batch No. 0105238 The firm could not provide any valid Determined justification for non conformance of the F. No. 3-15/2012- amount/100ml: products, in question, with the specifications. DDC-QC-II 1.006gm Show Cause Notice were issued on 07-08- Sated amount 2013 to the accused namely Mr. Saboor, /100ml: 0.9gm Director, Syed Asghar Afaque, Assistant Production manger and the Firm / through its Percentage: C.E.O.

111.77% Accused Licensee and accused were called for Limits: 95.0% to personal hearing 105.0% Does not comply Mr. Imran Saboor represented M/s Marion Laboratories and informed that his father S.M Saboor, the Director of the firm, is seriously ill. He stated that the samples were drawn from the 16 batches of various drugs but only

110 04 samples were declared sub-standard. However, on instructions of the DRAP authorities, they recalled all the batches, including the one declared standard, from the market. He further claimed that their production was suspended due to sub-standard manufacturing. However, The DRAP authorities later allowed resumption of production after confirming that the firm has made required improvements.

Decision:-

The Board in view of the personal hearing and available record of the case decided to cancel registration of

111 Normal Saline Injection.

(iii). Marivell-5 M/s Marrion Sub-Standard:- Not Challenge Samples drawn from manufacturer’s premises Injection Batch Laboratories on 19-03-2012 by ADC Karachi from In respect of No.0205852 , Karachi consignment meant for export. Endotoxins Test (Dextrose) The firm could not provide any valid Does not comply justification for non conformance of the F. No. 3-15/2012- products, in question, with the specifications. DDC-QC-II Show Cause Notice, were issued on 07-08- 2013 to the accused namely Mr. Saboor, Director, Syed Asghar Afaque, Assistant Production manger and the Firm / through its C.E.O.

Accused Licensee and accused were called for personal hearing

Mr. Imran Saboor represented M/s Marion Laboratories and informed that his father S.M Saboor, the Director of the firm, is seriously ill. He stated that the samples were drawn from the 16 batches of various drugs but only 04 samples were declared sub-standard. However, on instructions of the DRAP authorities, they recalled all the batches, including the one declared standard, from the market. He further claimed that their production was suspended due to sub-standard manufacturing. However, The DRAP

112 authorities later allowed resumption of production after confirming that the firm has made required improvements.

Decision:-

The Board in view of the personal hearing and available record of the case decided to cancel registration of Marivell-5 Injection.

(iv). Marivell-5 M/s Marrion Sub-Standard:- Not Challenge Samples drawn from manufacturer’s premises Injection Batch Laboratories on 19-03-2012 by ADC Karachi from In respect of No.0205854 , Karachi consignment meant for export. Endotoxins Test (Dextrose) The firm could not provide any valid Does not comply justification for non conformance of the F. No. 3-15/2012- products, in question, with the specifications.

113 DDC-QC-II Show Cause Notice, were issued on 07-08- 2013 to the accused namely Mr. Saboor, Director, Syed Asghar Afaque, Assistant Production manger and the Firm / through its C.E.O.

Accused Licensee and accused were called for personal hearing

114 July, 2013 regarding Cancellation/ suspension of registration of Marivel-5 Injections for sub- standard export to Rawanda. (Case 03 (b) of Miscellaneous Cases of the Agenda). It was also noted that the Drug Manufacturing License of the firm has been suspended for six months by the Central Licensing Board.

Decision:-

The Board in view of the personal hearing and available record of the case decided to cancel registration of Marivell-5 injection.

2. Aerolin Syrup M/s Ankaz Sub-Standard: Adulterated Samples drawn from manufacturer’s premises Pharmex, on 19-07-2012 by FID Karachi-III Batch No. 404 Karachi Assay for Remarks:- Salbutamol: The firm requested for appellate testing (Salbutamol) During the analysis of Determined salbutamol Sulphate In response to Show Cause Notice the firm did F.No.03-16/2012- amount/5ml: Syrup unidentifiable not agree with the appellate Lab’s report. DDC QC 1.4778 mg peaks eluted alongwith active ingredient at the Show Cause Notices, were issued on 07-08- Stated amount/5ml: retention time of 2.48and 2013 to the accused namely Mr. Zafar Shah 2.0mg 4.803 minutes. The area Production Incharge, Mr. Jubair Ali, Quality Control Manager and the Firm / through its Percentage: of these unidentifiable C.E.O. 73.89% peaks found two times greater than the area of Accused Licensee and accused were called for Limits:- 90.0% to active ingredient 105.0 % Does not personal hearing

115 comply with BP Mr. Nazurl Islam, Quality Assurance Manager 2011 of Ankaz Pharmex represented the firm and stated that the drug is of standard quality as per test/analysis of the keeping samples by their Q.C Department and no adulteration was found. He further claimed that the NIH report wrongly interpreted the eluted extra peaks as unidentifiable which, in fact, were of excipient.

The Boar however was of the view that the issue needs to be thoroughly examined/investigated

Decision:-

The Board in view of the personal hearing and available record of the case decided as under:-

Production of Aeroline Syrup be stopped till further orders

Inspection of the firm by the following panel to thoroughly investigate the matter Director, DTL Lahore, DDG, (E&M) Karachi. Area FID.

116 3. Pracmol M/s Glitz Sub-Standard Sub-Standard:- Samples drawn from manufacturer’s premises Suspension Batch Pharma on 18-03-2013 by FID Islamabad No. PM-28 Islamabad Assay for Assay for Paracetamol:- Paracetamol:- The firm requested for appellate testing. (Paracetamol) Stated:- 120mg/5ml Determined Show Cause Notice, were issued on 07-08- Found:- 96.03mg/5ml F.No. 03-22/2013- amount/5ml: 2013 to the accused namely Chaudhry QC 99.264 mg Limit: 95-105% Munawar Hussain, Chief Executive Officer, Mr. Sheikh Imran Aslam, Production Stated amount: Percentage: 80.02% Manager, Mr. Kiramat ullah, Quality Control 120.0 mg Manger and the Firm / through its C.E.O. Percentage: Accused Licensee and accused were called for 82.72% personal hearing Limits:- 95.0% to 105.0% Does not Mr. Ch. Munawar Hussain, C.E, Shaikh Imran comply BP 2011 Aslam, Prod. Manager, Kiramat ullah, Q.C Manager, appeared before the Board and stated that the drug is of standard quality as per repeated test/analysis of the keeping samples by their Q.C Department and they are trying to find out the cause of the problem..

The Boar however was of the view that the consistent CDL and Appellate Lab’s results clearly indicate that the product is not up to the specified standards.

Decision:-

The Board in view of the personal hearing

117 and available record of the case decided as under:-

Suspend registration of Paracmol suspension for six months.

Inspection of the firm by the following panel to thoroughly investigate the matter Prof. Dr. Rafi-uz-Zaman DDG, (E&M) Islamabad. Area FID.

118 Case No.03: MISCELLANEOUS CASES.

Case No a. MANUFACTURE AND SALE OF SPURIOUS, SUBSTANDARD AND ADULTERATED ISOTAB TABLETS BY M/S. EFROZE CHEMICAL INDUSTRIES KARACHI.

In January, 2012 on receipt of reports of number of deaths / serious reaction in large number of patients, receiving medicines from the Punjab Institute of Cardiology, the than Drug Control Administration and Government of Punjab initiated investigation to find out facts the case. Subsequently a foreign laboratory reported contamination of antimalarial drug “Pyrimethamine” in samples of Isotab tablets of M/s Efroze Chemical Industries, sent by the Punjab Government. Since at that time the subject of “Drugs and Medicines” was devolved to the provinces under 18th Amendment, therefore, the Drug Control Administration at Federal level could not process the matter further.

The Punjab Government, however, initiated its own independent investigation during this period. An FIR, against M/s Efroze Pharmaceuticals, Karachi, was lodged by Punjab Government and a Judicial Commission, headed by Judge of High Court, had also been set up by them for carrying out detail investigation of the case.

The Provincial Quality Control Board, Punjab later, vide its order dated 01-02-2012, reported that the samples of Tablet Isotab-20 Batch No. J-093, manufactured by M/s Efroze Chemical industries (Pvt) Ltd., Karachi, drawn by Drug Inspector, Data Ganj Bakhsh Town Lahore, (from stocks of the medicines retrieved from the patients (who received free medicines from PIC Lahore), were declared to be adulterated with “Pyrimethamine”, by the Government Analyst, Drug Testing Laboratory, Punjab. The quantity of “Pyrimethamine” determined, was 46.21 mg per tab and percentage of Isosorbide-5-mononitrate (API) was declared to be 122.8%, whereas the official limit of active ingredient was 95-105%. The Provincial Quality Control Board Punjab, after considering the matter recommended cancellation of Registration of Isotab Tablet and Drug Manufacturing License of M/s Efroze Chemical Industries, Karachi vides its ordered dated 01-02-2012.

The recommendations regarding cancellation of Drug Manufacturing License was taken up by Central Licensing Board in its 231st meeting held on 30-01-2013, wherein the Board, suspended Tablet Section of Efroze Pharma and ordered to launch prosecution against the

119 responsible persons of the firm. The Board further recommended to the Registration Board for the cancellation of registration of Isotab Tablet.

The Drug Registration Board in its 237th meeting held on 26-02-2013 considered the matter and took following decisions. i) Registration of Isotab Tablet is suspended for one year. ii) Show Cause Notice to be issued to the Firm( for cancellation of Drug Registration) iii) The case be evaluated/investigated by an Expert Committee to be constituted by the Chairman, Policy Board

As per above decisions of the Board, the following actions have been taken.

a. Firm has been issued Show Cause Notices dated 09-04-2013 b. Registration of Isotab Tablets has been suspended vide letter dated 22nd March, 2013 c. A seven member committee headed by Prof. Dr. Tahir S. Shamsi of National Institute of Blood Disease and Bone Marrow Transplant, has been constituted vide letter dated 08-03-2013 to evaluate the case in detail and give its comprehensive report and recommendations with in seven days. The CLB in its 232nd meeting directed that the Committee may be asked to finalize its report on top priority basis preferably with in week’s time.

The report of the Committee has been received recently. The Committee, as per its TOR, has evaluated report of Defective Drugs Inquiry Tribunal, recommendation of PQCB Punjab, investigation of area of FID Karachi and Inspection/investigation reports of National and International Agencies. The Committee also inspected the firm for assessing the GMP compliance status. The report of the Committee discussed the actions taken by Federal and Provincial Authorities against M/s Efroze Chemical Industry and its finding related to GMP status of the firm. The excerpts of the report and remarks of the Committee is Annexed

It is further Informed that M/s Efroze Chemical Industries, also file in appeal before appellate Board against suspension of their Tablet Section by CLB. The Appellate Board allowed manufacturing in Tablet Section on limited scale under strict monitoring. M/s Efroze Chemical Industry has been called for personal hearing with reference to the Show Cause Notice issued for cancellation of registration of Isotab Tablet. Decision:- The Board decided to defer the case till next meeting in order to provide final opportunity of personal hearing to M/s Efroze Chemical Industry, Karachi, failing which an ex-parte

120 decision shall be taken. In the mean time, the members may also study the report of the

Committee and come up with their recommendations/views in next meeting.

Case No b. Manufacture and Export of Sub-Standard Marivell-5 Injections by M/s Marion Laboratories (Pvt) Karachi

The Secretary Central Licensing Board has forwarded have the following decision of the Central Licensing Board taken in its 232 meeting held on 29-30 July,2013 for consideration of Drug Registration Board:-

“The Board also decided to send recommendation to the Registration Board for cancellation/suspension of registration of Injection Marivell-5 (Dextrose 5%) 500ml under Section 42 of Drugs Act, 1976 and rules framed there under for manufacturing and supply of Sub-Standard drug in the importing country”.

M/s Marion laboratories manufactured and exported two consignments of Marivell- 5 Injection (246240 Bottles) to Rawanda via Darussalam Tanzania through M/s Royal Groups Karachi in early 2012. The Consignments were reported to be declared sub- Standard by Rawanda Bio Medical Center of the importing country which also recommended for rejection of whole consignments. A dispute between M/s Marion Labs and M/s Royal Group arose on the issues of the destructions of stocks at Darussalam and Rawanda and compensation. Falling to settle the matters with M/s Marion, the Royal Group approached the DRAP Authorities for support claiming that manufacture of sub- standard drug for export by M/s Marion Lab’s has put Pakistan reputation at stake and could seriously effects export of drugs of Pakistani origin if the dispute is not appropriately settled. The DRAP Authorities and Central Licensing Board asked M/s Marion Laboratories number of times to settle the matter amicably with M/s Royal particularly regarding destruction of the Sub-Standard exported consignments lying at the port of Darussalam and at Rawanda, in order to avoid bringing bad name to Pakistan export. M/s Marion, however, failed to cooperate and appeared to have resorted to delaying tactics.

With regards to substandard exports, a GMP inspection of the firm was carried out and the production of the firm remain suspended till September, 2012. Thereafter the firm was found closed by an inspection panel which visited the firm on 11th, June 2013. The panel formally closed production of the firm vides its inspection report dated 11-06-2013.

121 The matter was subsequently considered by the Central Licensing Board in its 232nd meeting wherein Board took number of decision including suspension of Drug Manufacturing License of M/s Marion Lab’s Karachi for six months. Decision:- The Board considered the case along with sub-standard cases of M/s Marion Laboratories Karachi, included in the New Cases {Case No.2(1)}of the Q.C Agenda, wherein the Board already decide to cancel the registration of Marivell-5 Injection for sub-standard manufacturing.

Case No c: MANUFACTURE / SALE OF SUBSTANDARD MACRONIDE INFUSIONS BY M/S MAC & RAIN PHARMACEUTICALS, LAHORE.

The Federal Inspector of Drugs on 31st May, 2011 and 4th June, 2011 drew samples of five different batches of Macronid 100ml Infusion from the Main Medical Store, MCH and Store of Children Hospital at PIMS. On 4th June, 2011 different batches of Macronid Infusions at Burn Center, Store of Children Hospital and Main Store at PIMS were also ordered Not to Dispose off for three months by the FID. The FID, Islamabad later reported that the reports of the aforementioned samples were not received until May, 2012. On 17th May, 2012 photocopies of two substandard test reports, number 489/2011 & 490/ 2011 dated 28-05-2011, issued in respect of Macronid Infusion batch No. 105209 and 105208 were received. The other three batches of Macronid Infusions i-e 104262, 105123 and 010271 were declared standard Quality as per photocopies of reports of CD L provided by FID.

Immediately, on receipt, the two substandard reports were sent to PIMS and stocks of substandard batches were again ordered Not to Dispose off 18(1)(i) of Drugs Act, 1976 by FID on 21-05-2012 at Burn Center, Main Medical Store and MCH at PIMS and requested for extension of not to dispose off period under Section 18 of the Act. The FID’s request for extending not to dispose off orders was put up in June 2012, but file returned in April 2013, without any action. The Federal Inspector of Drug in the mean time also called explanation of the manufacturer M/s Mac & Rains Pharmaceuticals Lahore. The firm in response did not agree with the repots and stated that one of batch of Macronid Infusion (No 105208) was already declared standard by DTL, Punjab and further stated that the direct temperature shock applied on

122 the bottle during sealing (remarks of Federal Government Analyst) has compromised the sterility of the product.

The Federal Inspector of Drugs is of the view that the same method of seal was applied to all the other sample of Mecronid Infusion sent to Central Drug Laboratory and the reports of other three batches of the product, wherein the thermal shock was also reported by the Federal Government Analysis, were of standard quality and the firm’s contention therefore is not valid. The Federal Inspector of Drugs, therefore, concluded that the firms has violated the section (23) (1) (a) (V), of Drug Act 1976.

Decision:-

The Board, in view of the available record and facts of the case, decided as under:-

Show Cause Notice be issued to the firm and responsible persons. FID may be advised to pass not to dispose off orders/make seizure, which ever is applicable, for the sub-standard stocks at PIMS. Initiate recall proceedings for sub-standard stocks if supplied in the market

123

Item No.V Any Other Item with permission of chair

Registraion-I Case No: 01. Aplications for registration (locally manufactured Veterinary drugs (me- too/new drugs) for fast track.

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision Applicant Size Life 1. M/s. Mylab (Pvt) Nemasol Plus Drench Decontrolled 02 Approved Ltd. Khanqah Each ml contains:- 150ml years Sharif, Levamizole …………..15mg 500ml Bahawalpur. Oxyclozanide………..30 mg 1000ml Cobalt Sulphate ...…1.67 mg 5 Litre Sodium Selenite ..….0.50mg 10 Litre

2. M/s. Mylab (Pvt) Hepanol Oral Solution Decontrolled 02 Deferred for Ltd. Khanqah Each 100ml contains:- 100ml years application on Sharif, Sorbitol …………...….35gm 250ml Form 5 D along Bahawalpur. Acetyl Metionine …….10gm 500ml with revised Fee Choline HCL ……….7.5 gm 1000ml and comments of Betain …………….6.0 gm following experts; Lysine Hydrochloride .2.0gm 1. Dr. M Ashraf, UVAS 2. Head of Pharmacolog y Deptt. UAF 3. Dr. M. Arshad, Member DRB. 3. M/s. Mylab (Pvt) Imnate Injection Decontrolled 02 Approved Ltd. Khanqah Each ml contains:- 10ml years Sharif, Imidocarb 20ml Bahawalpur. Dipropionate………120mg 50ml 100ml 4. M/s. Mylab (Pvt) Melodyl Injection Decontrolled 02 Deferred for Ltd. Khanqah Each 100ml contains:- 10ml years application on Sharif, Cyanocobalamine …0.05mg 20ml Form 5 D along Bahawalpur. Sodium Selinite ……100 mg 50ml with revised Fee Adenosine Triphosphate 100ml and comments of Tetrasodium following experts; Trihydrate……………0.1gm a. Dr. M Ashraf, Potassium Aspartate Semihydrate UVAS …………1.0gm b. Head of Magnesium Aspartate Pharmacology

124 Tetrahydrate ……….1.5gm Deptt. UAF c. Dr. M. Arshad, Member DRB 5. M/s. Mylab (Pvt) Rivaflor 300 Injection Decontrolled 02 Approved Ltd. Khanqah Each ml contains:- 10ml years Sharif, Florfenicol ………...300mg 20ml Bahawalpur. 50ml 100ml 6. M/s. Mylab (Pvt) Terralon 50 Injection Decontrolled 02 Approved Ltd. Khanqah Each ml contains:- 10ml years Sharif, Oxytetracycline ……50mg 20ml Bahawalpur.

7. M/s. Mylab (Pvt) Tetrasol Injection Decontrolled 02 Deferred for Ltd. Khanqah Each ml contains:- 100ml years application on Sharif, Chlortetracycline.2.45% w/w Form 5 D along Bahawalpur. (Antibiotic) with revised Fee and comments of following experts; a. Dr. M Ashraf, UVAS b. Head of Pharmacology Deptt. UAF c. Dr. M. Arshad, Member DRB 8. M/s. Mylab (Pvt) Xylax Injection. Decontrolled 2 years Approved Ltd. Khanqah Each ml contains:- 5ml Sharif, Xylazine HCl 23.32mg. 10ml Bahawalpur. (Analgesic, Sedative). 20ml 25ml 30ml 50ml 100ml 9. M/s. Mylab (Pvt) Duretic Injection. Decontrolled 2 years Approved Ltd. Khanqah Each ml contains:- 5ml Sharif, Furosemide………50mg. 10ml Bahawalpur. (Diuretic). 20ml 30ml 50ml 100ml 10. M/s. Mylab (Pvt) Vantix Solution Decontrolled 03 Deferred for Ltd. Khanqah Each 100ml contains:- 100ml years application on Form Sharif, Fipronil……….0.25gm 250ml 5 D along with Bahawalpur. (Disinfectant). 500ml revised Fee and 1000ml comments of following experts; a. Dr. M Ashraf, UVAS

125 b. Head of Pharmacology Deptt. UAF c. Dr. M. Arshad, Member DRB 11. M/s. Baariq Zoleriq 10% Oral Drench Decontrolled 02 Approved Pharmaceuticals, Each ml oral drench contains:- 100ml years Raiwind Road, Albendazole……100mg 250ml Lahore. (Benzimidazole). 500ml 1000ml 12. M/s. Baariq Oxfendaox Plus Oral Drench Decontrolled 02 Approved Pharmaceuticals, Each ml contains:- 100ml years Raiwind Road, Oxyclozanide ……..62.50mg 500ml Lahore. Oxfendazole …………22.65 1000ml Cobalt Sulphate……1.67mg 2500ml Sodium Selenite…….0.50mg (Salicylanilide, Benzimodazole, Trace Elements). 13. M/s. Baariq Zolesel-CS Oral Drench Decontrolled 02 Approved Pharmaceuticals, Each ml contains:- 100ml years Raiwind Road, Albendazole……….50mg 500ml Lahore. Cobalt Sulphate……3.82mg 1000ml Sodium Selenite……0.35mg 2500ml (Benzimodazole, Trace Elements). 14. M/s. Baariq Levoxbar-Plus Drench Decontrolled 03 Approved Pharmaceuticals, Each ml contains:- 100ml years Raiwind Road, Levamisole HCL..15mg 150ml Lahore. Cobalt Sulphate…1.67mg 500ml Oxyclozanide…………30mg 1000ml Sodium Selenite……0.50mg 2500ml (Salicylanilide, Trace Elements).

15. M/s. Baariq Levacob-SS Oral Drench Decontrolled 03 Approved Pharmaceuticals, Each ml contains:- 100ml years Raiwind Road, Levamisole HCL……15mg 500ml Lahore. Cobalt Sulphate……3.82mg 1000ml Sodium Selenite…….0.50mg 2500ml (Salicylanilide, Trace Elements). 16. M/s. Baariq Amantadox-T Water Soluble Decontrolled 02 Approved Pharmaceuticals, Powder 100gm years Raiwind Road, Each 1000 gm powder contains:- 250gm Lahore. Tylosin Tartrate 500gm …….100gm 1000gm Doxycyline HCL……200gm 2500gm Amantadine HCl…….45gm 5000gm (Antibiotic) 17. M/s. Baariq Colibect Water Soluble Powder Decontrolled 02 Approved Pharmaceuticals, Each 100gm powder contains:- 100gm years Raiwind Road, Colistin Sulphate…500,000,000 IU 250gm Lahore. (Antibiotic, Antibacterial). 500gm 1Kg

126 2.5Kg 5Kg 10Kg 25Kg 18. M/s. D-Maarson LEVANIDE-CS Suspension Decontrolled 02 Approved, with Pharmaceuticals, Each 100ml contains:- 100ml years Brand Name Rawat, Islamabad. Oxyclozanide…….3.0g 150ml change Levamisole HCl …1.5g 250ml Cobalt Sulphate ….0.382% 400ml 500ml 1Litre 2.5Litre 25 Litre

19. M/s. D-Maarson ALBENMARS Suspension Decontrolled 02 Approved Pharmaceuticals, Each 100ml contains:- 100ml years Rawat, Islamabad. Albendazole…….2.5g 150ml Sodium selenite ...0.035% 250ml Cobalt chloride …0.075% 400ml 500ml 1Litre 2.5Litre 25 Litre 20. M/s. D-Maarson LEVAMARS Suspension Decontrolled 02 Approved Pharmaceuticals, Each 100ml contains:- 100ml years Rawat, Islamabad. Levamisole HCl …1.5% 150ml 250ml 400ml 500ml 1Litre 2.5Litre 25 Litre

21. M/s. D-Maarson TOLTRA MARS Liquid Decontrolled 02 Approved, with Pharmaceuticals, Each 1000ml contains:- 100ml years Brand Name Rawat, Islamabad. Toltrazuril …..25g 250ml change Vitamin K3 …3g 500ml 1Litre 2.5Litre 22. M/s. D-Maarson FENMARS Suspension Decontrolled 02 Approved Pharmaceuticals, Each ml contains:- 100ml years Rawat, Islamabad. Oxfendazole … 22.65mg 150ml 250ml 400ml 500ml 1Litre 2.5Litre 25 Litre 23. M/s. Medi-Vet Floxivet-Col + Oral Solution Decontrolled 02 Deferred as (Pvt) Limited, Each 100ml contains:- 100ml years production of firm

127 Lahore. Enrofloxacin HCI 250ml has been stopped CP………………..10.0gm 500ml by CLB Amantadine HCI 1000ml BP………………..04.0gm Colistin Sulphate BP…...... 3.5gm (Antibiotic/Antibacterial/Antiviral). 24. M/s. Medi-Vet Floxivet-C Injection Decontrolled 02 -Do- (Pvt) Limited, Each ml contains:- 100ml years Lahore. Enrofloxacin B.P Vet…100mg/ml 250ml Colistin Sulphate BP..250000 iu/ml 500ml (Antibiotic/Antibacterial). 1000ml

25. M/s. Medi-Vet Amcol-Vet Oral Suspension Decontrolled 03 Rejected as firm (Pvt) Limited, Each 100ml contains:- 100ml years does not have the Lahore. Amoxicillin base (as 250ml separate Penicillin Trihydrate……..B.P…15gm 500ml Section. Colistin Sulphate B.P…..50 MIU 1000ml (Antibiotic/Antibacterial).

26. M/s. Medi-Vet Medi-Voc Injection Decontrolled 02 Deferred as (Pvt) Limited, Each ml contains:- 100ml years production of firm Lahore. Ivermectin B.P………..10mg 250ml has been stopped (Dewormer/ Anthelmintic). 500ml by CLB 1000ml

27. M/s. Medi-Vet Medi-Dox Plus Solution Decontrolled 02 -Do- (Pvt) Limited, Each 100ml contains:- 100ml years Lahore. Tylosine Tartrate B.P 500 ml Vet………………..10gm 1000ml Doxycycline HCI B.P……………….20gm Colistin SulphateB.P…….500,000 IU Bromhexine HCI B.P…………………500mg (Antibiotic/Antibacterial).

128 Case No.2: Change of formulation of already approved veterinary drugs.

M/s. D-Maarson Pharmaceuticals, Islamabad have requested for change of formulation of their already approved veterinary drugs by the Drug Registration Board in its 237th meeting held on 26-02-2013. The registration letters of the drugs have not been issued so far due to new formulation. Now the firm has requested for change of formulation as per already approved drugs:- S.No. Existing Formulation. New Formulation. 1. Col-Plus Oral Liquid Col-Plus Oral Liquid Each 100 ml contains:- Each 100 ml contains:- Florfenicol……15gm. Florfenicol…… 20gm Colistin Sulphate … 50 MIU 2. Coli En Liquid. Coli En Liquid. Each 100ml contains:- Each 100ml contains:- Enrofloxacin ……10gm. Enrofloxacin ……..20gm Colistin sulphate…. 55 MIU Colistin sulphate …50 MIU

Decision: Request of the firm was acceded by the Board.

Case No.3: Change of manufacturing site of registered imported drug

M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the change of manufacturing site of their registered imported drug namely “Galvus Tablets 50mg (Reg. No.059038)” from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis Farmaceutica S.A., Spain.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have deposited required fee Rs.50000/= (Pages 44-45/Corr) and submitted following supporting documents:-

i) Copy of registration letter. ii) Original legalized EMA CPP of new manufacturing site. iii) Copy of NOC for CRF. iv) Registration of the drug is valid.

Decision: The board after detailed discussion approved the change in manufacturing site of Galvus Tablets from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis

129 Farmaceutica S.A., Spain. The Board advised to deposit balance fee as per revised fee schedule and site master file of new manufacturing site.

Registration-II Case No.4 Deferred cases.

a. Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi Following product of M/s Adamjee Pharmaceuticals, Karachi was deferred for review the case after submission of balance fee, GMP of source, COA and stability data by the Expert Committee of Registration Board in its 237th meeting.

Name of Drug & Composition Pack size Demanded MRP Papazole Capsule 2x7’s As Per SRO Each capsule contains:- Pantoprazole sodium sesquihydrate equivalent to Pantoprazole…………….40mg (Selective inhibitor of Cyclic Guanosine Monophosphate)

Now the firm has requisite information as under:- i) Pantoprazole Pellets will be import from M/s Glukem Pharmaceuticals (Pvt.) Ltd, Plot No. 205/2A, First Floor, IDA, Phase-II, Cherlapally, Hyderabad, Andhra Pradesh, India

ii) GMP Certificate of bulk import source issued on 23-07-2012 valid for one year.

iii) Certificate of Analysis iv) Stability data (Accelerated i.e 400C / 75% RH and long term studies i.e 250C / 65% RH) v) Balance fee Rs.240,000/- Decsion: Regsitartion Board approved firm’s request. However, the Borad advised to provide valid GMP certicate or identify another manufacturer and submit its relevant documents and authorized its Chairman to accord approval for issuance of regiatration letter.

130 b) M/s Abbott Laboratories, Karachi

The Registration Board in 237th meeting deferred registration of following drug of M/s Abbott Laboratories, Karachi reason mentioned in last column. S. Name of drug(s) & Proposed Demanded Date of Decision No Composition Price application, Pack size Diary No. & Form

1 Klaricid-DS Granules 60ml Rs.630/- 16-06-2011 Sub-Committee decided to review Dy.No.1601 Each 5ml contains: the case after Clarithromycin 250 mg Form-5 submission of balance fee, GMP Rs.8000/- (Antibiotics) of source, COA and Rs.12000/- stability data

12-10-2012 Rs.40,000/- 29-1-2013

M/s Abbott Labs, Karachi has now furnished the following documents:- i) GMP Certificate of API source M/s Ranbaxy Laboratories Ltd, Industrial Area No.3 A.B. Road, Dewas 455 001 (MP), India issued on 15-02-2013 valid till 15- 01-2015.

ii) Certificate of Analysis

iii) Stability data (only long term studies for 36 months at 250C / 60% RH) iv) Remaining fee Rs.240,000/- for each product for the purpose.

Decsion: Regsitartion Board approved Klaricid-DS Granules for registration with source of pellets mentioned above.

c) M/s PharmEvo (Pvt.) Ltd, Karachi The Registration Board in 227th meeting deferred following product of M/s PharmEvo Pakistan, Karachi

131 Name of drug(s) & Proposed Demanded Decision Composition Price Pack size

Acrova Tablet 7’s Rs.1200.00 Deferred for confirmation of Each tablet contains:- 14’s Rs.2400.00 formulation Rivaroxaban ……..10mg

(Anti thrombotic agent)

Later on scrutiny of registration data reveals that the above formulation is already approved in 238th meeting of Registration Board for M/s Getz Pharma, Karachi under the brand name “Xalto Tablets 10mg”.

Decsion: Regsitartion Board approved Acrova Tablet for registration.

d) Pharmatec Pakistan (Pvt.) Ltd, Karachi. Following product of M/s Pharmatec Pakistan, Karachi was deferred, for submission of application of Form-5D with balance fee, by the Expert Committee of Registration Board in its 237th meeting. Name of Drug & Composition Pack size Demanded MRP Maltofer Fol Syrup 150ml As per PRC Each 5ml contains: Iron as iron (III) hydro oxide ploymaltose………..….100 mg Folic acid…………….400 mcg (Supplementation and treatment of ID and IDA)

Now the firm has furnished registration application on Form-5D along with remaining fee Rs.90,000/-. The firm has also submitted the justification for the proposed syrup dosage form that it has better compliance and tolerability.

132 Decision: Registration Board deferred request for PSI by Director DTL, Karachi and area FID. Moreover, case will be referred to Head, dept of Gynacology, FGSH, PIMS and RGH. e) M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi

The firm M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi had applied for the registration of the below mentioned formulation, which was considered in the 237th meeting of the Registration Board and deferred for reason recorded in the last column:

S. Name of Name of drug(s) Decision No. applicant(s)

1. M/s Amarant Cycline 250mg Capsule Deferred for Pharmaceuticals , confirmation of Karachi Each capsule contains: manufacturing facility. Cycloserine……250mg (A broad spectrum antibiotic)

Now the firm has submitted that they have the facility for manufacture of the said formulation i.e., Capsule (General) section and that a number of firms are manufacturing the same product in Capsule (General) section. Decision: Registration Board approved Cycline 250mg Capsule for registration.

f) M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, Karachi

The Registration Board in its 229th meeting deferred following products of M/s Pakistan Pharmaceutical Products, Karachi for the reasons mentioned in last column.

S. Name of drug(s) & Formulation Pack MRP Reason No. size

1. Pilot Suspension 125mg/5ml Rs.11.25 / Deferred for panel inspection to

133 Each 5ml contains:- 5ml evaluate GMP compliance & track Cefadroxil ………….….125mg record (Antibiotics)

2. Pilot Suspension 250mg/5ml Rs.20.83 / -do- 5ml Each 5ml contains:- Cefadroxil …………….250mg (Antibiotics)

3. Pilot Capsule 500mg Rs.25.75 -do-

Each capsule contains:- (Per capsule) Cefadroxil …………...500mg

(Antibiotics)

Now, the firm has submitted product specific inspection report dated 28-02-2011 of panel constituted by the Registration Board in its 227th meeting and routine GMP inspection dated 13- 02-2013 conducted by the area FID. Where the FID has mentioned in inspection report that firm has concerned Cephalosporin Oral Dry Syrup and Capsule Sections and concluded as follows:- “ based on the areas inspected, the people met and the documents reviewed , and considering the findings of the inspection of M/s Pakistan Pharmaceutical Products, site was considered to be operating at good level of compliance with GMP guidelines as per Drugs Act, 1976 and rules framed there under” Decision: Registration Board deferred request for PSI by Director DTL, Karachi and area FID.

g) M/s Aventis Pharma, Karachi – Claforan 2.0gm Injection

The Registration Board in 237th meeting deferred following application of M/s Aventis Pharma, Karachi for reason recorded in last column. Name of drug(s) & Proposed Demanded Date of Decision Composition Price application, Pack size Diary No.

134 & Form

Claforan 2.0g Injection Per vial Rs.550.43 19-05-2011 Deferred for approval by Each vial contains:- 1257 USFDA, EMA, regulatory body of Cefotaxime as Form-5 Japan & Australia. Sodium ….2gm Rs.8000/- (Antibiotics) Rs.72,000/- 29-1-2013

Now the firm has submitted that the above formulation is already registered for several firms including M/s Alina Combine, Karachi under the brand name “ Hexime Injection 2gm” Reg. No.012814 and M/s P.D.H Pharmaceuticals, Karachi under the brand name of “Cephronate Injection” Reg. No.019699. The said formulation has also been approved by USFDA, MHRA & Regulatory Body of Australia.

Decision: Registration Board approved Claforan 2.0g Injection for regsitration. h) M/s Macter International, Karachi The Registration Board in 237th meeting deferred registration of following drug of M/s Macter International, Karachi reason mentioned in last column. S. Name of drug(s) & Proposed Demanded Date of Decision No Composition Price application, Pack size Diary No. & Form

1 Itoguard OD 150mg 10’s Rs.33/- 06-09-2012 The Sub- Capsule Committee decided 14’s Per Cap. 1515 to review the case Each capsule contains: 20’s Form-5 after submission of Itopride hydrochloride balance fee, GMP (as sustained release 30’s Rs.8000/- of source, COA and stability data pellets)……….150 mg Rs.52,000/-

(Gastro kinetic) 23-1-2013

M/s Macter International, Karachi have now furnished the following documents:- i) Certificate of Analysis

135 ii) Comparative Dissolution Method

iii) GMP Certificate of source M/s Spansules Formulation, India

iv) Stability study data

v) Fee Rs. 300,000/- for the purpose.

Decision: Registration Board approved Itoguard OD 150mg Capsule for regsitration.

i) M/s Amarant Pharmaceuticals, Karachi

The Registration Board in 228th meeting deferred for expert opinion the registration of following drug of M/s Amarant Pharmaceuticals, Karachi S. Name of drug(s) & Composition Proposed Demanded No Price Pack size

1 Amprexa-F Capsules 6/25mg As per As per SRO SRO Each capsule contains:- Olanzapine …………..…6mg Fluoxetine HCl ……….25mg

Later on scrutiny of registration data reveals that the above formulation is already registered for M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg. No.073778. Decision: Registration Board approved Amprexa-F Capsules 6/25mg for regsitration.

j) M/s Nabiqasim Industries, Karachi

The Registration Board in 237th meeting deferred for confirmation of Me-Too status the registration of following drug of M/s Nabiqasim Industries, Karachi S. Name of drug(s) & Composition Proposed Demanded No Price Pack size

1 Co-Dep 6/25 Capsule 10’s As per PRC

136 Each capsule contains: 14’s

Olanzapine ……………6 mg 20’s

Fluoxetine HCl………..25 mg 30’s

(Anti psychotropic)

2 Co-Dep 3/25 Capsule 10’s As per PRC

Each capsule contains: 14’s

Olanzapine ……………3 mg 20’s

Fluoxetine HCl………..25 mg 30’s

(Anti psychotropic)

Decision: Registration Board approved above products for regsitration.

Case No.3 BULK IMPORT AND LOCAL REPACKING – M/S GLAXOSMITHKLINE PAKISTAN LTD, KARACHI

M/s GlaxoSmithKline Pakistan Ltd, Karachi has requested for grant of permission for bulk import from parent UK source and local repacking in limited quantity i.e 04 million tablets in divided shipments of Zinacef 250mg, Reg. No.011340 containing Cefuroxime to avoid any shortages in local market due to extension and renovation of their Cephalosporin facility at Korangi Factory (DML No.000248).

Firm has also deposited fee Rs.100,000/- for the purpose.

Decision: Registration Board deferred firm’s request and advised to provide following documents for decision: a. Renovation plan with time lines duly approved by manitenace department of the firm and confirmation by licensing section, DRAP. b. Manufacturing status of other products in same section.

137 c. Legalized COPP for proposed manufacturer. d. Form 5.

Case No.4 Change of Formulation a) M/s Noa Hemis Pharmaceuticals, Karachi

M/s Noa Hemis Pharmaceuticals, Karachi has requested for change of formulation of following registered drug. Existing and proposed formulations are as under.

S. Reg. Previous formulation Proposed formulation No No.

01 032179 Mucof Syrup Mucof Syrup

Each 100ml contains:- Each 5ml contains:-

Ephedrine HCl …………...100mg Chlorpheniramine Maleate…5mg Chlorpheniramine Maleate.100mg Terpinhydrate…………….10mg Terpinhydrate…………….200mg Pot. Bicarbonate ………...0.1mg Pot. Bicarbonate …………...2mg Ammonium Chloride…….25mg Ammonium Chloride…….500mg Menthol …………………..1mg Tr. Senega ………………..1.0ml Aminophylline Ph Eur …….32mg Menthol …………………..20mg Pot. Guaicol Sulph ……….5mg Bromhexine HCl ………….20mg Pot. Guaicol Sulph ……….100mg Pot. Citrate ………………..0.1mg Pot. Citras ………………..…2mg Flavour & Base ……………q.s Tr. Ipecac …………………0.5ml Ext. Glycyrrhiza Liq. ……….2ml

Firm has submitted that proposed formulation is already registered in fvaour of M/s CCL Pharmaceuticals, Lahore i.e Pulmonol Syrup, Reg. No.000874. Firm has also furnished new form-5 along with requisite fee Rs.20,000/- for the purpose.

138 Decsion: Registration Board deferred firm’s request for PSI by Director DTL, Karachi and DDG (E&M), Karachi.

Case No.5 Registration for export purpose containing controlled drugs M/s Amarant Pharmaceuticals, Karachi and M/s Pharmatec Pakistan, Karachi has requested for registration of following drugs for export purpose only:- S. No. Name of Name of drug(s) & Composition Manufacturer(s)

1 M/s Amarant Amalor-D Tablet Pharma, Karachi Each tablet contains:- Loratadine ……………..5mg Pseudoephedrine HCl ….60mg

2 M/s Pharmatec Flu-Gone Day and Night Capsule (Combi Pack) Pakistan, Karachi Each combi pack contains:-

Each day-time capsule contains:- (Strip-1) Paracetamol ……………….400mg Psedoephedrine HCl …….. 30mg Caffeine Anhydrous ………30mg

Each night-time capsule contains:- (Strip-2) Paracetamol ……………….400mg Psedoephedrine HCl …….. 30mg Cetirizine (as Dihydrochloride)..10mg Dextramethorphan HBr ……..10mg

139 Decision: Committee on allocation of controlled Drug has already conveyed that Registration Board may take decision according to its rules. Thus Board approved firm’s request. Matter regarding allocation of quota will be dealt by Committee on allocation of controlled Drug accordingly.

Case No. 6 De-Registration of registered drugs. Following manufacturers have requested for de-registration of their registered drugs. Details are as under:- S. Name of Reg. No. Name of drug(s) Reason / No. applicant(s) Justification

1. M/s Bosch Pharma, 050507 Telocin 400mg Tablet Not interested Karachi in Each film coated tablet manufacturing contains: and marketing Telithromycin……400mg

2. -do- 030606 Arbel 50 tablets -do- Each tablet contains:- Losartan Potassium …50mg

3. M/s Tabros 004088 Paracetamol Compound Not mentioned Pharma, Karachi Tablets (Paracetamol + Aspirin)

4. -do- 004175 Sulphadiazine Tablets -do- (Sulphadiazine)

5 -do- 004173 Sulphadimidine Tablets -do- (Sulphadiamidine)

Decsion: Registration Board de-registered above products. However, the Board advised firm to provide undertaking for not pending any case at any forum.

140 Case No.7 Request for withdrawal of registration application – M/s AsianContinental (Pvt.) Ltd, Karachi M/s AsianContinental (Pvt.) Ltd, Karachi has requested for withdrawal of their registration application i.e Extrac Plus Tablets, containing Clopidogrel …75mg + Aspirin…..75mg submitted on August, 2010. Decsion: Registration Board approved firm’s request for withdrawl of above regsitartion application (Extrac Plus Tablets).

Case No.8 Correction in minutes

a) M/s High-Q, Karachi Following product of M/s High-Q, Karachi was considered in the 236th meeting of the Registration Board.

Pirokeu 20mg tablet Each tablet contains: Piroxicam Betacyclodextrin eq. to Piroxicam ….. 20mg (NSAID)

The aforementioned registration application was referred to the committee comprising Prof. Dr. Rafi-uz-Zaman Saeed-ul-Haq, Member Registration Board, DDC (Reg-II), and DDG Reg. However, in the minutes of the said subcommittee meeting, the above mentioned product was erroneously approved as “Piroxicam 20 mg tablet” instead of “Piroxicam Betacyclodextrin 20mg tablet” and the registration letter has not been issued. The firm has now requested that the registration may be granted with the correct formulation.

Decsion: Request of firm for correction as Piroxicam Betacyclodextrin 20mg tablet approved by the Board.

b) M/s Getz Pharma, Karachi The Registration Board in its 238th meeting had considered registration application file in Month of May & June, 2010. However, the following registration application of M/s Getz Pharma, Karachi was erroneously not included in Agenda of 238th meeting. Details of the case are as under:-

141 S. No. Date of Remarks Name of drug(s) & Proposed Demanded application, Composition Pack size Price Diary No. & Form 1. Trizid MR Tablets 35mg Comparative 19/05/2010 Each film coated tablet dissolution Dy. No. 1013 contains:- profile with 20’s Rs.300.00 Form 5 Trimetazidine originator 30’s Rs.450.00 Rs. 8000/- Dihydrochloride……35mg brand and Rs.12,000 (Anti-anginal) related 20-2--2013 documents

Decsion: Registration Board deferred firm’s request for submission of comparative dissolution profile with brand leader.

Case No.9 Transfer of registration from import to local toll manufacturing

M/s High-Q International, Karachi has informed that following drugs are registered for import in finished form. Now they have intend to transfer the registration from import to local manufacturing under contract manufacturing arrangements as mentioned against each. Details are as under:- S. Reg. Name of Drug(s) Existing Import Proposed Contract No. No. Manufacturer(s) Manufacturer (s) 1 045616 Ruling Injection 40mg M/s Hainan M/s Nabiqasim Each vial contains:- Lingkang Industries, Karachi Omeprazole Pharmaceutical Co., (as Sodium) ….40mg Ltd., China

(Bulk Import and Local repacking)

2 018501 Remethan Injection M/s Shin Poong M/s Surge Labs, 75mg Pharmaceutical Co Sheikhupura Each 3ml contains:- Ltd, Seoul Korea Diclofenac Sodium………….75mg

3 019467 Cycin 100mg / 50ml M/s Shin Poong M/s Surge Labs, Injection I.V/ I.M Pharmaceutical Co Sheikhupura Each vial contains:- Ltd, Seoul Korea Ciprofloxacin ..100mg

4 019468 Cycin 200mg/100ml M/s Shin Poong M/s Surge Labs,

142 Injection I.V/ I.M Pharmaceutical Co Sheikhupura Each vial contains:- Ltd, Seoul Korea Ciprofloxacin ..200mg

5 022645 Hizone Injection M/s Shin Poong M/s Surge Labs, 250mg IM Pharmaceutical Co Sheikhupura Each vial contains:- Ltd, Seoul Korea Ceftriaxone as Sodium………250mg (Bulk import and local repacking)

6 018300 Hizone Injection 1gm M/s Shin Poong M/s Surge Labs, IV Pharmaceutical Co Sheikhupura Each vial contains:- Ltd, Seoul Korea Ceftriaxone as Sodium………1gm (Bulk import and local repacking)

7 014947 Cefapezone Injection M/s Shin Poong M/s Surge Labs, 1gm Pharmaceutical Co Sheikhupura Each vial contains:- Ltd, Seoul Korea Cefoperazone Sodium………..1gm (Bulk import and local repacking) 8 015589 Fugacin Tablets M/s Shin Poong M/s High-Q Each film coated tablet Pharmaceutical Co Pharmaceuticals, contains:- Ltd, Seoul Korea Karachi Ofloxacin ……..200mg 9 019522 Cycin 500mg Tablets M/s IL Dong M/s High-Q Each tablet contains:- Pharmaceutical Co. Pharmaceuticals, Ciprofloxacin Ltd, Korea Karachi HCl………… 500mg 10 019523 Cycin 250mg Tablets M/s IL Dong M/s High-Q Each tablet contains:- Pharmaceutical Co. Pharmaceuticals, Ciprofloxacin Ltd, Korea Karachi HCl………… 250mg

Firm has furnished following information to support their request.  Registration dossier on Form -5.

 Original consent of M/s Nabiqasim Industries (Pvt.) Ltd, Karachi (page12/Corr) and M/s Surge Laboratories, Sheikhupura & M/s High-Q Pharmaceuticals, Karachi

143

 Contract manufacturing agreement with M/s Nabiqasim Industries (Pvt.) Ltd, Karachi and M/s Surge Laboratories, Sheikhupura (page 26/Corr) & M/s High-Q Pharmaceuticals, Karachi

 Copy of Registration letters & Renewal

 Fee of Rs.50,000/- for each product for the purpose.

Decision: Registration Board deferred firm’s request till next meeting for detailed delibrations in light of contract manufacturing policy.

Case No.10 Extension in contract manufacturing permission.

The Registration Board in its 238th meeting had considered case for extension in contract manufacturing permissions. However, the following case of M/s Sami Pharmaceuticals, Karachi was erroneously not included in Agenda of 238th meeting. Details of the case are as under:- S. Applicant Contract Reg. No. Name of drug(s) & Date of Category No. manufactur Composition applicatio er n, Diary No. & Form 1. M/s Sami M/s 037541 Oroxim 100mg Film 15-04- Dedicated Pharma, Healthek Coated Tablets 2013 facility Karachi Pvt. Karachi Each film coated Dy.No.13 Cephalosp tablet contains: 5 orin Cefpodoxime proxetil Form-05 eq. to Rs.50,000/ cefpodoxime..100 mg -

Decsion: Registration Board extended above product till 30.06.2015.

144 Case No.11: Fast track registration scrutinized by evaluators.

S.N Name of Name of drug with Pack Demande Date Remarks o manufacturer composition size d price 1. M/s. Valiant-M Tablets’ 10’s As Per 24-4- Recommended Ferozsons Labs, Each film coated tablet 30’s SRO 2013 Nowshera contains:- Vildagliptin………….50 mg Metformin HCl…..850 mg (Ant-diabetic)

2. -do- Valiant-M Tablets’ 10’s As Per -do- Recommended Each film coated tablet 30’s SRO contains:- Vildagliptin…………… …….50 mg Metformin HCl………...1000 mg (Ant-diabetic)

3. M/s. Winbrain Cefwell 250mg Injection Per As Per 22-5- The products are Research IM Vial SRO 2013 recommended Laboratories, Each vial contains:- if manufacturer is Hattar Ceftriaxone Sodium already producing Toll ≡ the same drugs as manufactured Ceftriaxone………..250 it is an by M/s. mg application of toll Weather Fold (Anti-infective) manufacturing Pharmaceutical, and not Hattar manufacturing by M/s. Winbrain. Note:- Weather Fold is already having approved section for production of Cephalosporin Injection and registered product as well. 4. -do- Cefwell 500mg Injection Per As Per -do- -do- IM Vial SRO Each vial contains:- Ceftriaxone Sodium

145 ≡ Ceftriaxone………..500 mg (Anti-infective)

5. -do- Cefwell 1gm Injection Per As Per -do- -do- IM Vial SRO Each vial contains:- Ceftriaxone Sodium ≡ Ceftriaxone………..1gm (Anti-infective) 6. M/s. Shazeb Zeesol-5% I.V Infusion 100ml As Per 13-5-2013 No Batch Size Pharmaceutical Each 100ml contains:- SRO description s, Distt Dextrose Anhyrous……..5 Batch cycle Haripur gm Sterilization (Caloric solution) Cycle Source of Raw Materials Testing of Raw Materials Price Paper / Comparison of Dextrose 5% Not recommended. Shortcoming rectified 7. -do- Zeesol-NS O.V Solution 100ml As Per -do- No Batch Size Each 100ml contains:- SRO description Sodium Batch cycle chloride……….0.9 gm Sterilization (Electrolyte) Cycle Source of Raw Materials Testing of Raw Materials Price Paper / Comparison of Dextrose 5% Not recommended. Shortcoming rectified 8. -do- Zee Hesta 3% 500ml As Per -do- Check Each 1000ml contains:- SRO Hydroxyethyl

146 Hydroxyethyl Standards Starch………30 gm Not Sodium recommended. Chloride…….……9 gm Shortcoming (Plasma Substitute) rectified 9. -do- Zee Haemagel I.V 500ml As Per -do- Not Infusion SRO recommended. Each 1000ml contains:- The firm has Degraded gelatin informed that they Polygeline) of average can’t rectify molecular weight…….35 immediately g therefore thye Sodium requested to Chloride….….…..8.50 g postpone till next Potassium DRB meeting. Chloride….……0.7 g Calcium chloride…….....0.38 g (Plasma Substitute)

10. M/s. Bloom Darcin-250mg Capsules 1x6’s As Per 16-5- Method of Pharmaceuticals Each capsule contains:- SR 2013 Manufacturing , Hattar Azithromycin dihydrate) Detail required for ≡ >45% humidity Azithromycin……..….250 and >30 C mg temperature. (Macrolide) Method of Analysis Method (Limits) are for Doxycycline Hyclate. Method 2 Is spectrophotometer method but in detail is given Chromatograph Specification. Clinical Indication Vogue. 03 years shelf life Stability Studies not given Type of Mixer (Bottle Mixer)

147 not clear. Not recommended. Shortcoming rectified 11. M/s. Genome Ibufam Tablets 10’s As Per 2-5- Dual core tablet Pharmaceutical Each film coated tablet SRO 2013 machine s, Hattar contains:- unavailable. To Ibuprofen………..800 be deferred. mg Outline of Famotidine……..26.6 mg method of (NSAID/H2-receptor) manufacture

does not contains the coating process. However, in detailed procedure it has been given in general. IPA is inflammable substance. Safety measures for tray drawing of materials containing IPA has not been provided. Specification of sodium starch glycolaed have been provided in dossier but the material is not reflecting in the composition of drug. Recommended with above corrections.

148 12. M/s. Onyx Sulpride 50mg Tablets 1`0’s As Per 20-5- Minor Pharmaceutical Each tablet contains:- SRO 2013 shortcoming s, Mansehra Levosulpiride………..50 rectified. mg (Antidpressant/Anti- gastroprokinetics)

Decsion: Registration Board decided as follows: Products at S.No. 1, 2, 6, 7, 10 and 12 approved for registration, as firms have rectified shortcomings in registration dossiers. Products at S.No. 3, 4 and 5 deferred for discussion in forthcoming meeting in light of contract manufacturing policy. Products at S.No. 8 and 9 deferred for PSI by Director DTL, Peshawar and area FID. For product at S.No.9, firm will rectify shortcomings as mentioned above. Products at S.No.11 for correction of shortcomings.

149 Case No.12: CCL Pharmaceuticals (Pvt.) Ltd., Lahore. Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th meeting as under:-

Name of the drugs with Pack Proposed Decision composition Size Price Epipro CR Tablets 5x10’s As per SRO Deferred for submission of Each tablet contains:- comparative Divalproex Sodium dissolution profile USP……..500mg with originator and relative documents. (Anti-Epileptics)

The firm has submitted comparative dissolution profile of their product EPIPRO CR Tablet with originator reference product Tablet EPIVAL CR of M/s Abbott Laboratories Pakistan Ltd. Decision: The Drug Registration Board deferred the case till expert evaluation of comparative dissolution profile documents by Director DTL Peshawar. Case No.13: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.

Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th meeting for confirmation of formulation in developed countries. Name of the drugs with Pack Proposed Decision composition Size Price CIP Suspension 10% 60ml As per SRO Deferred for confirmation of Each 5ml contains:- 100ml formulation in Ciprofloxacin HCl developed countries. USP……..500mg (Anti-Biotic)

The firm has submitted that the drug is approved by US-FDA with the name of CIPRO for M/s Bayer Pharmaceuticals Corporation, USA and provided copies of references (approvals / study). The firm also submitted that the same formulation has been approved in 227th meeting of DRB held on 26-27 Aug 2010 for M/s Wilshire Lab. Lahore and Drug Pricing Committee fixed its price in its 14th meeting held on 11th January 2011. It is submitted that ciprofloxacin microcapsules in base form is used in FDA approved Bayer’s Cipro formulation. Price has also

150 been approved for base form as Microencapsulated Ciprofloxacin eq.to Ciprofloxacin ….500mg, while in this formulation Ciprofloxacin HCl has been applied. Decision: The Drug Registration Board deferred the case for confirmation of USFDA approval of formulation and confirmation of formulation with originator.

Case No.14: Grant of registration-New formulation & fast track. Following firms have applied following products on Form 5-D as new applications and fast track fee. Decision is recorded in last column.

S.N Name of Name of the drugs with Pack Proposed Date of Decision o Firm composition Size Price Submission

1. M/s Saffron Provate GM Topical Ointment 20gm Rs.300.00 10-7-2013 Deferred for Pharmaceut Each gram contains:- 10gm Rs.150.00 Rs.60,000/- confirmation icals (Pvt) Betamethasone…0.05% w/w 05-09-2013 of availability of Ltd, Gentamicin….0.1% w/w Rs. 90,000/- formulation Faisalabad. Miconazole….2% w/w Form 5-D in FDA, (cortisteriod/antibiotic/antifungal) EMA, Australia and Japan.

2. -do- Provate GM Topical Cream 20gm Rs.300.00 10-7-2013 Deferred for Each gram contains:- 10gm Rs.150.00 Rs.60,000/- confirmation Betamethasone…0.05% w/w 05-09-2013 of availability of Gentamicin….0.1% w/w Rs. 90,000/- formulation Miconazole….2% w/w Form 5-D in FDA, (cortisteriod/antibiotic/antifungal) EMA, Australia and Japan. 3. M/s Tagipmet XR 100/1000Tablet N.A N.A 10-04-13 Deferred for Highnoon Each bilayered tablet contains:- Rs. 150,000/- confirmation Lab. Ltd. Sitagliptin (as Form-5D of availability Lahore phosphate)…100mg of Metformin HCl (as sustained formulation release)…1000mg in FDA, (Anti-diabetic) EMA, Australia and Japan.

151 4. -do- Tagipmet XR 50/500Tablet N.A N.A 10-04-13 Deferred for Each bilayered tablet contains:- Rs. 150,000/- confirmation Sitagliptin (as phosphate)…50mg Form-5D of availability Metformin HCl (as sustained of release)…500mg formulation (Anti-diabetic) in FDA, EMA, Australia and Japan.

5. -do- Tagipmet XR 50/1000Tablet 10-04-13 Deferred for Each bilayered tablet contains:- Rs. 150,000/- confirmation Sitagliptin (as phosphate)…50mg Form-5D of availability Metformin HCl (as sustained of release)…1000mg formulation (Anti-diabetic) in FDA, EMA, Australia and Japan. 6. -do- Axesom 10 Sachet 22-04-13 Deferred for Each Sachet contains:- Rs. 150,000/- confirmation Esomeprazole (as Magnesium Form-5D of availability trihydrate) …10mg as Gastro- of resistant granules formulation in FDA, EMA, Australia and Japan. 7. -do- Ebernet 1% Cream 10gm Rs.320.00 21-06-2011 Deferred for Each gram contains:- Rs. 8000/- confirmation Eberconazole (as nitrate)….10mg 27-06-2011 of availability of (anti fungal) Rs. 7000/- formulation 10-7-2013 in FDA, 135000/- EMA, (Total: Rs. Australia and 150000/-) Japan. Form-5D 8. M/s Servier Daflon 1g Tablet 20’s Rs. 30-04-13 Deferred for Research Each tablet contains:- 32.50/table Fee Rs. confirmation and Diosmin… 900mg t 150,000/- of availability Pharmaceut Hesperidine …100mg Form-5D of icals (pvt). (Vascular protector and formulation Ltd. Venotonic) in FDA, Lahore. EMA, Australia and

152 Japan.

9. -do- Natrilam 10mg Tablets 30’s Rs.72.52/T 20-6-2012 Deferred for Each tablet contains:- ablet Rs.8000/- confirmation Indapamide SR…..1.5mg 30-04-13 of availability Amlodapine Besilate…..10mg Rs. 130,000/- of (Antihypertensive diuretic + Total Fee Rs. formulation Calcium antagonist) 150,000/- in FDA, Form 5-D EMA, Australia and Japan.

10. -do- Natrilam 5 mg Tablets 30’s Rs.36.26/t 05-04-2011 Deferred for Each tablet contains:- ablet Rs.8000/- confirmation Indapamide SR…..1.5mg 30-04-13 of availability Amlodapine Besilate…..5mg Rs. 130,000/- of (Antihypertensive diuretic + Total Fee Rs. formulation Calcium antagonist) 150,000/- in FDA, Form 5-D EMA, Australia and Japan.

11. -do- Natrilam 2.5 mg Tablets 30’s Rs.26.26/t 05-04-2011 Deferred for Each tablet contains:- ablet Rs.8000/- confirmation Indapamide SR…..1.5mg 30-04-13 of availability Amlodapine Besilate…..2.5mg Rs. 130,000/- of (Antihypertensive diuretic + Total Fee Rs. formulation Calcium antagonist) 150,000/- in FDA, Form 5-D EMA, Australia and Japan.

12. M/s. CCL OAB Tablets 4mg 28’s As per 03.02.2011 Deferred for Pharmaceut Each tablet contains: brand Fee 15000 confirmation icals, Fesoterodine Fumarate …. 4mg leader 20.05.2013 of availability Lahore (Muscarinic receptor antagonist) Fee.135,000 of Form 5-D formulation in FDA, EMA, Australia and Japan.

153 13. -do- OAB Tablets 8mg 28’s As per 03.02.2011 Deferred for Each ER tablet contains: brand Fee 15000 confirmation Fesoterodine Fumarate …… 8mg leader 20.05.2013 of availability (Muscarinic receptor antagonist) Fee.135000 of Form 5-D formulation in FDA, EMA, Australia and Japan.

14. -do- Virata Tablets 90mg 20’s As per 12.01.2012 Deferred for Each tablet contains: brand Fee 15000 confirmation Ticagrelor ………. 90mg leader 20.05.2013 of availability (Platelet inhibitor) Fee.135000 of Form 5-D formulation in FDA, EMA, Australia and Japan. 15. -do- Lina-Met 2.5/500 Tablet 14’s As per 08.04.2013 Deferred for Each tablet contains: brand Fee 50000 confirmation Linagliptin...... 2.5mg leader Fee.100000 of availability Metformin HCI………500mg 20.05.2013 of Form-5D formulation in FDA, EMA, Australia and Japan. 16. -do- Lina-Met 2.5/850 Tablet 14’s As per 08.04.2013 Deferred for Each tablet contains: brand Fee 50000 confirmation Linagliptin…...... 2.5mg leader Fee.100000 of availability Metformin HCI…………850mg 20.05.2013 of Form-5D formulation in FDA, EMA, Australia and Japan. 17. -do- Lina-Met 2.5/1000 Tablet 14’s As per 08.04.2013 Deferred for Each tablet contains: brand Fee 50000 confirmation Linagliptin ...... 2.5mg leader Fee.100000 of availability Metformin HCI……….1000mg 20.05.2013 of Form-5D formulation in FDA, EMA, Australia and Japan.

154

18. M/s Neutro Nupreced Injection 2ml Rs. 5500/- 17-05-13 Deferred for , Lahore Each 2ml contains:- per Fee Rs. confirmation Dexmedetomidine ampoule 60,000/-+ Rs. of availability Hydrochloride…200mcg 90,000(28- of

(Sedative) 05-13) formulation Form5-D in FDA, EMA, Australia and Japan.

155 Case No.15. Extension in Contract Manufacturing Permissions:

Following cases were considered and decided by the Registration Board in 238th meeting but erroneously missed in minutes. The decision of Board is recroded in last column.

156 S.# Name of Name of Reg. Name of Drug with Date & diary # Category Decision Applicant Manufacturer No. composition & Fee 1. M/s Noble M/s EG 023134 Cefodime Injection 15-04-13 import to local Extended till Pharmaceutical, Pharmaceutical Each vial contain: Dy. contract 30.06.2015 Islamabad Islamabad earlier Ceftazidime……..1gm No.2248R&I manufacturing approved Dy. No. 1356. manufacturer DDC(R-III) was Biorex Rs.50000/ Pharmaceutical Rs.8000/-(23- Islamabad 06-2010) 2. -do- -do- 023135 Cefodime Injection -do- -do- -do- Each vial contain: Ceftazidime…..250gm 3. M/s Focus & M/s Bio Labs. 054652 Ruzone Injection 250mg 15-04-13 Dedicated Extended till Rulz (Pvt) Ltd, Each Vial Contains:- Dy. facility 30.06.2015. The Pharmaceutical, Islamabad earlier Ceftriaxone Sodium No.1251R&I Cephalosporin firm will deposit Islamabad approved equivalent to Rs.20,000/ remaining fee & manufacturer Ceftriaxon…250mg select IM/IV was M/s Spadix (USP Specification) Pharmaceutical, Islamabad

4. -do- -do- 054653 Ruzone Injection 500mg -do- -do- -do- ` Each Vial Contains:- Ceftriaxone Sodium equivalent to Ceftriaxone…500mg (USP Specification) 5. -DO- -do- 054654 Ruzone Injection 500mg -do -do- -do- Each Vial Contains:- Ceftriaxone Sodium equivalent to

157 Ceftriaxone…500mg (USP Specification)

6. -do- -do- 054655 Trag Injection 250mg -do- -do- Extended till Each Vial contains:- 30.06.2015. The Cefotaxime sodium firm will deposit equivalent to remaining fee Ceftotaxime…250mg 7. -do- -do- 054656 Trag Injection 500mg -do- -do- -do- Each Vial contains:- Cefotaxime sodium equivalent to Ceftotaxime…500mg 8. -do- -do- 054657 Trag Injection 500mg -do- -do- -do- Each Vial contains:- Cefotaxime sodium equivalent to Ceftotaxime…500mg 9. M/s Medley M/s Fassgen 030245 Qsef Injection 250mg 15-04-13 Dedicated Extended till Pharmaceutical, Pharmaceutical Each vial contain:- Dy. No.2319 facility 30.06.2015 Plot 41-A, P.S.I. Hatter. Earlier Cefotaxime Sodium eq. R&I Cephalosporin E. Jhang Bahtar approved to Cefotxime Dy. No. Road Wah Cantt. contract …….250mg 1358D.D.C(R- Rawalpindi manufacturer III) was M/s Neutro Rs.50000/- Pharma Hattar 10. -do- -do- 030246 Qsef Injection 500mg -do- -do- -do- Each vial contain:- Cefotaxime Sodium eq. to Cefotxime …….500mg 11. -do- -do- 030247 Qsef Injection 1gm -do -do- -do-

158 Each vial contain:- Cefotaxime Sodium eq. to Cefotxime …….1gmmg 12. -do- -do- 030243 Kintrex 500mg Injection -do- -do- Extended till I.V 30.06.2015. the firm Each vial contains:- will select either Ceftriaxone Sodium eq. IM/IV to. Cefriaxone….500mg 13. -do- -do- 030244 Kintrex 1gm Injection -do- -do- -do- I.V Each vial contains:- Ceftriaxone Sodium eq. to. Cefriaxone….1gm 14. -do- -do- 030241 Kintrex 500mg Injection -do- -do- -do- I.M Each vial contains:- Ceftriaxone Sodium eq. to. Cefriaxone….500mg 15. M/s Goodman M/s Spadix 056677 Martazone 250mg IM 11-02-13 Dedicated Extended till Laboratories, Pharmaceutical Injection Dy. No.1497 facility 30.06.2015. the firm Islamabad Islamabad. Each vial contains:- R&I Cephalosporin will deposit Earlier approved Ceftriaxone Sodium Dy. No. remaining fee & contract equivalent to 41D.D.C(R- slect IM/IV manufacturer Ceftriaxone…250mg III) was M/s Global (USP Specification) Rs.20000/- Pharmaceutical Extended till Islamabad 30.06.2015 & Rs.8000/- (29-09-2010)

16. 056678 Martazone 500mg IV -do- -do- -do- Injection

159 Each vial contains:- Ceftriaxone Sodium equivalent to Ceftriaxone…500mg (USP Specification) 17. 056679 Martazone 1gm IV -do- -do- -do- Injection Each vial contains:- Ceftriaxone Sodium equivalent to Ceftriaxone…1gm (USP Specification) 18. M/s Fassgen M/s Medley 056452 Stigen 0.5mg Injection Fee not General Deferred since the Pharmaceutical, Pharmaceutical, Each ml contains:- deposited products request of firm does Hattar Wah Cantt. Neostigmine Dy. No. 1378 not fall under Earlier approved Methylsuphate….0.5mg Dated:09-05- present contract contract (USP specification) 2013 policy & applicant manufacturer has to deposit fee. was M/s WelMark Pharmaceuticals Hattar 19. -do- -do- 056453 Traxic 250mg Injection -do- -do- -do- Each 5ml contains:- Tranexamic Acid…..250mg (B.P Specification) 20. -do- -do- 056454 Traxic 500mg Injection -do- -do- -do- Each 5ml contains:- Tranexamic Acid…..500mg (B.P Specification) 21. -do- -do- 056456 Dyronex 500 Infusion -do- -do- -do-

160 Each 100ml contains:- Metronidazole USP (USP Specification) 22. -do- -do- 056457 Cebect Infusion 200mg -do- -do- -do- Each 100ml contains:- Ciprofloxacin Lactate eq. to Ciprofloxcin USP…..200mg (USP Specification) 23. -do- -do- 056458 Vectra 75mg Injection -do- -do- -do- Each 3ml contains:- Diclofenac Sodium …….75mg (Medley Specification) 24. -do- -do- 056459 Pepgen 20mg Injection -do- -do- -do- Each 2ml contains:- Famotidine………20mg (Medley Specification) 25. -do- -do- 056461 Suxagen 100mg -do- -do- -do- Injection Each 2ml contains:- Suxamethonium Chloride BP…..100mg (Medley Specification) 26. -do- -do- 056462 Artegen 80mg Injection -do- -do- -do- Each 1ml coantains:- Arthemether………..80 mg (Medley Specification) 27. -do- -do- 056463 Vibra 40mg Injecgion -do- -do- -do- Each 1ml contain:- Triamcinolone acetonide

161 BP………40mg (B.P Specification) 28. -do- -do- 056464 Mecobon 500mg -do- -do- -do- Injection Each 1ml Contain:- Mecobalamine ………500mcg (Medley Specification) 29. -do- -do- 056466 Fasdic Injection -do- -do- -do- Each 2ml ampoule contains:- Diclofenac sodium 75mg Lidocain HCl…..20mg (Medley Specification 30. -do- -do- 056825 Levotar Infusion 500mg -do- -do- -do- Each vial contain:- Levofloxacin (as hemihydrates)…..500m g (Medley specification) 31. -do- -do- 056826 Fasicam 20mg Injection -do- -do- -do- Each 1ml apoule contains: Piroxicam USP….20mg (Medley Specification) 32. M/s Danas M/s Global 045077 Burgundy Igm Injection 15-04-13 Dedicated Extended till Pharmaceutical, Pharmaceutical, Each Vial contain: Dy. No.2218 facility 30.06.2015. The Islamabad Islamabad. Ceftriaxone R&I Cephalosporin firm will select Earlier approved (as Sodium)…...1gm Dy. No. IM/IV contract (USP Specification) 115D.D.C manufacturer (R-III) was M/s Florence Rs.42000/-

162 Islamabad Rs.8000/-(30- 09-2010) 33. -do- -do 045078 Burgundy 250mg -do- -do- -do- Injection Each Vial contain: Ceftriaxone (as Sodium) ……..250mg (USP Specification) 34. -do- -do- 045079 Burgundy 500mg -do- -do- -do- Injection Each Vial contain: Ceftriaxone (as Sodium) ……..500mg (USP Specification) 35. -do- -do- 045080 Milkish 1gm Injection -do- -do- Extended till Each Vial contain: 30.06.2015 Cefepime (as HCl with L-Arginine) ……..1gm (USP Specification) 36. -do- -do- 045081 Milkish 500mg -do- -do- -do- Injection Each Vial contain: Cefepime ( as HCl with L-Arginine) ……..500mg (USP Specification) 37. -do- -do- 045093 Joop 1gm Injection -do- -do- -do- Each Vial contains: Cefoperazone (as Sodium)……….0.5gm Sulbactam (as Sodium)………0.5gm

163 (USP Specification) 38. -do- -do- 045094 Joop 2gm Injection -do- -do- -do- Each Vial contains: Cefoperazone (as Sodium)…….1gm Sulbactam (as Sodium)……1gm (USP Specification) 39. M/s Benson M/s Shawan 060423 Triben 1gm Injection Dy. No. 2274 Dedicated Extended till Pharmaceuticals Pharmaceuticals, I/V R&I 15-04-13 facility 30.06.2015. The Islamabad. Each vial contains:- Dy. No.1168 Cephalosporin firm will select Earlier approved Ceftriaxone Sodium eq. DDC(R-III) either IM/ IV contract to Ceftriaxone …..1gm (22-2-2013) manufacturer (USP Specs.) Rs.20,000/- was (22-4-2013)& M/s Fassgen Rs. 30,000 Pharmaceuticals, (15-4-2013) Lahore 40. 060424 Triben 500mg Injection Dy. No. 2275 -do- -do- I/V R&I 15-04-13 Each vial contains:- Dy. No.1176 Ceftriaxone Sodium eq. DDC(R-III) to (22-2-2013) Ceftriaxone………..500 Rs.20,000/- mg (22-4-2013)& (USP Specs.) Rs. 30,000 (15-4-2013)

41. 060425 Triben 250mg Injection Dy. No. 2283 -do- -do- I/V R&I 15-04-13 Each vial contains:- Dy. No.1167 Ceftriaxone Sodium eq. DDC(R-III) to Ceftriaxone...250mg (22-2-2013)

164 (USP Specs.) Rs.20,000/- (22-4-2013)& Rs. 30,000 (15-4-2013)

45. 060426 Benzone 1gm Injection Dy. No. 559 -do- Extended till Each vial contains:- R&I 22-02-13 30.06.2015. Cefoperazone (as Dy. No.1169 Sodium)……..500mg DDC(R-III) Sulbactam (as (22-2-2013) Sodium)…………500m g Rs.20,000/- (USP Specs.) (22-4-2013)& Rs. 30,000 (15-4-2013) 46. 060427 Benzone 2gm Injection Dy. No. 2280 -do- -do- Each vial contains:- R&I 15-04-13 Cefoperazone (as Dy. No.1170 Sodium)……..1gm DDC(R-III) Sulbactam (as (22-2-2013) Sodium)…………1gm Rs.20,000/- (USP Specs.) (22-4-2013)& Rs. 30,000 (15-4-2013)

47. 060428 Benpime 1gm Injection Dy. No. 2281 -do- -do- Each vial contains:- R&I 15-04-13 Cefepime (as HCl) Dy. No.1171 …….1gm DDC(R-III) (USP Specs.) (22-2-2013) Rs.20,000/- (22-4-2013)& Rs. 30,000

165 (15-4-2013)

48. 060429 Benpime 500mg Dy. No. 2276 -do- -do- Injection R&I 15-04-13 Each vial contains:- Dy. No.1174 Cefepime (as HCl) DDC(R-III) …….500mg (22-2-2013) (USP Specs.) Rs.20,000/- (22-4-2013)& Rs. 30,000 (15-4-2013)

49 053607 Taxiben 250mg Dy. No. 2282 -do- -do- Injection R&I 15-04-13 Each vial contains:- Dy. No.1173 Cefotaxime (as DDC(R-III) Sodium)………250mg (22-2-2013) (USP Specs.) Rs.20,000/- (22-4-2013)& Rs. 30,000 (15-4-2013)

50. 053608 Taxiben 500mg Dy. No. 2277 -do- -do- Injection R&I 15-04-13 Each vial contains:- Dy. No.1172 Cefotaxime (as DDC(R-III) Sodium)………500mg (22-2-2013) (USP Specs.) Rs.20,000/- (22-4-2013)& Rs. 30,000 (15-4-2013)

51. 053609 Taxiben 1gm Injection Dy. No. 2278 -do- -do-

166 Each vial contains:- R&I 15-04-13 Cefotaxime (as Dy. No.1175 Sodium)………1gm DDC(R-III) (USP Specs.) (22-2-2013) Rs.20,000/- (22-4-2013)& Rs. 30,000 (15-4-2013)

52. M/s Drugs Inn M/s EG 022619 Prezone 250mg IM/IV 12-04-13 import to local Extended till Pharmaceutical Pharmaceutical, Injection Dr. contract 30.06.2015. The Islamabad Islamabad. Each vial contains:- No.1060R&I manufacturing firm will select Earlier approved Ceftriaxone Sodium eq. Dy. No. either IM/ IV contract to 250mg Ceftriaxone 1212D.D.C(R- manufacturer Sodium base. III) was M/s Biorex Rs.42000/- Pharmaceutical Rs.8000/- Islamabad (23-06-2010) 53. -do- -do- 023168 Prezone 500mg -do- -do- -do- Injection Each vial contains:- Ceftriaxone Sodium eq. to 500mg Ceftriaxone Sodium base. 54. -do- -do- 022654 Prezone 1GM Injection -do- -do- -do- Each vial contains:- Ceftriaxone Sodium eq. to 1gm Ceftriaxone Sodium base. 55. -do- -do- 022694 Kefcef 250mg Injection -do- -do- -do- Each vial contains:- Ceftriaxone Sodium eq.

167 to 250mg Ceftriaxone Sodium base. 56. -do- -do- 022695 Kefcef 500mg Injection -do- -do- -do- Each vial contains:- Ceftriaxone Sodium eq. to 500mg Ceftriaxone Sodium base. 57. -do- -do- 022696 Kefcef 1gm Injection -do- -do- -do- Each vial contains:- Ceftriaxone Sodium eq. to 1gm Ceftriaxone Sodium base. 58. -do- -do- 022653 Gencef 1gm Injection -do- -do- Extended till Each Vial contains:- 30.06.2015. Ceftotaxim Sodium eq. to 1gm Cefotaxime Sodium base. 59. M/s Well Care M/s Fassgen 060808 Carewel 250mg 15-04-13 Dedicated Extended till Pharmaceutical, Pharmaceutical Injection Dr. No.2314 facility 30.06.2015. The A/7 P.S.I.E Hatter.Earlier Each injection contains: R&I Cephalosporin firm will select Sargodha approved Ceftriaxone sodium eq Dy. No. either IM/ IV contract to Ceftriaxone 1363D.D.C(R- manufacturer U.S.P……50mg. III) . was M/s Neutro Rs.50,000/- Pharmaceutical Lahore. 60. -do -do- 060809 Carewel 500mg 15-04-13 -do- -do- Injection Dr. No.2314 Each injection contains: R&I Ceftriaxone sodium eq Dy. No. to Ceftriaxone U.S.P… 1356D.D.C(R- 500mg III) Rs.50,000/-

168 61. -do -do- 060810 Carewel 1gm Injection -do- -do- -do- Each injection contains: Ceftriaxone sodium eq to Ceftriaxone U.S.P…….1gm

62. M/s Salus M/s Warafana 021057 Salxone 0.25gm 19-12-11 import to local Extended till Pharmaceutical Pharmaceutical Injection Dy. No.993 contract 30.06.2015. The Rawalpindi Islamabad Each Vial Contains: R&I manufacturing firm will select Ceftriaxone Sodium Dy. No. either IM/ IV. Eq. to Ceftriaxone 1415D.D.C(R- ….0.25gm III) . Rs.50,000 63. -do- 021058 Salxone 1gm Injection 19-12-11 -do- -do- Each Vial Contains: Dy. No.993 Ceftriaxone Sodium R&I Eq. to Ceftriaxone Dy. No. ….1gm 1416D.D.C(R- III) Rs.50000 64. -do- 021059 Salxone 0.5gm Injection 19-12-11 -do- -do- Each Vial Contains: Dy. No.993 Ceftriaxone Sodium R&I Eq. to Ceftriaxone Dy. No. ….0.5gm 1417D.D.C(R- III) Rs.50000

169 Case No.16. Correction in minutes of 238th meeting.

a. Grant of registration-Vetrenary Drugs:

S. # Name of Name of Drug(s)/Composition Price/Pack Shelf Decision Correct Applicant Size Life recoded in Decision 238th meeting

1. M/s. Noble Nobiaminox Injection Decontrolled 02 Deferred for Approved Pharma, Mir Pur 100ml years application However the Each ml contains:- Azad Kashmir. 200ml on Form 5 D Registration Novaminsulfon……..40.00mg 450ml along with Board Etilefrin……………...0.20mg 500ml revised Fee. advised the 1000ml registration Calcium Gluconate……..100.00mg sections to Magnesium Gluconate…..10.00mg again review the Nicotinamide……..….0.03mg Registration Caffeine………….…10.00mg Dossiers before Sodium Salicylate………...7.00mg issuance of Boric Acid………….10.00mg Registration letters. (Electrolytes)

2. M/s. A & K Adeka Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 50ml years Each 1ml contains:- Sargodha Road, 100ml Faisalabad. Vitamin A………..100000 IU Vitamin D3………40000 IU Vitamin E………..40mg (Nutritional Supplement).

3. M/s. A & K Genin Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Tylosin Tartrate………..100mg 50ml Gentamycin Sulphate….50mg 100ml

(Antibiotic). 4. M/s. A & K Genak-10 Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Gentamycin Sulphate…100mg 50ml 100ml

170 (Antibiotic). 5. M/s. A & K Ectin Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Ivermectin…………10mg 50ml (Anthelemtic). 100ml

6. M/s. A & K Fenak Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Ketoprofen…………100mg 50ml (NSAID). 100ml

7. M/s. A & K Folak Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Florfenicol…………300mg 50ml (Antibiotic). 100ml

8. M/s. A & K Tine-20 Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Tylosin Tartrate……..200mg 50ml (Antibiotic). 100ml

9. M/s. A & K Rofox-10 Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Enrofloxacin……….100mg 50ml (Antibiotic). 100ml

10. M/s. A & K FMO Injection Decontrolled 02 -Do- -Do- Pharmaceutical, 10ml years Each 1ml contains:- Sargodha Road, 20ml Faisalabad. Oxytetracycline BP………..300mg 50ml Flunixine Meglomine USP..20mg 100ml (Antibiotic).

171 b. Grant of registration-Human drugs: S. # Name of Name of Drug(s)/Composition Price/Pack MRP Decision Correct Applicant Size recoded in Decision 238th meeting 1 M/s. Saaaf Heap Syrup 120ml As Per Deferred for Approved Pharmaceuticals, Each 5ml contains:- SRO fee The Risalpur. Iron (III) polymaltose complex eq. to Registration elemental iron ………50mg Board Folic Acid……………0.35mg advised the (Heamatinic) Registration sections to again review the Registration Dossiers before issuance of Registration letters Domprid Suspension 60ml As Per -Do- -Do- Each 5ml contans:- 120ml SRO Domperidone……….5mg (Antidopaminergic)

Zinc Saf Suspension 60ml As Per -Do- -Do- Each 5ml contains:- 120ml SRO Zinc Sulphate ……….20mg (Antidiarroeals)

Diasaf Plus Suspension 60ml As Per -Do- Deferred for Each 5ml contains:- 120ml SRO review of Metronidazole……………75mg formulation by Furazolidone……………..25mg review (Amobecide) committee

Losaf Suspension 60ml As Per -Do- Approved Each 5ml contains:- 120ml SRO The Loratadine…………5mg Registration (Antihistamine) Board advised the Registration sections to again review the Registration Dossiers before issuance of Registration letters

172 c. Registration Board in 238th meeting extended following contract manufacturing permissions for Khos Pharma, Hyderabad. But scrutiny of record revealed that these products are registered for M/s Treat Pharma, Bannu. Correct details are as follows:

M/s Treat M/s Mediate 073248 K-Xime Suspension 15-04-2013 Dedicated Extended till 30.06.2015. Pharma, Bannu Pharmaceuticals, Each 5ml contains: DyNo.229 facility Karachi Cefixime……….200 mg Form-05 Cephalosporin Rs.42,000/- Rs.8000/- 18.08.2011

-do- -do- 073247 K-Xime Suspension 15-04-2013 Dedicated Extended till 30.06.2015. Each 5ml contains: DyNo.229 facility Cefixime……….100 mg Form-05 Cephalosporin Rs.42,000/- Rs.8000/- 18.08.2011

-do- -do- 073246 K-Xime Capsule 15-04-2013 Dedicated Extended till 30.06.2015. Each capsule contains: DyNo.229 facility Cefixime……….400 mg Form-05 Cephalosporin Rs.42,000/- Rs.8000/- 18.08.2011

d. Registration Board in 238th meeting extended following contract manufacturing permissions for contract manufactured by M/s AGP Health Care Pvt. (Formerly, Eli Lilly Gohar, Karachi). Later on scrutiny of record revealed that contract manufacturer is M/s PharmEvo, Karachi. Submitted for correction and issuance of corrigendum as per following correct details.

M/s AGP, Kar. M/s PharmEvo, 003755 Kefzol 500mg Injection 12-04-2013 Dedicated Extended till 30.06.2015 Karachi Each vial contains: DyNo.308 facility

173 Cefazolin sodium……….…500mg Form-05 Cephalosporin Rs.42,000/- Rs.8000/- 02-6-2011 -do- -do- 003756 Kefzol 1g Injection 29-04-2013 -Do- Extended till 30.06.2015 Each vial contains: DyNo.309 Cefazolin sodium……….…1gm Form-05 Rs.42,000/- Rs.8000/- 02-6-2011

Case No.17. Extension in contract manufacturing permissions.

M/s Sapient M/s Mediate 060472 COA Dry Suspension 15-04-2013 Dedicated Extended till 30.06.2015. Pharma, Lhr Pharmaceuticals, Each 5ml contains: Form-05 facility Kar. Cefixime……….200 mg Rs.42,000/- Cephalosporin Rs.8000/- 07.09.2010

-do- -do- 060473 COA Capsule 15-04-2013 Dedicated Extended till 30.06.2015. Each capsule contains: Form-05 facility Cefixime……….400 mg Rs.42,000/- Cephalosporin Rs.8000/- 07.09.2010

174 (Medical Devices)

Case No.18. Applications for registration of Medical Devices for Import.

The Registration Board considered the following applications of medical devices and decided as mentioned against each. These applicationshave already been recommended by Expert Committee on Medical Devices. Approved applications are subject to inspection of manufacturer abroad, verification of storage facilities etc as per policy.

A: CATHETERS:

S.No. Name of Importer and Name of Medical Demanded Shelf life Decision Manufacturer/Exporter. Device. price & Pack size 1. M/s.Cor-Med, Fairway Decontrolled 24 Approved. 2nd Floor, 36/62, Rehman Rapid Exchange months Plaza, Bank Road, Saddar, dilatation catheter for (Different Rawalpindi PTCA product codes

Manufactured by Length (mm): available) M/s. IHT, Iberhospitex 10,15,20, 25,30, 35,40. S.A, Barcelona, Spain Dia (mm): 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5.

B: STENTS:

S.No. Name of Importer and Name of Medical Demanded Shelf life Decision Manufacturer/Exporter. Device price & Pack size 1. M/s.Cor-Med, Bionert Inert Coronary Decontrolled 24 Approved. 2nd Floor, 36/62, Rehman Stent months

Plaza, Bank Road, Saddar, (Bare Metal Stent) (Different Rawalpindi product Bionert : Manufactured by codes Stent Length (mm): M/s. IHT, Iberhospitex S.A, available) 9, 14, 18, 23, 28, 36. Barcelona, Spain. Stent Dia (mm): 3.0, 3.50, 4.00, 4.50.

Bionert Small: Stent Length (mm): 9, 14, 19, 23, 28.

175 Stent Dia (mm): 2.0. 2.25, 2.50, 2.75.

2. M/s.Cor-Med, Active Paclitaxel Decontrolled 18 Approved. 2nd Floor, 36/62, Rehman Eluting Coronary months Plaza, Bank Road, Saddar, Stent.

Rawalpindi Active : (Different Manufactured by Stent Length (mm): product M/s. IHT, Iberhospitex S.A, 9, 14, 18, 23, 28, 36. codes Barcelona, Spain. available) Stent Dia (mm): 3.0, 3.50, 4.00, 4.50.

Active Small: Stent Length (mm): 9, 14, 19, 23, 28, 36.

Stent Dia (mm): 2.0. 2.25, 2.50, 2.75.

C: SYRINGES:

S.No. Name of Importer and Name of Medical Device. Demanded Shelf Decision Manufacturer/Exporter. price & life Pack size 1. M/s. Excel Corporation, A-Star Disposable syringe Decontrolled 5years Approved. 435 BYJ Society, 1ml Bahadurabad, Karachi 3ml Manufactured by 5ml M/s. Changzhou Jinliyuan 10ml Medical Devices, Co., Ltd., 20ml No.6 West Xihe Road, Sanhekou, Zhenglu Town, Wujin District, Changzhou City, China.

2. M/s. Excel Corporation, A-Star Disposable syringe Decontrolled 5years Approved. 435 BYJ Society, 30ml Bahadurabad,Karachi 50ml Manufactured by M/s. Changzhou Jinliyuan Medical Devices, Co., Ltd., No.6 West Xihe Road, Sanhekou, Zhenglu Town, Wujin District, Changzhou City, China.

3. M/s Becton Dickinson BD Emerald TM Pro (Reuse Decontrolled 5 years Approved. Pakistan (Pvt) Ltd, Prevention) Luer Slip

176 19-D/1, Gulberg-III, Syringe. 2ml Lahore. 5ml 10ml Manufactured by: M/s Becton Dickinson, S.A. Ctra. Mequinenza, s/n 22520 Fraga (Huesca), Spain.

Case No.19. Registration of Medical Devices of M/s Otsuka Pakistan Limited, Lasbela Distt. Balochistan.

Registration Board in its 230th meeting considered and approved the following medical devices of M/s. Otsuka Pakistan Limited, Lasbela Distt. Balochistan subject to inspection of manufacturer abroad, local storage facility etc:-

S.No. Name of Importer and Name of Drug (s) Demanded Shelf Life Manufacturer / Exporter. Composition & Price & Therapeutic Group. Pack Size. 1. M/s. Otsuka Pakistan Limited, Jive PTCA Balloon Decontrolled 02 years Lasbela Distt. Balochistan. / Catheter (Medical Device). M/s. Mircroport Medical (Shanghai) Co. Ltd., Shanghai. P.R. China. 2. M/s. Otsuka Pakistan Limited, Mustang Stent Decontrolled 02 years Lasbela Distt. Balochistan. / Stainless Steel Coronary Stent M/s. Mircroport Medical System (Shanghai) Co. Ltd., (Medical Device). Shanghai. P.R. China.

3. M/s. Otsuka Pakistan Limited, Firebird Rapamycin Decontrolled 12 months Lasbela Distt. Balochistan. / Eluting Stainless Steel Coronary Stent M/s. Mircroport Medical System (Shanghai) Co. Ltd., (Medical Device). Shanghai. P.R. China. 4. M/s. Otsuka Pakistan Limited, Firebird 2 Decontrolled 09 months Lasbela Distt. Balochistan. / Rapamycin Eluting Cobalt Chromium M/s. Mircroport Medical Coronary Stent (Shanghai) Co. Ltd., System Shanghai. P.R. China. (Medical Device).

177

Accordingly inspection of M/s. Microport Medical (Shanghai) Co. Ltd., Shanghai. P.R. China was conducted by the nominated panel. During the inspection, the panel of inspectors observed certain shortcomings related to GMP and therefore did not recommend the products for registration.

M/s Microport Medical (Shanghai) Co. Ltd., Shanghai. P.R. China submitted an Action Plan for taking corrective actions on the deficiencies mentioned in the inspection report. After that M/s Otsuka Pakistan Ltd., Karachi submitted the Corrective Action Report dated 12th October, 2012, forwarded by their principal manufacturer in which the manufacturer submitted that they have taken Corrective Action on the non-conformities mentioned in the inspection report and are ready for re-inspection of their premises. Accordingly a panel of inspectors was nominated for re-inspection. The panel conducted the inspection of all key manufacturing areas which were involved in manufacturing and quality control of applied products. The points observed by the previous panel were also checked. The panel has given the following recommendations:-

(i) Mustang Stent Stainless Steel Coronary Stent System is recommended for grant of registration with shelf life of 24 months alongwith following sizes:-

Stent Dia (mm): 2.0, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00, 4.50, 5.00. Stent Length (mm): 5 to 40.

(ii) Firebird 2 Rapamycin Eluting Cobalt Chromium Coronary Stent System is recommended for grant of registration with shelf life of 12 months alongwith following sizes:-

Stent Dia (mm): 2.5, 2.75, 3.0, 3.5, 4.0. Stent Length (mm): 13, 18, 23, 29, 33. Quantity of Rapamycin Coated on stent (µg): 120, 160, 210, 268, 305.

(iii) Jive PTCA Balloon Dilatation Catheter is not recommended for grant of registration because the product is neither registered by SFDA China nor available in China. However, the firm manufactures it for export purpose only.

(iv) Firebird Rapamycin Eluting Stainless Steel Coronary Stent System is not recommended for grant of registration because the registration status of the product by SFDA China is valid till April, 2013 and firm has already

178 discontinued its domestic sale hence it’s not on free sale in China. Moreover, management of M/s Microport also informed that they don’t intend to apply for extension of its registration beyond April, 2013 for local sale. However, they will continue to export the product, if ordered.

Decision: The Board approved Mustang Stent Stainless Steel Coronary Stent System with shelf life 24 months and Firebird 2 Rapamycin Eluting Cobalt Chromium Coronary Stent System with increased shelf life of 12 months as recommended by the panel of inspectors while the Board rejected Jive PTCA Balloon Dilatation Catheter and Firebird Rapamycin Eluting Stainless Steel Coronary Stent System as recommended by the panel of inspectors.

179 Biological Evaluation & Registration

Case No.20: Import in GE pack and Local Printing of Reg. No., MRP and Urdu labelling at own licensed site: F-268, SITE, Karachi having DML No. 000233

M/s GlaxoSmithKline, Karachi has requested import of Fluarix in GE packing and local printing of Registration number, MRP, and Urdu version at their licensed site at F-268, SITE, Karachi DML No. 000233. The reason is because of centralized manufacturing at one Global manufacturing site at GlaxoSmithKline, Belgium where the GE packs are now manufactured and due to production time constraints the seasonal flu vaccine has one year shelf life and 6 month window period in which it is to be used. Pakistan specific packing is not possible in this short time hence availability in Pakistan is a major issue. Therefore Reg. No., MRP and Urdu instructions can be printed at the company’s own licensed site at Karachi for a period of two years. Fee Rs 5000/- has been paid by the firm. Board is requested to allow the permission for import of Fluarix vaccine in GE packing and local printing of Reg. No., MRP., and Urdu printing with inject printing at GlaxoSmithKline, Karachi licensed site F-268, SITE, Karachi having DML No. 000233. Decision: Board permitted the import of Fluarix vaccine in GE packing and local printing of Reg. No., MRP., and Urdu version with inject printing at GlaxoSmithKline, F-268, SITE, Karachi having DML No. 000233 for a period of two years.

Case No.21: Registration letter correction- Fluarix vaccine reg no. 022612.

M/s GlaxoSmithKline, Karachi’s Fluarix vaccine is an inactivated influenza vaccine (split virion) containing antigens of at least three strains of the seasonal influenza viruses that are notified by WHO for each year. Thus 15 mcg of haemagglutinin of each of the recommended strain has to be added in the vaccine; therefore the wording on the Reg. letter needs to be corrected to reflect the same as following: Exiting wording on the Reg letter Correct wording as per CPP and Form 5 original application “Each 0.5 ml vaccine dose contains: 15 mcg “Each 0.5 ml vaccine dose contains: 15 mcg of haemagglutinin (inactivated and purified of haemagglutinin of each of the split influenza vaccine)” recommended strain”. The case was submitted on 19.09.2012.

180 The Board is requested to please allow the correction to meet international requirements subject to submission of fee by the firm.

Decision: The Board allowed the correction to meet international requirements subject to submission of fee by the firm.

Case No. 22: Engerix B vaccines in prefilled syringes: 10 mcg Reg No. 012370; 20 mcg Reg No. 009823 M/s GlaxoSmithKline, Karachi has requested import in GE packing and local printing of Registration number, MRP, and Urdu version on their registered product at their licensed site Karachi F-268, SITE, Karachi DML No. 000233. The reason is because of centralized manufacturing at one Global manufacturing site at GSK Belgium where the GE packs are now manufactured and due to production constraints Pakistan specific packing is not possible hence availability is a major issue. Whereas the GE pack is readily available and can be imported at the time of need and locally the Reg. No. MRP and Urdu instructions can be printed at the company’s own site. Fee Rs 5,000/- has been paid by the firm. Board is requested to allow the permission for import of Engerix B vaccines in prefilled syringes and in GE packing and local printing of Reg. No., MRP., and Urdu printing with inject printing at GlaxoSmithKline, Karachi licensed site F-268, SITE, Karachi having DML No. 000233. Decision: Board allowed the permission to import Engerix B vaccines in prefilled syringes in GE packing and local printing of Reg. No., MRP., and Urdu version with inject printing at GlaxoSmithKline, F-268, SITE, Karachi having DML No. 000233 for a period of two years. Case No. 23: Registration of “Sterile water for injection-0.5ml vial” for reconstitution of Vaxapox vaccine Reg No. 074628.

M/s Sind Medical Store, Karachi has requested that their varicella vaccine Vaxapox is already registered vide reg no. 074628 to be imported from M/s Changchun BCHT Biotechnology Co., Changchun China but the case of registration of its diluent was not submitted at that time, hence the company is not able to market it in combo pack. Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost. Complete application on Form 5-A, product dossier, Embassy certified Free sale certificate,

181 CPP, copies of the cGMP certificate, and DML, are in file; the production and quality control procedures are in order. The Board is requested to grant registration of “Sterile water for injection-0.5ml” for reconstitution of Vaxapox (Varicella) vaccine Reg No. 074628 to be supplied free of cost along with the vaccine manufactured by the same company i.e., M/s Changchun BCHT Biotechnology Co., Ltd., China. Decision: The case was deferred due to payment of full fee and other codal formalities. The Board advised to present detailed case in next meeting. Case No. 24: Registration of “Sodium Chloride Injection BP-0.1 ml ampoule for reconstitution of BCG vaccine reg no. 053816.

M/s Hospital Services and Sales, Karachi has requested that their product BCG vaccine is already registered but the case of registration of diluent to be supplied with the BCG vaccine for its reconstitution was not submitted at that time to be imported together with the vaccine from M/s Serum Institute of India Ltd., India in combo pack. Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost. Complete application on Form 5-A, product dossier, Embassy certified Free sale certificate, CPP, copies of the cGMP certificate, and DML, are in file; the production and quality control procedures are in order. The Board is requested to grant registration of diluent to be supplied free of cost with the BCG vaccine to be imported with vaccine from the same supplier in combo pack. Decision: The case was deferred due to payment of full fee and other codal formalities. The Board advised to present detailed case in next meeting. Case No. 25: Registration of “Diluent for Indirab injection-1.0 ml for reconstitution of Indirab 1ml injection.

M/s Sind Medical Store, Karachi has requested their rabies vaccine Indirab injection which was approved in the 227th meeting of DRB held on 26-27th, 2010 requires a diluent for the reconstitution. The vaccine cannot be imported without the diluent which is to be supplied free of cost. The vaccine registration letter has not been issued due to pending inspection. Hence both the cases may be treated together for registration. Both the products are manufactured by M/s Bharat Biotech International Limited, Andhra Pradesh, India. Fee Rs

182 50,000 thousand has been paid by the firm. The Board is requested to allow combining the vaccine and its diluent case together for registration.

Decision: The case was deferred due to payment of full fee and other codal formalities. The Board advised to present detailed case in next meeting.

Case No. 26: Approved cases whose foreign inspections have been successfully conducted: a) M/s Hitech Pharmaceuticals, Lahore had applied for new site inspection of their three already registered products with change of brand names and one diluent for vaccine. The site inspection has been conducted by the panel comprising of Dr Noor Muhammad Shah and Prof Dr. Ijaz Ahmad, the report was submitted on 22.05.2013. The panel has recommended their products and the site at Fort Dodge Saude Animal Ltda, Brazil for cGMP compliance. The products are as follows: S.No. Registration Existing Brand name New requested Inspection Number Brand Name Report Remarks 1 009677 EDS Vaccine EDS Vac. Good 2 003787 Poulvac Marek Poulvac Ovoline Good (CVI+HVT) (CVI+HVT) 3 010719 Egg Drop Syndrome- EDS New Bronz Good Newcastle Disease Vac. Infectious Bronchitis Vaccine

The firm had also applied for inspection of their foreign site for the manufacture of diluent for their already registered vaccine Poulvac Ovoline CVI+HVT Reg No. 003787 under the new DRAP policy to register the diluent as a separate entity; the same panel also visited the diluent manufacturing site at M/s Baxter Hospitalar Ltda, Brazil and recommended the product and the plant for cGMP compliance. S.No. Registration Brand Name Inspection Report Number Remarks 1 New to be supplied Pro-Cell sterile diluent for Good with vaccine Marek Vaccine reg no. 003787

Decision: The Board approved change of manufacturing site and brand name for above products. The Board also approved registration of diluent for Poulvac Ovoline vaccine.

183

b) M/s Martin Dow had applied for the registration of six biological products which were approved in the 237th DRB meeting and for which panel inspection was conduct by a panel consisting of Dr Uzar ul Ghani, Dr Najmus Saqib of the firm M/s Nanogen Biopharmaceuticals, Tang NhonPhua ward, Vietnam. The panel has submitted the report on 09.04.2013 and have recommended following products for registration: S. No. Product Brand Generic name Inspection Report Name Remarks 1. PEGNANO, PFS Peg Interferon alfa-2a 180 Good mcg 2. FERONSURE, Interferon alfa-2a 3MIU Good PFS 3. FERONSURE, Interferon alfa-2a 3 MIU Good VIAL 4. NANOKINE, Erythropoietin alfa, 4000 Good PFS IU 5. FICOCYTE, PFS Filgrastim, 30 mcg Good 6. PEGCYTE, PFS Peg Filgrastim, 6 mg Good

Decision: Registration Board deferred above cases for confirmation of evaluation by ECBD.

c) M/s Aster had applied for the registration of their five biological products which were approved in 237th DRB. Panel inspections have been conducted for the inspection of their three biological products to be imported from M/s LG Korea. The inspection has been conducted by Mr. Ghulam Rasool Dutani and Mr. Arif Choudary. They have recommended these products and manufacturer for cGMP compliance. The same panel has also recommended two biological products to be imported by the same company from M/s Beijing Shuanglu Pharmaceutical Co. Ltd., China. S. No. Product Brand Generic name Inspection Report Name Remarks 1. Consensus- Each Vial containing Good Asteron alpha 9 Recombinant Consensus M/s Beijing Shuanglu mcg injection Interferon alpha 9 mcg, Pharmaceutical Co. Ltd., China 2. Consensus- Each Vial containing Good Asteron alpha 15 Recombinant Consensus M/s Beijing Shuanglu mcg Injection Interferon alpha 15 mcg Pharmaceutical Co.

184 Ltd., China 3. Epotiv Recombinant human Good 2,000IU/0.5ml Pre- erythropoietin 2,000 M/s LG Lifge filled syringe. IU/0.5ml Sciences. Ltd., Korea 4. Epotiv Recombinant human Good 4,000IU/0.4ml Pre- erythropoietin, 4,000 M/s LG Lifge filled syringe IU/0.4ml Sciences. Ltd., Korea 5. Epotiv 10,000I Recombinant human Good U/ml Injection erythropoietin 10,000 M/s LG Lifge 10000 IU/ml Pre- IU/ml Sciences. Ltd., Korea filled syringe

Decision: Registration Board deferred above cases for confirmation of evaluation by ECBD.

Case No.27: FDA/EMA/TGA/WHO approved new cases of important Biologicals for registration as per import policy.

S.No. Product Name Drug Category/ Applicati Registration Status Revised Major Indication on/Dossie Fee/ r Filing EMA Fee Date US-FDA Differential Australia (TGA) Paid Japan

1. PROLIA Injection NCE/Post 14.11.201 EMA - Yes (Denosumab 60mg) Menopausal 1 Approved Importer M/s Osteoporosis US FDA - GlaxoSmithKline, and bone loss in Approved Karachi patients Complete dossier undergoing present From Manufacturer: hormone ablation EMA CPP verified M/s Amgen for prostate or by Embassy of Manufacturing breast cancer. Pakistan present Limited, Juncos, Each prefilled Puerto Rico, USA syringe contains 60mg of denosumab in 1ml solution (60mg/1ml) 2. XGEVA Injection NCE/Cancer 15.05.201 EMA - Yes (Denosumab 120mg) Therapy – 2 Approved prevention of US FDA - Importer M/s skeletal related Approved

185 GlaxoSmithKline, events with bone Complete dossier Karachi metastates from present solid tumors. FDA CPP verified From Manufacturer: by Embassy of M/s Amgen Each vial contains Pakistan present Manufacturing 120mg of Limited, Juncos, denosumab in 1.7 Puerto Rico, USA ml solution (70mg/1ml)

Shelf life 36 months 3. BENLYSTA Injection autoantibody 16.05.201 EMA - Yes (Belimumab 120mg) positive Systemic 2 Approved lupus US FDA - Importer M/s erythematosus Approved GlaxoSmithKline, (SLE) Complete dossier Karachi. present Manufacturer: M/s Each vial contains CPP verified by Hospira Inc, Kansas, 120 mg Embassy of Pakistan USA. Supplying site: belimumab present GlaxoSmithKline (80mg/ml after Manufacturing S.p.a., reconstitution) Pharma, Itlay. Shelf life 36 months 4. BENLYSTA Injection autoantibody 16.05.201 EMA - Yes (Belimumab 400mg) positive Systemic 2 Approved lupus US FDA - Importer M/s erythematosus Approved GlaxoSmithKline, (SLE) Complete dossier Karachi. present Manufacturer: M/s Each vial contains CPP verified by Hospira Inc, Kansas, 400 mg Embassy of Pakistan USA. Supplying site: belimumab present GlaxoSmithKline (80mg/ml after Manufacturing S.p.a., reconstitution) Pharma, Itlay. Shelf life 36 months 5. Qlaira, (eastradiol Hormone 24.08.201 TGA approved Yes valerate) Hormone replacement 1 CPP verified by combination therapy Embassy of Pakistan present Importer M/s Bayer Film coated tablet Complete dossier Pakistan (Pvt) Ltd., contains: 3.0 mg present Karachi from estradiol valerate

186 M/s Bayer Weimer as active GmbH und Co. KG ingredients Doebereinerstrasse 20 99427 Weimer, Germany. 6. Eylea (Aflibercept) Ophthalmogicals/ 29.03.201 EMA/FDA approved Yes 40mcg/ml neurovascular 3 EMA CPP verified degeneration by Embassy of Importer M/s Bayer Pakistan present Pakistan (Pvt) Ltd., Each vial contains Complete dossier Karachi from Aflibercept 40 present M/s Bayer Pharma AG mg/ml Mullerstrabe 178 13353 Berlin Shelf life 2 years Germany. 7. Yellow fever vaccine Yellow fever 11.09.201 WHO prequalified Yes (live Freezedried) 2 vaccine 3 vaccine, doses ampoules/1.0 ml Importer M/s Hospital Each single 0.5ml The other yellow Services & Sales, dose of vaccine fever vaccine Karachi from contains: available from M/s Federal State Unitary Yellow fever virus Sanofi Aventis, Enterprise on no less than 1,000 France has Manufacture of LD50 or 1,600 PFU developed some Bacterial and Viral technical problems Preparations of Supplied with as notifed by the Chumakov Institute of diluent water for company on Poliomyelitis & Viral injection 1.25 ml 11.09.2013 so Encephalitis, Russian in ampoules supply of another Academy of Medical vaccine is necessary Sciences, Russia. to cover any shortage, hence this application is presented CPP, FSC, GMP certificate, and other relevant documents verified by the Pakistan Embassy present 8. Yellow fever vaccine Yellow fever 11.09.201 -do- Yes (live Freezedried) 5 vaccine 3 doses ampoules/2.5 ml Importer M/s Hospital Each single 0.5ml Services & Sales, dose of vaccine Karachi from contains:

187 Federal State Unitary Yellow fever virus Enterprise on no less than 1,000 Manufacture of LD50 or 1,600 PFU Bacterial and Viral Preparations of Supplied with Chumakov Institute of diluent water for Poliomyelitis & Viral injection 3.0 ml in Encephalitis, Russian ampoules Academy of Medical Sciences, Russia.

Decision: Registration Board referred above case for consideration of ECBD, as these cases have not been yet evaluated by the aforementioned committee.

Case No. 28: Change of source of an approved vaccine for local manufacture:

The case relates to “Bulk import local repacking” of the then WHO prequalified vaccine i.e., Pentavalent vaccine that was approved in 213 DRB meeting with the following composition and source: From: Amsovax-5: Diptheria, Tetanus, whole cell Pertussis, Hepatitis-B and Haemophilus influenza type B conjugate vaccine as per WHO formula, from M/s Shanta Biotech India, India.

. At the time of application this source was WHO prequalified but latter on it was derecognised by WHO, hence the local company applied for change of source to a new WHO prequalified source;

To: Amsovax-5: New WHO prequalified product from M/s Biological E, Ltd., India with the same composition of vaccine. The application was submitted on 16.09.2011 and the dossier of the new product was submitted on 28.10.2011. The vaccine is Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and Haemophilus Type B Conjugate Vaccine (Adsorbed)-(Hib vaccine lyophilised in separate vial which is to be reconstituted with DTwP-rHepB vaccine filled in a separate vial). Shelf life is 24 months. The packing applied for is 10 doses per vial. As per Schedule I of DRAP Act, 2012 the naked vials without labels will be imported in bulk quantities that will be locally labelled and Vaccine Vials Monitor (VVM) will be applied before packing in cartons).

The firm was communicated the approval on 11.03.2013 and was asked to submit the WHO approval and technical information on the CTD format; the firm submitted the required information on 01.04.2013. The WHO approval status has been verified from the WHO Web site as well.

188 The local facility is a licensed to manufacture vaccine by way of formulation since 1995 for HepB, TT, and antivenom serum; recommended for approval subject to local panel inspection for facility suitability for handling such product.

Decision: Registration Board deferred firm’s request for evaluation by ECBD.

Case No. 29: Registration of WHO prequalified liquid Pentavalent vaccine to be imported in finished form for EPI in single vial.

M/s Amson Vaccine & Pharma (Pvt) Ltd., Islamabad submitted a case for import of a Pentavalent vaccine in finished form for EPI from M/s Biological E. Ltd., India. Rs 100,000 fee has been paid. The vaccine is WHO prequalified and has following composition:

Source: Composition Presentation M/s Biological E Ltd., Diphtheria Toxoid 25Lf(≥30IU) 10 dose vials Shameerpet Mandal, Tetanus Toxoid 5.5Lf(≥60IU) Andhra Pradesh, India B.pertissis (Whole cell) 16IOU(≥4IU) r-HBsAg 12.5 mcg Purified capsular polysaccharide 11 mcg Tetanus Toxoid (Carrier protein) 30.36.7mcg +++ Al (as AlPO4) ≤1.25 mg Thiomersal BP 0.01%w/v

Decision: Registration Board deferred firm’s request for evaluation by ECBD.

189 Case No. 30: Registration of safe drugs. Registration Board discussed letter written by Dr.Obaid Ali, Deputy Drug Controller dated 22.08.2013 on matter of registration of drugs. The Board discuused points mentioned in letter as follows: a. Registration of Drugs without Assessment, Review and evaluation of Application Dossier. The Board showed their satisfaction on present system of scrutinization / evaluation of registration applications. The Board was informed that DRAP has agreed in principal to creat a cell for evaluation of registration applications. The cell will be operative soon and will be entrusted with the duty of scrutinization / evaluation of registration applications as required under Drug Act, 1976. b. Registration of Drugs without Assessment of site master file etc and GMP inspection. As per procedure in vogue, licensing section is responsible for the grant of licenses / sections to pharmaceutical units after completion of all requirements as required under Drugs (Licensing, Registering & Advertising) Rules, 1976. Registration Board considers registration application on the basis of approvals granted by licensing section. Similarly Quality Assurance section conducts inspections of licensed units for compliance towards GMP. Registration Board considers these inspection reports while considering registration applications. Moreover, the Board also constitutes its own panel for product specific inspections, where it considers necessary. Members of the Board were satisfied with the procedure adopted for inspection of pharmaceutical units. However, for better compliance of GMP, the Board advised QA section to strictly monitor the GMP of the licensed units for manufacturing of quality products for ailing masses. c. Registration of Drugs without summary of approvals and transparency. As mentioned in point a, the evaluation cell will evaluate the registration applications and forward its recommendation including summary of approval for consideration of the Board. Registration applictions are included in agenda of the meeting on FIFO basis. d. Registration of Drugs without Post Marketting Requirements & Commitments. After promulgation of DRAP Act, 2012; Pharmacovigilance section has been established under Pharmacy Services Division. This section will perform all the activities of Pharmacovigilance including post marketing survelliance etc of the marketed products. The pharmaceutical companies will coordinate with this section for matters related to

190 pharmacovigilance. Members showed their desire that Registration Board be informed about the pharmacovigilance activities per formed by the Pharmacy Services Division. e. Registration of drugs/ Blanket approval on its Label Claim and Promotion. Regsitartion Board grant registration of drug based on label claim approved by the regulatory body of country of origin / USFDA / EMA / TGA / Japan / developed countries. However, evaluation cell for the scrutinization / evaluation of registration application will also review all label claims of the applicant. f. Ignorance of International Norms and implementation of Harmonized Documents. Presently registration applications are submitted on prescribed Forms (5, 5A, 5D, 5E) as required under Drugs (Licensing, Registering & Advertising) Rules, 1976. The matter of submission of the application on CTD format is already under discuusion in DRAP and will be implemented after ammendement in aforementioned rules. g. Barricade of working of DDC (Biological Drugs) and authorization of illegitimate working. It is an administrative matter and not related to Registration Board.

X X Dr. Obaid Ullah Mr. Ghulam Rasool Dutani Secretary, Drug Registration Board Chairman, Drug Registration Board

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