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

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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
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