The 203rd meeting of the Drug Registration Board was held on 23rd December,
2006 in the Committee Room, Ministry of Health, Islamabad, under the Chairpersonship of Maj. Gen. (R) Shahida Malik, Director General (Health). It commenced with the recitation of verses from the Holy Quran and was attended by the following members:-
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Maj. Gen. ® Nasir-ul-Islam, Physician, Rawalpindi.
2. Lt. Col. Aslam Khan, Pulmanologist,
Army Medical College, Rawalpindi.
3. Prof. Dr. Muhammad Jamshaid, Principal,
University College of Pharmacy, University of the Punjab, Lahore.
4. Mr. Abdul Latif Sheikh,
Director Pharmacy, Nutrition & CSSD Services, Aga Khan University Hospital, Karachi.
5. Dr. Ijaz Ahmed, Associate Professor,
University of Veterinary and Animal Sciences, Lahore.
6. Dr. I.U. Beg,
Consultant Surgeon,
Federal Government Services Hospital, Islamabad.
7. Dr. R.H. Usmani,
Animal Husbandry Commissioner,
Ministry of Food, Agricultural & Livestock, Government of Pakistan, Islamabad.
8. Dr. Jalil-Ur-Rehman,
Director General Health Services, Government of NWFP, Peshawar,
Member
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Assistant Chief,
Ministry of Industries & Production, Government of Pakistan, Islamabad.
Mr. Muhammad Saad Qureshi, Deputy Secretary,
Ministry of Law, Justice & Human Rights, Islamabad.
Mr. Amanullah, Cost Accountant, Ministry of Health,
Government of Pakistan, Islamabad.
Dr. Farnaz Malik, Drugs Controller, Ministry of Health,
Government of Pakistan, Islamabad.
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Secretary
Mr. Zafar Mooraj, representative of Pharma Bureau, Karachi, Mr. Zahid Seed, representative of Pakistan Pharmaceutical Manufacturers Association, Karachi and Mr. M. Naeem Shami, representative of Pakistan Chemists & Druggists Association, Karachi also attended the meeting as observers.
Mr. Ghulam Rasool Dutani, Deputy Director General (Registration) was also present to assist the Secretary Registration Board with the agenda and issues related to imported human/veterinary drugs.
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ITEM NO.I. i) S.# 1. DRUGS DEFERRED FOR INSPECTION OF MANUFACTURER ABROAD. The Drug Registration Board considered and approved the following drugs subject to Name of Importer/ Manufacturer. M/s. Bosch Pharmaceuticals, Karachi/ To be imported in naked vial from M/s. Shanghai Wanxing Bio-Pharmaceutical Co. Ltd., Shanghai, China and Labeling & Packing will be locally. -do- Name of Drug (s)/ Composition. Demanded Price & Pack Size. price calculation:-
Alferon-3 Injection. Rs.890.00/Per vial. Each vial contains:- Recombinant Human Interferon Alfa-2b equivalent to 3MIU of Interferon alfa-2b 2. 3. 4. 5. 6. 7. Alferon-5 Injection. Each vial contains: - Recombinant Human Interferon Alfa-2b equivalent to 5MIU of Interferon alfa-2b. Alferon-10 Injection. -do- Each vial contains: - Recombinant Human Interferon Alfa-2b equivalent to 10MIU of Interferon alfa-2b. M/s. Dow-Convatec Jipailin 2,000IU/0.2ml Injection. Pakistan Ltd., Lahore/ Each 0.2ml contains:- M/s. Hangzhou Jiuyuan Gensparin .. 2000IU. Gene Engineering Co., Ltd., Hangzhou, China. -do- Jipailin 3,000IU/0.3ml Injection. Each 0.3ml contains:- Gensparin ….3000IU. -do- Jipailin 4,000IU/0.4ml Injection. Each 0.4ml contains:- Gensparin …..4000IU. -do- Jipailin 5,000IU/0.5ml Injection. Each 0.5ml contains:- Gensparin….5000IU. Rs.1250.00/Per vial. Rs.3000/Per vial. Rs.264.00/1’s. Rs.1324.00/5’s. Rs.396.00/1’s. Rs.1980.00/5’s. Rs.528.00/1’s. Rs.2640/5’s. Rs.660.00/1’s. Rs.3300.00/5’s. 3
8. 9. 10. 11. 12. 13. 14. Jilifen 300ug/1.2ml Injection. Each 1.2ml contains:- RHG-CSF 300ug. -do- Jilifen 450ug/1.8ml Injection. Each 1.2ml contains:- RHG-CSF 450ug. M/s Hoffmann Human Espogen 10,000 IU/ml Injection. Health Pakistan Limited, Each ml contains:- Lahore/ Recombinant human erythropoietin M/s. LG Life Sciences Ltd, 10,000 I.U. Korea. M/s. Biomedics Medical Heparinol 5000 Sterile Solution for System, Rawalpindi/ Injection. M/s. AIN Medicare Each ml contains:- SDN.BHD., Malaysia. Heparin Sodium Bovine 5000IU. -do- Heparinol 1000 Sterile Solution for Injection. Each ml contains:- Heparin Sodium Bovine 1000IU. M/s.Cirin Pharmaceuticals Abhayrab (Pvt) Ltd., Hattar, Distt. Each Immunizing dose (0.5ml) Haripur/ contains:- M/s. Human Biological Purified Vero Cell Rabbies Vaccine Institute, India. Antigen (Inactivated) > 2.5 IU. Human Serum Albumin 12mg. Maltose 40 mg. Thiomersal 0.01%. M/s. Hakimsons (Impex) Lyssavac N (Pvt) Ltd., Each dose contains:- Karachi/ Rabies inactivated virus at least 107 M/s. Cadila Healthcare LD50 at least 2.5 I.U. Limited, India. -do- Rs.3700/1’s. Rs.18,500/5’s. Rs.5550/1’s. Rs.27,750/5’s. Rs.4800/vial. Rs.14400/3vials. Rs.28800/6vials. Rs.115/Per vial. Rs.110/Per vial. Rs.820/Per vial/ dose. Rs.745/Per vial. 4
ii). S.# 1. The drug Registration Board considered and approved the following veterinary drugs:- Name of Importer/ Manufacturer. M/s. U.M. Enterprises, Karachi/ M/s. Malaysian Vaccines and Pharmaceuticals SDN BHD, Malaysia. -do- Name of Drug (s)/ Composition. IBD V877 Vaccine. (Infectious Bursal Disease Vaccine). Demanded Pack Size. 1000doses vial. 1000doses x10 vials. Price. De-controlled. 2. 3. -do- MyVAC K811 Vaccine. (New Castle Disease Vaccine B1 Type, LaSota Strain). MyVAC 102 Vaccine. (New Castle Disease Vaccine B1 Type, LaSota Strain). 1000doses (500ml). 1000doses x10 vials. 1000doses vial. 1000doses x10 vials. -do- -do- iii). S.# 1. The Drug Registration Board considered and reject the following drugs as per reasons Name of Importer/ Manufacturer. M/s. Pearl & Pearl Rawalpindi/ M/s.VINS Bioproducts limited India. M/s. Hakimsons (Impex) (Private) Limited, Karachi/ M/s. Green Cross Corporation, Korea. Name of Drug (s)/ Composition. Recommendation of the panel. Snake Venom Antiserum I..P. Facility was closed due to (Lyophilized) some up-gradation work so compliance to cGMP could not observed. Re-inspection suggested. Varicella Vaccine –GCC The applications for Injection. registration of the applicant Each vial (0.7ml) contains :- firm’s may be disposed off Live attenuated varicella as rejected as they have not virus........NLT 1,400 PFU. arranged for inspection of their principal firms as directed by Ministry of health. mentioned against each:- 2. 5
3. 4. M/s. Gene Tech Laboratories, Karachi/ M/s. Beijing Kawin Bio-Tech Co. Ltd. Beijing, China. -do- Kaferon 3MIU Injection. Each vial contains:- Interferon alpha 2b (rhIFN b 2-b) 3MIU. Kaferon 5MIU Injection. Each vial contains:- Interferon alpha 2b (rhIFN b 2-b) 5MIU. Recombinant Streptokinase for Injection 1.5MIU/Vial. Each vial contains :- Recombinant Streptokinase 1,500,000 IU. -do- -do- 5. M/s Highnoon Laboratories Ltd. Lahore/ M/s Shanghai SLLC-SMU Biotech Co, Ltd. Shanghai, China. -do- 6
ITEM NO.II. DRUGS DEFERRED BY THE REGISTRATION BOARD IN THE 202ND
MEETING HELD ON 8TH & 9TH DECEMBER, 2006.
The members of the Board who has inspected the firms in Argentina apprise the Board regarding the system in Argentina, informed that M/s. Laboratorios IMA S.A.I.C., Argentina is only responsible for the manufacturing of pharmaceutical products for his licenced holders and is not responsible for any legal matter. However, M/s. Servycal S.A., Argentina, M/s. Laboratorio Dosa S.A., Argentina and M/s. Laboratorio Varifarma S.A., Argentina are the licence holders for M/s. Laboratorios IMA S.A.I.C., Argentina and the licence holders are responsible for the raw material, packaging material, finished goods and quality control of the finished products. Inspection of M/s. Laboratorios IMA S.A.I.C., Argentina and M/s. Servycal S.A., Argentina has already been conducted by the panel and the panel recommends import of applied products. After detailed discussion on the matter the Board has also decided that if any importer submit request for the registration of products from a manufacturer having different licence holders, the panel will inspect the premises of manufacturer as well as the licence holder to verify the facility and cGMP practice. The Registration Board approved the registration of the products applied by M/s. CCL Pharmaceuticals (Pvt) Ltd., Lahore, Board also approved the registration of the products applied by M/s. Ghani Brothers, Karachi subject to inspection of licence holder to verify the facility and cGMP compliance:- S.# 1. Name of Importer/ Manufacturer. M/s. CCL Pharmaceuticals (Pvt) Ltd., Lahore/ M/s. Servycal S.A., Argentina. Name of Drug (s)/ Composition. Mebrexel 80mg Injection. Each vial contains:- Anhydrous Docetaxel 80mg. + Each vial of diluent contains:- Ethanol 95% 0,780ml. Water for injection 5,22ml. Mebrexel 20mg Injection. Each vial contains:- Anhydrous Docetaxel 20mg. + Each vial of diluent contains:- Ethanol 95% .. 0,195ml. Water for injection 1,305ml. Oncoplatin 50mg Injection. Each vial contains:- Cisplatin…..50mg. Demanded Price & Pack Size. Rs.30500.00/ Per vial. 2. -do- Rs.9345.83/ Per vial. 3. -do- Rs.885.09/Per vial. 7
4. -do- 5. -do- 6. -do- 7. -do- 8. -do- 9. -do- 10. -do- 11. -do- 12. -do- 13. -do- 14. -do- Doxocin 10mg Injection. Each vial contains:- Doxoribicin HCl 10mg. Doxocin 50mg Injection. Each vial contains:- Doxoribicin HCl 50mg. Lymphoside 100mg Injection. Each vial contains:- Etoposide 0.100gm. Cytotecan 100mg Injection. Each 5ml vial contains:- Tryhydrated Irinotecan HCl 100mg. Leucofolate 50mg Injection. Each vial contains:- Calcic Leucovorin equivalent to 50mg base Leucovorin. Osteopam 30mg Injection. Each vial contains:- Pentahydrated Sodium Pamidronate 39.68mg (equivalent to 30mg Anhydrous Sodium Pamidronate). Osteopam 90mg Injection. Each vial contains:- Pentahydrated Sodium Pamidronate 119.05mg (equivalent to 90mg Anhydrous Sodium Pamidronate). Xaliplatin 50mg Injection. Each vial contains:- Oxaliplatin 50mg. Xaliplatin 100mg Injection. Each vial contains:- Oxaliplatin 100mg. Metaplaxel 30mg Injection. Each 5ml vial contains:- Paclitaxel 30mg. Metaplaxel 150mg Injection. Each 25ml vial contains:- Paclitaxel 150mg. Rs.699.37/Per vial. Rs.2170.10/ Per vial. Rs.794.25/Per vial. Rs.13348.80/ Per vial. Rs.564.00/Per vial. Rs.10876.50/ Per vial. Rs.30628.00/ Per vial. Rs.10500.00/ Per vial. Rs.20000.00/ Per vial. Rs.9642.60/ Per vial. Rs.30000.00/ Per vial. 8
15. -do- 16. -do- 17. -do- 18. -do- 19. 20. M/s. Ghani Brothers, Karachi/ Manufactured by M/s. Laboratorios IMA S.A.I.C., Argentina. Licence holder M/s. Laboratorio Dosa S.A., Argentina. -do- Toxiplatin 150mg Injection. Each vial contains:- Carboplatin 150mg. Toxiplatin 450mg Injection. Each vial contains:- Carboplatin 450mg. Fosfamide 1gm Injection. Each vial contains:- Ifosfamide 1gm. Zoldic 4mg Injection. Each vial contains:- Monohydrated Zoleronic Acid (equivalent to anhydrous Zoledronic Acid 4mg) 4.264mg. Vilne Injectable Solution. Each ml contains:- Vinorelbine (as vinorelbine ditartrate) 10mg. Vilne Injectable Solution. Each 5ml contains:- Vinorelbine (as vinorelbine ditartrate) 50mg. Potekam 4mg/4ml Lyophilized Injection. Each ml contains:- Topotecan (as topotecan hydrochloride) 1mg. Plustaxano Anhidro 20mg/0.5ml Concentrate Solution for Infusion. Each 0.5ml contains:- Anhydrous Docetaxel..20mg. Diluting Solution for Plustaxano Anhidro 20mg/0.5ml Concentrate Solution for Infusion. Contains:- 95% Alcohol 191.1mg. Water for injection to a final volume of 1.6ml. Rs.1893.62/ Per vial. Rs.4450.00/ Per vial. Rs.797.40/Per vial. Rs.19000/ Per vial. As per leader price. -do- 21. -do- -do- 22. -do- -do- 23. -do- Free of cost. 9
24. -do- 25. -do- 26. -do- 27. -do- 28. -do- 29. -do- Plustaxano Anhidro 80mg/2ml Concentrate Solution for Infusion. Each 2ml contains:- Anhydrous Docetaxel..80mg. Diluting Solution for Plustaxano Anhidro 80mg/2ml Concentrate Solution for Infusion. Contains:- 95% Alcohol 764.4mg. Water for injection to a final volume of 6.2ml. Dalys Concentrate Injectable for Infusion. Each 5ml contains:- Paclitaxel……… 30mg. Dalys Concentrate Injectable for Infusion. Each 16.7ml contains:- Paclitaxel……… 100mg. Dalys Concentrate Injectable for Infusion. Each 25ml contains:- Paclitaxel……… 150mg. Dalys Concentrate Injectable for Infusion. Each 50ml contains:- Paclitaxel……… 300mg. As per leader price. Free of cost. As per leader price. As per leader price. As per leader price. As per leader price. 10
ITEM NO.III. each:-
ANY OTHER MATTER WITH THE PERMISSION OF THE CHAIR.
The Drug Registration Board in its 202nd meeting held on 8th & 9th
December, 2006 rejects the following veterinary products on the reasons mentioned against Sl.No. Name of manufacturer. 1. Name of Drug (s). Reasons. No therapeutic advantage in injection form. -do- 2. M/s. Star Laboratories Vernil 10% Injection. (Pvt) Ltd., Lahore. Each ml contains:- Levamisole …….. 100mg. -do- Vernil 7.5% Injection. Each ml contains:- Levamislole ……… 75mg.
The case was again discussed by the Board and its was absorbed that Levamisle Injection is approved by the FDA in the strength 13.65%. The Board after detailed discussion has decided to defer the case for confirmation of applied strengths.
The meeting ended with the vote of thanks to the chair.
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