Government of Pakistan s5

No. F. 10-25/2013-Lic (Misc) Government of Pakistan Drug Regulatory Authority of Pakistan Ministry of National Regulation & Services *****

Islamabad the April, 2015. Director (Management Information Services) Drug Regulatory Authority of Pakistan (DRAP), Islamabad

Subject: UP-GRADATION OF OFFICIAL WEBSITE.

Please refer to your letter No. F.1-1/2013-Dir (MIS) dated 28th October, 2013 on the subject cited above. The Licensing Division has prepared detailed progress report regarding working of this Division for the period from 01st March, 2015 to 31st March, 2015 for uploading the same on the official website of Drug Regulatory Authority of Pakistan (DRAP) for information of all concerned. The hard and soft copies of the progress report are attached herewith.

(Salateen Waseem Philip) Assistant Drug Controller / Deputy Drugs Controller (Lic) PH:-051-9202627

Copy for information to:- i) PS to Chief Executive Officer, DRAP, Islamabad. ii) Director Drug Licensing, DRAP, Islamabad. iii) Concerned file. iv) Master Folder. DIVISION OF DRUG LICENSING

MONTHLY PROGRESS REPORT TO BE UPLOADED ON OFFICIAL WEBSITE OF DRAP FOR THE PERIOD FROM 01-03-2015 to 31-03-2015

NO. OF CASES / S. TYPE OF ASSIGNMENT WORK NO. DISPOSED OFF Verification of Site for Establishment of Pharmaceutical Units 02 1. Approval of Site for Establishment of Pharmaceutical Units 02 2. Approval of Building Layout Plans / Expansion 3. 20 Direction Issued for Panel Inspections for Grant of Additional 4. Sections 04

Grant/approval of Additional Sections by CLB/ conveyed thereof 5. 00

Approval of Technical Staff under rule 15&16 of Drugs (Licensing, 6. Registering & Advertising) Rules, 1976 04

Direction Issued for Panel Inspection for Grant Of New Drug 7. Manufacturing LICENSES 00

New Drug Manufacturing Licenses / issued / conveyed by CLB/ 8. conveyed thereof 02

Direction issued for Panel Inspection (s) of Pharmaceutical Units for 9. Renewal of Drug Manufacturing Licenses 07

Renewal of DML (issuance of Renewal of Drug Manufacturing 10. 07 Licenses) Inspection Books issued 11. 02 Change of company names/ title / management of firm under Rule 12. 5(6) of Drugs (Licensing, Registering & Advertising) Rules, 1976 01

Miscellaneous (deficiencies / shortcomings with respect to lop, Technical Staff, completion of applications for Grant / Renewal of 13. 42 DML, Site Approval / Verification documents etc) S. TYPE OF CASES / WORK DISPOSED OFF & NAMES OF FIRMS NO 1. VERIFICATION OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (02) 1. M/s Bliss Industries (Pvt) Ltd, Pot No. GA-52-A6, Karachi. 2. M/s Iqra Pharmaceuticals, Plot No.2, S-9, RCCI Industrial Estate, Rawat Rawalpindi.

2. APPROVAL OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (02) 1. M/s Musani Pharmaceuticals Ltd, Karachi. 2. M/s Zen Pharma Labs, Islamabad.

3. APPROVAL OF BUILDING LAYOUT PLANS / EXPANSION (20)

1. M/s High-Q Pharmaceuticals, Plot No.224, Sector 23, Korangi Industrial Area, Karachi. 2. M/s Mexitech Pharma (Pvt) Ltd, Karachi. 3. M/s Pharma Lord (Pvt) Ltd, Layyah. 4. M/s Lisko Pakistan (Pvt) Ltd, Karachi 5. M/s Akhai Pharmaceuticals (Pvt) Ltd., A-248 & A-256 to A-259, Hub Industrial Trading Estate Lasbella, Balochistan. 6. M/s BF Bioscinences Ltd., 5-Km, Sundar Raiwind Road, Raiwind Lahore. 7. M/s Standpharm Pakistan 21 Km Ferozepur Road, Lahore. 8. M/s Farm Aid Group (Pvt) Ltd Plot NO. 3/2, Hattar Industrial Area, Hattar. 9. M/s Leads Pharma (Pvt) Ltd, Plot No .81-A, Street No.6, I-10/3. Islamabad. 10. M/s Reckitt & Benckiser Pakistan Ltd, F-18, SITE, Karahi. 11. M/s Next Pharmaceutical Products (Pvt.) Ltd., Plot No. 44-A & 44-B, Sundar Industrial Estate, Lahore 12. M/s GMP Pharmaceuticals, Lahore. 13. M/s FYNK Pharmaceuticals, 19-Km, Ferozepur Road, G.T. Road, Kala shah Kaku, Lahore. 14. M/s Enzone Pharma Labs (Pvt) Ltd, Lahore. 15. M/s Valor Pharmaceuticals, Islamabad. 16. M/s BJ Pharmaceuticals, Lahore. 17. M/s Medisure Laboratories (Pvt) Ltd, Karachi. 18. M/s Aurik Pharmaceuticals, Rawalpindi. 19. M/s Leads Pharma (Pvt) Ltd, Islamabad. 20. M/s Amson Vaccines & Pharma (Pvt) Ltd, Islamabad.

4. DIRECTION ISSUED FOR PANEL INSPECTIONS FOR GRANT OF ADDITIONAL (04)

1. M/s Bosch Pharmaceuticals (Pvt) Ltd, 221 Bosch House, Sector 23, Korangi industrial Area, Karachi. 2. M/s Medicon Pharmaceuticals Industries (Pvt) Ltd., B-1-11, Industrial Estate Hayatab, Peshawar. 3. M/s Getz Pharmaceuticals, 30-31, Sector 27, Korangi Industrial Area, Karachi. 4. M/s High-Q Pharmaceuticals, Plot No.224, Sector 23, Korangi Industrial Area, Karachi.

5. GRANT/APPROVAL OF ADDITIONAL SECTIONS BY CLB/ CONVEYED THEREOF (00) 6. APPROVAL OF TECHNICAL STAFF UNDER RULE 15&16 OF DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (04)

1. M/s Merck (Pvt) Ltd, Karachi. 2. M/s CSH Pharmaceuticals (Pvt) Ltd, Lahore. 3. M/s MBL Pharma, Balochistan. 4. M/s Jinnah Pharmaceuticals (Pvt) Ltd, Lahore.

7. DIRECTION ISSUED FOR PANEL INSPECTION FOR GRANT OF NEW DRUG MANUFACTURING LICENSES (00)

8. NEW DRUG MANUFACTURING LICENSES / ISSUED / CONVEYED BY CLB/ CONVEYED THEREOF (02)

1. M/s Winthrox Laboratories, Karachi. 2. M/s Amaan Pharma, Lahore.

9. DIRECTION ISSUED FOR PANEL INSPECTION (S) OF PHARMACEUTICAL UNITS FOR RENEWAL OF DRUG MANUFACTURING LICENSES (07)

1. M/s The Searle Company Limited, F-319, Karachi. 2. M/s Amson Vaccines & Pharma (Pvt) Ltd, Islamabad. 3. M/s Jassh Pharma Lahore. 4. M/s OBS Pakistan (Pvt) Ltd , Karachi. 5. M/s English Pharm, Indus Link Katarband Road, Thokar Niaz Beg, Lahore. 6. M/s Lisko Pakistan Ltd, L-10-D, Block 21, Industrial Federal B Area, Karachi.

10 RENEWAL OF DML (ISSUANCE OF RENEWAL OF DRUG MANUFACTURING . LICENSES) (07)

1. M/s Silver Surgical Complex (Pvt) Ltd. C-40, SITE, Super Highway, Industrial Estate, Scheme 33, Karachi. 2. M/s Macquin’s International, F/2-H, S.I.T.E, Karachi. 3. M/s English Pharm, Indus Link Katarband Road, Thokar Niaz Beg, Lahore. 4. M/s Envoy Pharmaceuticals (Pvt) Ltd., 27-Km, Multan Road, Maraka Lahore 5. M/s Bosch Pharmaceuticals (Pvt) Ltd, 221 Bosch House, Sector 23, Korangi industrial Area, Karachi. 6. M/s FYNK Pharmaceuticals, 19-Km, Ferozepur Road, G.T. Road, Kala shah Kaku, Lahore. 7. M/s Curatech Pharmaceuticals (Pvt) Ltd., 35-Km, Multan Road, Lahore.

11 INSPECTION BOOKS ISSUED (02) . 1. M/s Ameer & Adnan Pharmaceuticals (Pvt) Ltd, Lahore. 2. M/s Hiranis Pharmaceuticals (Pvt) Ltd, Karachi.

12 CHANGE OF COMPANY NAMES/ TITLE / MANAGEMENT UNDER RULE 5(6) OF . DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (01).

1. M/s Vetz Pharmaceuticals (Pvt) Ltd, Kotri Sindh. 13 MISCELLANEOUS (DEFICIENCIES / SHORTCOMINGS WITH RESPECT TO LOP, . TECHNICAL STAFF, COMPLETION OF APPLICATIONS FOR GRANT / RENEWAL OF DML, SITE APPROVAL / VERIFICATION DOCUMENTS ETC) (42)

1. M/s Wenogen Pharmaceuticals, Hattar. 2. M/S SPL Pharmaceuticals (Pvt) Ltd, Hattar. 3. DDC QA/LT Islamabad. 4. CEO DRAP, Islamabad. 5. Secretary Drug Registration Board, Islamabad. 6. M/s Pulse Pharmaceuticals (Pvt) Ltd, Lahore. 7. M/s Walt Danzay Pharmaceuticals, Taxila 8. M/s Novins international (Pvt) Ltd, Karachi. 9. M/s Klifton Pharma Jamshoro. 10. DDC LA Islamabad. 11. Director MIS DRAP Islamabad. 12. M/s Hawk Bio Pharma (Pvt) Ltd, Rawalpindi. 13. DDO DRAP Islamabad 14. DDO DRAP Islamabad 15. DDO DRAP Islamabad 16. M/s Caliph Pharmaceuticals (Pvt) Ltd, Risalpur. 17. AD ADMIN-I DRAP Islamabad. 18. M/s Wazon Pharmaceuticals, Islamabad 19. M/s English Pharmaceuticals Industries Lahore. 20. PPMA, Islamabad. 21. Pakistan Pharma Bureau Karachi. 22. Dr. Obaid Ali FID Karachi. 23. M/s Spectrum Laboratories (Pvt) Ltd, Lahore. 24. DDO DRAP Islamabad 25. DDO DRAP Islamabad 26. DDO DRAP Islamabad 27. DDO DRAP Islamabad 28. DDO DRAP Islamabad 29. DDO DRAP Islamabad 30. DDO DRAP Islamabad 31. Director QA/LT Islamabad. 32. M/s Qamar Cotton Industries Okara. 33. M/s Marion Laboratories (Pvt) Ltd Karachi. 34. Secretary Registration Board. Islamabad. 35. M/s Lisko Pakistan (Pvt) Ltd Karachi. 36. M/s Revive Pharmakon Lahore. 37. M/s Goodman Laboratories, Rawat. 38. M/s Florence Pharmaceuticals (Pvt) Ltd Islamabad. 39. M/s Ali Industries, Lahore. 40. M/s Ferozza International Pharmaceuticals (Pvt) Ltd Lahore 41. M/s Jenner Pharmaceuticals (Pvt) Ltd Sheikhupura. 42. Director Administration, DRAP Islamabad.