No. F. 10-25/2013-Lic (Misc)
Government of Pakistan
Drug Regulatory Authority of Pakistan
Ministry of National Regulation & Services
*****
Islamabad the January, 2015.
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 December, 2014 to 31st December, 2014 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
Director (Management Information Services)
Drug Regulatory Authority of Pakistan (DRAP),
Islamabad.
Copy for information to:-
i) PS to Chief Executive Officer, DRAP, Islamabad.
ii) Concerned file.
iii) Master Folder.
DIVISION OF DRUG LICENSING
MONTHLY PROGRESS REPORT TO BE UPLOADED ON
OFFICIAL WEBSITE OF DRAP
FOR THE PERIOD FROM 01-12-2014 to 31-12-2014
S. NO. / TYPE OF ASSIGNMENT / NO. OF CASES / WORK DISPOSED OFF1. / Verification of Site for Establishment of Pharmaceutical Units / 04
2. / Approval of Site for Establishment of Pharmaceutical Units / 02
3. / Approval of Building Layout Plans / Expansion / 14
4. / Direction Issued for Panel Inspections for Grant of Additional Sections / 02
5. / Grant/approval of Additional Sections by CLB/ conveyed thereof / 08
6. / Approval of Technical Staff under rule 15&16 of Drugs (Licensing, Registering & Advertising) Rules, 1976 / 09
7. / Direction Issued for Panel Inspection for Grant Of New Drug Manufacturing LICENSES / 02
8. / New Drug Manufacturing Licenses / issued / conveyed by CLB/ conveyed thereof / 01
9. / Direction issued for Panel Inspection (s) of Pharmaceutical Units for Renewal of Drug Manufacturing Licenses / 06
10. / Renewal of DML (issuance of Renewal of Drug Manufacturing Licenses) / 05
11. / Inspection Books issued / 01
12. / Change of company names/ title / management of firm under Rule 5(6) of Drugs (Licensing, Registering & Advertising) Rules, 1976 / 02
13. / Miscellaneous (deficiencies / shortcomings with respect to lop, Technical Staff, completion of applications for Grant / Renewal of DML, Site Approval / Verification documents etc) / 36
S. NO / TYPE OF CASES / WORK DISPOSED OFF & NAMES OF FIRMS
1. / VERIFICATION OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (04)
1. M/s Mazton Pharmaceuticals (Pvt) Ltd, 35-KM, Ferozepur Road, Lahore.
2. M/s Littman Pharmaceuticals, Plot No. 33, Street No.S-6, RCCI Industrial Zone Rawat Rawalpindi.
3. M/s Wazen Pharmaceuticals, Plot No. 23,24, Phase S1, Industrial Estate, Rawat.
4. M/s Salute Pharmaceuticals, Plot No E/61-A, SITE Super Highway Phase-II, Karachi.
2. / APPROVAL OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (02)
1. M/s Shine Pharmaceuticals, 3-KM, Off Lahore Faisalabad Road at Shahkot Towards Sangla Hill District Nankana Sahib.
2. M/s Biorise Pharmaceuticals, 19-KM, Lahore Road Multan.
3. / APPROVAL OF BUILDING LAYOUT PLANS / EXPANSION (14)
1. M/s Katrina Pharmaceutical Industries (Pvt) Ltd, 10-KM, Sheikhupura Faisalabad Rod, Sheikhupura.
2. M/s Care Pharmaceuticals, Thokar Raiwind Road, Lahore.
3. M/s Bosch Pharmaceuticals (Pvt) Ltd, Karachi.
4. M/s Cirin Pharmaceuticals (Pvt) Ltd, Hattar.
5. M/s Highnoon Laboratories Ltd, Lahore.
6. M/s Aries Pharma (Pvt) Ltd, Peshawar.
7. M/s Medicaids Pakistan (Pvt) Ltd, Karachi.
8. M/s Hilton Pharma (Pvt) Ltd, Karachi.
9. M/s Stiflex Pharmaceuticals, Islamabad.
10. M/s Athan Pharmaceuticals, Hattar.
11. M/s Medipak Limited, Lahore.
12. M/s Barrett Hodgson Pakistan (Pvt) Ltd, Karachi.
13. M/s Tristar Pharmaceutical, Gujranwala.
14. M/s Pharmedic laboratories (Pvt) Ltd, Lahore.
4. / DIRECTION ISSUED FOR PANEL INSPECTIONS FOR GRANT OF ADDITIONAL (02)
1. M/s Lotus Pharmaceuticals (Pvt) Ltd, Islamabad.
1. M/s Weather Folds Pharmaceuticals, Hattar.
5. / GRANT/APPROVAL OF ADDITIONAL SECTIONS BY CLB/ CONVEYED THEREOF (08)
1. M/s Univet Pharmaceuticals, Rawalpindi.
2. M/s CCL Pharmaceuticals (Pvt) Ltd, 62 Industrial Estate, Kot Lakhpat, Lahore.
3. M/s Abbott Labs, (Pak) Ltd, Landhi, Karachi.
4. M/s Nextar Pharma (Pvt) Ltd, Plot No. E-58, North Western Industrial Zone, Port Qasim, Karachi.
5. M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi.
6. M/s Jasons Pharmaceuticals, Rawat.
7. M/s Venus Pharma (Pvt) Ltd, 23 Km Multan Road, Lahore.
8. M/s Macter International (Pvt) Ltd. F-216, SITE, Karachi.
6. / APPROVAL OF TECHNICAL STAFF UNDER RULE 15&16 OF DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (09)
1. M/s Saydon Pharmaceutical Industries (Pvt) Ltd, Peshawar.
2. Ms Renacon Pharma (Pvt) Ltd, Lahore.
3. M/s Alen Pharmaceuticals (Pvt) Ltd,138-A, Road No.1, Indus Estate, Risalpur.
4. M/s Life Pharma Co., 24-III Industrial Estate, Multan.
5. M/s Saibins Pharmaceuticals, Islamabad.
6. M/s Enterprises Ltd, Radha Kishan Road, Kasur.
7. M/s Quaper (Pvt) Ltd., 26-A, S.I.E. Lahore Road, Sargodha.
8. M/s Biogen Pharma, 8-KM, Rawat Chak Beli Road, Rawat, Rawalpindi.
9. M/s Servier Research and Pharmaceuticals Pak (Pvt) Ltd, 9 Km Sheikhupura Road, Lahore.
7. / DIRECTION ISSUED FOR PANEL INSPECTION FOR GRANT OF NEW DRUG MANUFACTURING LICENSES (02)
1. M/s Mission Pharmaceutical, Karachi.
2. M/s Amaan Pharma, Sheikhupura Road, Lahore.
8. / NEW DRUG MANUFACTURING LICENSES / ISSUED / CONVEYED BY CLB/ CONVEYED THEREOF (01)
1. M/s Vision Pharmaceuticals Plot No.22-23, Industrial Triangle Kahuta Road, Islamabad.
9. / DIRECTION ISSUED FOR PANEL INSPECTION (S) OF PHARMACEUTICAL UNITS FOR RENEWAL OF DRUG MANUFACTURING LICENSES (06)
1. M/s Rotexmedica Pakistan (Pvt) Ltd., Plot No.206-207, Industrial Triangle, Kahuta Road, Islamabad.
2. M/s Biogen Pharma, 8-KM, Rawat Chak Beli Road, Rawat, Rawalpindi.
3. M/s A&K Pharmaceutical, 94-A, Punjab SIE, Sargodha Road, Faisalabad.
4. M/s Wilson’s Pharmaceuticals, 266&387-388, I-9, Sector, Industrial Area, Islamabad.
5. M/s Alen Pharmaceuticals (Pvt) Ltd,138-A, Road No.1, Indus Estate, Risalpur.
6. M/s Silver Surgical Complex (Pvt) Ltd, C-40, SITE, Super Highway, Industrial Estate, Scheme 33, Karachi.
10. / RENEWAL OF DML (ISSUANCE OF RENEWAL OF DRUG MANUFACTURING LICENSES) (05)
1. M/s Macter International (Pvt) Ltd. F-216, SITE, Karachi(000111).
2. M/s Macter International (Pvt) Ltd. F-216, SITE, Karachi.(000141).
3. M/s Aventek Pharmaceuticals, Plot No. 44-c, Sunder Industrial Estate, Lahore.
4. M/s Cherwel Pharmaceuticals (Pvt) Ltd., Plot No.20, Phase-4, Industrial Estate, Hattar.
5. M/s Gelcaps (Pak) Ltd, Hub, Plot No. B-3, SITE, Basochistan.
11. / INSPECTION BOOKS ISSUED (01)
1. M/s Agror Pharma (Pvt) Ltd, Rawat.
12. / CHANGE OF COMPANY NAMES/ TITLE / MANAGEMENT UNDER RULE 5(6) OF DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (02).
1. Alza Pharmaceuticals Jehlum Road, Rawalpindi (formely M/s Al Shifa Pharmaceuticals).
2. M/s A-Z Pharmaceutical Co. Ltd, Manga Road, Raiwind (Management).
13. / MISCELLANEOUS (DEFICIENCIES / SHORTCOMINGS WITH RESPECT TO LOP, TECHNICAL STAFF, COMPLETION OF APPLICATIONS FOR GRANT / RENEWAL OF DML, SITE APPROVAL / VERIFICATION DOCUMENTS ETC) (36)
1. DDG (E&M) DRAP, Lahore.
2. M/s Hoover Pharmaceuticals (Pvt) Ltd., Plot No.16, Zain Park Industrial Area, Saggain By Pass Road, Lahore.
3. M/s Zafa Pharmaceutical Labs, L-1/b, Block 22, Federal B Area, Karachi.
4. AD (Admn), DRAP, Islamabad.
5. Prof. Dr. Ali Akbar Sial, Dean , Faculty of Ziauddin University, Karachi.
6. Director (MIS) DRAP, Islamabad.
7. M/s Biofine Pakistan (Pvt) Ltd, 74-Industrial Estate, Multan.
8. DDG (E&M) DRAP, Lahore.
9. M/s Renacon Pharma Lahore
10. Area FID, DRAP, Lahore.
11. M/s ICI Pakistan Limited, Lahore
12. M/s National Absorbent Cottton Mills Co, A/37, SITE, Mangopir Road, Karachi.
13. M/s Hamayun Intl..Pharma (Pvt) Ltd, 20 Km Satiana Road, Faisalabad.
14. M/s Cresent Cotton, Chowk Depalpur, Okara.
15. M/s Johnson & Johnson (Pak) Ltd, Plot NO.10&25, Sector 20, Korangi Industrial Area, Karachi.
16. Ch. M Shahbaz Farooq, office of the provincial inspector of drugs, Jinah Town, Faisalabad.
17. M/s Qamar Cotton Industries, Okara.
18. M/s Popular Chemical Works, 9th Mile Sheikhupura Road, Lahore.
19. Drawing & Disbursing Officer, DRAP, Islamabad.
20. M/s Medpharm Research Lab. Lahore.
21. M/s Martin Dow limited, Karachi.
22. M/s Alpha chemical (Pvt) Ltd, 65-km Lahore-Multan National Highway, Industrial Zone, Chunian, Kasur.
23. Mr. Qaiser Muhammad, Chief Drug Inspector, Karachi.
24. Syed Jawed Yousaf Bukhari, Karachi.
25. M/s Kamtex Cotton Industry, Gujranwala.
26. M/s W.Woodward Pakistan (Pvt) Ltd, Karachi
27. Syed Muied Ahmed, Karachi.
28. Drawing & Disbursing Officer, DRAP, Islamabad.
29. FIA, Lahore.
30. M/s CKD Pharmaceuticals Labs, 50/28, Korangi Industrial Area, Karachi.
31. M/s Quaper (Pvt) Ltd., 26-A, S.I.E. Lahore Road, Sargodha.
32. DDG (E&M) DRAP, Lahore.
33. M/s Biogen Pharma, Rawalpindi.
34. M/s PCP Laboratories, Okara.
35. M/s Lisko Pakistan Ltd, L-10-D, Block 21, Industrial Federal B Area, Karachi.
36. M/s Life Pharma Co., 24-III Industrial Estate, Multan.