No. F. 10-25/2013-Lic (Misc)

Government of Pakistan

Drug Regulatory Authority of Pakistan

Ministry of National Regulation & Services

*****

Islamabad the December, 2014.

Subject: UP-GRADATION OF OFFICIAL WEBSITE.

Please refer to your letter No. F.1-1/2013-Dir (MIS) dated 12th November, 2013 on the subject cited above. The Licensing Division has prepared detailed progress report regarding working of this Division for the period from 03rd November, 2014 to 30th November, 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 03-11-2014 to 30-11-2014

S. NO. / TYPE OF ASSIGNMENT / NO. OF CASES / WORK DISPOSED OFF
1.  / Verification of Site for Establishment of Pharmaceutical Units / 07
2.  / Approval of Site for Establishment of Pharmaceutical Units / 03
3.  / Approval of Building Layout Plans / Expansion / 08
4.  / Direction Issued for Panel Inspections for Grant of Additional Sections / 02
5.  / Grant/approval of Additional Sections by CLB/ conveyed thereof / Nil
6.  / Approval of Technical Staff under rule 15&16 of Drugs (Licensing, Registering & Advertising) Rules, 1976 / 10
7.  / Direction Issued for Panel Inspection for Grant Of New Drug Manufacturing LICENSES / 03
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 / 07
10.  / Renewal of DML (issuance of Renewal of Drug Manufacturing Licenses) / 06
11.  / Inspection Books issued / 05
12.  / Change of company names/ title / management of firm under Rule 5(6) of Drugs (Licensing, Registering & Advertising) Rules, 1976 / 01
13.  / Miscellaneous (deficiencies / shortcomings with respect to lop, Technical Staff, completion of applications for Grant / Renewal of DML, Site Approval / Verification documents etc) / 15
S. NO / TYPE OF CASES / WORK DISPOSED OFF & NAMES OF FIRMS
1.  / VERIFICATION OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (07)
1.  M/s Zen Pharma Labs, RCCI Rawat, Rawalpindi.
2.  M/s Edwin Pharmaceuticals (Pvt) Ltd, Plot No.168 sector 23, Korangi Industrial Area, Karachi.
3.  M/s Umbiqa Pharmaceutical, Rawalpindi.
4.  M/s Hilton Pharma (Pvt) Ltd, Plot No.43, Sector 15, Korangi Industrial Area, Karachi.
5.  M/s Warria Brothers, Surgical Cotton Factory, Tehsil Zafarwal, District Narowal.
6.  M/s AFK Pharmaceuticals, Faisalabad.
7.  M/s Vetec Laboratories, Industrial Area, Rawat.
2.  / APPROVAL OF SITE FOR ESTABLISHMENT OF PHARMACEUTICAL UNITS (03)
1.  M/s Bosch Pharmaceuticals (Pvt) Ltd, Plot No. 219/1, Sector 23, Korangi Industrial Area, Karachi.
2.  M/s Maverick Pharmaceuticals, Multan.
3.  M/s AJM Pharma (Pvt) Ltd, Karachi.
3.  / APPROVAL OF BUILDING LAYOUT PLANS / EXPANSION (08)
1.  M/s Albert Pharmaceuticals (Pvt) Ltd, Sunder Industrial Estate, Lahore.
2.  M/s Tayyab Pharmaceuticals, Rawat, Rawalpindi.
3.  M/s Rasco Pharma Lahore DML NO.000530.
4.  M/s Getz Pharma (Pvt) Ltd, Karachi. DML NO.000284
5.  M/s Simz Pharmaceuticals (Pvt) Ltd, Sunder Lahore.
6.  M/s Atco Laboratories (Pvt) Ltd, B-18, SITE, Karachi.
7.  M/s Attabak Pharmaceutical Industries, Islamabad.
8.  M/s A.H Pharmaceuticals, Faisalabad.
4.  / DIRECTION ISSUED FOR PANEL INSPECTIONS FOR GRANT OF ADDITIONAL (02)
1.  M/s Tas Pharma, (Pvt) Ltd, 209 Sehala Triangle Kahuta Road, Islamabad.
2.  M/s Sayyed Pharmaceuticals (Pvt) Ltd Plot No. 67/2, Phase 3, Industrial Estate Hattar.
5.  / GRANT/APPROVAL OF ADDITIONAL SECTIONS BY CLB/ CONVEYED THEREOF (Nil)
6.  / APPROVAL OF TECHNICAL STAFF UNDER RULE 15&16 OF DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (10)
1.  M/s Surge Laboratories (Pvt) Ltd, Sheikhupura.
2.  M/s General Pharma, Farm Road, 3-KM, G.T. Road, Manhes Kamoke, District Gujranwala.
3.  M/s Ipram International, Plot# 26, SS-3, National Industrial Zone Rawat, Rawalpindi.
4.  M/s Arsons Pharmaceuticals Industries (Pvt) Ltd., 22-km Multan Road, Off 4 KM Defence Road, Lahore.
5.  M/s Harison Pharmaceutical, 10-Km Lahore Road, Sargodha.
6.  M/s Seatle Pharmaceuticals Pakistan Ltd, 45 Km, Multan Road, Lahore.
7.  M/s English Pharm, Indus Link Katarband Road, Thokar Niaz Beg, Lahore.
8.  M/s International Pharma Labs, Raiwind Road, Bobhtain chowk Defence Road, 1-km, Toward Khana Lahore.
9.  M/s Aptcure (Pvt) Ltd., 30-Km, Multan Road, Lahore.
10.  M/s British Pharmaceuticals, Lahore.
7.  / DIRECTION ISSUED FOR PANEL INSPECTION FOR GRANT OF NEW DRUG MANUFACTURING LICENSES (03)
1.  M/s Bio-Oxime Pharmaceuticals, Plot No. 31-32, Millat Garment City,Dry Port Road, Faisalabad.
2.  M/s ICI Pakistan Limited, 45-KM, Off Multan Road, Lahore.
3.  M/s Vision Pharmaceuticals Plot No.22, Industrial Triangle, Kahuta Road, Islamabad.
8.  / NEW DRUG MANUFACTURING LICENSES / ISSUED / CONVEYED BY CLB/ CONVEYED THEREOF (01)
1.  M/s IPP (Pvt) Ltd, Valley Road, Gulkada No.III, Saidu Sharif, Swat.
9.  / DIRECTION ISSUED FOR PANEL INSPECTION (S) OF PHARMACEUTICAL UNITS FOR RENEWAL OF DRUG MANUFACTURING LICENSES (07)
1.  M/s Ipram International, Plot# 26, SS-3, National Industrial Zone Rawat, Rawalpindi.
2.  M/s Perfect Pharma (Pvt) Ltd, 5Km Manga Road, Raiwind, Lahore.
3.  M/s Harmann Pharmaceutical, Labs, 15-16 Km, Shahpur Multan Road, Lahore.
4.  M/s Caraway Pharmaceuticals, Plot No. 12, Street No. S-4, National Industrial Zone, (RCCI) Rawat.
5.  M/s Convell Laboratories, Sadi Sharif, Swat.
6.  M/s Surgical Textile (Pvt) Ltd, 70 Km Multan Road, Near Patoki.
7.  M/s Aptcure (Pvt) Ltd., 30-Km, Multan Road, Lahore.
10.  / RENEWAL OF DML (ISSUANCE OF RENEWAL OF DRUG MANUFACTURING LICENSES) (06)
1.  M/s Unexolabas, 9.5 Km Sheikhupura Road, Lahore.
2.  M/s Unison Chemical Works Raiwind Road, Lahore.
3.  M/s Gelcaps (Pak) Ltd, Hub, Plot No. B-3, SITE, Basochistan.
4.  M/s Arsons Pharmaceuticals Industries (Pvt) Ltd., 22-km Multan Road, Off 4 KM Defence Road, Lahore.
5.  M/s Pliva Pakistan Ltd, Plot NO.B-77 Hub Industrial Estate, Lasbela, Balochistan.
6.  M/s Asian Fibre, Plot No. 41-42, Sector 25, Korangi Industrial Area, Karachi.
11.  / INSPECTION BOOKS ISSUED (05)
1.  M/s Karachi Pharmaceutical Labs, S-54, SITE, Karachi. Lahore.
2.  M/s Saydon Pharmaceuticals Industries ltd, 77/A, Hayatabad, Industrial Estate, Peshawar.
3.  M/s Mediceena Pharma (Pvt) Ltd, 27 Km Raiwind Road, Lahore.
4.  M/s Stallion Pharmaceuticals (Pvt) Ltd, Plot No. 581, Sunder Industrial Estate, Lahore.
5.  M/s Standpharm Pakistan 21 Km Ferozepur Road, Lahore.
12.  / CHANGE OF COMPANY NAMES/ TITLE UNDER RULE 5(6) OF DRUGS (LICENSING, REGISTERING & ADVERTISING) RULES, 1976 (01).
1.  M/s Bio-Oxime Pharmaceuticals, Plot No. 31-32, Millat Garment City,Dry Port Road, Faisalabad.
13.  / MISCELLANEOUS (DEFICIENCIES / SHORTCOMINGS WITH RESPECT TO LOP, TECHNICAL STAFF, COMPLETION OF APPLICATIONS FOR GRANT / RENEWAL OF DML, SITE APPROVAL / VERIFICATION DOCUMENTS ETC) (15)
1.  DDG (R-I) DRAP, Islamabad.
2.  DDG (E&M) DRAP, Peshawar.
3.  M/s English Pharm, Indus Link Katarband Road, Thokar Niaz Beg, Lahore.
4.  DDG (R-I) DRAP, Islamabad.
5.  M/s Harison Pharmaceutical, 10-Km Lahore Road, Sargodha.
6.  M/s Seatle Pharmaceuticals Pakistan Ltd, 45 Km, Multan Road, Lahore.
7.  DDG (E&M) DRAP, Lahore.
8.  Assistant Director (A-I) DRAP, Islamabad.
9.  Drawing & Disbursing Officer, DRAP, Islamabad.
10.  M/s Sunshine Pharmaceuticals, Gunjranwala.
11.  M/s Danas Pharmaceuticals (Pvt) Ltd, Plot No .312-Industrial Triangle, Kahuta Road, Islamabad.
12.  Director Administration DRAP, Islamabad.
13.  Director QA&LT, DRAP, Islamabad.
14.  M/s Herbion Pakistan (Pvt) Ltd, Industrial Triangle Kahuta Road, Hummak, Islamabad.
15.  M/s Caraway Pharmaceuticals, Plot No.12, Street No.N-3, National Industrial Zone, RCCI, Rawat Rawalpindi.