Islamabad (Pharmaceutical Review; www.pharmareview.wordpress.com). The Director General Health, Maj. Gen. (R) Shahida Malik HI (M), chaired the 206th meeting of the Central Licensing Board held on 8th – 9th June, 2007 in the Committee Room of Ministry of Health, Block-C, Pakistan Secretariat, Islamabad. The Chairperson welcomed all the members of the Board. The following members attended the meeting: –
1. Maj. Gen. (R) Nasir-ul-Islam HI (M) Rawalpindi.
2. Lt. Col. Aslam Khan, Classified Medical Specialist Military Hospital,
Rawalpindi.
3. Brig. Muzammil Hassan Najmi Professor of Pharmacology and Head of Department, Army Medical College, Rawalpindi
3. Mr. Abdul Latif Sheikh, Director Pharmacy, Nutrition and CSSD Services Aga Khan University Hospital Karachi
5. Prof. Dr. Ijaz Ahmad, University of Veterinary and Animal Sciences, Lahore
6. Prof. Dr.Muhammad Jamshaid, Dean Faculty of Pharmacy, Punjab University, Lahore
7. Dr. Rana M. Ikhlaq, Deputy Animal Husbandry Commissioner,
Ministry of Food, Agriculture and Livestock, Islamabad.
8. Mr. Arshad M. Tabassum Deputy Secretary, M/o Law Justice & Human Rights Islamabad.
9. Representative of Director General Health Services, Government of Punjab, Lahore
10. Mr. Sabir Ali, Chief Drug Inspector Representative of Director General Health Services, Government of NWFP, Peshawar
11. Mr. Atta-u-Rehman, Chief Drug Inspector Representative of Director General Health Services, Government of Balochistan, Quetta.
12. Mrs. Yasmeen Abbassi, Controller of Patents Government of Pakistan
Karachi.
13. Deputy Secretary, M/s Industries & Production Islamabad
14. Mr. Amanulha, Cost Accountant, Ministry of Health, Islamabad.
15. Dr. Farnaz Malik, Secretary Drug Controller, Ministry of Health,
Islamabad.
16. Mr. Zahid Saeed, Observer Pakistan Pharmaceuticals Manufacturers Association, Karachi
17. Mr. M. Zafar Mooraj, Observer Advisor, Pharma Bureau, Karachi
18. Mr. Shami; Chairman, Observer Pakistan Chemists and Druggists Association, Karachi
The meeting started with the recitation of the Verses from the Holy Quran. The following decisions were recorded: –
Item-I CONFIRMATION OF THE MINUTES OF THE 205th MEETING.
The Board confirmed the minutes of the 205th meeting held on 30th – 31st March, 2007.
Item-II: GRANT OF DRUG MANUFACTURING LICENSE (RECOMMENDED)
On the recommendations of the panel of experts the Board approved the grant of Drug Manufacturing Licenses to the following firms: –
| S # | Name of Firm | Type of License | Sections |
| 1 | M/s Healthtek (Pvt.) Ltd., Karachi | Formulation/ Repacking | Dry Powder Injectable (Cephalosporin) Dry Powder Suspension (Cephalosporin) Capsules (Cephalosporin) Tablet (Cephalosporin) HVAC system has been installed |
| 2 | M/s Curatech Pharma (Pvt) Ltd., Lahore | Formulation | Tablet (General) Capsule (General) HVAC has been installed |
| 3 | M/s Himont Pharmaceuticals (Pvt) Ltd., Lahore | Basic Manufacture | Item:
Iron Protein Succinylate
|
| 4 | M/s Mallard Pharmaceuticals, GT Road, Multan | Formulation Veterinary | Powder General Powder Antibiotic Liquid (General) HVAC has been installed. |
| 5 | M/s Intervac (Pvt.) Ltd., Sheikhupura | Formulation/ Veterinary | Powder (Antibiotic) Liquid (Antibiotic) Powder (General) HVAC system has been installed. |
Item-II: (B) GRANT OF ADDITIONAL SECTION (ALREADY LICENSED UNIT RECOMMENDED.
On the recommendations of the panel of experts the Board approved the grant of additional section to the following firm: –
| S # | Name of Firm | Type of License | Sections |
| 1 | M/s Otsuka Pakistan Ltd, Hub Balochistan | Formulation | 100ml to 2000ml Plabottle Molding & Filling / Sealing Section and Finished Goods Warehouse HVAC system has been installed |
| 2 | M/s Saffron Pharmaceuticals Faisalabad | Formulation | Tablet (General) Ointment (General)
HVAC system has been installed. |
| 3 | M/s Zesion Pharmaceuticals | Formulation | Dry Powder Suspension (General Antibiotic) HVAC system has been installed |
Item-III:(A) RENEWAL OF DRUG MANUFACTURING LICENSES . RECOMMENDED
On the recommendations of the panel of experts the Board renewed the Drug Manufacturing Licenses to the following firms subject to clearance of C.R.F. accounts and verification of HVAC system. The firms without HVAC facility will be granted renewal till 31st December, 2007: –
| S # | Name of Firm | Type of License | Duration |
| 1 | M/s Life Pharmaceutical Company, Multan | Formulation | (29.12..2004 to 28.12.2009) |
| 2 | M/s Pharmix Laboratories, Lahore. | Formulation | (28.06.2004 to 27.06.2009) |
| 3 | M/s Lahore Pharma, Lahore. | Formulation | (26.03.2006 to 25.03.2011) |
| 4 | M/s MBL Pharma Hub Blochistan. | Formulation | (04.03.2007 to 03..03.2012) |
| 5 | M/s Pakheim International Pharmaceuticals (Pvt) Ltd, Lahore. | Formulation | (2.01.2007 to 01.01.2012) |
| 6 | M/s Farm Aid Group Pakistan,
Hattar |
Formulation | (5.10.2005 to 24.10.2010) HVAC have been installed in Tablet Section (Human) |
Item-IV: MISCELLANEOUS
1. Change of name.
The Board approved the change of name to the following firm: –
i. M/s. Spencer Pharma (Pvt) Ltd., D-105, SITE, Karachi
DML # 000272 – Formulation
To
M/s Spencer & Co. (Pakistan) Ltd., D-105, SITE, Karachi
DML # 000272 – Formulation
ii. M/s Cardex Pharmaceuticals (Pvt.) Ltd.,
38-A, Industrial Estate, Hayatabad, Peshawar
DML # 000511 – Formulation
to
M/s CSH Pharmaceuticals – North (Pvt) Ltd.,
38-A, Industrial Estate, Hayatabad, Peshawar
DML # 000511 – Formulation
2. Site Verification.
Following sites verified for establishment of pharmaceutical units have been recommended for approval with certain conditions, are placed before the Board for approval or otherwise: –
| S # | Name of Firm / Applicant | Status | Condition | Remarks | Decision |
| 1 | M/s Meezab International Pakistan (Pvt) Ltd., Karachi. | A fertilizer Company exists adjacent to the proposed pharmaceutical unit. | Special precautionary and effective measures need to be taken in the layout plan and construction to avoid and possible contamination. | Rejected. | |
| 2 | M/s Skans Pharma, Sheikhupura | An under constructed oil unit lies adjacent to the proposed pharmaceuticals unit. | The under constructed oil unit is likely to produce obnoxious odour of smoke from the boiler that can deteriorate the quality of bleached cotton fiber being very adsorptive in nature which can harm the patient too. | The management have given undertaking that if the aforementioned oil unit produced obnoxious odour or smoke they will not demand the DML, | Rejected. |
| 3 | M/s S.S. Pharma, Faisalabad. | Un-classified area about 2-Km, away from main bypass chowk Faisalabad. Parallel to this plot is 6 feet wide agri-water course | Covering of 6 feet wide agri-water course and construction of unpaved road measuring 300 yards. | The firm has given an undertaking to fulfill the aforementioned conditions. | Approved. |
3. Rejection of Application for Renewal of Drug Manufacturing License of M/s Risma Laboratories Karachi.
The case of M/s Risma Laboratories Karachi was discussed in 206th meeting of the Board with reference to additional surcharge of Rs.45000/- for submitting renewal application 09 days late after expiry of validity period. The representative of the firm during personal hearing in 204th meeting agreed to submit the additional fee but did not comply later on.
Decision:
Rejection of renewal application, but the firm next day deposited the dues, therefore the renewal application approved.
4. Cancellation of Drug Manufacturing License of M/s B.I Drug Company, Mughalpur Lahore.
The case of M/s B.I. Drug Co, Mughalpura Lahore (residential unit) was discussed in the 206th meeting of the Board with reference to the show cause notice issued to the firm in the light of statement given by the firm regarding establishment of a new pharmaceutical unit at an appropriate site before 31.12.2005. The firm did not submit any reply to the show cause notice issued on 03.08.2006 and the reminders sent to the firm on 17.05.2007 was received back undelivered. The call letter was issued for personal hearing but no response was shown and the area FID Lahore also failed to contact with the management.
Decision:
Rejection of Renewal Application for Drug Manufacturing License.
5. Renewal of Drug Manufacturing License of M/s Orient Laboratories, Lahore.
The case of M/s Orient Laboratories, Lahore was discussed with reference to the show cause notice issued on 05.05.2006 for Good Manufacturing Practices non compliance and for being in residential area and subsequent decision of the Board in 198th meeting held on 10.06.2006 to re-inspect the unit.
The panel conducted inspection on 23.04.2007 and reported that no further improvements can be incorporated in the unit being very congested and firm may be allowed to conduct production in the current premises for a period of one year. Accordingly the representative of the firm was called for personal hearing. He requested the Board for grant of two years period for shifting of the unit.
Decision:
Grant of 1½ years period subject to the deregistration of some products and submission of progress report periodically
6. Renewal of Drug Manufacturing License of M/s Prawa Pharmaceuticals, Azad Kashmir.
The case of M/s Prawa Pharmaceuticals, Azad Kashmir was discussed in 206th meeting with reference to the explanation issued on 13.01.2007 in the light of panel inspection report. The firm did not submit any reply to the explanation letter and subsequent reminders issued on 28.03.2007 and 07.05.2007. The call letter was issued on 04.06.2007 for personal hearing but no person appeared before the Board.
Decision:
Rejection of Renewal Application for Drug Manufacturing License.
7. Renewal of Drug Manufacturing License- Pending Inspections.
The cases of pending renewal inspection was discussed in 206th meeting of the Board in the light of decision of the Board in 204th meeting held on 23rd – 24th February, 2007 to grant time period till 31st March 2007 to all those firms whose renewal is pending for more than two years.
Decision:
To strictly adhere to the rule 13 of Drugs (Licensing, Registering & Advertising) Rules, 1976, as panel member has affirmed their availability and also list of firms may be put up to Board who are not ready for inspection for the last 2 years. No fresh registrations would be granted to such companies and validity of DML and cGMP certification will not be granted for participation in the tenders.
8. Grant of Drug Manufacturing License – M/s Maple Pharmaceuticals (Pvt) Ltd., Karachi.
The case of M/s Maple Pharmaceuticals (Pvt) Ltd. Karachi was discussed in 206th meeting with reference to the decision taken in 204th meeting of the Board held on 23rd – 24th February, 2007 to conduct inspection for site verification to fulfill all the legal requirements pertaining to the grant of Drug Manufacturing License. The area FID has submitted site verification report of the unit, situated at Plot No.147, Korangi Industrial Area, Karachi and declared site suitable for conducting production of pharmaceuticals products.
Decision:
The Board decided to grant drug manufacturing license under the name M/s Maple Pharmaceuticals (Pvt) Ltd. However to ensure M/s Efroze Chemical Industries as an independent self contained pharma unit inspection may be conducted for renewal of drug manufacturing license.
9. Renewal Of Drug Manufacturing Licenses / Grant Of Additional Section of M/s . Venus Pharma Lahore .
The case of M/s Venus Pharma, Lahore was discussed with reference to the decision of the Board in 204th meeting held on 23rd -24th February, 2007 wherein the firm was directed to suspend production till removal of deficiencies within three moths time and the subsequent inspection conducted on 13.04.2007 by a panel of experts comprising Mr. Hyder Bux Bozdar, DDG (E&M), Mr. Abdul Rashid Sheikh, FID and Mr.Ghazanfar Ali Khan ADC. The panel recommended the renewal of the firm keeping in view the improvements made by the firm to upgrade the facility as per cGMP requirements. However panel did not include a member of the Board.
Decision:
The Board granted permission to resume production in the light of improvements made by the firm. For renewal of drug manufacturing license and grant of additional sections it was decided to re-inspect the firm by a panel including member of the Board.
The meeting ended with the vote of thanks to the Chair.