DECISIONS OF 186TH MEETING OF THE CENTRAL LICENSING BOARD HELD ON 13-14TH OCTOBER, 2004

 

 

The Director General Health, Dr. Abdul Majid Rajput, chaired the 186th  

meeting of the Central Licensing Board held on 13th – 14th October, 2004 in the

Committee Room of Ministry Health, Islamabad. The following members attended the meeting: -

 

1.                  Maj. Gen. ® Nasir-ul-Islam,

Rawalpindi.

           

            2.         Maj.Gen. Shujaat Hussain, SI(M), HI (M),

                        Principal Army Medical College,

Rawalpindi

 

3.         Dr. Rafaqat Hussain Raja,

Animal Husbandry Commissioner,

M/o Food, Agriculture and Livestock,

Islamabad.

 

4.         Prof. Shahnawaz,

Professor of Pharmacology and Head of the Department,

Ayub Medical College,

Abbottabad.

 

5.         Shaikh Ansar Ahmed,

Cost Accountant,

Ministry of Health,

Islamabad.

 

6.         Dr. Ijaz Ahmed,

Associate Professor,

University of Veterinary and Animal Sciences,

Lahore

 

            7          Dr. I.U. Beg,

                        Association Surgeon,

                        Federal Government Services Hospital,

                        Islamabad.

 

8.         Mr. Sabir Ali, 

(Representative of Director General Health Services

Government of NWFP),

Peshawar.

 

 

9.         Syed Abdul Saleem 

(Representative of Director General Health Services

Government of Balochistan),

Peshawar.

 

10.       Mr. Attaullah Khattak,

                        Chief Research Officer,

                        Ministry of Industries and Production,

                        Islamabad.

 

11.       Dr. Farzana Chowdhary,                                              Secretary

                        Drugs Controller,

                        Ministry of Health,

Islamabad

 

12.       Mr. Amjad Ali Jawa,                                                    Observer         

                        Representative of

                        Pakistan Pharmaceutical Manufacturers Association,

                        Islamabad.

 

 

Item-II:           NEW DRUG MANUFACTURING LICENSES GRANTED.

 

                       

 On the recommendations of the panel of experts the Board approved the grant of Drug Manufacturing Licenses to the following firms:-

 

Sl.No.

Name of the firm

Type of License

Sections

1.

M/s  Attabak Pharmaceuticals, Islamabad    

Formulation

(Veterinary)

 

 Liquid, Powder, Injectable

2

M/s  Zafa Surgitex, Nooriabad, Dadu

 

Formulation

 

 

Surgical Bandages and

Crepe Bandages

3

M/s Farmaceutics International, Karachi

 

 

Formulation

 

Tablets (Non Quinolone)

Tablets (Quinolone)

Capsules (Quinolone)

Capsules (Non Quinolone)

Dry Syrup (Non Quinolone)

Dry Syrup (Quinolone)

Liquid Syrup

Sterile Liquid Ampoules/ Vial Injectable

Sterile Ophthalmic Drops &

Ointments

 

4

M/s Aneeb Pharmaceutical (Pvt.) Ltd., Lahore

Formulation

Tablet (General) &

Capsules (General)

 

5

M/s Festel Laboratories,

Lahore

 

Formulation

 

Tablet (General),

Tablet (Macrolid),

Tablet (Quinolone)

 

 

Item-III:         ADDITIONAL SECTIONS OF ALREADY LICENSED UNITS GRANTED

 

 

 

Sl.No.

Name of the firm

Type of License

Sections

 

1

M/s Ophth Pharma (Pvt.) Ltd., Karachi

 

Formulation

 

 

Surgical Sutures.

 

2

M/s Sapient Pharma, Lahore

 

Formulation

 

Suppositories

 

 

 

 

Item-IV:          RENEWAL OF DRUG MANUFACTURING LICENSES GRANTED.

                                   

           

 

Sl.No.

Name of the firm

Type of License

Duration

 

1.

M/s Stanley Pharmaceuticals (Pvt.) Ltd., Peshawar

 

Formulation

 

 

(16.6.2004 to 15.6.2009)

2.

M/s Bryon Pharmaceuticals (Pvt.) Ltd., Peshawar

 

Formulation

 

(26.6.2004 to 25.6.2009)

 

3

M/s English Pharmaceutical Industries, Lahore

Subject to clearance of CRF within 30 days.

 

Formulation

 

(19.7.2004 to 18.7.2009)

 

4

M/s Rakaposhi Pharmaceutical (Pvt.) Ltd., Peshawar

 

Formulation

 

(21.6.2004 to 20.6.2009)

 

 

5

M/s PharmaWise Labs. (Pvt.) Ltd., Lahore

 

The Board also advised that they should rectify the shortcoming, identified by the panel.

.

Formulation

 

(21-12-1999 to 20.12.2004)

 

 

 

 

 

Item V             MISCELLANEOUS

 

 

1.                     M/S HOME CHEMICAL INDUSTRIES LAHORE.

 

                                               

                        On the request of the firm the Board decided to reconstitute panel of inspection, comprising: -

 

            1.         Dr. Farazana Chowdhary,        

                        Drugs Controller, Ministry of Health, Islamabad.

 

            2.         Dr. Ikram-ul-Haq,

                        Health Department,

                        Government of Punjab, Lahore

 

            3.         Dr. I.U. Beg,

                        Associate Surgoen,

                        Federal Government Services Hospital,

                        Islamabad.

 

4.                  Dr. Shaikh Akhtar Hussain,

Federal Inspector of Drugs, Lahore

 

5.                  Area Assistant Drugs Controller, Lahore

 

  

2.                     M/S BIOTIC PHARMACEUTICALS, MULTAN ROAD, LAHORE -SITE VERIFICATION

 

                       

                        The Board decided to reject the proposed site for establishment of the Pharmaceutical unit for not

complying with requirements of rues under schedule ‘B’.  

 

  

3.                     M/S UNITED DRUG COMPANY, LAHORE.

 

            The Board decided to get the unit re-inspected after prior notice and coordination of the management.

 

  

4.                     PENDING CASES OF CENTRAL RESEARCH FUND.

 

                        Considering that M/s Hassan Pharmaceuticals, Peshawar, despite repeated notices, had failed to deposit/clear their  Central Research Fund as a condition of Drug Manufacturing License, the Board decided to issue final notice to the firm.

 

 

5.                     IMPLEMENTATION STATUS OF THE AMENDMENTS IN THE DRUGS ACT 1976.

 

 

                        The Board requested Maj. Gen. Shujaat Hussain, SI(M), HI (M), for  examining the whole issue of implementation

                        of the amendments in the Drugs Act 1976, with such assistance as he may like, and give his recommendations.

 

 

                        The meeting ended with a vote of thanks to the chair.

 

 

 

 

 

(SALVANA NADEEM)

Deputy Drugs Controller (L&A)