DOC

A

By Ray Elliott,2014-04-15 02:38
11 views 0
The meeting started with the recitation o the Verses from the Holy Qura'n. The following decisions were recorded: - Item-II (A): GRANT OF NEW DRUG MANUFACTURING LICENSE Caster Oil. Zinc Oxide. Boric Acid. Sulphur (Precipitated)

     THMINUTES OF THE 198 MEETING OF THE CENTRAL LICENSING BOARD

    HELD ON 10.06.006

     th The Director General Health, Dr. Abdul Majid Rajput, chaired the 198 meeting

    thof the Central Licensing Board held on 10 June, 2006 in the Committee Room of Ministry of

    Health, Islamabad. The Chairmen welcomed all the members of the Board. The following

    members attended the meeting: -

    1. Maj. Gen. ? M.I. Burney HI (M), SI,

    National Institute of Health Islamabad.

    2. Brig Muzammil Hassan Najmi,

     Professor of Pharmacology and Head of Department,

     Army Medical College,

     Rawalpindi

    3. Lt. Col. Aslam Khan,

     Pulmanologist,

     Army Medical College,

     Rawalpindi

    4. Dr. I.U. Baig,

     Federal Governments Services Hospital

     Islamabad.

    5. Dr. Ijaz Ahmed,

    Associate Professor,

    University of Veterinary and Animal Sciences,

    Lahore

    6. Dr. Muhammad Akram

    Asstt. Animal Husbandry Commissioner,

    Representative M/o Food, Agricultural & Live stock,

    Islamabad.

    7. Dr. Ikram-ul-Haq

    Director, DTL

    Representative o Director General Health Services,

    Government of Punjab,

    Lahore

    8. Representative o Director General Health Services,

    Government of NWFP,

    Peshawar.

    - 2 -

    9. Director General Health Services,

    Government of NWFP,

    Quetta.

    10. Mr. Attaullah Khattak

    Assistant Chief (Inv-I),

    Representative of M/O Industries & Production,

    Islamabad.

    11. Mr. Amanullah,

    Cost Accountant

    Ministry of Health

    Islamabad

    12. Dr. Farnaz Malik, Secretary

     Drugs Controller,

     Ministry of Health,

    Islamabad

    13. Mr. Babar Mahmood Choudhary Observer

     Representative of

     Pakistan Pharmaceutical Manufacturers Association,

     Karachi.

     14. Mr. M Zafar Mooraj, Observer

     Representative of Pharma Bureau,

     Karachi.

     15. Representative of Observer

    Pakistan Chemists and Druggists Association

    Karachi.

     16. Mr. Ayaaz Kiani, Observer

     Executive Director,

     The Network for Consumer Protection,

     Islamabad.

    The meeting started with the recitation o the Verses from the Holy Qura’n. The following decisions were recorded: -

Item-I: CONFIRMATION OF THE MINUTES OF 196th MEETING.

     nd The Board confirmed the minutes of the 196th meeting held on 22 - 23rd

    February, 2005.

    Item-II (A): GRANT OF NEW DRUG MANUFACTURING LICENSE

     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 Hafiz Pharma, Formulation Cotton and Bandages.

    G.T. Road, Distt:

    Gujranwala. Repacking Items:

     Liquid Paraffin

    Glycerin

    Caster Oil

    Zinc Oxide

    Boric Acid

    Sulphur (Precipitated)

    Sodium Benzoate

    Magnesium Sulphate

    Potassium Iodide

    Sodium Thiosulphate

    Salicylic Acid

    Calamine Powder

    Gentian Violet

    Zinc Sulphate

    2 M/s Cherished Formulation Oral Powder (Veterinary)

    Pharmaceuticals Liquid Oral (Veterinary)

    (Pvt) Ltd., Liquid Injectable (Veterinary)

    Lahore

3 M/s High-Q Formulation Section:

    Pharmaceuticals, Tablet (General)

    Karachi. Tablet (General Antibiotic/Quinolone)

     Tablet (Psychotropic)

    Liquid (General)

    Capsule (General)

4 M/s M/s E-Pharm Formulation Section:

    Laboratories, Liquid (General)

    Karachi. Tablet (General)

     Ointment / Cream

     Injectable Liquid

     Capsule (Cephalosporin)

    Dry Syrup (Cephalosporin)

    Dry Powder Injectable

    (Cephalosporin)

    Item-II (A): GRANT OF DRUG MANUFACTURING LICENSE.

     While considering the case of M/s Jassh Pharmaceuticals, Lahore for grant of new

    Drug Manufacturing License, it was pointed out that the inspection team does not include

    member of the Board. The Board therefore, decided to get the unit re-inspected by the panel by

    including member of the Board.

    Item-II(B): GRANT OF ADDITIONAL SECTION ALREADY LICENSED

    UNIT (RECOMMENDED)

     On the recommendation of the panel of experts the Board approved the following

    additional sections: -

    S # Name of Firm Type of Sections

    License

    1 M/s Medera Pharmaceuticals Formulation Tablet (General Antibiotic)

    (Pvt) Ltd., Islamabad Capsule (General Antibiotic)

    They will manufacture these items

    on campaign basis in Tablet

    (General) & Capsule (General)

    sections.

2 M/s S.J. & J G. Fazull Ellahi Formulation Dry Powder Injectable

    (Pvt) Ltd., Karachi (Cephalosporin)

    3 M/s Pharmacare Labs (Pvt) Formulation Capsule (Cephalosporin)

    Ltd., Lahore Dry Powder Suspension

    (Cephalosporin)

    4 M/s Chemiworld (Pvt) Ltd., Formulation Additional Items:

    Peshawar

    Iron (III) Hydroxide Polymatose

    Complex (Syrup Grade)

    5 M/s Bosch Pharmaceuticals Formulation Dry Suspension (Penicillin)

    (Pvt) Ltd., Karachi Capsule (Penicillin)

    Injectable (Penicillin)

Item-II: (C) GRANT OF ADDITIONAL SECTION ALREADY LICENSED UNIT

    (RECOMMENDED)

     The Central Licensing Board considered the case for following additional sections of M/s

    Saydon Pharmaceuticals Industries (Pvt) Ltd., Peshawar which were approved by the Central

    Licensing Board in its 188th meeting held on 28.12.2004 but, approval letter was held up due to

    clearance of Central Research Fund: -

     1. Injectable Dry Powder

     2. Injectable Liquid

     3. Infusion small volume

     The Board while considering the case observed that since provision of HVAC system is

    necessary as per policy, therefore, the firm will have to provide the said facilities for the

    aforesaid sections.

     The Board therefore, decided that approval for additional section to the firm be granted

    after verification of installation of HVAC system.

    Item-III RENEWAL OF DRUG MANUFACTURING LICENSERECOMMENDED

     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. account: -

    S # Name of Firm Type of Duration

    License

    1. M/s Pharmacare Labs Formulation (13.06-2004 to 12-06-2009)

    (Pvt) Ltd., Lahore

    2. M/s Sarco Chemical Formulation 20.09.2004 to 19-09-2009)

    Industries, Multan

    3. M/s Eli Lilly Gohar (Pvt) Formulation (15.07.2004 to 14.07.2009)

    Ltd., Karachi

    4. M/s Macter International Basic (24.11.2004 to 23.11.2009)

    (Pvt) Ltd., SITE., Karachi Manufacture

    5. M/s Delux Chemical., Formulation (09.01.2006 to 08.01.2011)

    Industries, Karachi

    6. M/s Bliss Industries Ltd. Formulation (21.12.2005 to 20.12.2010)

    Karachi

    7. M/s Mediate Formulation (18.11.2005 to 17.11.2010)

    Pharmaceuticals (Pvt)

    Ltd., Karachi

    8. M/s Platinum Formulation (07.08.2005 to 06.08.2010)

    Pharmaceuticals (Pvt)

    Ltd., Karachi

    9. M/s Libra (Pvt) Ltd., Formulation (17.11.2005 to 16.11.2010)

    Peshawar

    10. M/s Roche Pakistan Ltd., Formulation (09.02.2006 to 08.02.2011)

    Karachi

    11. M/s Adamjee Formulation (10.02.2006 to 09.02.2011)

    Pharmaceuticals (Pvt)

    Ltd., Karachi

    12. M/s Shahbaz Laboratories Formulation (25.10.2004 to 24-10-2009)

    Hyderabad

    13. M/s Silver Oak Formulation (27.10.2005 to 26.10.2010)

    Corporation

    Hattar.

ITEM-III: RENEWAL OF DRUG MANUFACTURING LICENSES

     RECOMMENDATION NO CLEAR

    1 M/s Farband International, Formulation While, considering the inspection

    Lahore report conducted on 09.03.2006 for 16.10.2004 to 15.10.2009

    renewal of license, the Board

    observed that the panel of experts

    had rated the firm as satisfactory and

    recommended the renewal of license

    for the period of two years, whereas,

    the duration of license is five years

    under the rules.

    The Board decided to defer the

    renewal of drug manufacturing

    license till the firm improve to a

    “Good” level. Re-inspection.

ITEM-III (B): RENEWAL OF DRUG MANUFACTURING LICENSES -NOT

     RECOMMENDATION NO CLEAR

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

     A panel had been constituted as per confirmation by the firm that shortcomings /

    rectifications required have been fulfilled for re-inspection for the purpose of renewal of license.

    The Board decided that the case for renewal of license be considered in the light of report of the

    panel.

Item-IV: CHANGE OF NAME

     The Board approved the change name of the following firms: -

    1. M/s Medipak Pharma Industries Limited., Lahore

     DML No. 000257 (Formulation)

     to

     M/s Medipak Limited, Lahore

     2. M/s Drugpharm Corporation, Lahore.

     DML No.000366 (Formulation)

     to

     M/s Drugpharm (Private) Limited, Lahore

Item-V (A): MISCELLANEOUS

    APPROVAL OF ABBREVIATED ADDRESS

     The Board approved the abbreviated address of M/s Abbott Laboratories (Pakistan) Ltd., Karachi from: -

     M/s Abbott Laboratories (Pakistan) Ltd., Karachi.

     Opp: Radio Pakistan Transmission Center,

     Hyderabad Road, Landhi, Karachi

to

     M/s Abbott Laboratories (Pakistan) Ltd.,

    Landhi, Karachi.

Item-V (B): MISCELLANEOUS

(A) RENEWAL OF DRUG MANUFACTURING LICENSE SHOW CAUSE NOTICES

    ISSUED - PERSONAL HEARING THEREOF

1. M/s Sulson Pharmas, 10-Old F.C.C. Ferozepur Road, Lahore.

     The renewal of drug manufacturing license of M/s Sulson Pharmas, Lahore was due for

    the period 17.01.2000 to 16.01.2005. A panel of inspectors of experts had carried out the

    inspection on 02.03.2005 and 24.03.2005. While it was reported that the unit was located in a

    residential area and conditions in the unit was not inconformity with the conditions of license /

    good manufacturing Practices as laid down under rule 16 of the Drugs (Licensing, Registering &

    Advertising) Rules, 1976. Accordingly, a show cause notice had been given to the firm and their

    Chief Executive / Managing Director called for personal hearing.

     Mr. Bashir Ahmed, Advocate appeared before the Board for personal hearing on behalf

    of the company. While defending the case he had stated that to stop production was not justified

    and without lawful authority. He has further added that the amendments that para-2(k) of

    schedule to the Drugs (Licensing, Registering & Advertising) Rules, 1976 was incorporated on

    31.05.1983 and therefore, the said conditions is not applicable in their case.

     The Board after having heard the presentation of the advocate, decided to re-inspect the

    unit.

    2. M/s Orient Labs. (Pvt) Ltd., 2-A New Town, Opp. Benz Factory, Multan Road,

    Lahore

     The inspection of the unit M/s Orient Labs (Pvt) Ltd., Lahore was conducted by the Federal Inspector of Drugs on 07.07.2005 had reported that the unit was situated in a residential area and noted a number of shortcomings / observations. Accordingly, a show cause notice had been given to the firm and their Managing Director was called for personal hearing.

     Sheikh Zubair Iqbal, Chief Executive of the firm, alongwith his advocate Mr. Ziaullah appeared before the Board for personal hearing. The advocate while defending the case had stated that the Federal Inspector of Drugs was not authorized to stop the production and his action was without lawful authority. The stoppage of production for one month by the Federal Inspector of Drugs, was violation of section 19 (7) of the Drugs Act, 1976. As regard the location to their unit in the residential area he had added that para 2(k) of schedule to the Drugs (Licensing, Registering & Advertising) Rules, 1976 was inserted on 31.05.1983 and therefore the said amendments is prospective and not retrospective and therefore not applicable in this case.

     The Board after having heard the presentation of the representatives of the firm and taking into consideration the facts of the case, decided to re-inspect the unit.

     While discussing the case of the aforesaid firms the Board also observed that since the units of M/s Schazoo Labs and M/s Remington Pharma are also situated in the residential area, therefore, the position shall be verified for further necessary action

    3. M/s Nafar Pharmaceuticals Labs (Pvt) Ltd., 27/28-B, Industrial Estate, Jamrud

    Road, Peshawar.

     The renewal of drug manufacturing license of M/s Nafar Pharmaceuticals Labs (Pvt) Ltd., Peshawar was due for the period 07.09.2005 to 06.09.2010. A panel of inspectors / experts had carried out the inspection their premises on 19.11.2005. Whereas the panel had not recommended the renewal of license and noted that a number of deficiencies which were directed to rectify previously were still available besides the drug manufacturing license was granted on Plot No.27-28-B, but Plot No.27 was reported by the FID to be sold out. Accordingly, a show cause notice had been issued to the firm, and their Chief Executive / Managing Director called for personal hearing.

     Mr. Muhammad Nadeem Gul, Chief Executive of the firm appeared before the Board for personal hearing. He had submitted written arguments stating that he has purchased this unit on January, 2006 and the new management took over the charge of unit on 17.02.2006 and presented Form-29 giving particulars of the new Directors. While pleading his case he had added that he had invested an amount of Rs.10 Million to bring the unit in accordance with the GMP requirements. He had presented a certificate issue from the Industrial Estate, Peshawar, Sarhad Development Authority, confirming that the unit is located on Plot No.27B and 28-B, measuring 12000 sq.ft.

     The Board after having heard the presentation of the new Chief Executive of the firm and taking into consideration of the case decided to re-inspect the unit.

4. M/s Shamsi Pharmacy, Justice Sharif Scheme, Samanabad, Lahore.

     The renewal of drug manufacturing license of M/s Shamsi Pharmacy, Lahore was due for the period 12.08.2000 to 11.8.2005. A panel of inspectors / experts had carried out the inspection of their premises on 30.05.2001. Whereas the case was considered by the Central Licensing Board in its 161st meeting held on 04.05.2001 and in its 167th meeting held on 11- 12 December, 2001 and Mr. Mehfoozul Haq Khan, Advocate and Mr. Faisal Maqbool, Proprietor of the firm appeared before the Board giving the assurance that they will shift the unit to the new premises within two months time. Whereas the Federal Inspector of Drugs, inspected the unit on 20.12.2005 and reported that the existing unit was located in the residential area and conditions in the existing unit were not inconformity with the conditions of license / GMP as laid down under rule 16 of the Drugs (Licensing, Registering & Advertising) Rules, 1976. Besides in the new proposed unit machinery equipment and quality control laboratory instruments were not installed. Accordingly, a show cause notice had been issued to the firm, and the Proprietor of the firm called for personal hearing.

     Mr. Faisal Maqbool, Proprietor of the firm appeared before the Board for personal hearing he informed the Board that they have shifted most of the machinery to the new premises and now setup of the laboratory is under process and requested that they may be given time for shifting upto September, 2006. He added that if they failed to shift the unit within the stipulated period the Board may take necessary action under the rules and they will never make request for further extension of time for shifting of unit.

     The Board after having heard the details presentation of the Proprietor of the firm and taking into consideration of the case decided to acceded to request of the firm fro giving time for complete shifting.

    5. Status of Drug Manufacturing License of M/s M/s Biosynth Pharma (Pvt) Ltd., at

    the premises, 334-Lane-5, Peshawar Road, Rawalpindi and the Progress report of

    the new unit.

     M/s Biosynth Pharma (Pvt) Ltd., had suspended the production activities in the existing premises, 334-Lane-5, Peshawar Road, Rawalpindi, whereas, the firm had also made an application for renewal of license at the existing premises. The layout plan was approved for establishment of a new pharmaceutical unit at plot No.41, Kamal Industrial Estate, Taxila, on 25.06.2005. Therefore, the Chief Executive of the firm called for personal hearing before the Board.

     Mr. Javed Iqbal Chichti, Chief Executive of the firm appeared before the Board for personal hearing. The Chief Executive of the firm informed the Board that the Production activities were suspended in the existing unit as it was a rented building. The renewal application was made as it was shifting case from residential to an industrial area where their new unit is near to completion. He has given the assurance that the construction of the new unit will be completed within six months time. He added that he had submitted the progress report of the new unit by sending photographs etc.

     The Board appreciated the action taken by the firm to shift the existing unit from residential to an industrial area and the assurance given by the firm to shift the unit within six months time.

Report this document

For any questions or suggestions please email
cust-service@docsford.com