Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

NCLB implements Lot release and Lab testing of Biological Drugs as per Schedule I of DRAP Act, 2012 (Act No. XXI of 2012)

and is part of DRAP Authority under Section 3 of this Act.

DRAP Act, 2012 scanned pdf file. 

Http://www.dra.gov.pk

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S.R.O. 782(I)2000 Dated November 02, 2000

GOVERNMENT OF PAKISTAN
MINISTRY OF HEALTH
 

S.R.O. 782 (I)/2000, - The following draft certain amendments in the Drugs (Licensing, Registering and Advertising) Rules, 1976, which are proposed to be made in exercise of the powers conferred by section 43 of the Drugs Act, 1976 (XXXI) of 1976, are hereby published, as required by sub-section (3) of the raid section, for the information of all persons likely to be affected thereby and notice is hereby given that the draft will be taken into consideration after fifteen days of its publication in the official Gazette.

2. Any objection or suggestion which may be received from any person in respect of the said draft before the expiry of the said period will be considered by the Federal Government.

DRAFT AMENDMENTS

In the said Rules:-

(1) In rule 2, after clause (bb) the following new clauses shall be inserted namely:-

(a) "(be) 'Lot Release' means an approval for the release into the market of a specific lot of a biological drug, based upon certification that the lot meets the in-process controls and control tests on final product."

(b) "(bd) 'biological drugs' means medicinal products produced by biological systems and which require standardization by biological assays and includes -

(i) blood products including Plasma, Albumin, Clotting Factors, Factors VIII, IX, Mixed Clotting Factors Tractions, Fibrinogens, Immunoglobulins.

(ii) immunological products including Antisera, Antitoxins, Monoclonal Antibodies, Specific Immunoglobulins:

(iii) in vivo diagnostics including Tuberculins, Lepronin, Histoplasmin, Coccidioidin, Allergens, Allergens Extracts, Antibodies conjugated with isotopes for imaging studies Antigens, Cytokines/Antibodies/Cells injected to elicta biological response;

(iv) vaccines:-

(a) bacterial including live, killed whole cell, protein sub unit, polysacchride or glyconjugate, toxin derivatives. rDNA.

(b) viral including Live, Inactivated, sub-unit, rDNA:

(v) toxins and Venoms including snake venoms;

(vi) immunostimulants of biological origin including BCG vaccine for immunotherapy;

(vii) biotechnology products including rDNA products recombinant antibodies, Monoclonal Antibodies and derivatives Gene therapy Products"; and

(2) In rule 30, after sub-rule (9), the following new sub-rule shall be added, namely:-

"(10) No biological drug, whether imported or locally manufactured shall be released for sale, unless a "Lot Release Certificate" is obtained from the Federal Government Analyst, National Control Laboratory for Biologicals,

Provided that the Registration Board may, for the reasons to be recorded in writing, allow the sale of a lot in an exigency in the public interest".

       

[No. F. 27-2/2000-NCA-QC.]

MUHAMMAD DIN,
Deputy Secretary (Admn.).

 

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