Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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Drug Laws

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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cGMP RULES
Drugs Act 1976
Drugs Spec Rules 1978
Drugs LRA rules, 1976

Presently Biological Drugs are being registered and licensed under Drugs Act, 1976 and Drugs (Licensing, Registration & Advertising) Rules 1976.

Biological Drugs are manufactured under strict cGMP Rules

Biological Drugs are compared to WHO specification that are referred to in the Drugs Specification Rules, 1978.

 

 

 

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Last modified: 01-Sep-2018