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. 


inside nclb left wing nclb enterance inside nclb right wing

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