Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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Drug Laws

All function of NCLB are now under DRAP Act, 2012 (Act No. XXI of 2012) and all previous actions and SROs are protected.

Lot Release is now under Schedule I, and NCLB is part of DRAP under Section 3 of this Act.

For detailed description of various aspects of DRAP Act, 2012 visit this link


DRAP Act, 2012 pdf file. 


Drugs Act 1976
Import & Export Rules
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 compared to WHO specification that are referred to in the Drugs Specification Rules, 1978.

Similarly the import and export is also under Export & Export Rules.

DBER is now under process of formulating specific rules adopting the already existing Drug Laws and Rules and synchronize them with international best practices applicable to Biological Drugs.



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Last modified: 17-Mar-2015