Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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3. Product Reg.

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. 



Market Authorization (Product Registration)

Market Authorization or Product registration is the first step, all drugs put up for sale needs to be registered under the Drug Act 1976.

For the registration of the Biological Drugs the guiding document is available. This document was developed with the assistance of W.H.O. Right Click on the image and download.


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Last modified: 17-Mar-2015