Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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4. L & GMP IMU

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. 



Licensing and GMP Inspection of Manufacturing Units (LIMU)

All local manufacturers need to have a valid drug manufacturing license and twice yearly cGMP inspection reports.

For cGMP inspection 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