Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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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. 



National Control Laboratory (Biological) was established in year 2000 to oversee the quality of  locally manufactured Biologicals Drugs; initially only NIH manufactured vaccines were included in this system latter on in the year 2007 this applied to all vaccine imported or locally manufactured.

Biologicals is a term used for all products which originate from biological material and are tested in a biological system. Presently there is a long list of products that are produced using some kind of animal cells, bacteria or yeast. Vaccines are the single largest component of the biological group.

All Biologicals fall under the jurisdiction of Drug Regulatory Authority of Pakistan.


Phone: 92 51 9255263




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Last modified: 17-Mar-2015