Ministry of National Health Services, Regulations and Coordination

Drug Regulatory Authority of Pakistan

National Control Laboratory for Biologicals

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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.

2021 is 21st year of service of NCLB


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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



List of Products presently under going Lot Release Performance of NCLB Lot Release system from 2007 onwards  

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Last modified: 13-Jul-2021