Ministry of National Health Services, Regulations and Coordination
Drug Regulatory Authority of Pakistan
National Control Laboratory for Biologicals
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.
Presently Biological Drugs are being registered and licensed under Drugs Act, 1976 and Drugs (Licensing, Registration & Advertising) Rules 1976.
Biological Drugs are manufactured under strict cGMP Rules
Biological Drugs are compared to WHO specification that are referred to in the Drugs Specification Rules, 1978.
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