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.
DIVISION OF BIOLOGICAL EVALUATION AND RESEARCH
This Division is one of the thirteen Divisions of the Drug Regulatory Authority of Pakistan dealing specifically with Biological Drugs.
Legal Background: Section 4 (e) of DRAP Act, 2012. The Division is to headed by Director Biological Drugs, following are the functions:
Section 4 (e): "Director Biological Drugs.- He shall be incharge of the Division of biological evaluation and research which shall be responsible for the evaluation, assessment, registration and licensing of biologicals for human beings, animals and to perform other functions connected therewith including all the functions of national control authority for biologicals as required for the prequalification by World Health Organizations of locally manufactured human biological drugs;"
Section 2 (xi): “Director” means director of a department of the Authority;
Section 2 (v) “biologicals” means biological drugs as defined in Schedule-I
Director Biological Drugs
phone: 051 9262174
fax: 051 9107318
Postal address: Fourth Floor, TF Complex, 7-Mauvve Area, G-9/4, Islamabad.
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