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.
At the time of independence there were no vaccine manufacturing units in the country. A small group of Army Medical Corps (AMC) personnel headed by Col Afridi and twelve technician started the Biological industry of Pakistan in 1948 and become the pioneers of this industry by manufacturing typhoid and cholera vaccine in Korangi barracks in Karachi. This unit was named as Bureau of Laboratories, Karachi (BOL) and it become the mother of today's National Institute of Health, Islamabad (NIH).
BOL was shifted to Islamabad in 1965, initially it worked in the Chaklalla airport area army barracks for two years before it was permanently housed in the present NIH premises.
BOL became a centre of excellence according to the techniques of the time, it graduated into a modern vaccine manufacturing unit in 1980's and was renamed as Biological Production Division (BPD) of the NIH which became an autonomous body.
BPD carried on the tradition of manufacture of good quality vaccine and antisera. Million of children were immunized with the vaccine manufactured by BOL and BPD.
Global eradication of small pox during the late 1970s encouraged the developed countries to shift their focus to preventive immunization through vaccination. Hence an Expanded Program of Immunization (EPI) was also started in Pakistan. To cater the needs of increase in demand of vaccines such as measles, Polio, tetanus, diphtheria, pertussis, BCG, and rabies, NIH established new manufacturing units with the financial and technical assistance from CIDA, UNICEF, WHO, and USAID.
At the start of Expanded Program on Immunization manufacture of Oral Polio Vaccine was started with the technical technology transfer assistance through Canadian International Development Agency (CIDA). A Canadian firm then named Connaught Laboratories Limited, Canada was the source of technology transfer to Pakistan, this firm is now called Sanofi Pasteur Canada. Similar technology transfer agreements led to the establishment of basic manufacture of cell culture Measles and Rabies vaccines through CIDA and Tetanus Toxoid vaccine through USAID.
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