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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

Http://www.drap.org.pk

DRAP Act, 2012 pdf file. 

 

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Information for Public Use

 What are Biologicals?

Biologicals is a term generally used to describe immunogens derived from a biological system. Modern Vaccines, antisera and Biotechnology products are included in this definition. Immunogens are those high molecular weight protein molecules that are capable of triggering an immune response either in the form of IgG or cell mediated response.

 Are all Biologicals safe?

Generally Biologicals are considered safe, because when a Biological is commercially available it has a past history of development comprising of different stages of safety testing. However, when in field some Biologicals may cause some reaction in individuals which are recorded as Adverse Events Following immunization or AEFI. this behavior is normal and is investigated to show that the product causing AEFI is within the defined limits. In case the response is severe or uncalled for the Biological in question is immediately stopped from being used and is ultimately recalled from market.

 What are the safety issues in the use of multiple Biologicals?

Multiple Biologicals are used in some case of treatment, for example in case of rabid animal bite Cell Culture Vaccine is given as well as Rabies Immune Serum is used at the site of bite. This is necessary to neutralize free virus at the site of bite using IgG and to trigger the immune response for longer protection using the vaccine antigen.

 Is there any allergic content in the Biologicals?

Sometimes the components of vaccines, which are in very minute quantity, may trigger an allergic reaction. Components such are antibiotics, or some antigens derived from eggs of poultry, or hyper immune sera derived from horses may cause allergic reactions. Generally these reaction are very rare, but for the person allergic to constituents of vaccine it is important to have the necessary protective measures ready before using a Biological.

   How is Pakistan ensuring the quality of Biologicals?

Government of Pakistan through Ministry of Health has ensured that only safe Biologicals are registered and only safe batches of registered vaccine are imported. For this purpose every batch or lot of biological imported in the country goes through a procedure of lot release. Since this system was started in 2007, no failure of quality has been reported.

 

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Last modified: 17-Mar-2015