Ministry of National Health Services, Regulations and Coordination
Drug Regulatory Authority of Pakistan
National Control Laboratory for Biologicals
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
National Control Laboratory for Biologicals (NCLB)
NCLB specifically deals with the Biological Drugs defined under DRAP Act, 2012.
1. How is Lot Release applicable to imported batches?
This is clarified that Lot Release is applicable to each lot in every shipment. If the same lot is imported once gain but at a different time and shipment the Lot Release shall still apply.
2. A question has arises whether field samples of a lot released by NCLB may be retested by NCLB?
This is clarified that Lot Release and testing of field samples are two different procedures and both are the responsibility of the NCLB. Field samples collected from one city may have different results from samples of the same lot collected from another city. Therefore, they are to be tested by the NCLB separately without any doubt and confusion even if they were passed earlier by NCLB.
Lot release certificate guarantees the required potency of the vaccines or other temperature sensitive biologicals only when they are stored at proper temperature, otherwise test reports of samples of the same lot stored under two different storage conditions could not be the same.
3. A question has earlier arisen whether veterinary vaccines are to be included in the definition of "Biological Drugs" or not for the purpose of "Lot release"?
Academically and scientifically veterinary vaccines are "Biological drugs" but for the purpose of "Lot Release" W.H.O. Guidelines are followed that relate to human biological drugs only; veterinary vaccines are covered by World Organization for Animal Health (OIE), these vaccines presently do not require "Lot Release", a few brands of avian influenza vaccines may required quality control by the National Veterinary Laboratory and this is mentioned on the Registration Letter issued by the GOP.
Federal Government Analyst for Biological Drugs
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