Ministry of National Health Services, Regulations and Coordination

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


DRAP Act, 2012 pdf file. 


Biologicals in PK
1. Lot Release
2. Lab. Testing
3. Product Reg.
4. L & GMP IMU
5. Clinical Trials
6. AEFI and PMS
NCAB Project
Related links
Drug Laws


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.


Information for Public Use

 What are Biologicals?

 Are all Biologicals safe?

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

 Is there any allergic content in the Biologicals?

   How is Pakistan ensuring the quality of Biologicals?


Information for the Importers, and



NCLB Pakistan Guidelines     

A quick guide for Lot release
(download in pdf format)  

The Lot Release System is based on:- Summary Protocol Review.

According to Word Health Organization (WHO) the primary responsibility of the quality of a Biological Drug rests with the manufacturer. The national regulatory authorities of each country assures that the manufacturers are performing necessary control measures at each level of production through regular inspection, testing and  batch production record review process that is applied on each lot manufactured in the country...

WHO guidelines for national authorities on quality assurance for biological products.
TRS 822, Annex 2.

Brocher of NCLB

Guidelines for Licensing / Registration of Biological Drugs

(download new pdf format)


Registration and licensing of biological products.

TRS 858, Annex I.

Guidelines for cGMP Inspections of Biological drugs Manufacturers

download new pdf format) 


Biological products, GMP

Title: Good Manufacturing Practices for biological products; Adopted 1991,

TRS No 822, Annex 1




nclb enterance

inside nclb left wing inside nclb right wing

the whole picture-NCLB NCAB

Federal Government Analyst for Biological Drugs

Contact Information

+92 51 9255263
+92 51 8312640
Postal address
NCLB at NIH premises, NIH Chak Shazad, Islamabad. Pakistan.
Electronic mail
General Information:;


[ Home ] Biologicals in PK ] 1. Lot Release ] 2. Lab. Testing ] 3. Product Reg. ] 4. L & GMP IMU ] 5. Clinical Trials ] 6. AEFI and PMS ] NCAB Project ] Related links ] Drug Laws ]

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Last modified: 17-Mar-2015