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National Institute of Biologicals

(राष्ट्रीय जैविक संस्थान)

Ministry of Health & Family Welfare, Government of India

स्वास्थ्य एवं परिवार कल्याण मंत्रालय,भारत सरकार
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Historic Perspective

National Institute of Biologicals  an autonomous Institution under the Ministry of Health & Family Welfare (MOHFW)-Government of India, was set up in January, 1992 to act as the national control laboratory for assuring the availability of high standard and good quality biological products for consumption in India and for exports. It was set up as a society  (vide No. S-22590) under the Societies Registration Act 1860. laid down in Bye-Laws of the institute, for quality control of indigenously produced and imported biological products.  Initial financial assistance in setting up the institute was provided by USAID and OECF - Japan.
 


Notifications !!  

 

 Revised conditions 

 for purchase of :

 

1. Sera Panels

 

2. National Reference Standards

 

 

 

Revised specification/criteria of acceptance for quality test performed on HIV 1 &/or 2-Ab, HIV 1 p24 Ag, HCV-Ab and HBsAg kits

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2003new

 

Turnaround time for testing 

 

 

 

Guidance Document for Industry : submission of stability data and related documents for review & expert opinion for granting post approval changes in shelf life of Recombinant Biotherapeutic Products and Therapeutic Monoclonal Antibodiesnew

 

 

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in Indianew

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