National Institute of Biologicals has been established as an autonomous organization under the Ministry of Health & Family Welfare (MOH&Fw)-Government of India. registered in January 1992 (vide No. S-22590) under the Societies Registration Act 1860. laid down in Bye-Laws of  the institute.

The institute responsibly assures and reviews the quality of number of  Biological products available through domestic manufacturers or imports. The operations are carried out in the state of the art Facility of the Institute and in close coordination with Government of India regulatory authorities as Office of Drug Controller of India, Indian Pharmacopeia's Commission.

With the current science and technology leading to the development of newer biologicals in the domestic market,  the testing and specifications may vary for each specific products which  requires  an improved understanding of quality and safety issues.In recent years the licensing and quality control for manufacturer and National Regulatory Authorities alike has become even more complex. With this overall objective and to strengthen the regulations of biologicals in India, NIB, which is supported by the authorities constituted of Governing body and General body of the Institute plays a vital role.