The National Institute of Biologicals (NIB) is an autonomous institution under India’s Ministry of Health and Family Welfare. Established in 1992 and based in Noida, Uttar Pradesh, it serves as a national centre for quality assessment of biological and biotherapeutic products. The institute is notified as a Central Drugs Laboratory and Central Medical Device Testing Laboratory, and conducts testing in accordance with applicable Indian or international pharmacopoeial standards. Its work covers products such as insulin, erythropoietin, blood products, diagnostic kits, therapeutic antibodies and vaccines.

NIB operates specialized laboratories for biological and chemical testing, including facilities for sterility, molecular diagnostics, blood products, vaccines and antisera, and medical-device-related testing. Its laboratories are accredited by the National Accreditation Board for Testing and Calibration Laboratories within defined scopes. The institute also develops national reference standards, supports biological product specifications for the Indian Pharmacopoeia, and provides technical training for public- and private-sector personnel. In addition, NIB contributes expertise to inspections and implements India’s Haemovigilance Programme to promote safer blood transfusion practices.