The National Institute of Biologicals (NIB) had been set up in 1992. NIB is an apex autonomous institute under the administrative control of Ministry of Health & Family Welfare (MoHFW), Government of India. The Institute is located at A-32, Sector-62, NOIDA, Uttar Pradesh in an area of 74,000 Sq. M.
The Institute is performing primary statutory function of Quality Control of Biologicals e.g. Insulin, erythropoietin, blood products, diagnostic kits e.g. HIV, HBV, HCV, therapeutic monoclonal antibodies like Trastuzumab and Rituximab used in cancer treatment etc. in accordance with provisions of Drugs & Cosmetics Act 1940 and Rule 1945 amended from time to time.
The Immunodiagnostic kit Laboratory of the Institute is a WHO Collaborating Centre for Quality Control of HIV, HCV, HBsAg and Syphilis In-Vitro Diagnostic Assays and Support Cell for WHO Pre-Qualification Programme for In-Vitro Diagnostics.
The Institute is notified Central Drugs Laboratory and Central Medical Device Testing Laboratory under these statutory provisions. The biological products are tested as per statutory standards laid down in Indian Pharmacopoeia or relevant pharmacopoeia or International norms, in the NIB laboratories. The laboratories are also accredited by NABL as per the scope defined. Some of the NIB scientists have also been notified as Government Analysts and Medical Device Testing Officers for biological products as per Statutory Norms.
The scientists of the institute are committed towards their duty and follow the mandates and functions meticulously. Some of them are as hereunder:
i) to ensure quality of Biological and Biotherapeutic products, both imported and manufactured indigenously moving in the Indian market.
ii) to contribute in finalizing the specifications for biological products to be incorporated in Indian Pharmacopoeia.
iii) to prepare National Reference Standards for biological products.
iv) to train technical personnel in the public and private sectors in the field of Quality Control of Biological products and Haemovigilance programme.
v) to collaborate with other National and International Scientific Institutions/ organizations in upgrading technologies and keeping abreast of scientific advances made in the field of quality assessment of Biological and Biotherapeutic products.
vi) to extend technical expertise during joint inspections of manufacturing premises of biological products with the officers of CDSCO.
vii) to implement the Haemovigilance Programme of India to promote safe blood transfusion practices.
The Laboratory and Animal House facility of the Institute, constructed in February, 2006, have 42 Biosafety Level (BSL)-2 laboratories equipped with modern scientific equipment for testing of Biological and Biotherapeutic products. There are 20 walk-in-cold rooms and 03 walk-in-deep freezers (-20oC), and 64 bio-safety cabinets. All equipment are under Annual Maintenance Contract (AMC) or Comprehensive Maintenance Contract (CMC) and are regularly calibrated by a NABL accredited calibration laboratory.
The expenditure made by the Institute on salaries, maintenance, procurement of reagents, chemicals, scientific equipment etc., is met from the grants given by the Ministry of Health & Family Welfare, Govt. of India. The revenue generated from testing of biologicals is deposited in the consolidated fund of Government of India with Ministry of Health & Family Welfare.