NATIONAL INSTITUTE OF BIOLOGICALS
About NATIONAL INSTITUTE OF BIOLOGICALS
Medical Institution · Plot No. A, 32, Institutional Area, Block A, Industrial Area, Sector 62, Noida, Uttar Pradesh 201309The National Institute of Biologicals (NIB) was established in 1992. NIB is a supreme autonomous institute under the administrative control of the Ministry of Health and Family Welfare (MoHFW), Government of India. The institute is located on A-32, Sector-62, Noida, Uttar Pradesh, covering an area of 74,000 square meters.
The institute performs its primary statutory function of quality control of products such as insulin, erythropoietin, blood products, diagnostic kits, HIV, HBV, HCV, and therapeutic monoclonal antibodies such as trastuzumab and rituximab used in cancer treatment, etc., in accordance with the provisions of the Drugs and Cosmetics Act, 1940, and Rules, 1945, as amended from time to time. The institute is notified as a Central Drugs Laboratory and a Central Medical Device Testing Laboratory under these statutory provisions. Biological products are tested in NIB laboratories according to the statutory standards set out in the Indian Pharmacopoeia, relevant pharmacopoeias, or international standards. The laboratories are also accredited by NABL as per the scope defined by the institute.
The Institute is accredited to ISO/IEC 17025:2017 by NIB in accordance with the defined scope for the discipline of biological testing and chemical testing in biological products.
Some of NIB's scientists are notified as government analysts for biological products and medical device testing authorities as per statutory norms.
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