Welcome to NIB
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.
Institute is NABL accredited for ISO/IEC 17025:2017 as per the scope defined for
discipline of Biological testing and Chemical testing in Biological products.
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.