regulatory services
Testing Support at National Institute of Biologicals, NOIDA
National Institute of Biologicals (NIB) had been set up in 1992 as an apex autonomous Institute under the administrative control of the Ministry of Health & Family Welfare, Government of India for promoting and protecting human health through various activities assigned to it.
The mandate of the Institute includes ensuring provision of quality biological drugs i.e Invitro diagnostics, Vaccines and Biotherapeutics, including therapeutic monoclonal antibodies used by patients suffering from cancer and autoimmune diseases by undertaking high end science based testing with R&D interface for application of science. One of the main functions of the Institute, as per by-laws 3.5.8, is to undertake research, establish linkages and exchange personnel with different institutions in India and abroad for furtherance of its mandate.
Other subjects forming part of its mandate are
- Developing and validating standards for quality control testing;
- Developing linkages with other National/ International institutions and keep abreast with worldwide scientific research and technological developments;
- Providing training facilities in quality control of biological;
- Assessing from time to time the availability of qualified manpower; and
- Implementing and co-ordinating activities of Haemovigilance Programme of India.