The Biotechnology Regulatory Authority of India Bill, 2013, to establish a statutory independent regulator, for biotech sector covering research, transport, import, manufacture and use of organisms and products of modern biotechnology has been introduced in the Lok Sabha. The Bill has been on the drafting board for years and had run into stiff opposition from green activists.
The bill provides for the setting up of an inter-ministerial governing board to oversee the performance of the proposed Biotechnology Regulatory Authority of India (BRAI), which would be the nodal agency of the Government to ensure comprehensive safety assessment of organisms and biotech products. The biotech regulator would regulate trials preceding the clinical trials in the health sector and the present mechanism for regulating clinical trials would continue.
The Biotechnology Regulatory Advisory Council, with representatives from 17 government agencies involved in the regulation of biotech products, will render strategic advise to the Authority on matters relating to developments in modern biotechnology and their implications in the country.