Crop Biotech Update

Biotechnology Regulatory Authority of India Bill Introduced in Parliament

April 24, 2013

India's Science and Technology Minister S. Jaipal Reddy introduced the Biotechnology Regulatory Authority of India (BRAI) bill in the Lok Sabha, the Lower House of the Parliament of India on 22 April 2013. The bill seeks to create a statutory independent regulator for biotech sector called Biotechnology Regulatory Authority of India (BRAI). It also envisions a 17-member inter-ministerial governing board to oversee the authority's performance and a Biotechnology Regulatory Appellate Tribunal where BRAI decisions could be challenged. It will also provide for setting up the Biotech Advisory Council to render strategic advice to the authority on matters relating to developments in modern biotechnology and their implications in India.

BRAI's aims at providing a single window platform for the scientific risk assessment of all biotech products including agriculture, health, environment and industrial sector. The authority will supervise and regulate field trials of genetically modified crops and, the research, transport, import, manufacture and the use of organisms and products of modern biotechnology in the country. It will also help India keep pace in regulatory measures with the rapid technology advancement in biotechnology and at the same time ensure safety to human and animal health and environment.

The commercialization of biotechnology products in agriculture and healthcare would be subject to all other laws for the time being in force, the bill stated. Importantly, the current regulatory system under the EPA Rules 1989 has approved about two dozen of rDNA based drugs and deregulated Bt cotton that occupies 93% of the country's cotton area in 2012.

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