Ashok B. Sharma

New Delhi -- The government is planning to set up a new autonomous body to regulate the development and release of genetically modified (GM) crops, livestock and fishes, and food, as well as recombinant pharma and industrial products. The department of biotechnology (DBT) has already drafted the National Biotechnology Regulatory Bill-2008 for setting up of the proposed National Biotechnology Regulatory Authority (NBRA).

Though the proposed NBRA would be autonomous, it would attached to DBT in the same lines as the autonomous Food Safety and Standards Authority (FSSA) is attached to the Union health ministry.

Though the FSSA is empowered by law to regulate GM foods, the DBT proposal said, "from an operational standpoint, there are opportunities to coordinate the safety assessment of GM foods between FSSA and the NBRA." It suggested that the risk assessment unit of NBRA can undertake risk assessment on behalf of FSSA and submit its report to its chairperson for approval. Alternatively, GM food safety assessment can remain exclusively under FSSA and the regulation of GM foods be vested with NBRA.

The public sector, Biotech Consortium India Ltd is slated to conduct a series of public consultations on the Bill and the proposed authority. It is proposed that NBRA will be headed by a chairperson and consists of chief regulatory officers, regulatory branches for different products, a risk assessment unit, and cross-sectoral offices for national and international policy coordination, legal affairs, economic analysis, and capacity building. The NBRA chairperson will be assisted an inter-ministerial advisory body and a national biotechnology advisory body. But these two bodies will not interfere in the product specific decisions taken by NBRA. The draft bill has deviated from the suggestions of Swaminathan and Mashelkar panels, which had said that the proposed NBRA should have separate wings for GM crops, GM livestock and fisheries, and recombinant pharma and industrial products. It has, however, suggested setting up of the National Biotechnology Regulatory Appellate Tribunal.