The Biotechnology Regulatory Authority of India (BRAI) will only deal with the safety and efficacy aspects of biotech products, leaving the controversial commercialisation aspect hanging in the air, according to the latest version of the BRAI Bill, 2010.

The Bill, which was supposed to be introduced in the last session of Parliament, is back in limbo after objections by the Health Ministry. However, the latest version of the Bill has incorporated the changes demanded by the Environment Ministry.

One of the major amendments includes a clarification that since the BRAI Bill will only handle safety and efficacy, “any decision on commercialisation will have to be taken by competent authorities under relevant laws,” according to Environment Minister Jairam Ramesh.

“There is no clarity on which authorities would be competent or which laws would be relevant,” he admits. “In the case of GM [or genetically-modified] foods, it may still be with the Ministry of Environment and Forests,” he says. “Or it could be Health, Agriculture or the DST [Department of Science and Technology],” he added, leaving the door open for a further turf war.

Mr. Ramesh feels that decision can be taken later, while the Bill itself should be passed into law in the next session of Parliament.

Originally, the BRAI was supposed to come under the control of the Department of Biotechnology (DBT).

Mr. Ramesh suggested that in order to avoid conflicts of interest, a regulatory body should come under a Ministry unrelated to biotechnology promotion, or under the Cabinet Secretariat. However, he has accepted the compromise of the Department of Science and Technology as the nodal Ministry.

In a deal worked out between DBT and the Environment Ministry on Independence Day, just before the Cabinet considered the Bill, the Ministry agreed to give up control of the current body responsible for GM food clearances, the Genetic Engineering Approvals Committee. Its role will now be taken over by the Environment Appraisal Panel, whose decisions can be reversed by its parent body, the BRAI.

However, in return, the Environment Ministry has wrested the right to appoint the chairman and member secretary of the Panel.

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