No say for Health Min on GM food

“CDSCO,being the nodal agency for clinical trials,would receive all applications for all clinical trials of live and complex genetically modified organisms and products and the Drug Controller General (of India) — after making preliminary examination — will forward the proposals to BRAI for evaluation and recommendation,” says the approved draft of the Bill.

A member of CDSCO would be inducted in the BRAI committee that evaluates the proposals for clinical trials and conversely,a BRAI representative would be included in CDSCO for recommending trials as well as to approve new drugs. However,on biotech foods,the S&T Ministry is clear that “environmental and safety assessment of GM foods containing live modified organisms as well as processed foods with respect to genetic modification shall be undertaken by BRAI so as to have a single point of regulation”.

The Bill is amply clear on GM crops with the final approving authority vested with BRAI. “Protection of Plant Variety & Farmers Rights Authority would register GM crop varieties only after approval of the BRAI,” it says. The Health Ministry had objected to such powers for BRAI seeking retention of its mandate to regulate all pharmaceuticals including recombinant-based therapeutic drugs and cosmetics. “Food,medical and pharmaceutical biotechnology should be excluded from the ambit of BRAI and the regulatory function should remain in the ministry’s mandate,” it wrote. It also claimed that the proposed powers to BRAI would end in “conflict of interest” as Department of Biotechnology — under whose direct control BRAI would be — was primarily keen on addressing the growth of biotech sector with an eye on investments.

The Environment Ministry too objected to BRAI lording over other regulatory authorities through amendments in the Environment (Protection) Act,Food Safety & Standards Act and Drugs & Cosmetic Act. It said the new regulator would eventually be “bound by directions on policy” from the Department. The BRAI would comprise a chairperson,two full time and two part time members,each with an expertise in life sciences and biotechnology application in agriculture,healthcare,environment and biology. They would be selected by a Committee of Secretaries headed by the Cabinet Secretary. The proposed authority will now deal only with safety and efficacy issues.