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India Proposes New Body With GM-Based Drug Authority

This article was originally published in PharmAsia News

Executive Summary

India's National Biotechnology Regulatory Authority now in the planning stage may be given responsibility for genetically modified drugs, taking them away from the Drug Controller General of India. The DCGI has responsibility for recombinant biologics, DNA vaccines and other GM drugs from the clinical stage to the market. Draft legislation, however, would transfer that purview to the proposed NBRA, whose role would be confined to drugs such as live vaccines containing organisms, but not human insulin or recombinant vaccines derived from, but not containing GMOs. (Click here for more
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