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Biotech regulations to be revamped

Our Bureau

CHENNAI, Sept. 13

THE Ministry of Science and Technology will shortly announce revamped regulatory processes and fast-track clearance mechanisms for medical biotechnology products, according to Dr. V.K. Vinayak, Adviser, Department of Biotechnology.

The regulations will be notified within ten days, and will benefit the pharmacology and health care industries which have biotechnology-based medical products in the pipeline. Framed after extensive discussions with the industry, it will cover the entire gamut of regulations governing research and development, and up to commercialisation of a product, he said.

Under the new system, according to Dr. Vinayak, the entrepreneurs will deal with just a single new regulatory authority, the Drug Controller General of India Advisory Committee (DCGIAC). The DCGIAC will in turn handle the discussions with the existing In stitutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC).

Thus, those with medical biotechnological products will not have to go through repetitive meetings with each of the other committees, a problem now faced by entrepreneurs. Further, strict deadlines will be announced for each stage of approval, with autom atic approval if the deadlines were not met by the appropriate authorities.

A similar fast-track mechanism will be put in place for plant biotechnology products, he said.

Dr. Vinayak was addressing the four-day Cornell University conference on `Biotechnology for Development' here.

He regretted that the industry was not always in tune with market requirements. While 17 diagnostic kits have been developed under Indian conditions, and are awaiting commercialisation from the industry, irrelevant kits were being imported at high cost.

The DBT was interested in setting up biotech incubator facilities jointly with the private sector. The Confederation of Indian Industry had evinced interest and will act as facilitator, he said.