India’s Union government cabinet has approved the setting-up of a Central Drugs Authority, which is to be an autonomous organisation with the Ministry of Health and Family.

In further new developments aimed at improving India’s drug licensing and enforcement activities, plus safety and quality controls, the position of Drug Controller of India is to be upgraded to the level of Additional Secretary to the Government of India, from its current rank of Joint Secretary. In addition, the post of Additional Drugs Controller is to be re-established, again at Joint Secretary level, and one Additional Drug Controller position will be created.

The Cabinet has also approved a phased five-year transition in the system of granting drug licenses, with the process moving from state to central level over this period, and for the Drugs and Cosmetics Amendment Bill of 2006 to be incorporated into the 1940 drugs and Cosmetics Act.

- Meantime, the Health Ministry has announced that 522 medicines will be newly reimbursable from mid-February. 211 are “first generic” drugs (the first generic versions of previously patented drugs), plus 259 other generics and 52 innovative drugs. The latter are described as “not breakthrough” products, but another reimbursement list of “truly innovative” drugs is due to be published in February. By Lynne Taylor

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