India's NDA "in place in 2006"

20 March 2006

India will have a new agency, modelled on the US Food and Drug Administration, in place by the end of 2006, according to local media reports. The go-ahead from the Indian government's cabinet is expected soon. The new body - the National Drug Agency - would replace the exist-ing Central Drugs Standard Control Organization and local state-level drug regulation agencies.

As a result, the functions of approving new drugs; issuing marketing and import licenses for new drugs; manu-facturing licenses; inspection of production facilities; and trade licensing, will all be dealt with by the same authority.

The NDA would be governed by an advisory board, assem-bling representatives from the Ministry of Health, the Ministry of Chemicals and the Department of Biotech-nology, together with patient and consumer groups and non-governmental organizations.

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