India's new drug authority to have sweeping powers

2 July 2006

India's new statutory Central Drug Authority, to be set up shortly, will be a fully-autonomous and financially self-sustaining body with separate divisions for regulatory oversight of clinical trials, new drugs, medical devices, cosmetics, vaccines and biologicals and Good Manufacturing Practice-compliance, a senior official of the Chemicals Ministry, which overseas the pharmaceutical sector, has said.

The CDA would be modelled on the lines of the USA's Food and Drugs Administration, Drugs Controller General of India, Ashwini Kumar, told the Financial Express in an interview.

The CDA would be authorized to devise a fee structure for its regulatory services and recruit personnel, the official said. The proceeds from the service charges would be utilized by the CDA to meet its capital spending and day-to-day expenses.

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