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INDIA PLANS US FDA-STYLE REGULATOR

June 30, 2005

The Indian government is to set up a regulatory body modelled on the US FDA. India's family and welfare minister, Dr Anbumani Ramadoss, has stressed the need to make drug regulation in the country more stringent to ensure that new quality standards are met.

In the first phase of development, mechanisms will be put in place based on those currently operational in the US FDA. In the second phase, the Indian regulatory authorities intend to partner with the US agency, and could offer mutual approval of clinical trials and products. A need for tighter controls, especially in terms of labelling, is seen as crucial to reforming India's drug market. Officials have described the current system as "old, fragmented and not independent."

Meanwhile, India hopes its new patent laws and VAT system will boost market development. The Indian Chamber of Commerce is also currently calling for the liberalisation of pricing controls, which have stunted growth in recent years.