FDAnews Device Daily Bulletin

Clinical Trial Hold in India Leaves Devicemakers Unsure How to Proceed

Feb. 12, 2013
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India’s lack of a specific regulatory framework for medical devices is once again causing confusion and concerns within the industry — this time due to a two-month hold on clinical trials imposed by the country’s Supreme Court. The Jan. 3 ruling also strips the Central Drugs Standard Control Organization of clinical trial oversight powers and gives them to the Ministry of Health & Family Welfare.
International Medical Device Regulatory Monitor