Centre plans shelf-life norms revision for imported drugs
New Delhi, June 27 -- The Union ministry of health and family welfare has proposed revising the residual shelf-life requirement for imported drugs to ensure medicines entering India have a longer usable shelf life while easing regulatory requirements for the pharmaceutical sector.
A draft notification published by the ministry proposes amendments to Rule 31 of the Drugs Rules, 1945, to rationalise the residual shelf-life requirement for imported drugs and promote ease of doing business in the pharmaceutical sector. Under existing Drugs and Cosmetics Rules, 1945, a drug cannot be imported or distributed in India unless it has more than 60% of its usable shelf life remaining. As per health ministry, the draft amendment proposes replacing current requirement with a minimum residual shelf life of 12 months at the time of import....
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