India finalises drug recall guidelines

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■ The Indian Central Drugs Standard Control Organisation (CDSCO) has finalised it’s guidelines on recall and rapid alert system for drugs, with no substantial changes made from the draft version, published just weeks earlier.* The aim of the new guidelines is to bring India’s recall system more closely in line with systems used by the US FDA and the EMA. * see Reactions 1428 p2; 801161386 CDSCO - Central Drugs Standard Control Organisation. GUIDELINES ON RECALL AND RAPID ALERT SYSTEM FOR DRUGS (Including Biologicals & Vaccines). Internet Document : [28 pages], 30 Nov 2012. 803081084 Available from: URL: http://cdsco.nic.in

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Reactions 15 Dec 2012 No. 1432