Regulatory Focus™ > News Articles > India’s Health Ministry Acts on CDSCO Reform Recommendations

India’s Health Ministry Acts on CDSCO Reform Recommendations

Posted 07 November 2013 | By Louise Zornoza

India's Ministry of Health and Family Welfare (MHFW) has issued a report recommending the implementation of several reforms to the country's drug approval and clinical trials system.

The reforms had originally been submitted to the Ministry by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, created in response to the Parliamentary Standing Committee on Health and Family Welfare's critical 59th Report on the functioning of India's Central Drugs Standard Control Organisation (CDSCO). 

The Ministry has, among other things, agreed to the creation of a system for the accreditation of investigators, ethics committee and clinical trial sites, which will require amending existing law.  As a first step, Prof. Chaudhury will vet 20-25 experts who will provide recommendations concerning the creation of the accreditation system.

MHFW Report

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