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-  2019 

An audit of minutes of Subject Expert Committee meetings as a metric to assess the clinical research roadmap of India

DOI: 10.4103/picr.PICR_174_17

Keywords: CDSCO, Regulatory decision-making, Clinical Trials, Drug Approvals

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Abstract:

In January 2015, the Drugs Controller General of India approved the formation of 25 Subject Expert Committees [SEC] to aid the office of the Central Drugs Standard Control Organization [CDSCO] with regards to decision making. The present study is an audit of the minutes of the meetings the SECs held over the past three years

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