CDSCO plans more steps to further streamline clinical trial sector

Joseph Alexander | | New Delhi | 10 April 2014

As part of the efforts to further streamline the clinical trials sector with more transparency and accountability, the functioning of the New Drug Advisory Committees (NDACs) will also be improved to limit the number of cases to be taken up at their meeting and ensuring the participation of experts included in the panels, apart from a slew of other regulatory measures.

Against the backdrop of criticism that the NDACs did not function well as desired, the authorities are taking several steps apart from increasing the number of panels from the current 12 to 50 on a gradual basis. The number of cases to be evaluated in a meeting will be limited only to eight to 10, instead of the current practice of clearing all the proposals pending.

Further, the technical committee formed to oversee the trials, would also invite the subject experts while evaluating the recommendations and approvals by the NDACs. The sponsors and clinical trial organizations will be asked to put all the details of clinical trials being conducted in the public domain, sources said.

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