CDSCO plans more steps to further streamline clinical trial sector

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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.

The Central Drugs Standard Control Organisation (CDSCO) is also planning to further strengthen the clinical trial monitoring cells in the headquarters as well as in the zonal offices, with a view to enhance the monitoring exercises.

Pushed by the Parliamentary committee on the functioning of the regulatory mechanism and under pressure from the judiciary, the CDSCO had formed 12 NDACs to advise on matters related to review and regulatory approval of clinical trials and new drugs (except for Investigational New Drugs).

In some of the NDACs, the expert members have retired, some of the members are no more associated with the organisation and some had refused to attend the meetings, citing busy schedules and engagements, thus defeating the very purpose of the NDACs. The practice is that the pharmacologist specified for particular NDACs are only called to offer expert opinion, not full-time attendance at the meetings.

Source: PharmaBiz


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