CDSCO in the process of constituting 38 more new drug advisory committees

Joseph Alexander | PharmaBiz.com | New Delhi | 26 May 2014


With a view to further beef up the process of approvals to clinical trials, the health ministry has begun the process of increasing the number of new drug advisory committees (NDACs) from the current 12 to 50.

The Central Drugs Standard Control Organisation (CDSCO) has already in principle finalized the composition of the new NDACs. The members for the new panels have already been contacted and many of them had given consents verbally and through mails. As and when the consents come from other members, the panels would be formally constituted, sources said.

Following the recommendations by the Parliamentary committee on the functioning of the regulatory mechanism and under pressure from the judiciary, the Health Ministry 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).

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