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

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).

The technical committee and the apex committee on clinical trials, the two high-level panels set up by the ministry, had recommended the increase in the number of NDACs with a view to involve more experts in the process of clearing the clinical trials in a fool-proof manner.  However, there were criticism that the NDACs were not functioning properly.

Another concern was the lack of sufficient number of pharmacologists in the panels. It has been decided that the permission for clinical trials should not be given without consultation with the pharmacologists. In case of permissions cleared by NDACs without pharmacologists, the proposals would again be referred to the pharmacologists of other NDACs.

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