In order to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of drugs an Expert Committee was constituted by the Ministry of Health & Family Welfare. The Expert Committee submitted its report to the Ministry of Health & Family Welfare. The actions proposed to be taken on the recommendations of the Expert Committee were finalized by the Ministry of Health & Family Welfare.
As per the report, following actions were amended –
There are 25 SEC Committees that are constituted as under:
The DCG(I) shall invite an expert who has an experience in that particular area of specialization required by SEC, pertaining to the specified application. The DCG(I) may add names of experts from Govt . Medical Colleges / Hospitals or eminent persons in the panels wherever necessary through a standard procedure.
Subject Expert Committee (SEC) comprises of 8 medical experts (01 Pharmacologist and 07 medical specialists) shall be constituted to select names of the experts from the respective panels approved by the Ministry. If an expert fails to attend the SEC meeting, another expert from the same panel shall be invited to attend the meeting.