The Union health ministry has given its approval for a total of 28 clinical trial proposals, 14 proposals of global clinical trials (GCTs) and 14 in other areas, after these were approved by Subject Expert Committees (SECs) and thereafter the Technical Committee, a high-level committee constituted by the ministry on this purpose on the directive of the Supreme Court.

Sources in the Union health ministry said that the high-powered Apex Committee on clinical trials, constituted by the Union health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country, deliberated upon the new proposals and concurred with the recommendations of the Technical Committee.

The Technical Committee had deliberated on a total of 31 cases related to approval of clinical trials. Out of these 31 cases, 15 cases were related to GCTs and clinical trials of NCEs and remaining 16 cases were related to clinical trials for approval of New Drugs including fixed dose combinations, subsequent new drugs, medical devices and biologicals.

The Technical Committee had evaluated each of the 15 cases related to GCTs and NCEs and made recommendations considering all aspects of safety, efficacy especially in terms of the three parameters viz. risk versus benefit to the patients; innovation vis-a-vis existing therapeutic option; and unmet medical needs in the country. After detailed deliberations, the Technical Committee recommended approval of 14 out of 15 cases. In one case, the committee did not recommend the conduct of the study.

The Technical Committee also evaluated the remaining 16 cases other than GCT clinical trial of NCEs. After detailed deliberation, the Committee recommended approval of 14 out of 16 cases.

Out of total 31 cases relating to clinical trials, the Technical Committee recommended approval of 28 cases. In one of the remaining three cases, the Technical Committee sought some additional information. In another case, the Technical Committee did not recommend conduct of study. In another case, which was a case of withdrawal of application by the applicant, the Technical Committee did not find the proposal to be appropriate for deliberation in the Technical Committee.

The Apex Committee in its 19th meeting held on 24-12-2014 under the chairmanship of secretary, ministry of health, deliberated upon the proposals and concurred with the recommendations of the Technical Committee.