The 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, has given its green signal for a total of 28 clinical trial proposals, 7 proposals of global clinical trials (GCTs) and 21 in other areas, after these were approved by Subject Expert Committees (SECs) and thereafter the Technical Committee, another high-level committee constituted by the ministry on this purpose on the directive of the Supreme Court.
According to sources, the Apex Committee in its 18th meeting held on November 25 deliberated in detail on the new proposals and ratified the recommendations made by the Technical Committee. The Technical Committee had deliberated on a total of 31 cases related to approval of clinical trials and protocol amendments. Out of these 31 cases, 10 cases related to GCTs and remaining 21 cases concerned clinical trials for approval of New Drugs including fixed dose combination, subsequent new drugs and biologicals.
Out of the 10 GCT cases, six cases were related to approval of clinical trials and the remaining four concerned protocol amendments. Out of six proposals, one case of GCT of Rifampiline involved fresh examination based on new facts brought out during the presentation by the applicant.
The Technical Committee had evaluated the 10 cases relating to global clinical trials and made recommendations after due consideration of all aspects of safety and efficacy especially in terms of the three parameters set by the Supreme Court, risk versus benefit to the patients; innovation vis-a-vis existing therapeutic option; and unmet medical needs in the country. The Technical Committee had recommended approval of three out of five cases of GCTs and all four cases of protocol amendments.
The Technical Committee also evaluated the remaining 21 cases other then the GCT/clinical trials of NCEs. After detailed deliberations, the Technical Committee had recommended approval of all 21 cases.
The Apex Committee after deliberations ratified the Technical Committee recommendations.