The Union health ministry's Apex Committee, headed by Union health secretary, has turned down a proposal by the Drugs Controller General of India (DCGI) to dispose of clinical trial proposals of new drugs already approved in other countries, fixed dose combinations (FDCs), subsequent new drugs, vaccines, etc by the DCGI office.

According to sources, the Apex Committee in its 17th meeting held on October 15, 2014 decided to continue the present system of evaluation of all kinds of clinical trial proposals including proposals of New Chemical Entities (NCEs), Global Clinical Trials (GCTs), clinical trial of new drugs already approved in other countries, FDCs, subsequent new drugs and vaccines through a three-tier system of Subject Expert Committee (SEC), Technical Committee and then Apex Committee.

“The Committee after detailed deliberation recommended that the present practice of evaluating all categories of clinical trial proposals (GCT/NCEs and other than GCT/NCEs) through Technical Committee and Apex Committee shall continue”, the Apex committee while turning down the DCGI proposal said.

Earlier, the DCGI had placed before the Technical Committee that it may be appropriate for the Technical Committee to consider the evaluation of the proposals of clinical trial which are related to GCTs/NCEs only and clinical trial proposals of drugs related to other than GCT/NCEs may be disposed of at CDSCO level.

After detailed deliberations, the Technical Committee in its 18th meeting held on October 13 agreed to the suggestion of the DCGI and recommended that henceforth only clinical trial proposals of GCTs & NCEs should be placed before the Committee for evaluation. Other proposals of clinical trial of New Drugs already approved in other countries, Fixed dose combination, Subsequent New Drugs and vaccines etc., may be disposed of at CDSCO level.

The Technical Committee then forwarded the proposal to the Apex committee which turned down its proposal and asked to continue the present three-tier system.

The DCGI's proposal in this regard came on the background of Supreme Court orders. In its order dated 03.01.2013 in the matter of  Swasthya Adhikar Manch, the Supreme Court had ordered that all the cases of clinical trials of new chemical entity should be conducted strictly in accordance with the procedure prescribed in Schedule 'Y' of Drugs & Cosmetics Act, 1940 under the direct supervision of the union health secretary. Consequently, the Union health ministry constituted Technical Committee under the chairmanship of DGHS and Apex Committee under the chairmanship of health secretary to evaluate the clinical trial proposals.

The Supreme Court in its order dater 21.04.2014 also directed that henceforth the format seeking information from the applicants, three specific columns for risk versus benefits to the subjects, innovation vis a vis existing therapy and unmet need to the country should be inserted for the purpose of NCEs/GCTs.