Press Information Bureau
Government of India
Ministry of Health and Family Welfare
24-August-2012 13:18 IST
Clinical Trials
Clinical trials of new drugs are regulated under the provisions of the Drugs and Cosmetic Rules, 1945. The requirements and guidelines for undertaking clinical trials are specified in Schedule Y of these rules. Schedule Y also mandates that clinical trial is conducted as per the Good Clinical Practices (GCP) guidelines issued by the Central Drugs Standard Control Organisation (CDSCO). As per the GCP guidelines, the Sponsor of the clinical trial is responsible for selecting the Investigator(s) / Institutions taking into account the appropriateness and availability of the study site and facilities. Clinical trial proposals are examined in consultation with New Drug Advisory Committees consisting of eminent experts. During the evaluation of these proposals, the committee also examines the proposed sites of the clinical trials.

The regulatory provisions for clinical trials in the Drugs & Cosmetics Rules, 1945 are continuously being revised and strengthened, which is an ongoing process.

This information was given in written reply by the Union Minister for Health & Family Welfare Shri Ghulam Nabi Azad in Lok Sabha today.