**Summary:**
This order, issued by the Drugs Controller General of India (DCGI) on July 3, 2014, addresses the approval process for academic clinical trials. Referencing File No. 120114DC Pt.47 from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, the order clarifies that academic clinical research can be approved by the Institutional Ethics Committee (IEC). However, DCGI approval is required when a new drug is being evaluated or a new use for an existing drug is being evaluated, as per the Drug & Cosmetic Rules. The order stems from recommendations made by an Expert Committee chaired by Prof. Ranjit Roy Chaudhury, which was formed to formulate policy and guidelines for new drug approvals, clinical trials, and drug banning. The order is disseminated to all concerned parties, including the Medical Council of India (MCI), the Indian Medical Association (IMA), and the Under Secretary (US D) of the Ministry of Health and Family Welfare. The issuing authority is Dr. G.N. Singh, Drugs Controller General of India, located at FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Directorate General of Health Services: An attached office of the Ministry of Health and Family Welfare, Government of India, providing technical expertise in public health.
Ministry of Health Family Welfare: A ministry of the Government of India responsible for health policy.
New Delhi, Delhi: The location of FDA Bhawan and the Central Drugs Standard Control Organization.
Ranjit Roy Chaudhury: The Chairman of the Expert Committee constituted by the Ministry of Health Family Welfare.
Expert Committee: A committee constituted by the Ministry of Health Family Welfare to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
Institutional Ethics Committee IEC: A committee responsible for reviewing and approving research involving human subjects to ensure ethical conduct.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India, responsible for drug regulation and approval.