MoH&FW drafts Clinical Trial Rules, 2018

The government has invited suggestion/ comment/ objection within 45 days of gazatte notification

The Ministry of Health and Family Welfare has recently drafted the Clinical Trial Rules, 2018. The draft consist of 12 chapters and eight schedule. The government has invited suggestion/ objection from the industry within the 45 days of gazatte notification.

The draft consist of certain rules which the Central Government proposes to make, in supersession of Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945, and in exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby. The draft rules shall be taken into consideration on or after the expiry of a period of forty five days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

The draft applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee.

The draft states that the Drugs Controller General of India appointed by the Central Government in the Ministry of Health and Family Welfare shall be the Central Licencing Authority for the purposes of these rules. The Drugs Controller General of India, with the prior approval of the Central Government, may, by an order in writing, delegate all or any of powers of the Central Licencing Authority to any other Officer of the Central Drugs Standard Control Organisation not be below the rank of Assistant Drugs Controller. The officer to whom the powers have been delegated under sub-rule (1) shall exercise all or any of the powers of the Central Licencing Authority under its name and seal. The Drugs Controller General of India may designate any officer not below the rank of Assistant Drugs Controller as Controlling Officer; The Drugs Controller General of India shall, by an order, specify the areas and powers of the Controlling Officer and The Controlling Officer, designated under sub-rule shall supervise the work of sub-ordinate officers and shall exercise powers and perform functions which may be assigned to that Officer.