New Drugs and Clinical Trial Rules, 2019

On 19th March 2019, the Ministry of Health and Family Welfare (MoHFW) released the New Drugs and Clinical Trial Rules, 2019 [G.S.R. 227(E)]. These rules will be effective from the date of publication (the only exception being Chapter IV – Ethics Committee for Biomedical and Health Research). Chapter IV of these rules will come into force 180 days after the date of publication, i.e., 19th September 2019.

These rules describe the requirements and guidelines to obtain a permission to import or manufacture new drugs for sale or to undertake a clinical trial / bioavailability / bioequivalence study, in India. With the introduction of these rules, Part XA and Schedule Y of the Drugs and Cosmetic Act and Rules, are no longer applicable. However, New Drugs for veterinary use will continue to be regulated as per Part XA. The New Drugs and Clinical Trial Rules, 2019 can be accessed via the Central Drugs Standard Control Organization website.

Medical Devices Rules, 2017

On 31st January 2017, the Ministry of Health and Family Welfare (MoHFW) released the Medical Devices Rules, 2017 [G.S.R. 78(E)]. These rules have been effected since the 1st of January 2018.

The Medical Devices Rules, 2017 are applicable to:

Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i);

Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii);

Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

The Medical Devices Rules, 2017 can be accessed via the Central Drugs Standard Control Organization website.