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 With the introduction of these rules, Part XA and Schedule Y of the Drugs and Cosmetic Act and Rules, are no longer applicable.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.