Health ministry issues draft notification on NDCT Rules to substitute word “CLA” with “DRA” towards regulation

The NDCT Rules are today applicable to all new drugs, investigational new drugs for human use, clinical trial, BE study and Ethics Committee.

The Union health ministry has issued draft notification on New Drugs and Clinical Trials (NDCT) Amendment Rules, 2021 for inclusion of  word Designated Registration
Authority (DRA)” in place of “Central Licensing Authority (CLA)” towards effective regulation.

These draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which the copies of the Gazette of India containing these draft rules are made available to public.

The Union health ministry had notified the NDCT Rules, 2019 dated March 19, 2019 under the provisions of the D&C Act, 1940.

The NDCT Rules are today applicable to all new drugs, investigational new drugs for human use, clinical trial, BE study and Ethics Committee.

“Objections and suggestions which may be received from any person within the period specified  above will be considered by the Central Government. Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of  Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan,  New Delhi – 110011 or emailed at [email protected],” according to the draft notification.

As per the draft notification, the following draft of certain rules further to amend the NDCT Rules, 2019 which the Central Government proposes to make, in exercise of the powers conferred by sub-section(1) of section 12 and sub-section(1) of section 33 of the Drugs and Cosmetics (D&C) Act, 1940 (23 of  1940) following consultation with the Drugs Technical Advisory Board (DTAB).  These rules may be called the New Drugs and Clinical Trials (….Amendment) Rules, 2021. They shall come into force on the date of their final publication in the Official Gazette. In the NDCT Rules, 2019, in Eighth Schedule, in Form CT-03,─ (i) In para1, the words, “Regulation of”, shall be omitted; (ii) For the words, “Central Licensing Authority”, the words “Designated Registration Authority” shall be substituted.”