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

by Joseph K. Clark

TODAY, the NDCT Rules apply to all new drugs, investigational new drugs for human use, clinical trial, BE studies, and Ethics Committee.  The Union health ministry has issued a draft notification on New Drugs and Clinical Trials (NDCT) Amendment Rules, 2021, for inclusion of the word “Designated Registration. Authority (DRA)” in place of “Central Licensing Authority (CLA)” towards effective regulation of Biomedical Research.

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These draft rules shall be considered 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 the public. The Union health ministry had notified the NDCT Rules, 2019, dated March 19, 2019, under the D&C Act, 1940. TODAY, the NDCT Rules apply 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 specific rules further to amend the NDCT Rules, 2019, which the Central Government proposes to make, in the 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.”

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