Govt amends NDCT Rules 2019 to clarify definition of bioavailability, bioequivalence study centre

New Delhi: Amending the New Drugs and Clinical Trials Rules, 2019, through a recent gazette notification, the Ministry of Health and Family Welfare (MoHFW) has modified the definition of "bioavailability and bioequivalence study centre".

According to the new amendment, a "bioavailability and bioequivalence study centre" is defined as a centre created or established to conduct a bioavailability or bioequivalence study of a drug for either the clinical or analytical part of the study, or both the clinical and analytical parts of the study.

Through the amendment, the Ministry of Health and Family Welfare has included "either clinical part or analytical part or for both" in place of "either clinical part or for both", in the New Drugs and Clinical Trials Rules, 2019, in rule 2, in sub-rule (1), in clause (g).

The Ministry had previously notified a draft of certain rules to amend the New Drugs and Clinical Trials Rules, 2019, on February 5, 2021, inviting objections and suggestions from persons likely to be affected by the amendment before the expiration of a fifteen-day period from the date that copies of the official gazette containing the notification were made available to the public.

As per a recent notice, public copies of the Gazette were made available to the public on February 5, 2021, and the Central Government evaluated public objections and suggestions on the guidelines.

Therefore, in exercise of the powers conferred under section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, has made the following rules further to amend the New Drugs and Clinical Trials Rules, 2019, namely:—

(1) (1) These rules may be called the New Drugs and Clinical Trials (Amendment) Rules, 2021.

(2) They shall come into force on the date of their publication in the Official Gazette.

(2) In the New Drugs and Clinical Trials Rules, 2019, in rule 2, in sub-rule (1), in clause (g), for the words "either clinical part or for both", the words "either clinical part or analytical part or for both" shall be substituted.