MoH Amends New Drugs & Clinical Trial Rules To Change Definition Of Bioanalytical Laboratory

New Delhi : The Union ministry of health and family welfare has amended the New Drugs and Clinical Trial Rules 2019, bringing in changes in the definition of bioavailability and bioequivalence study centre. A Gazette Notification, imposing the amendment on the rules related to standalone bioanalytical laboratory was published on Tuesday, said the country’s drug regulator.

The amendment, named as the New Drugs and Clinical Trials (Amendment) Rules, brought in a change in the Rule 2, in sub-rule (1) in clause (g) of the Rules 2019, which has come into force from the date of publication in the official gazette.

The relevant rule defines bioavailability and bioequivalence study centre as a centre created or established to undertake bioavailability study or bioequivalence study of a drug for either clinical part or for both clinical and analytical part of such study.

According to the amendment, the words “either clinical part or for both”, the words “either clinical part or analytical part or for both”, shall be substituted. The amendment is to bring in more clarity to the particular rule and the definition.

The Ministry, on February 5, 2021, notified the draft amendment to the rule, inviting objections and suggestions from persons likely to be affected due to the amendment before the expiry of a period of fifteen days from the date on which the copies of official gazette containing the notification were made available to the public.

The Ministry, in its latest notification said that the objections and suggestions received from the public on these rules have been considered by the Central Government.

Following this, the Government with the powers under the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board, made the rules through the notification in the Official Gazette.

Earlier in August, the Centre has notified a draft amendment in the Drugs Rules, 1945, to add a provision for deemed approval of license to manufacture drugs for examination, test or analysis, if the authority does not communicate it in seven working days from the date of receipt of application.

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