Union health ministry amends NDCT Rules 2019 to bring clarity in definition of BA and BE study centre


In order to bring clarity in the definition of bioavailability (BA) and bioequivalence (BE) study centre, the union health ministry has amended the New Drugs and Clinical Trial (NDCT) Rules 2019 though a gazette notification.

The amendment, named as the NDCT (Amendment) Rules, has brought in a change in the Rule 2, in sub-rule (1) in clause (g) of the NDCT Rules 2019.

The relevant rule defines BA and BE 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 union health ministry, on February 5, 2021, had 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.

As per the notification, 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 (D&C) Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB), made the rules through the notification in the Official Gazette.

The union health ministry, in August this year, had notified a draft amendment in the Drugs Rules, 1945, to bring in provision for deemed approval of license to manufacture drugs for examination, test or analysis, if the competent authority does not communicate it in seven working days from the date of receipt of application.

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