In order to bring clarity in the definition of bioavailability (BA) and bioequivalence (BE) study centre, the union overall health ministry has amended the New Drugs and Clinical Trial (NDCT) Rules 2019 although a gazette notification.
The amendment, named as the NDCT (Amendment) Rules, has brought in a alter 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 produced or established to undertake bioavailability study or bioequivalence study of a drug for either clinical aspect or for each clinical and analytical aspect 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 overall health ministry, on February 5, 2021, had notified the draft amendment to the rule, inviting objections and recommendations from persons probably to be impacted due to the amendment just before the expiry of a period of fifteen days from the date on which the copies of official gazette containing the notification have been made out there to the public.
As per the notification, the objections and recommendations received from the public on these guidelines have been regarded by the Central Government.
Following this, the Government with the powers below the Drugs and Cosmetics (D&C) Act, 1940, just after consultation with the Drugs Technical Advisory Board (DTAB), made the guidelines by means of the notification in the Official Gazette.
The union overall 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 evaluation, if the competent authority does not communicate it in seven working days from the date of receipt of application.