DTAB Approves Notification System for Application of new drug, IND for clinical trial, BA-BE study
New Delhi: With an aim to streamline the process for permission to manufacture new drugs and investigational new drugs (IND) for clinical trials, bioavailability/bioequivalence studies (BA/BE), or for examination tests and analysis, the Drugs Technical Advisory Board (DTAB) has agreed to introduce the notification system for applications to manufacture drugs for analytical and preclinical testing, excluding sex hormones, cytotoxic drugs, beta-lactams, biologics with live microorganisms, and narcotics and psychotropic drugs.
In addition, the board has agreed to reduce timelines for processing applications for permission for other categories of new drugs and IND under Chapter VIII of the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules), from 90 working days to 45 working days.
This came in line with the proposal to amend NDCT Rules, 2019, for streamlining the process for permission to manufacture new drugs and investigational new drugs for clinical trials, BA/BE studies, or for examination tests and analysis:
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