DTAB Approves Notification System for Application of new drug, IND for clinical trial, BA-BE study

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:

The matter was discussed during the 92nd DTAB meeting held on April 24, 2025.

The Board was apprised with respect to streamlining the process for issuance of permission to manufacture new drugs or investigational new drugs for clinical trials, BA/BE studies, or examination tests and analysis.

DTAB deliberated the matter and agreed to the following proposed amendment under the NDCT Rules, 2019:

1. Notification system may be introduced for applications to manufacture for Analytical and Preclinical Testing of drugs excluding sex hormones, cytotoxic, beta lactam, Biologics with live microorganism and narcotics & psychotropic drugs.

2. To reduce timelines for processing of applications for permission for other categories of new drug and IND under Chapter VIII of NDCT Rules from 90 working days to 45 working days

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