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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-05-11T17:45:57+05:30 | Updated On 11 May 2025 5:45 PM IST

DTAB Calls for Issuance of Guidelines on Disposal of Expired, Unused Medicines

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:

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

Also Read: CDSCO issues Revised Export NOC Guidance document for Manufacture of Unapproved, Approved New Drugs

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751