The Drugs Technical Advisory Board (DTAB) has reaffirmed its position to include all antimicrobial drugs under the definition of “New Drugs” as per the New Drugs and Clinical Trials Rules, 2019. This decision was taken during the 93rd meeting of DTAB held on February 16, 2026, at FDA Bhawan, New Delhi.
Job Overview
The Drugs Technical Advisory Board (DTAB) has reaffirmed the classification of all antimicrobial drugs as “New Drugs”. This decision follows reconsideration and detailed deliberations, with the Board standing firm on its earlier recommendation. Classification as “New Drugs” typically requires additional regulatory approvals, clinical data, and oversight. However, DTAB has recommended that the change be implemented prospectively, meaning existing license holders can continue operations without additional compliance obligations. The recommendation aims to strengthen antimicrobial regulation and address concerns like antimicrobial resistance.
Important Dates
- Date of 93rd DTAB meeting: February 16, 2026
- Date of previous (92nd) DTAB meeting: April 24, 2025
Important Instructions
The proposed change is to be implemented prospectively, ensuring that existing license holders will not be burdened with new regulatory requirements. A detailed proposal outlining the licensing pathway will be circulated among all members to provide a structured framework for the transition. Further developments are expected once the detailed proposal is finalized and formally notified.
