Key Highlights of NDCT (Amendment) Rules, 2026
The latest major amendments related to the DCGI involve the New Drugs and Clinical Trials (NDCT) (Amendment) Rules, 2026, which were notified in late January 2026 and are set to become effective around mid-March 2026, 45 days after publication.
Objectives: These amendments to the NDCT Rules, 2019 aim to reduce regulatory burden, facilitate business operations, accelerate pharmaceutical R&D, and shorten drug development timelines by at least 90 days in many cases.
Key Changes in the NDCT (Amendment) Rules, 2026
Figure 1: Key Amendments in NDCT (Revised 2026)
- Substitution of Test Licence with Prior Intimation Mechanism: Non-commercial manufacture of new drugs or investigational new drugs includes the production of small quantities for purposes such as research, testing, analysis, clinical trials, and bioavailability/bioequivalence studies.
- No prior permission or test license is required for most low-risk categories.
- Companies must submit an online intimation to CDSCO through the SUGAM portal and await acknowledgment before proceeding.
- This regulation excludes high-risk categories like cytotoxic drugs, narcotic drugs, psychotropic substances, sex hormones, beta-lactams, and biologics with live microorganisms, which still require mandatory permission.
- Reduced Timelines: In categories requiring test licences/permissions, the statutory review period by CDSCO has been reduced from 90 days to 45 days (working days).
- Low-risk bioavailability/bioequivalence studies no longer require prior permission; instead, an online intimation and acknowledgment process has been established.
- Overall Effect: These reforms streamline processes, accelerate clinical research and pharmaceutical development, and align with government goals to enhance innovation and trust-based regulation while ensuring safety and oversight, including the CDSCO’s authority to suspend or cancel permissions for non-compliance, with options for appeal.
These amendments were communicated by the Union Ministry of Health and Family Welfare after prior consultations and backing from the Drugs Technical Advisory Board (DTAB).
References:
- CDSCO’s Gazette Notifications page lists- https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications
- Govt notifies key amendments to New Drugs and Clinical Trials Rules 2019 http://newsonair.gov.in/govt-notifies-key-amendments-to-new-drugs-and-clinical-trials-rules-2019/#:~:text=The%20Ministry%20of%20Health%20and,System%20and%20the%20SUGAM%20portal.
