Archive · 29 Jan 2026
India Eases Drug Research Rules
The Indian government has made big changes to the rules for making and testing new medicines.
These changes will make it faster and easier for companies to do research and develop new drugs.
They will have to tell the government online before they start, but they won't have to wait for a special permit in most cases.
This will help India make medicines faster and cheaper, while still keeping people safe.
The government will also use special websites to make everything more transparent and easy to do online.
These changes are expected to make India a bigger player in the global medicine market.
India's Health Ministry amended the New Drugs and Clinical Trials (NDCT) Rules, 2019 to reduce regulatory delays and ease compliance requirements.
Key changes include replacing test licence requirements with online intimation for non-commercial drug manufacture, reducing processing timelines for test licences, and waiving prior permission for low-risk BA/BE studies.
The amendments aim to cut drug development timelines by a minimum of 90 days and reduce the processing period for test licences from 90 days to 45 days.
The government will roll out dedicated online modules on the National Single Window System (NSWS) and the SUGAM portal for seamless submission of intimations and applications.
The reforms align with international best practices and are expected to benefit the domestic generic pharmaceutical industry and improve timely access to affordable medicines.
- Who
- Union Ministry of Health and Family Welfare, Government of India
- What
- Amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019
- When
- January 28, 2026
- Where
- India
- Why
- To reduce regulatory delays, ease compliance requirements, and accelerate clinical research and drug development
- Announcement Date
- January 28, 2026
- Global Generic Drug Exports
- 20%
- Annual Test Licence Applications
- 30,000-35,000
- Annual BA/BE Studies
- 4,000-4,500
- Reduction in Drug Development Timelines
- 90 days
- Reduced Processing Timelines for Test Licences
- 45 days
Sources
Health Ministry Amends Rules To Ease Drug Research, Cut Regulatory Delays By 90 Days
Govt notifies norms to skip test licensing for drug R&D to boost ease of doing business
Centre amends clinical trial rules - reduces approval timelines for research, optimizes use of CDSCO human resource
Govt amends guidelines to strengthen environmental governance
Govt notifies amendments to drugs, clinical trials rules to promote ease of doing business
Govt amends consent norms to streamline industrial approvals
