The Government of India has notified important changes to the New Drugs and Clinical Trials Rules, 2019, with the aim of making drug research and testing faster and more efficient. The amended rules, called the New Drugs and Clinical Trials (Amendment) Rules, 2026, were published in the Gazette of India on 20 January 2026 by the Ministry of Health and Family Welfare.
One of the major changes is the reduction in approval timelines. The time limit for granting permissions related to clinical trials, bioavailability, and bioequivalence studies has been cut from 90 working days to 45 working days. This move is expected to significantly reduce delays in drug development.
For certain categories of drugs meant only for analytical and non-clinical testing, companies will no longer need to wait for full approval. Instead, they can start manufacturing after submitting an online prior intimation and receiving its acknowledgment from the Central Licensing Authority. However, this relaxation does not apply to sensitive drug categories such as cytotoxic drugs, sex hormones, narcotics, psychotropic substances, and biologics containing live microorganisms.
The amended rules clearly state that drugs manufactured under these permissions or prior intimations cannot be sold in the market. They can only be used for research purposes like clinical trials, testing, analysis, or bioequivalence studies. Manufacturers must also maintain proper records of production, usage, and disposal.
The government has also strengthened enforcement provisions. The Central Licensing Authority now has clear powers to suspend or cancel permissions or acknowledgments if manufacturers fail to comply with the rules. Companies will have the right to appeal such decisions within a specified time period.
These amendments are expected to benefit Indian pharmaceutical companies, CROs, and research institutions by reducing regulatory delays while maintaining safety and quality standards. Faster approvals could help India remain competitive in global drug research and development.
The new rules will come into force 45 days after their publication, giving stakeholders time to align their processes with the updated regulatory framework.
