In January 2026, India’s Ministry of Health and Family Welfare made major amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. This has shortened the timeline for clinical trial approval from 90 to 45 working days, which will potentially improve the speed at which drugs are developed and tested in India.
The amendments also introduce a “prior intimation” mechanism. This mechanism allows manufacturers to commence certain analytical and non-clinical manufacturing activities upon receiving online acknowledgement by the Central Licensing Authority, instead of waiting for formal approval. This provision does not apply to higher-risk product categories such as cytotoxic drugs, live biologics, and controlled substances, which will continue to require prior permission.
At the same time, the government has retained safeguards to prevent misuse. Drugs manufactured under the revised amendments may only be used for clinical trials, bioavailability or bioequivalence studies, testing, or analysis. They are strictly prohibited from being sold or distributed in the market. Compliance with Good Manufacturing Practices remains mandatory.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.