The Indian Government has notified the New Drugs and Clinical Trials (Second Amendment) Rules, 2026 on January 21, 2026.

The amendment introduces “prior intimation route” for certain bioavailability and bioequivalence (“BA/BE”) studies conducted for export purposes. Eligible single-dose, crossover BA/BE studies on healthy adult volunteers involving oral dosage forms can now be initiated after submitting Form CT-05 online and obtaining acknowledgment from the Central Licensing Authority, without waiting for formal regulatory permission.

This relaxation applies only where the underlying drug or active molecule forming the basis of the BA/BE study is already approved in India or in the United States of America, European Union, Japan, Australia, Canada and the United Kingdom and excludes sensitive categories such as cytotoxic, hormonal, narcotic, psychotropic, narrow therapeutic index and highly variable pharmacokinetic drugs. Ethics Committee approval remains mandatory and a minimum sample size of eighteen participants has been prescribed.

Overall, the Second Amendment facilitates quicker initiation of eligible export-oriented BA/BE studies while maintaining robust regulatory controls for sensitive drug categories, thereby enabling faster international regulatory submissions and approvals and strengthening India’s position as a globally competitive pharmaceutical hub. This amendment will come into force after 90 days from the date of publication in the Official Gazette.