New Delhi: In a key regulatory update impacting India’s clinical research framework, the Ministry of Health and Family Welfare (MoHFW) has revised its August draft amendment to the New Drugs and Clinical Trials Rules, 2019, introducing a key change in the sample size requirement for bioavailability and bioequivalence (BA/BE) studies of new or investigational drugs.

The Ministry of Health and Family Welfare (MoHFW) has issued a corrigendum to its earlier draft notification—G.S.R. 587(E) dated August 27, 2025—which proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. The corrigendum, published on October 31, 2025 as G.S.R. 810(E), modifies the sample size condition under para 2 of the draft rules.

Earlier, the Medical Dialogues Team had reported that the Ministry

See Full Page