Overview

• The proposal shifts most test‑licence requirements to a notify‑and‑proceed system, with full licences retained for high‑risk drugs.
• Statutory processing time for remaining test‑licence applications would fall to 45 days from 90.
• Certain BA/BE studies could start on intimation only for oral formulations already approved in the US, EU, UK, Japan, Australia or Canada, with exclusions covering hormones, narcotics, cytotoxics, narrow‑therapeutic‑index drugs and highly variable drugs.
• Trials under the notification route would require approval by a CDSCO‑registered ethics committee and be capped at 48 participants, with committees retaining review records.
• Manufacturing of investigational products could proceed on notification except for categories like beta‑lactam antibiotics and products with live microorganisms, and the ministry projects roughly a 50% drop in licence filings with better CDSCO resource use.