Overview
- India’s Health Ministry has amended the NDCT Rules to replace test licences for non‑commercial small‑scale manufacture with prior online intimation to the CDSCO.
- Cytotoxic, narcotic and psychotropic drugs are excluded from the simplified pathway and will continue to require formal licences.
- Prior permission for certain low‑risk bioavailability/bioequivalence studies has been removed, allowing these studies to start on the basis of a simple intimation.
- For areas where licences still apply, the statutory processing timeline has been reduced from 90 days to 45 days, with the ministry projecting at least 90 days saved in development cycles.
- Dedicated online intimation modules will be rolled out on the NSWS and SUGAM portals, easing CDSCO’s workload from roughly 30,000–35,000 test‑licence and 4,000–4,500 BA/BE applications each year.