Overview

• The draft amendments were published in the Gazette of India on August 28 and are open for stakeholder feedback for 30 days.
• The proposal would cut statutory processing timelines for test licences and related permissions from 90 working days to 45.
• Applicants would no longer wait for test licences in most cases, with a shift to an intimation-only route except for a small high-risk drug category.
• Licence requirements would be waived for certain BA/BE study applications, allowing initiation upon intimation to the Central Licensing Authority.
• The ministry projects roughly a 50% reduction in licence applications and says CDSCO could redeploy staff, aligning the effort with the government’s ease-of-doing-business push.