Overview
- The Union health ministry published a draft notification on Sunday that would shorten statutory timelines for manufacturing licences and has placed the text in the Official Gazette and on the CDSCO website for about 30 days of public comment.
- Key numeric changes in the draft include cutting Class B licence grant from 140 days to 115 days and cutting Class C and D licence grants from 105 days to 90 days.
- The draft adds stage-by-stage caps such as 30 days for initial scrutiny, 30 days for site audits, 20 days for verification of compliance reports, and a reduction in licence issuance after inspection from 45 days to 20 days.
- The amendments keep mandatory Quality Management System (QMS) verification by notified bodies and require State Licensing Authorities to assign notified bodies and ensure site audits before licences are granted.
- Next steps call for review of stakeholder comments before a final Gazette notification; officials say the changes aim to speed approvals, improve predictability for manufacturers, and deliver faster patient access while retaining quality checks.