Union Health Ministry Proposes Immediate Suspension of Manufacturing Licences for Drugs Found Not of Standard Quality on Specified Critical Parameters

The Union Ministry of Health and Family Welfare proposed amendments to the Drugs Rules, 1945, to enable immediate suspension of manufacturing licences for drugs declared Not of Standard Quality on critical parameters.

• The Central Licensing Approving Authority or State Licensing Authority can immediately suspend the manufacturing licence upon receipt of a Government Analyst's report.
• Suspension continues until the manufacturer implements Corrective and Preventive Action (CAPA) and Root Cause Analysis to the satisfaction of the Licensing Authority.
• The Government Analyst's report will be endorsed to the Drugs Controller General of India, the relevant State/UT Licensing Authority, and the manufacturer and marketer.
• The proposed amendments follow recommendations from the 92nd meeting of the Drugs Technical Advisory Board on 24 April 2025.
• Draft amendments are open for public consultation for 30 days from the date of the Gazette of India notification.