Health Ministry proposes immediate licence suspension for substandard drugs
The Union Health Ministry seeks to amend the Drugs Rules, 1945, to allow instant suspension of manufacturing licences for medicines failing quality tests.
The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to allow for the immediate suspension of manufacturing licences for drugs declared Not of Standard Quality (NSQ), according to The Hindu.
The proposal aims to enable prompt regulatory intervention upon the detection of substandard medicines to prevent their continued manufacture and distribution. Under current provisions, the regulatory procedure requires issuing a show-cause notice before suspension or cancellation, which can create a time gap that allows substandard drugs to remain in circulation.
Under the new rules, the Central Licensing Approving Authority or a State Licensing Authority can suspend a licence immediately upon receiving a Government Analyst’s report. This applies when a drug fails critical parameters such as assay, dissolution, related substances, impurities, or sterility.
The suspension will remain in place until the manufacturer conducts a root cause analysis and implements Corrective and Preventive Action (CAPA). The licence can only be revoked after the licensing authority verifies that the corrective measures have been implemented to prevent recurrence.
The Ministry also proposed amendments to Form 13 to ensure the Government Analyst’s report is endorsed to the Drugs Controller General of India (DCGI), the relevant State or Union Territory Licensing Authority, and the manufacturer and marketer.
These proposals follow recommendations from the 65th meeting of the Drugs Consultative Committee on December 20, 2024, and the 92nd meeting of the Drugs Technical Advisory Board on April 24, 2025. The draft amendments are currently open for public consultation for 30 days.