The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to allow the immediate suspension of manufacturing licences for medicines found to be Not of Standard Quality (NSQ) on specified critical parameters.The move aims to prevent substandard drugs from remaining in circulation and protect patient safety.Under the proposed amendments, the Central Licensing Approving Authority or the concerned State Licensing Authority can immediately suspend the manufacturing licence of a drug upon receiving a Government Analyst’s report declaring it NSQ on parameters such as assay, dissolution, related substances, impurities or sterility.These parameters are critical to determining the quality and safety of medicines.Currently, suspension or cancellation of a manufacturing licence involves a prescribed regulatory procedure, including the issuance of a show-cause notice.This can create a time gap between a drug being declared substandard and regulatory action, during which the medicine may continue to remain in circulation, potentially posing risks to patients and making recalls more difficult.The proposed amendment seeks to enable prompt intervention in cases involving failures on these critical quality parameters.It also provides for mandatory corrective measures before a suspended licence can be restored. Manufacturers will have to conduct an effective Root Cause Analysis to identify the reasons for the quality failure and implement appropriate Corrective and Preventive Action (CAPA) to the satisfaction of the concerned Licensing Authority.The suspension will continue until the corrective and preventive measures have been implemented and verified by the Licensing Authority. The licence can be restored only after the authority is satisfied that the deficiencies have been addressed and safeguards are in place to prevent their recurrence.To improve regulatory coordination, the Ministry has also proposed consequential amendments to Form 13, which relates to the Government Analyst’s test report.Under the proposed mechanism, the report will be sent to the Drugs Controller General of India (DCGI), the concerned State or Union Territory Licensing Authority under whose jurisdiction the manufacturing site is located, and the manufacturer and marketer of the drug.The arrangement is intended to ensure timely communication of NSQ findings and facilitate coordinated action, while strengthening accountability across the drug manufacturing and marketing chain.The proposed amendments follow deliberations at the 65th meeting of the Drugs Consultative Committee (DCC), held on December 20, 2024, and recommendations of the 92nd meeting of the Drugs Technical Advisory Board (DTAB), held on April 24, 2025.The Ministry said the amendments would strengthen post-marketing surveillance, facilitate timely action against substandard medicines and promote greater accountability among manufacturers and marketers.