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In a major regulatory crackdown aimed at safeguarding patient safety and bolstering public health, the Union Ministry of Health and Family Welfare has proposed decisive amendments to the Drugs Rules, 1945.
Under the proposed draft notification issued by the Ministry of Health and Family Welfare, manufacturing licences for drugs declared Not of Standard Quality (NSQ) on critical parameters will now face immediate suspension without waiting through lengthy procedural show-cause delays. Under current provisions of the Drugs Rules, 1945, initiating regulatory action after a drug fails quality testing involves lengthy procedures, including issuing show-cause notices. This procedural lag creates a dangerous period during which substandard medicines remain in active circulation, endangering public health and complicating product recalls. The new amendments empower both the Central Licensing Approving Authority and State Licensing Authorities to instantly suspend manufacturing licences the moment a Government Analyst's report flags a non-compliant drug. The draft rules target core parameters essential to safety and therapeutic effectiveness. Immediate suspension will apply when a drug fails test reports for any of the following:Sub-potent or over-potent active ingredient content;Inability of the drug to dissolve correctly to deliver its therapeutic effect;Presence of unapproved chemical variants or degradation products;Toxic or unwanted chemical contaminants and microbially compromised injectables, eye drops, or sterile formulations. Suspensions will remain strictly in force until manufacturers complete a complete quality overhaul. Licences will not be restored automatically. Root Cause Analysis (RCA): The manufacturer must perform an exhaustive investigation to pinpoint the exact failure point. Corrective and Preventive Action (CAPA): The manufacturer must implement system-wide safeguards to ensure the defect cannot recur. On-Site Verification: Revocation of the suspension is permitted only after the relevant Licensing Authority inspects, verifies, and approves the implemented CAPA. To eliminate communication bottlenecks between states and central agencies, consequential amendments have been proposed for Form 13 (the official test report of the Government Analyst). Reports flagging NSQ findings will now be simultaneously endorsed to: The Drugs Controller General of India (DCGI); The State/UT Licensing Authority holding jurisdiction over the manufacturing facility; Both the Manufacturer and the Marketer of the drug. This nationwide broadcast loop strengthens post-marketing surveillance and enforces shared accountability across both makers and brand-marketing entities. The proposed regulatory overhaul stems from policy recommendations made during key expert body meetings: the65th Meeting of the Drugs Consultative Committee (DCC) held on Dec 20, 2024 and the92nd Meeting of the Drugs Technical Advisory Board (DTAB) held on Apr 24, 2025. The Ministry has published draft Gazette rules for public consultation. Stakeholders and citizens have 30 days from publication to submit objections and suggestions. (ANI)
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