Notification / Circular No – F. No. DC-DT-15011(11)/144/2025-eoffice dated October 07, 2025
Applicable Act/Rule: Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945
Applicable Section/Rule – Rules 74(c) and 78(c)(ii) of the Drugs Rules, 1945
The Central Drugs Standard Control Organisation (CDSCO) has reiterated the critical importance of ensuring the quality and safety of pharmaceutical products following recent incidents, including child fatalities in Madhya Pradesh allegedly linked to contaminated cough syrups.
The Drugs Controller General of India (DCGI) has directed all State and UT Drug Controllers to ensure strict compliance with Rules 74(c) and 78(c)(ii) of the Drugs Rules, 1945. These rules mandate that every licensee must:
Regulators are instructed to monitor compliance through inspections, issue necessary advisories to manufacturers, and verify that all manufacturers have robust vendor qualification systems ensuring procurement only from approved and reliable suppliers. Immediate acknowledgment and reports on the actions taken are required from State and UT authorities.
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