Notification/Circular No.: PSUR-11/13/2024-eoffice (Comp. No. 17367) dated June 3, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940 read with the Rules made thereunder and the New Drugs and Clinical Trials (NDCT) Rules, 2019
Applicable Section/Rule: Para 6.11 of Schedule M
Para 6.11 of Schedule M of the Drugs and Cosmetics Act, 1940 and Rules thereunder mandates that the licensee shall have a pharmacovigilance system in place for collecting, processing and forwarding the reports to the licensing authorities for information on the adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee.
The Office of the Drugs Controller General (India), Post Marketing Drugs Safety Monitoring Division, Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, has issued a circular directing all stakeholders to establish and maintain an effective pharmacovigilance system in compliance with the provisions of the Drugs and Cosmetics Act, 1940, the Rules made thereunder, and the NDCT Rules, 2019.
The circular further states that officers of CDSCO, State Licensing Authorities (SLA), and Union Territory (UT) administrations may verify compliance with the above requirements during routine inspections and other regulatory activities.
The circular is addressed to all stakeholders. Copies have been issued for necessary compliance to: all State/UT Licensing Authorities; all Zonal/Sub-Zonal offices of CDSCO; the concerned division of CDSCO; and the CDSCO website.
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