The Central Drugs Standard Control Organization (CDSCO) on June 03, 2026, issued a circular regarding the implementation of the Pharmacovigilance (PV) System as per the requirement of Schedule M of the Drugs & Cosmetics Act, 1940, and the Rules made thereunder.
The following has been stated:-
•All drug manufacturers and marketers are required to establish and maintain an effective pharmacovigilance (PV) system as mandated under Schedule M of the Drugs and Cosmetics Act, 1940, and related rules.
•The system must collect, process, and report adverse drug reactions associated with their products to the licensing authorities.
•Compliance is also required under the New Drugs and Clinical Trials (NDCT) Rules, 2019.
•CDSCO, State Licensing Authorities, and UT administrations may verify adherence to these requirements during inspections and other regulatory activities.
[Circular No.: File No. PSUR-11/13/2024-eoffice (Comp. No. 17367)]
