Implementation of Pharmacovigilance (PV) System as per the requirement of Schedule M of Drugs & Cosmetics Act 1940 and the Rules made there under

The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, has issued a circular dated 3 June 2026 mandating the implementation of effective pharmacovigilance systems by all stakeholders. In reference to Para 6.11 of Schedule M of the Drugs & Cosmetics Act, 1940, licensees are required to establish mechanisms for collecting, processing, and forwarding reports of adverse drug reactions to licensing authorities. This directive emphasizes compliance with both the Drugs & Cosmetics Act and the NDCT Rules, 2019. The circular highlights that officers from CDSCO, State Licensing Authorities (SLA), and Union Territory administrations will verify adherence during routine inspections and regulatory activities. The measure reinforces India’s commitment to strengthening post‑marketing drug safety monitoring, ensuring accountability among manufacturers and marketers, and safeguarding public health through systematic reporting and vigilance. Stakeholders are urged to ensure immediate compliance with these requirements.