CDSCO Directs Pharma Firms to Maintain Mandatory Pharmacovigilance, ADR Monitoring Systems Under Schedule M

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has directed all stakeholders to ensure the establishment and maintenance of an effective pharmacovigilance (PV) system in compliance with the provisions of the Drugs and Cosmetics Act, 1940, the Rules made thereunder, and the New Drugs and Clinical Trials (NDCT) Rules, 2019.

In a circular dated June 3, 2026, the Office of the Drugs Controller General (India) (DCGI) referred to Paragraph 6.11 of Schedule M of the Drugs and Cosmetics Act, 1940 and Rules thereunder, which mandates that licensees must have a pharmacovigilance system in place for collecting, processing and forwarding reports to the licensing authorities regarding adverse drug reactions emerging from the use of drugs manufactured or marketed by them.

The circular reiterates that the requirement is a statutory obligation under Schedule M and emphasises the need for an effective system for monitoring and reporting adverse drug reactions associated with marketed pharmaceutical products.

“In this regard, all the stakeholders are hereby directed to ensure the establishment and maintenance of an effective pharmacovigilance system in compliance with the provisions of the D&C Act, 1940 and the Rules made thereunder, and the NDCT Rules, 2019,” the circular stated.

CDSCO further informed that officers of the central regulator, State Licensing Authorities (SLAs), and Union Territory administrations may verify compliance with the pharmacovigilance requirements during routine inspections and other regulatory activities.

The circular has been issued to all stakeholders, while copies have been forwarded to State and UT Licensing Authorities, CDSCO's zonal and sub-zonal offices, and other concerned divisions for necessary compliance.