India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has issued a firm directive to all medicine manufacturers to build and maintain proper systems for tracking and reporting drug side effects.
The order, issued on June 3, 2026, comes six months after the revised Schedule M norms came into force on January 1. These norms require drug companies to upgrade their infrastructure, improve quality controls, and follow stricter documentation rules.
Under the new rules, every licensed drug company must have a dedicated pharmacovigilance unit to collect, process, and report adverse drug reactions (ADRs) on a daily basis. Companies must also maintain a Pharmacovigilance System Master File and appoint a trained, qualified officer specifically responsible for ADR reporting.
DCGI Rajeev Raghuvanshi confirmed that CDSCO and state authorities will verify compliance during routine inspections. Industry experts noted that while large companies already have such systems, this directive importantly brings smaller manufacturers under the same strict safety standards.
Written by: Arundhuti Chatterjee & Sharon Bose
Graphics by: Pramit Hazra
