New Delhi: Side effects from medicines sometimes appear only after widespread use. India’s drug regulator has asked pharmaceutical companies to set up stronger systems for tracking and reporting adverse reactions to medicines on the market.
In a June 3 circular, the Central Drugs Standard Control Organisation reminded manufacturers and stakeholders of their duty to maintain effective pharmacovigilance systems. These systems must collect and report adverse drug reactions for products they make or sell.
The requirement stems from Schedule M of the Drugs and Cosmetics Rules, which obliges licence holders to gather, process and send adverse reaction reports to authorities. Experts noted that Schedule M outlines Good Manufacturing Practices that firms must follow. The focus on pharmacovigilance strengthens post-marketing surveillance, also called Phase IV monitoring, to check medicine safety after patient use.
Such monitoring detects new or unknown reactions early, enabling regulators and companies to act promptly. Although clinical trials occur before approval, some effects emerge only with real-world use by many patients. Tracking these reactions supports better safety measures.
CDSCO stated that all parties must follow the Drugs and Cosmetics Act, related rules and the New Drugs and Clinical Trials Rules, 2019. Officials from CDSCO, state licensing bodies and Union Territory administrations may check compliance during inspections. The directive aligns with global trends that stress real-world data for spotting rare or delayed reactions.
