India tightens drug safety rules to prevent contaminated medicine risks

India’s drug regulator has introduced stricter rules for monitoring drug safety and adverse reactions. The Central Drugs Standard Control Organisation (CDSCO) issued a circular to strengthen pharmacovigilance systems across pharmaceutical companies. This move follows global concerns over contaminated medicines linked to child deaths in recent years. The updated guidelines require every licence holder in India to maintain a working pharmacovigilance system. Companies must now collect, process, and report adverse drug reactions (ADRs) from their products. These measures form part of Schedule M, which outlines Good Manufacturing Practices (GMP) and aligns Indian standards more closely with World Health Organization (WHO) benchmarks.

The CDSCO has also warned that compliance will be checked during routine inspections. Officers from the CDSCO, State Licensing Authorities (SLA), and Union Territory administrations will verify whether firms follow the new reporting rules. Regulators believe a stronger system will help detect safety risks earlier and prevent public health crises.

Health experts have welcomed the changes, calling them essential for improving accountability in drug manufacturing. A well-functioning pharmacovigilance system can lead to faster recalls of unsafe products and better protection for patients. The new pharmacovigilance rules aim to close gaps in India’s drug safety monitoring. By enforcing stricter reporting and inspections, the CDSCO hopes to reduce risks from contaminated or unsafe medicines. The changes also bring Indian regulations in line with international standards for pharmaceutical quality control.