The directive comes six months after the enforcement of the revised Schedule M norms on January 1 this year.
Schedule M of the Drugs and Cosmetics Rules prescribes quality standards and good manufacturing practices (GMP) for drugmakers, requiring them to upgrade infrastructure, improve quality-control systems and adopt stricter documentation processes.
The revised rules legally mandate all licensees to have dedicated PV units for collecting, processing and forwarding day-to-day reports to licensing authorities on adverse drug reactions (ADRs) arising from the use of drugs manufactured or marketed by the licensee.
This includes maintaining a Pharmacovigilance System Master File (PSMF), a detailed and independently maintained document that describes the licensee’s PV system, outlining responsibilities, processes and locations.
Drugmakers have also been asked to appoint a qualified PV officer-in-charge who is a formally authorised, medically or pharmaceutically trained professional. This individual will be responsible for the overall collection, processing and reporting of ADRs.
“Officers of the CDSCO, state licensing authorities and Union Territory administrations may verify compliance with the above requirements during routine inspections and other regulatory activities,” Drugs Controller General of India Rajeev Raghuvanshi said in a circular seen by Business Standard.
Industry observers said the move would strengthen the continuous monitoring, detection, assessment and prevention of ADRs and enhance patient safety.
“While almost all large companies have a robust pharmacovigilance system in place, the new rules especially seek to ensure that smaller drugmakers comply with important ADR reporting norms,” an executive with a Delhi-based pharmaceutical company told Business Standard.
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