India’s drug regulator has directed pharmaceutical companies across the country to immediately put in place a pharmacovigilance system to track and report adverse drug reactions, warning that compliance will be scrutinised during routine inspections.
The Central Drugs Standard Control Organisation (CDSCO) said all drug manufacturers, marketers and importers must establish and maintain such systems in line with existing regulations, amid increasing scrutiny of India’s post-market drug safety surveillance framework. Pharmaceutical licensees are also required to align their systems with the New Drugs and Clinical Trials (NCT) Rules, 2019.
Various countries in recent years flagged concerns about quality and safety monitoring standards among Indian generic drug-makers who supply nearly a fifth of the world’s medicines by volume.
Under the mandate, licensees are expected to designate qualified pharmacovigilance officers, maintain detailed records of all reported adverse drug reactions (ADRs), develop standard operating procedures (SOPs) for safety reporting and submit reports to licensing authorities within stipulated timelines.
Enforcement will be carried out by officers of CDSCO, state licensing authorities and Union Territory administrations during routine inspections and other regulatory activities, it said. Industry experts said large pharmaceutical companies are largely equipped to meet the requirements but smaller and mid-size manufacturers may struggle with resources and awareness.
“The licensee shall have a pharmacovigilance system in place for collecting, processing and forwarding the reports to the licensing authorities for information on the adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee,” CDSCO said in its directive dated June 3.
All stakeholders, including manufacturers, marketers, and importers, have been asked to treat compliance as an immediate priority. The CDSCO directive cited Para 6.11 of Schedule M of the Drugs & Cosmetics Act, 1940, which requires every pharmaceutical licensee to collect, process and forward ADR reports to the relevant licensing authorities.
