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CDSCO directs PSUR filings to start from actual drug launch date
India's CDSCO directed that PSURs for new drugs must start from the date of actual market launch rather than from the approval date. The advisory, issued on April 21, aims to strengthen post-marketing safety surveillance. It also states that a single PSUR should cover all dosage forms and indications, with separate safety data included in the same report as needed, and that the directive was circulated to stakeholders and CDSCO offices.
Why It Matters
It strengthens post-marketing safety surveillance by ensuring safety data reflect real-world exposure after launch, aiding earlier detection of adverse drug reactions.
Timeline
1 Event
CDSCO issues advisory directing PSURs to be filed from actual marketing date for new drugs
April 21, 2026
The Central Drugs Standard Control Organisation issued an advisory on April 21, 2026 directing manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date of actual marketing rather than from the date of regulatory approval. The advisory states this practice had led to loss of valuable safety insights and could affect post-marketing safety monitoring. It notes that PSUR timelines will commence from the date of actual marketing even if approval was granted earlier, and that ordinarily all dosage forms, formulations and indications should be covered in a single PSUR to avoid duplicates, with separate presentation of safety data for different forms or populations included within the same report. The directive was circulated to stakeholders and CDSCO's zonal and sub-zonal offices. It bases the change on the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, which requires PSURs as part of post-marketing surveillance.