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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Submission of Periodic Safety Update Reports (PSURs) for New Drugs

21-Apr-2026 | PSUR/4/2026-eoffice

This notification issued under the New Drugs and Clinical Trials Rules, 2019 and related CDSCO guidelines clarifies the requirements for submission of Periodic Safety Update Reports (PSURs) for new drugs through the SUGAM portal in cases where there is a delay between grant of approval and actual market launch of the drug. Manufacturers and importers of new drugs are required to ensure that PSUR submission timelines commence from the actual date of marketing or commercial launch of the new drug, irrespective of the earlier date of regulatory approval. The clarification aims to ensure availability of meaningful post-marketing safety data and improve pharmacovigilance monitoring. All manufacturers and importers are therefore required to align their post-marketing surveillance and PSUR submission practices with the revised compliance requirements prescribed by CDSCO.

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