Pharma Companies to Count PSUR Timeline from Market Launch, Not Approval Date: CDSCO

New Delhi: The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), has issued a new advisory regarding the submission of Periodic Safety Update Reports (PSURs) for approved new drugs through the SUGAM portal.

According to the advisory issued by the Office of the Drugs Controller General (India) [DCGI] on April 21, 2026, manufacturers and importers of new drugs must now submit PSURs based on the actual date of marketing of the drug rather than the date of regulatory approval, especially in cases where product launch is delayed.

The move comes after CDSCO observed that in certain instances, applicants obtain approval for marketing a new drug but launch the drug in the market at a later date and the applicant submits the PSUR data from the date of approval instead of date of launch thereby loosing valuable safety insights.

In view of the above, all manufacturers/importers are hereby directed to ensure strict compliance with the following:

1. PSUR submission timelines shall commence from the date of actual marketing of the new drug, even if approval was granted earlier.

2. Ordinarily all dosage forms and formulations as well as indications for new drugs should be covered in one periodic safety update reports. Within the single periodic safety update reports separate presentations of data for different dosage forms, indications or separate population need to be given so as to avoid duplicate submission of PSUR applications.

The directive has been issued under the provisions of the Fifth Schedule of the New Drugs and Clinical Trials (NDCT) Rules, 2019, and relevant CDSCO guidelines related to post-marketing drug safety surveillance.