Drugmakers must report safety data from launch date, not approval date: CDSCO

India’s drug regulator has directed pharmaceutical manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date the product is actually marketed, rather than from the date of regulatory approval, in a move aimed at tightening post-marketing surveillance and improving patient safety monitoring.

In an advisory issued on April 21, the Central Drugs Standard Control Organisation (CDSCO) said it had observed cases where companies received approval for a new drug but launched the product commercially much later, while continuing to submit PSUR data from the original approval date instead of the actual market launch date.

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According to the regulator, the practice weakens the quality of post-marketing safety monitoring by leaving out crucial real-world data generated after the drug reaches patients.

“The CDSCO said such a practice results in the loss of ‘valuable safety insights’ that are critical for monitoring adverse effects and ensuring patient safety after commercial roll out of medicines,” the advisory noted.

PSURs are mandatory reports submitted by manufacturers and importers under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019. The reports form a key part of post-marketing pharmacovigilance and are used to assess the ongoing risk-benefit profile of medicines after they enter the market.

“In view of the above, all manufacturers/importers are hereby directed to ensure strict compliance,” the advisory stated.The regulator clarified that PSUR submission timelines will now begin from the date of “actual marketing” of the new drug, “even if approval was granted earlier”.

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The advisory also sought to streamline safety reporting formats. The Drugs Controller General of India (DCGI) said that, ordinarily, all dosage forms, formulations and indications of a new drug should be covered in a single PSUR to avoid duplication of submissions.

At the same time, the regulator allowed companies to separately present safety data for different dosage forms, indications or patient populations within the same report.

The directive has been circulated to industry stakeholders as well as CDSCO’s zonal and sub-zonal offices.

PSURs are considered critical tools by regulators globally for detecting adverse drug reactions and identifying safety risks that may not emerge during clinical trials, particularly after wider commercial use across diverse patient populations.