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.
