The directive mandates that Periodic Safety Update Report (PSUR) submission timelines must commence from the date of actual marketing of a new drug not from the date of regulatory approval, a practice that had become common among several applicants.
The move gains significance as the authority noticed that a number of drug manufacturers were obtaining marketing approvals but delaying the commercial launch of their products by months, sometimes longer. Despite this gap, they were submitting PSUR data from the approval date rather than the launch date effectively reporting a period during which no patients were actually exposed to the drug.
“Thereby loosing valuable safety insights,” the note said, warning that such reporting distorts post-marketing surveillance data and could delay the detection of adverse drug reactions in real-world settings.
The regulator has also moved to streamline reporting by directing that all dosage forms, formulations, and indications of a new drug be covered under a single PSUR, rather than separate filings for each variant. Where different dosage forms, indications, or patient populations exist, separate data presentations must be included within the same report. The move is aimed at eliminating duplicate PSUR submissions, which have added to regulatory workload while fragmenting safety data that is more useful when viewed holistically.
Theo’s applies to all manufacturers and importers of new drugs marketed in India and is expected to prompt companies to review their internal pharmacovigilance timelines and reporting systems to ensure alignment with the new compliance requirements, people in the know told ET.
