India’s drug regulator has tightened post-marketing safety reporting rules for pharmaceutical companies, directing manufacturers and importers to submit Periodic Safety Update Reports for new drugs from the date the product is actually marketed, rather than from the date it receives regulatory approval. The move by the Central Drugs Standard Control Organisation is aimed at strengthening pharmacovigilance and ensuring that drug safety data reflects real-world use after medicines reach patients.
The issue arose because CDSCO observed cases where companies received approval for a new drug but launched it commercially much later. In some such cases, firms were submitting PSUR data from the original approval date instead of the actual market launch date. According to the regulator, this practice could lead to the loss of important post-launch safety information, especially adverse effects that may only become visible after wider use among patients.
CDSCO’s advisory was issued on April 21, 2026, and its public notice list describes it as relating to the “Submission of Periodic Safety Update Reports for New Drugs via SUGAM Portal on deferred basis in case of delayed Marketing after Approval.” Under the revised approach, the PSUR timeline will begin from the date of actual marketing of the new drug, even if approval had been granted earlier. This makes the reporting clock more closely aligned with the period when patients are actually exposed to the medicine.
Periodic Safety Update Reports are mandatory safety documents submitted by manufacturers and importers under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019. These reports are used to assess the continuing risk-benefit profile of medicines after market entry and to detect adverse drug reactions or safety signals that may not have appeared during clinical trials.
The regulator has also sought to simplify and streamline reporting. The advisory says that, ordinarily, all dosage forms, formulations and indications of a new drug should be covered in a single PSUR to avoid duplicate submissions. However, companies can present separate safety data for different dosage forms, indications or patient groups within the same report.
The decision is significant for India’s pharmaceutical sector because it places greater responsibility on companies to track medicines after commercial rollout, not merely after approval. For patients, the move can improve safety monitoring by ensuring that adverse events, usage patterns and real-world risks are captured from the moment the drug enters the market. For regulators, it improves the quality of post-marketing surveillance and helps maintain a more accurate picture of a medicine’s safety profile.
For the pharma industry, the change means companies will need tighter internal coordination between regulatory affairs, marketing, pharmacovigilance and distribution teams. Any delay between approval and launch must be clearly reflected in safety-reporting timelines, while post-launch data collection will need to begin as soon as the medicine is commercially available. In effect, CDSCO is signalling that approval is only one stage of drug regulation; continuous safety monitoring after patient exposure is equally important.
Sources:
https://cdsco.gov.in/opencms/opencms/en/Latest-Public-Notices
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