In an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) on April 21, the regulator said it has observed instances where companies obtained approval for a new drug but launched the product in the market much later while submitting Periodic Safety Update Reports (PSUR) data from the approval date instead of the launch date.
New Delhi:India’s drug regulator has directed manufacturers and importers to submit Periodic Safety Update Reports (PSURs) for new drugs from the date of actual marketing of the product rather than from the date of regulatory approval, in a move aimed at strengthening post-marketing safety surveillance.
In an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) on April 21, the regulator said it has observed instances where companies obtained approval for a new drug but launched the product in the market much later while submitting PSUR data from the approval date instead of the launch date.
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.
Under the Fifth Schedule of the New Drugs and Clinical Trials Rules, 2019, manufacturers and importers are required to submit PSURs as part of post-marketing drug safety monitoring.
“In view of the above, all manufacturers/importers are hereby directed to ensure strict compliance,” the advisory stated.
According to the regulator, PSUR submission timelines will now commence from the date of actual marketing of the new drug “even if approval was granted earlier”.
The advisory by the Drugs Controller General of India (DCGI) also said that ordinarily all dosage forms, formulations and indications for a new drug should be covered in a single PSUR to avoid duplicate submissions.
However, separate presentation of safety data for different dosage forms, indications or patient populations should be included within the same report, it added.
The directive has been circulated to stakeholders as well as CDSCO’s zonal and sub-zonal offices.
PSURs are critical documents used by regulators worldwide to assess the risk-benefit profile of medicines after they enter the market and help identify adverse drug reactions that may not have emerged during clinical trials.