NEW DELHI: The Drug Regulatory Authority of India has directed manufacturers and importers to submit periodic safety update reports for new drugs as of the actual marketing date of the product rather than the date of regulatory approval, in a move aimed at strengthening post-marketing safety monitoring.
In an advisory report issued by the Central Drugs Standard Control Board on April 21, the regulator said it had observed instances where companies received 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.
Such a practice results in the loss of “valuable safety insights” that are critical for monitoring adverse effects and ensuring patient safety after drugs are commercially released, CDSCO said.
Under Schedule V of the New Medicines and Clinical Trials Rules 2019, manufacturers and importers are required to submit PSURs as part of post-marketing safety surveillance of medicines.
“In view of the above, all manufacturers/importers are hereby directed to ensure strict compliance,” the advisory said.
According to the regulator, timelines for submitting a PSUR will now start from the actual marketing date of the new medicine “even if approval has been previously granted”.
The advisory issued by the Drug Controller General of India also said that all dosage forms, formulations and indications of a new drug should normally be covered in a single PSUR to avoid duplicate submissions.
However, a separate presentation of safety data for different dosage forms, indications or patient groups should be included in the same report, she added.
The directive has been circulated to stakeholders as well as the zonal and sub-zonal offices of CDSCO.
PSURs are important documents used by regulatory agencies around the world to evaluate the risk-benefit profile of drugs after they enter the market and help identify adverse drug interactions that may not have been apparent during clinical trials.
This article was generated from an automated news feed without any modifications to the text.
