The Central Drugs Standard Control Organisation (CDSCO) of India has issued a directive requiring pharmaceutical manufacturers and importers to submit Periodic Safety Update Reports (PSURs) starting from the actual date a new drug is marketed, rather than the date of regulatory approval. This advisory, released on April 21, aims to tighten post-marketing surveillance and enhance patient safety monitoring. The CDSCO noted that some companies have been submitting PSUR data from the approval date, which undermines the quality of safety monitoring by excluding critical real-world data generated after the drug reaches patients. PSURs are mandatory reports that play a crucial role in pharmacovigilance, assessing the risk-benefit profile of medicines post-launch. The CDSCO emphasized that compliance with this new timeline is essential to ensure the inclusion of valuable safety insights. Additionally, the advisory seeks to streamline safety reporting formats, allowing for the presentation of safety data across different dosage forms and indications within a single report.