The Central Drugs Standard Control Organisation (CDSCO), India's drug regulatory authority, has issued a directive to tighten post-marketing safety reporting for drug manufacturers and importers. The new regulation requires that Periodic Safety Update Reports (PSUR) commence from the actual marketing date of a new drug, rather than the date of regulatory approval. This change addresses a common practice where manufacturers delayed the commercial launch of drugs while still submitting PSUR data from the approval date, potentially leading to a loss of valuable safety insights during the period when no patients were exposed to the drug. The CDSCO noted that such practices distorted post-marketing surveillance data and could delay the identification of adverse drug reactions in real-world settings. Additionally, the new directive streamlines reporting by requiring all dosage forms, formulations, and indications of a new drug to be included in a single PSUR, reducing duplicate submissions and enhancing the utility of safety data. This move is expected to prompt drug manufacturers to reassess their internal pharmacovigilance processes to comply with the updated requirements.