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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 v
A Gujarat-based NGO has urged the government to bring nutraceuticals, including fortified foods and health supplements, under the ambit of drug regulators by implementing the recommendations of a 2024 inter-ministerial committee, citing concerns over product quality and unregulated pricing. In a representation to Union Health Minister JP Nadda, the organisation 'Right to Life' said the current regulatory framework, which classifies nutraceuticals as food products under the Food Safety and Standards Authority of India (FSSAI), has led to a "serious dilution" of manufacturing standards and oversight. The NGO argued that many nutraceuticals are routinely prescribed by doctors across specialties such as cardiology, orthopaedics and gynaecology as adjunct therapeutic interventions, and are dispensed through pharmacies in a manner similar to prescription drugs. "Patients have a reasonable expectation that such products meet pharmaceutical-grade quality and safety standards. However, their
In a move aimed at speeding up approvals for new drugs, the government has changed the way testing permissions are granted, allowing companies to begin laboratory testing immediately after filing applications instead of waiting for detailed scrutiny. In an official circular, the country's apex drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), said it has decided that "No Objection Certificate (NOC) for testing of drug samples at the designated laboratories (IPC, Ghaziabad; CDTL, Mumbai; CDL at CRI, Kasauli; or NIB, Noida) shall be issued immediately upon receipt of applications in the concerned division." Earlier, the regulator examined detailed specifications submitted by applicants before issuing permission for testing. These included "Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product," along with "Product development reports, forced degradation studies, and other relevant data, in ...