

Pharmacovigilance The practice of monitoring the safety of pharmaceuticals (i.e., drug, veterinary nutraceuticals etc.) and medical devices has seen significant advancements across various regions, reflecting a global commitment to patient safety. INDIA SCENARIO: 1. Medical Device Rules 2017: Implemented on January 1, 2018, a comprehensive framework for medical device regulation has now been effective in India. They encompass essential principles for manufacturing, conformity assessments, and post-market surveillance, aligning with global standards to ensure the safety and efficacy of medical devices. 2. Revised Schedule M: Implemented on December 28, 2023, Schedule M of the Drugs and Cosmetics Rules, 1945, CDSCO has been amended that all pharmaceutical manufacturers establish a robust pharmacovigilance system at each manufacturing site. This system requires qualified personnel [Pharmacovigilance Officer In-Charge] to collect, collate, and analyze adverse drug reactions (ADRs), ensuring continuous monitoring of drug safety. For more information visit - https://acplgroupindia.co.in Call – 9266665201 info@acplgroupindia.co.in
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