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Pharmacovigilance The practice of monitoring t...

2025-03-27T04:30:12
Accredited Consultants Private Limited
PharmacovigilanceThe practice of monitoring t...

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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