Authors : Shaik Nikhath Faheem; Zeba Sultana

Volume/Issue : Volume 9 - 2024, Issue 5 - May

Google Scholar : https://tinyurl.com/ycxkpvtf

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DOI : https://doi.org/10.38124/ijisrt/IJISRT24MAY509

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Abstract : Pharmacovigilance is a crucial process that aims to guarantee that patients are prescribed safe pharmaceuticals. The World Health Organisation describes it as "the discipline of science and activities relating to the identification, evaluation, comprehension, and avoidance of adverse effects and other drug-related problems." Recent advances in science have led to a major expansion in the role of medical devices in the healthcare delivery system. PV encompasses issues relating to medication therapy as well. To regulate the import, manufacture, sales, and distribution of medical equipment, the Indian government, along with the Drugs Technical Advisory Board, recently established the Medical Equipment Rules, in 2017. Postmarketing surveillance carried out by an Indian regulatory authority (MvPI) is becoming increasingly popular, comparable to that of international regulatory agencies. An essential instrument for protecting users from unforeseen effects and improving their health and safety, the adverse events reporting system (ADERS) allows for the recording of all types of medical device adverse events (MDAEs).

Keywords : Materiovigilance, Pharmacovigilance, Medical Devices, Indian Pharmacopoeia Commission, Central Drug Standard Control Organisation

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