ABSTRACT

In India, various programme run to ensure the health among population living in diverse economic condition, one of them is Pharmacovigilance Programme of India (PvPI) which is begin by Government of India (GoI) with the objective to improve patient’s safety during the administration of drugs in 2010. Under the umbrella of PvPI, evaluation of the benefits, drawbacks, efficacy, side effects, monitor adverse drug reactions and risk associated with the administration of pharmaceuticals by establishing an Adverse Drug Reaction Monitoring Centre (AMCs) which are set up to collect and report ADRs to the Indian Pharmacopoeia Commission (IPC), Ghaziabad’s through online software called VigiFlow. IPC working as a National Coordination Centre (NCC). After two years later, the Haemovigilance Programme of India (HvPI) launched in India in 2012 with the aim to monitor the adverse reactions associated with the blood and blood product transfusions. While, Materiovigilance Programme of India (MvPI), was initiated in 2015 at the IPC, Ghaziabad for post-marketing surveillance or tracking of potential outcomes arising from the practice of medical devices among the population of India. Due to dramatic increase in number and use of medical instruments, adverse events occur more frequently. Together all programme shows an essential component of the drug/ medical devices development process and clinical research. The collected, documented and analyzed safety profile will helpful for healthcare professionals, patients, manufacturing industries, and regulatoryinstitutions like Central Drug Standard Control Organization (CDSCO) for taking regulatory decisions on the safe use of drugs/ medical devices among the Indian Population. Keywords: Pharmacovigilance, Haemovigilance, Materiovigilance, IPC, CDSCO
Publication date: 01/11/2024

https://ijbpas.com/pdf/2024/November/MS_IJBPAS_2024_8465.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.11.8465