Pharmacovigilance and materiovigilance in India: A review

Abstract

: Pharmacovigilance defined by the world health organization as "the science and activities relating to the detection, assessment, understanding, assessment and prevention of adverse effects or any other drug related problems". It plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug’s adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes both at a regulatory and scientific level are being developed with the aim of strengthening pharmacovigilance and materiopvigilance. On a regulatory level, transparency and increased patient involvement are two important elements [1]. similarly Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences. Postmarketing surveillance of medical devices has been initiated in many countries, but it is still not as developed and robust as that of medicines. Materiovigilance program of India was launched on July 6, 2015, at Indian Pharmacopeia Commission with objectives to track the adverse events associated with the use of medical devices, to generate safety data, create awareness among the different stakeholders, and recommend the best practices and interventions to improve the patient's safety.