Abstract

MATERIOVIGILANCE: THE EMERGING PILLAR OF PATIENT SAFETY IN THE INDIAN HEALTHCARE LANDSCAPE

Dr. Shivaraj Gowda H.*, Dr. Rathai Rajagopalan, Dr. Anuradha H.V.

ABSTRACT

Background: Materiovigilance (Mv), the science of monitoring the safety of medical devices, is an evolving discipline globally. In India, the growing use of medical devices and the need for post-marketing surveillance have prompted the development of a national materiovigilance framework.[1] Objective: This review aims to provide an overview of the concept of materiovigilance, its global and Indian regulatory landscape, operational framework under the Materiovigilance Programme of India (MvPI), challenges, and future directions.[1] Methods: Literature was searched using PubMed, government documents, MvPI guidelines, WHO resources, and regulatory databases. Relevant policies and reports from CDSCO and IPC were reviewed. Discussion: Materiovigilance in India is in its nascent but evolving stage. The MvPI, launched in 2015, operates through nodal coordinating centers, medical device adverse event monitoring centers (MDMCs), and manufacturers. Despite initial progress, underreporting, lack ofawareness, and limited regulatory enforcement remain challenges.[1] Conclusion: Strengthening materiovigilance in India requires integration with healthcare systems, continuous capacity building, and stakeholder collaboration. Pharmacologists, with their drug safety expertise, can play a pivotal role in expanding the scope of MvPI.[2]

Keywords: Materiovigilance, MvPI, medical device safety, adverse event reporting, pharmacovigilance, CDSCO, India.