India Launching Nationwide Medical Device Surveillance Program
By Jof Enriquez,
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India’s government soon will launch a nationwide safety and surveillance program for medical devices. It is the first system to collect information on medical devices used specifically in India. To date, the country's healthcare providers have relied mostly on foreign data to determine the safety profiles of medical devices.
According to a PharmaBiz report, India's health ministry designed the Materio-vigilance Programme of India (MvPI) "to monitor medical device associated adverse events (MDAE), create awareness among healthcare professionals about the importance of MDAE reporting in India and to monitor the benefit-risk profile of medical devices. It is also meant to generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders."
A national-level committee is designing MDAE forms and is reviewing requirements for medical device causality assessments. Expected to commence in three months, the final system of reporting will be run out of MvPI "cells" in 10 medical colleges throughout India, the PharmaBiz report stated. The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology (SCTIMST) in Thiruvananthapuram is designated as the national collaborating center for the program.
" As part of the program, adverse events associated with medical devices will be reported online to the nodal collaborating center," India's Health Minister, J. P. Nadda, recently told The Economic Times. "Such events will thereafter be analyzed by the technical committee and based on the findings of the committee, further action as considered appropriate will be taken."
The Central Drug Standard Control Organisation (CDSCO) — India's equivalent of the U.S. Food and Drug Administration (FDA) — will coordinate with the institute on implementation. The CDSCO's central role in the MvPI initiative reflects the recent expansion of its oversight to include the country's medical device sector.
Meanwhile, the National Health Systems Resource Centre (NHSRC) Division of Healthcare Technology will provide technical assistance to the 10 medical colleges. The NHSRC recently was appointed as the fourth global World Health Organization (WHO) Collaborating Centre for Priority Medical Devices and Health Technology Policy.
India is trying to create a more coherent regulatory environment, both to meet growing local healthcare demand and to boost the country's domestic medical device sector. In addition to expanding regulatory oversight of medical devices, the CDSCO plans to enforce stricter accreditation standards for clinical trials, and to implement world-class manufacturing processes for better quality control of devices made in the country. The government also recently announced plans to build the country’s first industrial parks dedicated to medical device manufacturing in Gujarat and Chengalpattu.