India plans adverse effects monitoring regime for medical devices as India Health minister okays plan to monitor medical devices

Despite being a $3.1 billion market for medical devices, India has no system for registering adverse events caused by medical devices or for tracking the safety record of medical devices and is dependent on data from the developed countries

The proposed plan, to be coordinated by the Indian Pharmacopoeia Commission in Ghaziabad, envisages a nation-wide program, involving district hospitals, medical colleges and corporate hospitals.  The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram (Trivandrum) is to be the national collaborating center for the program, which is to be run in collaboration with the Central Drug Standard Control Organization (CDSCO).  Technical support for the program is to be provided by the Division of Healthcare Technology, a proposed World Health Organization collaborating center for priority medical devices and health technology policy in the National Health Systems Resources Centre.

The Materio Vigilance Programme of India (MvPI) is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices for India could be based on data generated here.  The program is meant to monitor medical device associated adverse events (MDAE), create awareness among health care 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.

The Pharmacovigilance Commission is supposed to meet every three (3) months to examine the reported adverse events and confirm the events to be reported to the drug committee.  Based on these reports, a decision will be taken on whether any change is required in the labeling of the devices, or whether a recall or a ban on the product is called for.  To begin with, MvPI cells are to be established in 10 medical colleges.  These programs will be funded by the government and be required to report on-line.  The program will be along the lines of the existing pharmacovigilance program and haemovigilance program.

REFERENCE:  The Times of India; 16 MAR 2015; Rema Nagarajan

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