Tracking Program for Medtech-Tied Adverse Events Approved in India

After several cases of malfunctioning medical devices that involved short-circuiting incubators and decaying hip implants, India’s health ministry has approved a “materio vigilance” program to ensure medical device safety.

Despite being a $3.1 billion market for medical devices, the country has no system for registering medical device adverse events or for tracking the safety record of such devices. It dependent entirely on data from developed markets.

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 will be the national collaborating center for the program, which is to be run in partnership with the Central Drug Standard Control Organisation (CDSCO). Technical support for the program will 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 generated data.

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 also is designed 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 scheduled to meet every three 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 labelling of the devices, or whether a recall or a ban on the product is called for, according to published reports.

Initially, MvPI cells are to be established in 10 medical colleges. The cells will be funded by the government to report online. The program will be modeled similar to the existing pharmacovigilance and haemovigilance programs.