After several horrific cases of malfunctioning medical devices, like babies being burnt to death due to short circuits in incubators or hip implants causing blood poisoning, the health ministry has approved a materio vigilance programme in an effort to ensure safety of 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 programme, involving district hospitals, medical colleges and corporate hospitals. The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram is to be the national collaborating centre for the programme, which is to be run in collaboration with the Central Drug Standard Control Organisation (CDSCO). Technical support for the programme is to be provided by the Division of Healthcare Technology, a proposed World Health Organisation collaborating centre 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 programme 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 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.
To begin with, MvPI cells are to be established in 10 medical colleges. These will be funded by the government to report online. The programme will be along the lines of the existing pharmacovigilance programme and haemovigilance programme.