India is a $3.1 billion market for medical devices and the government will soon institute a Materio Vigilance Program of India (MvPI) to enable a systematic collection of data on the use of these devices. This data will form the basis for regulatory decisions and recommendations on their safe usage.
The program will be coordinated by the Indian Pharmacopoeia Commission, and envisages district hospitals, medical colleges and corporate hospitals. The biotechnology wing of the prestigious Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram, Kerala will be the national collaborating center for the program which will run in collaboration with the Central Drug Standard Control Organization. Technical support for the program will be provided by the Division of Healthcare Technology, a proposed WHO collaborating center for priority medical devices and health technology policy in the National Health Systems Resources Center.
The MvPI 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,
- monitor the benefit-risk profile of medical devices
- generate independent, evidence-based recommendations on the safety of medical devices
- communicate the findings to all key stakeholders