In a strategic move to protect the health of the patients, the ministry of health & family welfare approved the commencement of the ambitious Materiovigilance Programme of India (MvPI) to monitor the safety of medical devices in the country. The MvPI was formally launched on July 6 at Indian Pharmacopoeia Commission (IPC), Ghaziabad by Dr G N Singh, Drug Controller General of India (DCGI).
It is understood that while IPC will function as the national coordination centre for MvPI, Sree Chitra Tirunal Institute of Medical Sciences & Technology (SCTIMST) will be functioning as National Collaborating Centre for the same. At the same time, the National Health Systems Resource Centre (NHSRC) under the ministry of health will collaborate and work as technical support and resource centre.
While stressing on the importance of this initiative, Dr Singh said this is an important step towards ensuring patient safety measures in the country as medical devices are as crucial and important aspect of healthcare as drugs.
“Considering the current healthcare needs of the country, MvPI is a necessity essential to safeguard the interest of the patients. Thus we would ask all the stakeholders to come forward and support us in this national cause,” he added.
He further stressed that this will go a long way in generating India’s safety data collection on the medical devices running in the market 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.
Dr V Kalaiselvan, principal scientific officer, IPC informed that following the launch, the technical committee had a high level meeting in which the members of the steering committee and working group took important decisions on identifying the 10 adverse effect monitoring centres and data management system, along with finalising the other aspects relating to the modalities for the same.
Interestingly, this 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 risk-benefit profile of medical devices. It will also play key role in generating independent, evidence-based recommendations on the safety of medical devices so as to communicate its results to the stakeholders.
At present, there is no mechanism to monitor or regulate the use of medical devices in the country against any possible adverse events. Thus experts from the industry strongly feel that this move will finally help in bringing some regulatory semblance to the sector. Especially since monitoring for possible adverse events pro-actively will not only help in ensuring better patient safety but also improve the standard of the industry as well.