While the industry expressed its happiness over the Centre’s plan to set up a Materio-Vigilance Programme of India (MvPI), they pointed out that it will only help the industry, if it is designed and implemented keeping in mind the dynamics of the medical device sector rather than pharma. These apprehensions were raised by the industry following the repeated failure by the government to recognize the medical device sector as an independent sector from pharma.

In the absence of any mechanism to monitor and control adverse events caused by medical devices, the Centre had recently announced its plan to initiate a nation-wide adverse events reporting (AER) initiative. It is understood that Thiruvananthapuram based Sree Chitra Thirunal Institute of Medical Sciences and Technology (SCTIMST), will be acting as national collaborating centre (NCC) for the same.

Rajiv Nath forum coordinator of Association of Indian Medical Device Industry (AIMED) informed that this is a welcome move albeit delayed one since its first reference almost four years back. He expressed hope that unlike in the past, this project does not get embroiled in bureaucratic process further delaying this process.

“The Centre had announced its plan to have some kind of mechanism for monitoring and reporting of the AERs of the medical devices some years back. Unfortunately the whole process was stalled and became a stalemate due to indecisiveness from the centre to formulate industry specific guidelines for the technology based medical device sector. As usual, they were keen on adopting from the lines of the pharmacovigilence programme which was not acceptable by the industry, but naturally, due to conflicting nature of the industries. We are happy that at least this time they have smartly chosen an expert institute to act as a NCC for the AERs, giving us hope that all is not lost for the sector,” stressed Nath.

Nath expressed that this is an excellent and much needed initiative and will give feedback to government on focussing on specific medical devices and regulations required. However, he stressed that the data should be used constructively and prudently as higher volume and more popular products will generate a relatively higher number of negative feedback reports.

D L Pandya, an expert from the industry and programme co-ordinator of the National Biomedical Engineering Society said, “It will finally give some regulatory semblance to the sector, in the wake of absence of any effective regulatory mechanism. 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. There will be more accountability within the whole system, further strengthening the trust and reputation of the sector within the country.”

At present, there is no mechanism to monitor or regulate the use of medical devices in the country against any possible adverse events. It is understood that the government in association with SCTIMST will formulate guidelines on what kind of parameters needs to be followed by the medical device companies to ensure patient safety to avoid undue incidence of adverse events.