The Government on Monday launched “MedTech Mitra: A Strategic Initiative to Empower MedTech Innovators and Advance Healthcare Solutions”, a platform to handhold the country’s young talents and give a final shape to their research, knowledge, logic etc.
“It will also help them get regulatory approval,” said Union Health Minister Mansukh Mandaviya after virtually launching the e-platform here.
He said that the medical devices sector is an essential constituent of the healthcare sector and India is adopting a holistic approach to health with a vision to transform its health landscape by 2047. Noting that India’s MedTech sector is highly import dependent, measuring up to 80 per cent, the health minister emphasized that “to ensure that medical devices are supplied within the country, this sector has seen phenomenal progress with the implementation of production-linked incentive schemes and investments for medical drug parks, the MedTech research policy and the MedTech research incentive scheme.
He said this collaborative initiative will facilitate the indigenous development of affordable and quality MedTech devices and diagnostics, leading to a considerable reduction in the import dependence of the sector. However, healthcare providers and manufacturers feel that at the ground level not much is done to help the indigenous medical device sector. In this connection, they cited the Bill to regulate Medical Device alongside Drugs, which according to them had many flaws which go against the local sector.
The AIMED Forum Coordinator Rajiv Nath, while expressing his disappointment, said that even after the assurance given by Union Minister of Health Minister Mandaviya, no committee was formed to review the different tenets of the Bill on a clause by clause discussion to align it or as suggested to use earlier separate Bill drafted by NITI Aayog in 2019.
“The need of the hour is a progressive modern separate law for addressing patient safety concerns. NITI Aayog had drafted an excellent Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 but in vain and we keep going in circles. Who gains from putting Indian manufacturers at a disadvantage over imports and by Drug pharmacists weighing biased regulatory controls? Even the impactful recent progressive legislations in countries like Canada, UK, EU, Brazil, Malaysia, Singapore and Saudi Arabia were not studied,” asked Nath.
“An inclusive process will help shape an appropriate Regulatory Policy that needs to impact the Medical Devices sector positively,” added Prof. Bejon Misra, Founder Director, Patient Safety and Access Initiative of Foundation India. He said, “Collective voices of the entire stakeholders should be heard, especially of the consumer and patient safety groups as the law is built to protect them and who should also be allowed to participate in formulating the regulations, which will help in ensuring affordable access to innovative medical devices that are safe.”
Nath rued that by keeping a chapter of penalties and punitive actions common with drugs, we are only reviving the Inspector Raj, which the nation cannot afford. We need competent auditors from engineering and science background and not dominant pharmacists with expertise of Drugs applying their drug regulatory inspection-based knowledge on medical devices that cannot have guarantee of absolute safety and are seeking an overkill.
Dr. Gyani emphasized, "In the national interest, it is crucial for us to highlight that if the Bill is passed as is, the healthcare providers sector, heavily reliant on medical devices and advocating for increased availability of affordable, high-quality, made-in-India medical devices, may once again face challenges in management of supply chain, leading to crisis and country wide lockdown similar to the onset of Covid. Domestic manufacturers might lose their capacity to swiftly address domestic demand, especially in the event of a pandemic”
