MedTech industry seeks fine print of newly announced medical device policy

MedTech makers seeking clarity on the new policy.

Days after the announcement of the National Medical Devices (NMD) Policy, 2023, medical technology device makers said they are seeking greater clarity from the government on the details of the policy, which aims to accelerate growth in the production of medical devices in the country.

Key leaders of the medical technology sector, while welcoming the newly announced policy, urged the union government to release its fineprint.

“The government is engaging the industry and having a lot of meetings to collect views and counterviews. What is disturbing is that in the last many years we have been meeting, none of the serious concerns have been addressed in reality. We see higher engagement and discipline, but execution is lacking,” Vishwaprasad Alva, founder of Skanray Technologies, told Moneycontrol.

The NMD policy, approved by the cabinet, aims to reduce the country's import dependence to around 30 per cent in the next few years and make India one of the top five global manufacturing hubs.

A pharma department official, requesting anonymity, said that the NMD policy was aimed to drive export manufacturing of high end offerings and make it affordable to Indian hospitals and laboratories, while reducing import dependence significantly.

Alva, who headed FICCI’s National Med Tech group previously, suggested that the government’s economic think tank, NITI Aayog, should cut the number of government bodies involved in regulatory approvals.

“Instead of incentivising production, we need to incentivise exports from India, getting products to global safety and quality standards. We need to incentivise investments in product R&D and core research and not assembly and screwdriver technology,” Alva said.

The Skanray MD alleged that none of the points suggested by the industry for the NMD had been incorporated in the newly announced policy.

Simplifying regulatory provisions

While the new policy has emphasised on the creation of a ‘Single Window Clearance System’ for the licensing of medical devices, industry leaders said streamlining regulatory approvals was the need of the hour.

Rajiv Nath, forum co-ordinator, AiMED, also demanded that the government lay down clear terms on streamlining regulatory approvals.

“The government has unveiled the policy but they haven’t spelt out the finer details of the policy. Streamlining regulatory provisions is extremely important, otherwise, uncertainty prevails. We have also sought a meeting with the government authorities on this issue,” he added.

Alva said the government had identified MedTech as an essential and sunrise sector but lamented that there were lots of regulatory bodies with no competence and clarity to regulate the sector.

“The new medical device policy doesn’t address this issue. No other country in the world has so many bodies. Even after so many representations, there are a lot of promises made but no action,” Alva added.

‘Enabling regulatory environment needed’

The government has said that the NMD policy is aimed at promoting research and development in India by establishing Centres of Excellence in academic and research institutions, as well as innovation hubs.

Manikandan Bala, MD, Elekta India, said that the government should enable the regulatory environment to encourage innovation in the country.

“We are all waiting for clarity. There has to be a roadmap towards it. It’s great to have a ‘Make in India’ strategy in the medical device sector but we also need to collaborate with technology manufacturers outside India. We don’t want to be lagging behind in technology,” he added.

Bala also said that the government, through the NMD policy, had taken some steps to streamline regulatory oversight but it still had a good distance to cover.

“Encouraging innovation while maintaining safe standards can be done only when there is collaboration with the medical device industry,” the Elekta MD said.

Industry leaders said Medical Technology approvals cut across ministries and coordination between ministries was always a challenge for the industry.

“There is no nodal agency that is active. MedTech is best under MEITY. MedTech clubbed with pharma is one of the most flawed policy decisions. Tinkering with it will not solve issues,” Alva said.