MedTech, leading the way

CII Healthcare Team works together with all stakeholders in facilitating potential collaboration between them by combining strengths, improving weaknesses, exploring opportunities and managing threats. The need of the hour is to raise India’s position in the global MedTech ecosystem, which can be achieved by providing incentives beyond PLI to manufacture indigenously and to spur continuous innovation. New pathways to validate indigenous innovation need to be created alongside localization strategy to support component manufacturing. There is also a need for creating ways to improve patient access to newer technologies. Another vital aspect is to simplify multiple regulatory authorities, complex regulations and unpredictable policy environment for smoother movement of processes. The key to promote Indian MedTech sector is to minimize the dependence on import of medical devices and equipment. Moreover, we should look at means to reduce the number of nodal departments overseeing medical devices and empower them to bring down their dependence on center and state coordination. The Government of India’s flagship Make in India initiative is an enabler, pushing the Indian medical devices sector to become self-reliant or Atmanirbhar Bharat.

The transformative policy proposed by CII NMTF seeks to unify and synchronize the efforts of multiple promoters of MedTech like National Medical Devices Promotional Council, DoP Pharma Bureau; Invest India; Engineering Export Promotion Council of India, and many more. National Medical Device Policy should also be released with at least a 10 years’ validity along the lines of National Health Policy (1983, 2002, 2017). Globally harmonized regulations under single regulatory authority would facilitate investments aimed at Make in India, for the world. The plan is to increase public health expenditure to 2.5 percent of GDP by 2025 to position India as a high consumption market which in turn will attract investments from across the world, this can be possible by discouraging the reuse of single use devices. To remove cost disadvantage in manufacturing and to make Indian companies globally competitive, the policy demands export incentives to the tune of 2-5 percent harmonized with MEIS with the current RoDTEP of .5-.7 percent, CapEx subsidy of 25 percent for MedTech manufacturing investment similar to MEITY policy and reinstatement of weighted tax deduction up to 200 percent on R&D investments. They also propose to make public procurement order more progressive by starting it from 30 percent and gradually increase it to 80 percent in 3 to 4 years’ time period as domestic manufacturing for products specified in PLI picks up.

But there are certain top priority recommendations, which require urgent attention. IMDRF consensus standards need to be adopted to facilitate innovation. Single regulator under MOHFW and clarity in respect to Medical Device Bill v/s CDSCO Roadmap will further simplify yet strengthen the regulatory system. Expanding production linked incentive schemes to cover MedTech MSME sector, other target segments and brown field projects is need of the hour. Separate parks for equipment, implants, consumables, and IVD devices can be looked at. Needy patients will be able to access new technologies by granting exemptions as under PPO 2020. The government should also look to rationalize the inverted duty structure, which leads to build up of credits and cascading costs for local producers. A balanced pricing mechanism is essential to be introduced for local manufacturers in order to provide access, enable innovation and competitiveness.

To further these agendas, there are some potential areas where CII NMTF and DPIIT National Medical Devices Promotional Council can collaborate. Quarterly workshops, seminars and other related networking activity for industry deliberations can be organized to build and sustain momentum with stakeholders. Such initiatives will enable India to promote local MedTech manufacturers and startups and help them rise to the levels of global standards.