Make in India push for medical devices

The National Medical Device Policy, 2023 approved by the Union Cabinet is aimed at reducing India’s import dependence for domestic production of medical devices. The government ensuring strict quality control and keeping prices under check will be vital to achieve one of its key objectives of providing quality healthcare to patients at lowered cost. India currently accounts for 1.5% of the global and government hopes that the policy would help the medical devices sector in the country grow from present size of 11 billion dollars 50 billion dollars. The Association of Indian Medical Devices Industry has been flagging concern that overpriced imported medical devices are severely affecting India’s manufacturing growth in the sector. The Parliamentary Standing Committee on Health and Family Welfare highlighted in one of its reports that 80% of the country’s requirement of medical devices is met through imports due to absence of high-end technology and lack of raw materials. The committee observed that importing is cheaper than manufacturing domestically due to low import duty, and a 12% GST on manufactured goods. The Committee recommended reducing the excise duty on importing machinery used for setting up manufacturing plants of medical devices. It also recommended ensuring the Quality Management System (QMS) and Quality Assurance of the medical devices to prevent zero defectives from reaching the market and for consistent performance. The Federation of Indian Chambers of Commerce and Industry estimates that right policy decision can help India’s capital intensive medical device industry to grow 12 times the present size over the next 25 years. The new policy has brightened hopes for fuelling the desired growth but not without challenges to be faced in its implementation. The parliamentary panel pointed out that electronic equipments, implants and surgical instruments account for the highest imports in the medical devices sector and these segments include highly important and widely used high-end technology devices such as CT Scanners, MRI, Ultrasound and X-Ray machines, knee and hip implants, dental fixtures, cancer diagnostics and other sophisticated surgical instruments. It harped on the need for medical devices sector having a robust Research and Development infrastructure and trained workforce for manufacturing of high-end technology devices with industry also taking a lead and leading manufacturers and manufacturers’ associations establishing convergence and collaboration between the industry and academia. The policy envisages promoting R & D and establishing Centres of Excellence in academic and research institutions, innovation hubs, ‘plug and play’ infrastructures and support to start-ups. Industry bodies in the sector have been mounting pressure on the government not to criminalize manufacturing defect to prevent manufacturers from withdrawing for the fear of persecution. However, public health being the topmost concern, it is the bounden duty of the government to ensure that quality of medical devices is of international standard. This is also important for boosting confidence of the patients and their family members not just within the country but also in other counties about the quality of medical devices manufactured by Indian industries. One of the six broad areas of policy intervention is creation of a Single Window Clearance System for Licensing of Medical Devices in order to ease of doing research and business and further to balance patient safety by enhancing the role of Bureau of Indian Standards and designing a coherent pricing regulation. Projects under the Production Linked Incentive scheme for medical devices and medical devices park being set up will play a crucial role in implementation of the new policy. Under the PLI scheme, domestic manufacturing of high-end medical devices including Linear Accelerator, MRI Scan, CT-Scan, Mammogram, C-Arm, MRI Coils, high end X-ray tubes, etc. has already started in the country. The Orthopedic Implants Manufacturing Association apprised the committee about the indigenous manufacturing industry being adversely affected by reduced import duties and facing tough times competing with imported products. The association also flagged the issue of industry being dependent on expensive import of two raw materials of orthopaedic implants- stainless steel and titanium, due to absence of indigenous manufacturers of these two. The effectiveness of the policy in addressing such specific challenges faced by Indian medical devices industries will be crucial towards achieving the missions of access and universality, affordability, quality, patient centred and quality care, preventive and promotive health, security, research and innovation and skilled manpower. The policy framework supports dedicated multidisciplinary courses for medical devices in existing institutions to ensure availability of skilled manpower for futuristic medical technologies, high-end manufacturing and research, to produce “future-ready MedTech human resources” and to meet the evolving needs of the sector. It also seeks to develop partnerships with foreign academic/industry organizations to develop medical technologies in equal pace with the world market. The new policy has laid roadmap for growth of medical device sector but for larger section of Indians, the growth lowering the healthcare cost should top the chart of priorities.