Medical Devices

INTRODUCTION

The healthcare and medical device sectors in India have grown significantly in the last decade. A wide range of medical devices, from consumable

es to implantable medical devices, are produced in India. The majority of medical devices manufactured in India are disposables like catheters, perfusion sets, extension lines, cannulas, feeding tubes, needles, and syringes, as well as implants like cardiac stents, drug-eluting stents, intraocular lenses, and orthopaedic implants. The medical devices sector is highly capital intensive, and also requires continuous training of the healthcare system providers to adapt to new technologies.

However, there is still a huge gap in the current demand and supply of medical devices in India, as India has an overall 70-80% import dependency on medical devices. At present, many medical device manufacturers (domestic and international) are chasing this massive under penetration of medical devices in India as a significant growth opportunity.

The government has come up with multiple initiatives and policies to promote India’s medical device sector. It was recognised as a focus sector in 2014 by the government during the Make in India campaign.

In the Union Budget 2025-26, Rs. 99,858 crore (US$ 11.48 billion) was allocated as a budget for the healthcare sector.

MARKET SIZE

The medical devices sector in India comprises large multinationals, small and midsized companies.

The size of the Indian medical devices market is estimated at Rs. 90,000 crore (US$ 11 billion) in 2022 and is expected to grow to US$ 50 billion by 2030 with a CAGR of 16.4 %. The Indian medical device market share in the global market is estimated to be 1.65%.

India is the 4th largest Asian medical devices market after Japan, China, and South Korea, and among the top 20 medical devices markets globally.

Between 2020-30, the diagnostic imaging market is likely to expand at a CAGR of 16.4%.

Export of medical devices from India stood at Rs. 19, 803 crore (US$ 2.40 billion) in FY22. The exports of medical devices during April-December, 2022 stood at Rs. 20,511 crore (US$ 2.49 billion), and are expected to rise to US$ 10 billion by 2025.

To increase export of medical devices in the country, the Ministry of Health and Family Welfare (MOHFW) and Central Drugs Standard Control Organisation (CDSCO) implemented the following initiatives:

• Re-examination and implementation of Schedule MIII (a draft guidance on good manufacturing practices and facility requirements)
• System for export labelling
• Clinical evaluation and adverse reporting clarification
• State licencing authority to extend free sales certificate validity from 2 years to 5 years to allow exports
• Create a list of manufacturers with export licencing for easy access to regulatory authorities worldwide.

INVESTMENTS

Some major investments and developments in the medical devices sector are as follows:

• In April 2023, Healthvista India, the parent company of the healthtech startup Portea Medical, received approval from the Securities and Exchange Board of India (SEBI) for its initial public offering (IPO). The IPO comprises a fresh issue of equity shares worth Rs. 200 crore (US$ 24 million) and an offer for sale (OFS) of up to 56,252,654 shares worth Rs. 800 crore (US$ 95.9 million).
• In March 2023, SMT was selected as the exclusive distributor of Penumbra’s peripheral and coronary vascular thrombectomy technologies in select domestic geographies in India.
• In August 2023, Union Health Minister Mr. Mansukh Mandaviya said that India is poised to become a global centre for medical technology and devices, while addressing the India MedTech Expo 2023.
• In August 2023, Manipal Academy of Higher Education (MAHE), Manipal and Siemens Healthineers signed a Master Research collaboration (MRA) for continued strengthening of future cooperation between both organisations in achieving shared outcomes for the stakeholders.
• As announced in August 2023, Omron Healthcare India Pvt. Ltd., a subsidiary of Japanese company Omron Healthcare Co. Ltd., which is in the supply of home healthcare monitoring devices in India, is planning to double its revenue in 3-5 years.
• In August 2023, Omron Healthcare India announced a collaboration with supermodel, film producer, and fitness enthusiast Mr. Milind Soman to enhance awareness around adopting home monitoring as an essential constituent of the health regime.
• In May 2023, Medtronic announced an investment of approximately Rs. 3,000 crore (more than US$ 350 million) to expand the Medtronic Engineering & Innovation Center (MEIC) in Hyderabad. MEIC is Medtronic’s largest research and development (R&D) centre outside of the US.
• In May 2023, Omron Healthcare, a Japan-based manufacturer and distributor of personal healthcare products, announced that it will set up a medical devices manufacturing plant in Tamil Nadu at a cost of US$ 15.5 million (Rs. 128 crore).
• Hindustan Syringes & Medical Devices Ltd, in April, 2023, has achieved another milestone of supplying 1.75 billion syringes of the total 13.3 billion COVID-19 vaccines administered globally.
• In March, 2023, Siemens Healthineers, a medtech company that is into precision medicine, transforming care delivery, improving the patient experience and digitalising healthcare, announced that it would invest Rs. 1,300 crore (US$ 157.2 million) at Bommasandra in Bengaluru to set up a full-fledged campus.
• Medtronic bolstered its presence in India by investing approximately Rs. 3,000 crore (US$ 362.8 million) to expand Medtronic Engineering & Innovation Center in Hyderabad.
• The first indigenously-developed RT-PCR kit for testing monkeypox was launched by Transasia at the Andhra Pradesh Medtech Zone (AMTZ) in August, 2022.
• BeatO, a supplier of diabetes treatment, has raised US$ 33 million in a Series B fundraising, which was headed by Lightrock India. HealthQuad and current investors Orios Venture Partners, Blume Ventures, and Leo Capital also participated.
• In August 2022, Wipro GE Healthcare announced that it had partnered with medical device maker Boston Scientific to offer comprehensive, cutting-edge cardiac interventional care solutions in India.
• FDI inflow in the medical and surgical appliances sector stood at US$ 3.22 billion between April 2000-September 2023.
• In July 2022, Godrej Appliances launched the new InsuliCool product range – Godrej InsuliCool and Godrej InsuliCool+, which are innovative cooling solutions especially designed for insulin storage, in order to address the challenge faced by diabetic patients with respect to insulin storage at recommended temperatures.
• In July 2022, the Rajiv Gandhi Cancer Institute and Research Center (RGCI) in New Delhi received its first-ever Made-in-India Surgical Robotic System, the SSI-Mantra, which was developed by med-tech startup SS Innovations.
• In July 2022, Ultrahuman announced its latest wearable: the Ultrahuman Ring, which can track users’ metabolism, measure movement, sleep and other body dynamics in real-time.
• Medtronic has launched a Surgical Robot Experience Center (SREC) in Gurugram, Haryana, the first of its kind in South Asia. The SREC will be focused on the education and training of surgeons in robot-assisted surgery.
• Indian Institute of Technology (IIT) Delhi has developed a national centre for medical technology development in an effort to help medical device startups produce their goods in a facility that has received ISO certification and secure the necessary certifications.
• In November 2021, Cipla launched ‘Spirofy’, India's first pneumotach based portable, wireless spirometer.
• In November 2021, Serene Envirotech Pvt. Ltd., a Mumbai-based start-up, launched a portable molecular hydrogen generating machine ‘udazH’ for personal use. The molecular hydrogen inhaler comes with a dual-use technology that lets two users simultaneuosly use the machine.
• In October 2021, Innovation Imaging Technologies Pvt. Ltd. (IITPL) established a ‘state-of-the-art’ facility in Bengaluru to manufacture 240 catheterisation laboratories in the next 12 months. Through this initiative, the company aims to strengthen the infrastructure to treat cardio-vascular diseases in the country.
• In October 2021, the HMD achieved a milestone by supplying 500 million 0.5 ml AD syringes to the government to accelerate the vaccination drive and contribute to India’s Atmanirbhar mission. The company further plans to achieve annual capacity of 3.5 billion syringes by March 2022.
• In September 2021, Medtronic India Private Limited collaborated with Stasis Health Private Limited to boost patient monitoring in India.
• In September 2021, Siemens Healthineers announced that molecular testing kits will be manufactured in its Vadodara unit in Gujarat.
• In September 2021, Siemens Healthineers extended its collaboration with SyntheticMR with a new licence agreement for distribution of the company’s (SyntheticMR) products.

GOVERNMENT INITIATIVES

The Government of India has commenced various initiatives to strengthen the medical devices sector, with emphasis on research and development (R&D) and 100% FDI for medical devices to boost the market.

• The Union Cabinet approved the National Medical Devices Policy, 2023 on April 26, 2023. The National Medical Devices Policy, 2023 is expected to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality, and innovation. The policy is expected to help the Medical Devices Sector grow from the present US$ 11 billion to US$ 50 billion by 2030.
• Under the PLI scheme for Medical Devices, till now, a total of 26 projects have been approved, with a committed investment of Rs. 1,206 crore (US$ 147 million) to enable growth and innovation in the MedTech industry and make India as the global hub for manufacturing and innovation in the coming years.
• In September 2022, the government of India approved the setting up of an export promotion council for medical devices, under the Department of pharmaceuticals, with its headquarters in Noida.
• In August 2022, the Department of Pharmaceuticals greenlit the "Promotion of Medical Device Parks" programme from FY21-25 with a total financial investment of Rs. 400 crore (US$ 48.97 million), with a maximum support under the programme of Rs. 100 crore (US$ 12.24 million) for each Medical Device Park.
• In August 2022, the Department of Pharmaceuticals reconstituted the National Medical Devices Promotion Council (NMDPC) under the Chairmanship of the Secretary of the Department of Pharmaceuticals.
• In July 2022, the government tabled a draft for the new Drugs, Medical Devices and Cosmetics Bill 2022, to assure and offer thorough legal protections to ensure that the medical items sold in India are reliable, efficient, and up to required standards.
• In the Union Budget 2022-23, Rs. 86,200 crore (US$ 11.3 billion) was allocated as a budget for the pharmaceutical and healthcare sector.
• In October 2021, the government announced plan to draft a new drugs, cosmetics and medical devices bill to increase the acceptability of Indian medical devices in the global market.
• In October 2021, the government announced that 13 companies have been approved under the PLI scheme for medical devices, which is expected to boost domestic manufacturing in the country.
• In September 2021, the government sanctioned a proposal worth Rs. 5,000 crore (US$ 674.36 million) to build a medical devices park in Himachal Pradesh’s industrial township, Nalagarh, in the Solan district.
• In September 2021, the government approved a medical devices park in Oragadam (Tamil Nadu) that is expected to attract an estimated investment of Rs. 3,500 crore (US$ 472.05 million) and offer direct and indirect employment to ~10,000 people.
• In July 2021, the government announced that they would build a medical park in Uttar Pradesh, which is expected to generate an estimated Rs. 500 crore (US$ 67.13 million) business in the state.
• In June 2021, the Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the Indian Certification of Medical Devices (ICMED) 13485 Plus scheme to undertake verification of the quality, safety and efficacy of medical devices
• To boost domestic manufacturing of medical devices and attract huge investments in India, the department of pharmaceuticals launched a PLI scheme for domestic manufacturing of medical devices, with a total outlay of funds worth Rs. 3,420 crore (US$ 468.78 million) for the period FY21-28.
• The Medical Devices Virtual Expo 2021 showcased Indian products and enabled direct interaction between Indian suppliers and buyers/importers from participating countries; 300 foreign buyers from the healthcare sector participated in this event.
• In March 2021, the PLI Scheme for pharmaceuticals worth Rs. 15,000 crores (US$ 1.96 billion) was launched. This scheme aims to enhance India’s manufacturing capabilities by increasing investment and production in the pharmaceutical and medical devices sectors and contribute to the availability of a wider range of affordable medicines for consumers.
• On March 25, 2021, the Department of Pharmaceuticals released a revised notice on the Public Procurement Order (PPO), incorporating 19 medical devices in the revised guidelines of the PPO, which is expected to improve domestic medical devices manufacturing (and strengthen ‘Make in India’) and reduce import bills by ~Rs. 4,000 crore (US$ 538.62 million).
• In April 2021, in order to expedite the clearance of medical devices such as nebulisers, oxygen concentrators and oxygen cannisters, the government made it easier to import critical medical devices by easing the requirements for clearance under the Legal Metrology Act (Packaging Rules 2011).

ROAD AHEAD

Policy makers in India will need to set out an action plan to reduce the country’s dependency on medical devices/technology imports. At present, NITI Aayog is reportedly drawing up a strategic road map for medical devices. Over the next few years, India might grow into a US$ 50 billion market for medical devices.

In BioAsia 2021, key stakeholders in the panel discussion on medical technologies predicted that India would become self-sufficient in domestic medical devices manufacturing by 2025-26. The panel observed that the government is taking supportive measures such as promoting indigenous manufacturing of high-tech medical devices, production-linked incentive schemes (PLIs) on medical devices, boosting new medical devices parks, etc. to boost the overall growth of the domestic medical devices market in India.

Medical device companies should develop India as a manufacturing hub for domestic and international markets, undertake India-based innovation in combination with indigenous manufacturing, collaborate across the Make in India and Innovate in India schemes, and produce low to medium technology products to cater to the underpenetrated domestic markets.