The Indian Medical Devices Industry has made remarkable progress in recent years. India is one of the leading medical device markets, with a size of about ?1,04,760 crores (US$12.8 billion) in 2023 and is likely to reach US$ 50 billion by the year 2030 with a CAGR of 16.4 %.

India's total healthcare expenditure is projected to rise from 1.15% of GDP in 2015 to 2.5% by 2025, amounting to nearly ?8,00,000 crores (US$110.34 billion). This demonstrates that the potential for medical devices in India is enormous.

According to IBEF (India Brand Equity Foundation), India’s share in the overall medical devices market is estimated at just 1.65%. India ranks 4th after Japan, China, and South Korea in the Asian medical devices market, and from the global perspective, it ranks among the top 20.

There is, therefore, a considerable potential still waiting to be tapped and explored by the Indian players. If India is to make a substantial dent in the global medical devices market, much must be done to provide the growth impetus. Even as the Indian medical devices and biotechnology companies are ensuring that India emerges strongly on the global MedTech map, there are various policies and support decisions that we are looking forward to from the Government to ensure this growth.

2023 was a decent year for the Indian MedTech industry, with various developments like

• National Medical Devices Policy 2023
• National Policy on Research and Development and Innovation in the Pharma-MedTech Sector in India
• Scheme for Promotion of Research and Innovation in the Pharma MedTech Sector (PRIP)
• Investment in the medical devices sector and the establishment of various medical device parks across the country

These are significant initiatives, and we would like to see the full impact and how they positively impact the medical devices industry.

• Indian medical devices export was ?19,803 crore (US$ 2.40 billion) in 2022 and is expected to rise to US$10 billion by 2025 (IBEF). The Indian Government formed the Export Promotion Council for Medical Devices (EPC-MD) under the Department of Pharmaceuticals in 2023. This body must be strengthened to address the MedTech industry's export issues adequately. EPC-MD has the potential to drive international growth and must be empowered and fast-paced. The Commerce Ministry has also set up a task force to address the exporters' woes of all exporters. Hopefully, they will also examine the MedTech exporters' woes and address their trade and technical barriers. A clear-cut path needs to be chalked out. We would certainly like to see significant development in this budget.
• Quality standardisation and rationalisation have been vital aspects hampering the overseas growth of Indian medical device companies. There is a need to bring in rationalisation and ensure that Indian standards like ICMED enjoy the same respect, credibility, and acceptance as international standards like ISO, FDA, CE, MDR and AIMD. Without an ‘at-par’ status, Indian exporters will continue to grapple with the bottleneck of seeking individual certifications for each product in every country they want to export to. This is a long-standing need and has now attained criticality.
• The Government’s decision last year to allow refurbished medical devices contravenes the National Medical Device Policy 2023. It opens the ground for the large-scale dumping of older technology and electronic waste from other countries. This is entirely against the spirit of Atma Nirbhar Bharat and Make in India and will stifle many Indian companies looking to develop low-cost, high-tech, newer solutions. This should only be allowed in exceptional and critical cases where Indian solutions may not be available for the next few years. For all other cases, this should be disallowed entirely.
• The Government is the largest buyer of medical device companies. They are dependent on Government procurement to make their business viable and sustainable. India’s procurement policy seems to favour imported devices, and the current trend highlights more imports than procurements from domestic players. Even though the government has created a policy for purchase preference for Made in India products, unfortunately, this policy has not worked. In most government purchases, there is no preference for 'Made in India' as the state governments are not implementing this policy effectively. This policy is either ignored or side-lined.
• Human resources are the most critical areas that need compelling government attention. This should be taken up on priority under the skill development initiative. The Government must work with the industry to identify the specific need-gap for timely addressal of the issue. Industry-academia linkages should be strengthened, and more professional courses that fully cater to the industry's skill requirements and ensure higher employment for the trained personnel need to be introduced.
• India understands the significance of Artificial Intelligence in the current global context and has a complete program under the Ministry of Information Technology that deals with AI strategy and policies. AI – ML – IoT, and telemedicine have a massive influence on the medical devices segment, and there is an urgent need to put safeguards and guidelines in place. AI adoption & implementation and data privacy issues require a comprehensive AI and cyber security policy to be drafted and implemented, and the Government must take a leadership position to put safeguards in place, especially in the context of the cyber-attack on AIIMS in 2022.
• Inverted duty structure remains a long-standing woe of the medical devices segment, with raw materials being taxed more than finished imported products. This makes manufacturing in India an unviable option. Despite numerous representations by the Industry, the Government’s stoic inaction on this front is surprising and dismaying.

There are numerous other issues, concerns, and attention areas that we have highlighted to the Government from time to time – insufficient raw material & supplies, access to clinical trial samples, and the limited effectiveness of the PLI scheme since it does not cater to the relatively less significant players. For India to shine on the global MedTech map, the Government must address these concern areas on a war footing.

India is the global Centre for frugal medical device engineering. Most technological products and innovations originate from a well-developed ecosystem, and the US, Europe, and Japan collectively account for roughly 85 per cent of the approximately $220 billion in revenues. There is an urgent need for G2G and P2G interactions and interfaces to transfer relevant technologies to India (as is happening in defence productions).

The Government should promote an innovation culture in India to promote indigenous industry and reduce our dependence on imports. By 2025, the Indian MedTech market may reach USD 50 billion with a growth rate (CAGR) of 22%.