Introduction

India carries one of the heaviest disease burdens in the world. The country is home to over 101 million people living with diabetes, approximately 315 million patients managing high blood pressure, and nearly 254 million individuals who are obese or unhealthily overweight. More than 300,000 patients are currently on maintenance dialysis for chronic kidney disease alone. Add to this the rising tide of cardiovascular disease, cancer, and respiratory illness, and the demand on India's healthcare system becomes immense.

Yet at the centre of delivering care for all of these conditions, medical devices remain a persistent vulnerability. A glucometer, a dialysis machine, an MRI scanner, a cardiac stent, a ventilator: these are not luxuries. They are necessities. And for decades, India has depended on other countries to supply them.

Despite efforts to ramp up domestic production, India remains reliant on imports for nearly 70% of its medical devices. That number represents a structural gap in the nation's healthcare readiness, one that affects cost, availability, and long-term resilience. The conversation around local medical device manufacturing is therefore not a debate about industrial policy alone. It is fundamentally a conversation about patient outcomes, healthcare equity, and national health security.

The Scope of India's Medical Device Market and Its Import Problem

India's medical device market is estimated to be 18.3 billion US dollars in 2026, up from 16.97 billion US dollars the previous year, and is projected to grow to 28.85 billion US dollars by 2035. That trajectory reflects a healthcare economy growing rapidly, driven by population growth, rising incomes, expanding health insurance coverage, and a sharp increase in lifestyle-related non-communicable diseases.

Yet the growth of the market has not translated into proportional growth in domestic manufacturing capacity. A parliamentary committee report in March 2026 flagged an import-export gap of 4.8 billion US dollars in FY25, with imports reaching 8.8 billion US dollars against exports of 4 billion US dollars. This is not a minor trade imbalance. For a healthcare system already strained by underfunding and unequal access, it has direct consequences for every patient who needs a diagnostic test or a life-saving procedure.

The deeper problem is structural. India primarily manufactures medical equipment within the low-tech segment, from consumables to implantable devices. This leaves domestic requirements unmet in the advanced technology segment, pushing the country to import expensive equipment from abroad. That import dependency drives up the cost of medical equipment, leading to higher diagnostic fees for end-users and placing a significant out-of-pocket financial burden on households across the country.

That burden falls disproportionately on patients in Tier 2 and Tier 3 cities and rural areas, where income levels are lower and public health infrastructure is thinner.

Why Local Manufacturing Directly Impacts Healthcare Affordability

The link between where a device is made and what it costs a patient is direct and significant. When a hospital purchases an imported MRI machine, it is paying for the device, international freight, import duty, currency exchange margins, and the distributor's markup. Those costs are eventually passed on to the patient through diagnostic fees.

Even for advanced Class-C medical devices, India manufactures 20% domestically at 10 to 40% cheaper costs than imported equivalents. That cost differential is not trivial. For a family paying out of pocket for a cancer screening or a cardiac evaluation, a 30% reduction in the cost of a scan can determine whether they seek care at all.

With the country now producing its own CT scanners, MRI machines, and dialysis equipment, hospitals and diagnostic centres gain access to high-quality technology at lower acquisition costs. Lower acquisition costs translate into lower procedure costs. Lower procedure costs translate into more patients receiving the diagnostics and treatments they need rather than delaying or avoiding care because it is unaffordable.

This is not an abstract economic argument. It is a question of lives.

Strengthening Healthcare Access in Rural and Semi-Urban India

India's rural healthcare challenge is well documented. The gap between what a patient in a major metropolitan hospital can access and what a patient in a district-level primary health centre can access remains vast. Local medical device manufacturing has the potential to begin closing that gap in a way that pure import dependence never can.

Devices such as handheld ultrasound probes, point-of-care testing kits, and portable ECG equipment empower primary health centres and rural clinics to provide prompt care without costly infrastructure, democratising healthcare access at the grassroots level.

When devices are manufactured locally, they can also be designed specifically for the conditions of Indian healthcare delivery. Devices built for unreliable electricity supply, portable enough for field use, and rugged enough for challenging environments are not standard priorities for multinational manufacturers focused on premium hospital markets in Europe or North America. Indian manufacturers building for Indian conditions can create solutions that imported equipment simply cannot match in practicality or price.

From a newborn in a district hospital to a cancer patient in a tertiary care centre, reliable, high-quality, and affordable medical devices have become indispensable to modern healthcare. The government has acknowledged this through programmes such as the Pradhan Mantri Ayushman Bharat Health Infrastructure Mission (PM-ABHIM), which targets upgradation of laboratories, critical care infrastructure, and disease surveillance systems at the district level. Local device manufacturing must keep pace with this expanding infrastructure to ensure that new facilities are meaningfully equipped.

Supply Chain Resilience and National Health Security

The COVID-19 pandemic exposed, with brutal clarity, the risk of depending on global supply chains for essential medical equipment. Shortages of ventilators, pulse oximeters, and personal protective equipment during the early phase of the pandemic created situations where healthcare systems across the world, including India, faced critical constraints at precisely the moment they needed maximum capacity.

Historically, India relied heavily on imports for many sophisticated medical devices. While those technologies improved healthcare outcomes, they also contributed to higher costs, supply chain vulnerabilities, and limited accessibility for a large portion of the population.

A robust domestic manufacturing base is the most effective long-term answer to supply chain vulnerability. When devices are manufactured within the country, disruptions to international trade, currency fluctuations, geopolitical tensions, or global health emergencies cannot interrupt the supply of critical equipment to Indian hospitals and clinics. This is healthcare infrastructure resilience in the truest sense, and it is an outcome that no amount of import diversification can fully replicate.

The National Medical Devices Policy 2023 has formally recognised this by embedding supply chain resilience as a core policy objective, alongside access, affordability, quality, and innovation.

Government Initiatives Driving the Sector Forward

India's policy architecture for domestic medical device manufacturing has expanded considerably in recent years. The Production Linked Incentive (PLI) Scheme, the National Medical Devices Policy 2023, dedicated medical device parks, and 100% foreign direct investment through the automatic route together form a framework designed to accelerate local manufacturing at scale.

As of March 2025, 21 approved projects under the PLI scheme had started manufacturing 54 unique medical devices, including MRI machines, CT scanners, dialyzers, and heart valves. The PLI Scheme carries a total budgetary outlay of Rs 3,420 crore and covers the period from FY2022-23 to FY2026-27. Production has commenced for 57 products, many of which are high-end devices on which India has been heavily import-dependent.

Three dedicated medical device parks are at an advanced stage of development in Greater Noida (Uttar Pradesh), Ujjain (Madhya Pradesh), and Kanchipuram (Tamil Nadu), with a combined project cost exceeding Rs 871 crore. The medical device park at the Yamuna Expressway Industrial Development Authority in Greater Noida, spread across 350 acres, has already attracted strong interest from 89 companies.

Major international investments are further reinforcing domestic manufacturing capacity. Medtronic announced a 350 million US dollar investment to expand its Engineering and Innovation Centre in Hyderabad. Omron Healthcare invested 15.5 million US dollars to establish a medical devices factory in Tamil Nadu. Siemens Healthineers committed Rs 1,300 crore toward an innovation and R&D hub in Bengaluru. These commitments signal that global players recognise India not merely as a consumer market but as a viable manufacturing base.

The Challenges That Remain

Honest analysis demands acknowledging that the path forward carries significant obstacles. The PLI scheme, while generating momentum, has encountered structural limitations. Incentives are paid on assembled output rather than component-level production. The components that drive the import bill, including X-ray tubes, flat-panel detectors, sensors, and reagent chemistries, are still sourced from outside India, and the current scheme design does not compel that to change.

This means that while final assembly of several devices is now happening domestically, the deeper goal of component-level manufacturing and genuine indigenous innovation remains largely unrealised for high-end categories. Building true self-reliance in medical technology will require sustained investment in research and development, materials science, component manufacturing, and a skilled technical workforce over a longer time horizon than a single policy cycle can deliver.

Regulatory harmonisation, quality assurance infrastructure, and robust clinical testing ecosystems will also be necessary to ensure that domestically manufactured devices are not only affordable but genuinely safe and effective. The Central Drugs Standard Control Organisation (CDSCO) plays a critical role in this regard, and strengthening its capacity to regulate a rapidly expanding domestic industry will be essential as the sector scales.

The Role of Innovation, Startups, and a Connected Ecosystem

India's medtech startup ecosystem is contributing solutions that are both innovative and built for Indian conditions. AI-powered diagnostic tools, wearable health monitors, low-cost point-of-care testing platforms, and telemedicine-integrated devices are emerging from engineering and healthcare innovation hubs across the country. These startups, often operating in collaboration with academic institutions and public health programmes, represent a different model of medical device development: one grounded in local need rather than premium global markets.

A coordinated ecosystem of government, industry, academia, hospitals, and startups can help India go beyond assembly to indigenous innovation and globally competitive, affordable medical solutions, thereby advancing the Atmanirbhar Bharat vision and delivering genuinely better healthcare outcomes.

Platforms such as Medicircle play an important role in this ecosystem by bringing together healthcare experts, medical innovators, hospitals, and the wider public through credible, evidence-based healthcare communication. As India's medtech sector matures, informed public discourse about the importance and implications of local manufacturing becomes as essential as policy itself.

Conclusion

India stands at a significant inflection point in its healthcare journey. The disease burden is enormous, the market is growing rapidly, and the policy intent to build a self-reliant medical device manufacturing ecosystem is genuine and sustained. Yet the gap between policy intent and ground-level reality, particularly in terms of component-level manufacturing, research and development investment, and rural healthcare access, remains real and consequential.

Local medical device manufacturing is not simply an economic aspiration. It is a public health imperative. Every CT scanner assembled in India, every affordable glucometer reaching a district hospital, every cardiac stent produced domestically represents a step toward a healthcare system where the cost and availability of medical technology no longer determine whether a patient receives timely care.

The work of building that ecosystem is complex and long-term. But the direction is clear, the stakes are high, and the capacity is within reach. India has built a generics pharmaceutical industry that supplies medicines to the world. The same determination applied to medical devices can transform the affordability and accessibility of care for over a billion people.

Frequently Asked Questions

Q1: Why does India import so many medical devices?

India has historically lacked the infrastructure, investment, and regulatory ecosystem required to manufacture high-end medical devices domestically. This has created a dependency on imports for approximately 70% of its medical device needs, particularly for advanced diagnostic and therapeutic equipment such as MRI machines, CT scanners, and cancer treatment devices.

Q2: How does local medical device manufacturing reduce healthcare costs in India?

When devices are manufactured domestically, import duties, international freight, and foreign currency exchange markups are removed from the cost chain. Data shows that even advanced Class-C devices manufactured in India cost 10 to 40% less than their imported equivalents, and these savings can be passed on to patients through lower diagnostic and treatment fees.

Q3: What is the PLI Scheme for medical devices in India?

The Production Linked Incentive (PLI) Scheme for medical devices carries a total outlay of Rs 3,420 crore and covers the period from FY2022-23 to FY2026-27. It offers a 5% financial incentive on incremental sales of domestically manufactured medical devices across four target segments. By March 2025, the scheme had supported production of 54 unique devices, including MRI machines, CT scanners, dialyzers, and heart valves.

Q4: How does domestic medical device manufacturing benefit rural India?

Locally manufactured devices such as portable ECG machines, handheld ultrasound probes, and point-of-care testing kits are more affordable and more widely distributed. They are also increasingly designed for conditions specific to Indian healthcare settings, including unreliable electricity supply and limited skilled workforce availability, allowing primary health centres and rural clinics to offer diagnostic services previously available only in large cities.

Q5: What is India's projected medical device market size?

India's medical device market is estimated at approximately 18.3 billion US dollars in 2026 and is projected to reach 28.85 billion US dollars by 2035. India is currently the fourth-largest medical device market in Asia and among the top 20 globally, making it a critical destination for both domestic and international medtech investment.

Resources

1. India Brand Equity Foundation (IBEF): Detailed industry profile covering market size, growth projections, FDI inflows, and PLI scheme progress for India's medical devices sector.
2. Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals: Official source for PLI Scheme updates, medical device park approvals, and disbursement data.
3. National Medical Devices Policy 2023, Press Information Bureau: The foundational government policy document outlining India's vision for the medical devices sector through access, affordability, quality, and innovation objectives.
4. Indian Council of Medical Research (ICMR): Source for disease burden data including the 2024 India Diabetes Study and non-communicable disease prevalence figures referenced in healthcare planning and policy contexts.
5. Invest India, Medical Devices Sector: Government investment promotion body providing data on FDI inflows, investor interest, manufacturing park development, and sector growth potential.

Interlinking Keywords

medical device manufacturing India, PLI scheme medical devices, India healthcare affordability, Atmanirbhar Bharat medtech, National Medical Devices Policy 2023, medical device import dependency India, rural healthcare access India, CDSCO medical device regulation, medtech startups India, Ayushman Bharat health infrastructure

Last medically reviewed by:

Dr. Manthan Tripathi, Medicircle Editorial and Medical Advisory Team on 15, September 2026

Disclaimer

This article is intended for general informational and educational purposes only. It does not constitute medical advice, clinical guidance, or a substitute for professional medical consultation. The data and policy information cited reflect publicly available sources as of the date of publication and may be subject to revision. Readers seeking guidance on specific medical conditions, devices, or treatment decisions should consult a qualified and registered healthcare professional. Medicircle does not endorse any specific medical device brand, manufacturer, or government scheme beyond factual reporting.