MedTech policy at three

The National Medical Devices Policy, 2023, has completed three years at a time when India’s health system is changing rapidly. Medical devices are no longer confined to hospitals and operating theatres. They are central to screening, diagnosis, emergency care, surgery, cancer treatment, critical care, rehabilitation, chronic disease management, and home-based care. Even a routine consultation may depend on a diagnostic device, a monitor, or a digital tool. For a country that seeks equitable, affordable, and quality healthcare, MedTech is therefore not only an industrial sector. It is an essential health-system capability.

This is why the 2023 policy mattered. It brought together patient access, affordability, quality, manufacturing, innovation, regulation, and global competitiveness within one national framework. It also recognised that India cannot rely indefinitely on imported technologies for a large portion of its healthcare needs. Three years later, the policy helped create direction, confidence, and a more organised national conversation. The next step is more demanding. India must convert this policy architecture into a trusted capability on the ground.

The early signs are encouraging. India’s medical-device exports increased from USD 2.53 billion in FY2020–21 to USD 4.01 billion in FY2024–25. Imports also rose, from USD 6.24 billion to USD 8.82 billion during the same period. These numbers should be read with care. They do not tell a simple story of success or failure. They show that the Indian market is expanding, domestic manufacturing is progressing, and demand for advanced technologies is also growing. They also remind us that India continues to rely heavily on imports in several high-technology segments. The direction is right, but the work is far from complete.

One clear gain has been the push toward higher-value manufacturing. Under the Production Linked Incentive Scheme for medical devices, cumulative sales reported up to September 2025 reached ₹12,344.37 crore, including ₹5,869.36 crore in exports. The supported product categories include cancer-care devices, imaging and radiology equipment, cardio-respiratory and renal-care devices, and implants. This matters. India’s MedTech story cannot rest only on syringes, gloves, and other low-complexity products. These products matter, but the country must also build strength in devices that offer greater clinical value, deeper technology, and stronger export potential.

However, factories alone will not create a strong MedTech ecosystem. A more meaningful policy shift is the increasing emphasis on developing a broader support system. The Scheme for Strengthening the Medical Device Industry, launched in November 2024 with an outlay of ₹500 crore, addresses some of the missing pieces: shared infrastructure, domestic production of components and accessories, skilling, clinical study support, and industry promotion. These are practical areas. The medical device industry needs testing facilities, calibrated laboratories, specialised vendors, trained technicians and engineers, design support, and credible clinical evidence. Without these, even a promising domestic product may struggle to scale.

The medical-device parks should also be seen in this light. As of September 2025, land had been allotted to 194 manufacturers across approved parks in Uttar Pradesh, Madhya Pradesh, and Tamil Nadu. The projected investment was ₹4,775.50 crore, with employment projected at 27,362 persons. This is useful progress. Still, parks should not be judged mainly by land allotment or investment intent. Their real value will depend on whether they become functioning clusters where manufacturers can access testing, logistics, regulatory support, common facilities, skilled talent, and linkages with hospitals, medical colleges, and engineering institutions. India needs productive clusters, not merely industrial plots.

Innovation is another area where the policy has started to create a stronger platform. The Promotion of Research and Innovation in Pharma-MedTech Sector scheme, with an approved outlay of ₹5,000 crore up to FY2029–30, signals the need to move beyond generic manufacturing. MedTech Mitra adds a useful handholding mechanism for innovators who often struggle with validation, regulatory navigation, and market access. From a health-system perspective, this matters. India needs devices that solve Indian problems: reliable diagnostics for primary care; portable technologies for remote areas; affordable critical-care equipment, robust rehabilitation products; and devices that work in district hospitals, emergency services, and public programs. Innovation must remain close to clinical need.

The next phase must place trust at its center. A growing MedTech industry needs a regulator that is strong, predictable, and scientifically equipped. The Medical Devices Rules, 2017, provided the basic regulatory framework, and the recent draft amendments show continued attention to specific compliance issues. But the larger agenda is still before us. India needs stronger post-market surveillance, adverse-event reporting, recall systems, and proportionate clinical-evidence requirements. It also needs sharper oversight for refurbished equipment, software-driven products, AI-enabled tools, and connected devices. Regulation should not become a barrier to innovation, but it must protect patients and build confidence in Indian products.

Quality is equally important. It is often discussed as a compliance issue, but it should be treated as a national competitiveness strategy. Indian devices will gain wider acceptance only when clinicians, hospitals, patients, and global buyers trust their reliability. This trust begins with design and materials. It continues through testing, manufacturing, calibration, clinical use, after-sales support, and maintenance. Quality cannot be added at the end of production. It must be built throughout the product journey.

Public procurement can shape the next phase. Government health systems buy diagnostics, imaging equipment, monitors, ventilators, laboratory platforms, implants, and point-of-care technologies at scale. Procurement should reward quality, performance, uptime, maintenance, interoperability, user training, and total cost of ownership. The lowest quoted price should not become the only measure of value. At the same time, preference for domestic products must remain linked to real local value addition and demonstrated quality. Patient safety cannot be compromised in the name of industrial preference.

In three years, the National Medical Devices Policy has created an important foundation. It has given India a clearer pathway and has brought manufacturing, innovation, regulation, and access into one conversation. The next phase must connect these pieces more deliberately with health-system needs. India should aim for a trusted MedTech capability that improves patient outcomes, reduces avoidable external dependence, supports skilled employment, and earns credibility in global markets. The true success of the policy will not lie in the number of schemes announced. It will lie in whether a patient, a clinician, and a hospital can increasingly rely on high-quality Indian medical technologies with confidence.

Dr K. Madan Gopal is a senior health sector expert, former senior consultant, NITI Aayog, and currently working as an advisor with the National Health Systems. Views expressed are personal.