India’s healthcare sector has long operated on a structural paradox. The country built world-class clinical capability, scaled tertiary care infrastructure, and trained an exceptional medical workforce yet remained heavily reliant on imported equipment to deliver that care. As per Aditya Kohli, CFO and Director, Allied Medical Limited, “Roughly 70 per cent of medical devices used in Indian hospitals were sourced from overseas, with critical care equipment among the most import-intensive segments.”
The pandemic turned that structural vulnerability into a crisis. And in 2026, the geopolitical context has grown more challenging, not less. Red Sea disruptions, US-China trade tensions, rising tariff walls, and semiconductor shortages have made medical devices what they always should have been recognised as: strategic assets tied directly to national healthcare security.
The numbers are unambiguous. As per Vivek Tiwari, Principal Investor, Truevis Technologies Pvt. Ltd., “India continues to rely heavily on imported medical devices, with imports at Rs 94,664 crore against exports of Rs 28,106 crore in FY26.”
The question before policymakers, manufacturers, and investors is no longer whether India should build domestic manufacturing capability. It is whether the ecosystems being built the dedicated MedTech zones, shared infrastructure clusters, and integrated parks are deep enough, fast enough, and integrated enough to actually reduce the country’s exposure when the next disruption arrives.
From industrial policy to healthcare security
The National Medical Devices Policy 2023 and the Production Linked Incentive (PLI) schemes have provided the policy scaffolding. But dedicated manufacturing clusters like the Andhra Pradesh MedTech Zone (AMTZ), and the emerging parks in Uttar Pradesh, Madhya Pradesh, Tamil Nadu, and others are where the actual work of building India’s MedTech capability is happening.
Tiwari frames the stakes precisely, “Geopolitical shifts and ongoing supply chain disruptions have made MedTech manufacturing a strategic priority for India, not just an industrial one.”
“In this environment, MedTech manufacturing zones become critical because they offer the clustered infrastructure needed to scale production faster, lower dependence on fragile cross-border supply chains, and strengthen resilience against future shocks. They also help India build domestic capacity in high-dependence segments such as imaging, diagnostics, and consumables, which are especially important for uninterrupted hospital functioning and diagnostic services. In that sense, these zones are not just about manufacturing efficiency; they are about healthcare security, strategic autonomy, and creating a more dependable supply base for the country.”
Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), has been making this argument consistently, “The last few years have fundamentally reshaped the global healthcare supply chain. Pandemicera shocks, ongoing geopolitical conflicts, Red Sea disruptions, semiconductor shortages, and rising protectionism have made it clear that medical devices are no longer just commercial commodities—they are strategic assets tied directly to national healthcare security. India’s continued dependence on imported highend devices, sensors, specialised polymers, and precision-engineered components exposes the country to significant vulnerabilities whenever global supply chains come under stress. These risks have elevated the strategic importance of dedicated MedTech manufacturing zones.”
Anish Bafna, CEO and MD, Healthium Medtech, adds historical context that the sector cannot afford to forget, “During the pandemic, hubs such as AMTZ had demonstrated the ability to rapidly scale domestic manufacturing of ventilators, RT-PCR kits, and oxygen concentrators when international supply chains were disrupted. Aligned with initiatives such as Make in India and Atmanirbhar Bharat, such ecosystems are positioning India as a globally competitive MedTech manufacturing hub.”
Kohli puts it plainly, “What has unfolded since is a structural shift in how medical devices are designed, manufactured, and serviced in India. The Production Linked Incentive (PLI) scheme for medical devices has been central to this. By offering financial incentives tied to incremental sales of domestically manufactured products in target segments, including critical care and respiratory equipment, the scheme has shifted the conversation from assembly-level localisation to genuine value addition.”
Prashant Krishnan, CEO, TI Medical, echoes this assessment, “The PLI scheme provides financial incentives for manufacturers to establish or expand their manufacturing activities in India, therefore encouraging both Indian and global manufacturers to set up manufacturing within India. This initiative will assist in building India’s medical technology manufacturing base and provide opportunities for India to become a global centre for advanced manufacturing of medical devices.”
“With increasing manufacturing capacity in India, there will also be lower costs of production of these devices which will improve patient outcomes by increasing access to advanced medical technologies in tier 2 and tier 3 cities,” Krishnan adds.
What AMTZ has actually built
Dr Jitendra Sharma, MD and Founder CEO, Andhra Pradesh MedTech Zone (AMTZ), and Divya Patil, Material Scientist, AMTZ, describe an ecosystem that goes well beyond a conventional industrial park.
“India’s medical technology sector is moving from an import-dependent ecosystem to a manufacturing and innovation-driven ecosystem, and MedTech zones such as Andhra Pradesh MedTech Zone are central to this transition. A few years ago, India was importing more than 80–85 per cent of its medical devices. Today, through integrated ecosystems like AMTZ, we are building end-to-end domestic capability across the entire healthcare spectrum. At AMTZ, we manufacture everything from masks, gloves, syringes, catheters to medical consumables to advanced technologies such as ventilators, implants, CT/MRI subsystems, precision engineered components, and even radioisotopes for clinical applications. In several consumable categories, we have already achieved 60–70 per cent localisation.”
“What makes AMTZ unique is that it is not just a manufacturing park—it is a complete MedTech ecosystem integrating cleanrooms, testing labs, sterilisation, biomaterials, additive manufacturing, precision engineering, regulatory infrastructure, and R&D within a single campus. This reduces infrastructure and compliance costs by nearly 30–40 per cent and enables rapid scale-up during crises. During COVID-19, companies at AMTZ rapidly scaled ventilator and oxygen concentrator manufacturing because testing, sterilisation, and regulatory infrastructure compliant with IEC 60601 and CDSCO requirements were already available within the ecosystem.”
Tiwari of Truevis, which is working within the AMTZ ecosystem describes the direct benefit, “For companies like Truevis Technologies Pvt Ltd, this kind of ecosystem is particularly valuable because it supports the localisation of highvalue equipment such as CT and PET-CT scanners, while also creating a pathway for future categories like MRI. The presence of shared scientific and manufacturing infrastructure, including radiation testing, EMC and safety testing, biomaterial testing, 3D printing, laser centres, superconducting magnet capabilities, gamma irradiation, and machining support, reduces development barriers and helps accelerate innovation.”
Bafna of Healthium frames the shared-access model’s significance for the broader industry, “Their biggest contribution lies in creating shared, worldclass infrastructure that individual manufacturers, especially startups and SMEs, would otherwise struggle to build independently. Facilities for testing, sterilisation, calibration, biomaterial validation, additive manufacturing and regulatory support are available within a single integrated ecosystem, significantly lowering capital expenditure and reducing production costs.”
Dr Saurabh Arora, Managing Director, Auriga Research, explains why shared infrastructure matters structurally for this sector, “MedTech manufacturing is very different from other sectors because it is highly interdisciplinary and interdependent. It requires machine rooms, injection moulding, dyes, CNCs, engineering capabilities, hardcore manufacturing expertise, polymer understanding, biotechnology capabilities, and regulatory knowledge.”
“All of this then interfaces with the human body, which means safety, efficacy, toxicology, and testing also become extremely important. If one company tries to build all of this on its own, the investment becomes very high. It would need to make dyes, manage injection moulding, handle biotechnology, develop antigens and antibodies for segments such as IVD, put everything together into a device, conduct trials and testing, get regulatory approvals, manage routine manufacturing, and also take care of sterilisation. This is where shared infrastructure becomes very valuable. Dedicated MedTech zones provide common facilities and bring different capabilities into one ecosystem.”
AMTZ is also confronting supply chain risks at the frontier. As per Dr Sharma and Patil, conventional MRI systems require nearly 1,500 litres of liquid helium. “Ongoing geopolitical tensions in West Asia have increased helium prices, extended lead times, and impacted MRI installation and servicing costs globally. This clearly demonstrates the risks of excessive import dependence in critical healthcare technologies.”
AMTZ is also developing low-helium MRI systems targeting <20 litres, along with future helium-free MRI technologies, to improve long-term supply security and technological self-reliance.
Today, AMTZ supports 180+ companies and 200+ startups across consumables, diagnostics, implants, imaging systems, AI-driven healthcare, and advanced medical technologies. At the same time, through organisations such as IBSC and Universal Biomedical Cross, we are not only manufacturing devices and technologies, but also actively upskilling biomedical engineers and developing specialised human resources required for the future health.
Why manufacturing alone is not enough
Brijesh Suneja, Director, Phantom Healthcare, approaches the MedTech zone conversation from a vantage point that often gets overlooked: what happens to a device after it ships.
“Medical devices are not “fit-and-forget” assets. They require preventive maintenance, corrective repairs, periodic upgrades, and dependable spare parts availability. In practice, operational availability often matters as much as the initial purchase price—particularly in imaging and diagnostics, where downtime directly affects patient throughput and care delivery.”
When spares, qualified service capability, and validated repair processes come from abroad, hospitals particularly those outside major metros become acutely exposed to crossborder delays and sudden cost escalations. Refurbishment and upgrade pathways, when locally supported, can extend equipment life and improve cost predictability in ways that procurement decisions alone cannot.
Suneja is clear about what MedTech zones must offer beyond factory space, “For MedTech zones to deliver strategic advantage, manufacturing infrastructure must scale alongside accredited testing and validation capacity. Certification facilitation aligned with global standards, reliable calibration facilities, and documentation-ready processes reduces time-to-market and strengthens quality discipline.”
His conclusion, “MedTech zones are well-positioned to reduce India’s strategic vulnerability to geopolitical shocks, but their impact will be strongest when they evolve into full-spectrum ecosystems. Manufacturing is the beginning; resilient healthcare supply chains require dependable lifecycle support—repair, refurbishment, upgrades, spares, testing, and validation—delivered with discipline and compliance.”
The ancillary gap: What needs to scale alongside the zones
Every expert makes the same point: a manufacturing zone is only as strong as the ecosystem surrounding it. And by most assessments, that surrounding ecosystem has significant gaps.
Nath enumerates them specifically, “India urgently needs to scale up testing and validation infrastructure — biocompatibility labs, EMC testing, calibration centres, accelerated ageing facilities, and simulation labs that meet global benchmarks; certification and regulatory support — in-park regulatory cells, documentation support, and harmonised standards to reduce dependence on overseas approvals; common R&D and tooling facilities — shared tool rooms, 3D printing hubs, moulding centres, and virtual prototyping labs, especially critical for MSMEs and startups; component manufacturing ecosystems — India still imports a large share of electronics, semiconductors, sensors, alloys, and medical-grade polymers; logistics and export facilitation — bonded warehouses, cold-chain systems, and export support centres; and skilling and academia collaboration-— specialised MedTech skilling programs, industry–academia R&D partnerships, and innovation incubation.”
Dr Sharma and Patil frames the challenge from the manufacturing floor, “A medical device today must comply with standards such as ISO 13485, IEC 60601, ISO 10993, GMP, and CDSCO requirements, which means India needs significantly larger capacity in NABL-accredited testing labs, EMC/EMI facilities, biocompatibility centers, calibration labs, and clinical validation infrastructure. Without these, manufacturing scale-up becomes a bottleneck. Similarly, India still depends on imports for 30–40per cent of critical upstream components such as sensors, specialty polymers, semiconductors, industrial gases, precision motors, and imaging subassemblies.”
Dr Arora adds a practical manufacturing dimension, “Even within manufacturing, there is a need for tool rooms and common facilities where high-cost activities such as dye development and injection moulding can be carried out. Testing and certification are also very important because MedTech products need to go through regulatory approvals and quality validation. For example, certifications such as CE marking require proper testing, validation, documentation, and protocols. It is important to have the capability to understand what needs to be tested, how it should be tested, and what protocols need to be followed. Along with this, logistics hubs, effluent treatment plants, laboratories, certification bodies, ancillaries, suppliers, and component manufacturers should also be co-located within or around these zones. This will make the process faster, more efficient, and more scalable.”
Tiwari identifies the imaging sector’s particular requirements, “For a company such as Truevis, the availability of CDSCO/ AERB approved and globally aligned testing labs, skilled regulatory and design talent, temperature-controlled logistics, and stronger local microelectronics and component manufacturing would reduce time-to-market, improve investor confidence, and make domestic manufacturing far more sustainable.”
Vadeesh Budramane, Founder and CEO, AlgoShack, points to the talent dimension that infrastructure conversations can overlook, “Skilled talent is the thread running through all of this. Engineering talent, regulatory affairs professionals, quality engineers, cybersecurity specialists, and clinical experts all need to exist in sufficient density around these zones for the ecosystem to function.”
Localisation gains and the work that remains
The picture on localisation is encouraging in some segments and stark in others.
India has made measurable progress in consumables and disposables, diagnostics and imaging accessories, orthopaedics and implants, critical care and renal care equipment, and cardiovascular products.
As per Bafna, “Government and industry estimates suggest import dependence began declining in 2023, with nearly 150 previously imported devices now being manufactured domestically. Over time, these ecosystems can help India transition from being a large MedTech consumption market to becoming a strategic global manufacturing and innovation hub with strong export potential.”
He identifies where the momentum is clearest, “The strongest gains so far have emerged in consumables, disposables, diagnostics, hospital consumable packs, basic surgical instruments, and selected implant categories. These segments combine high domestic demand with manageable regulatory complexity and relatively faster commercialisation cycles, making them ideal for near-term localisation.”
A recent example illustrates both the progress and the remaining vulnerability. As per Dr Sharma and Patil, “West Asia geopolitical disruptions impacted petrochemical supply chains and pushed up prices of medical-grade polymers PP and PVC by nearly 20–40 per cent.
“Because India now has stronger domestic manufacturing ecosystems and localized consumable production capacity, the sector has been able to absorb these shocks more effectively without major supply disruptions in critical consumables like syringes, IV sets, and catheters.”
But high-value segments remain heavily import-dependent. As per Tiwari, “The PLI scheme has already supported 19-22 commissioned projects producing 44-55 products, including MRI/CT scanners, stents, dialysis machines, and heart valves, which shows that the ecosystem is beginning to move from policy intent to practical output. At the same time, radiology still represents one of the biggest whitespace areas in Indian MedTech. Advanced imaging systems, service-intensive components, and software enabled diagnostics infrastructure continue to depend heavily on imports, while component localisation remains a bottleneck.”
Kohli notes a visible downstream effect, “Indian-manufactured ICU ventilators are now competing on clinical specifications rather than price. However, component-level localisation remains the harder problem. Several critical components continue to be imported. The PLI framework has begun to pull supplier ecosystems closer to the OEMs, and the parks are starting to attract Tier-2 vendors who previously had no commercial reason to set up in India.”
Nath identifies the structural work still required, “True localisation requires deep backward integration. Different MedTech segments need specialised clusters aligned with common technologies and materials, for example: electronics-focused clusters for imaging, monitoring, and AI-enabled devices; stainless steel and alloybased ecosystems for surgical instruments and orthopaedic implants.”
Suneja frames the same point from an operational perspective, “Over time, these clusters can also help build a deeper supplier base for electronics, precision components, medicalgrade materials, and specialised consumables — an area that is critical for meaningful localisation.”
Dr B.V.R. Mohan Reddy, Founder Chairman of Cyient Group, Chairman of the Board of Governors at IIT Hyderabad, and Founding Director of THub, offers a structural argument for why progress is achievable, “The shifting geopolitical landscape and persistent global supply chain disruptions have made a compelling case for India to decisively strengthen its domestic MedTech manufacturing base. For a nation of India’s scale and ambition, this is precisely the moment to look inward building genuine self-reliance and sovereign capability in medical device production. A structural advantage works in India’s favour here. Unlike cuttingedge semiconductor applications that demand 4 or 5 nanometre chips, most medical devices function effectively on mature 28 or 40 nanometre nodes-a segment where India is steadily developing indigenous manufacturing capability.”“Beyond semiconductors, the broader MedTech ecosystem is well within India’s reach. Over the next two years, the country has a real opportunity to not only deepen its medical device manufacturing capabilities, but to forge resilient domestic supply chains and build sovereign technological capacity establishing India as a globally competitive, self-reliant hub for healthcare manufacturing.”
Startups, innovation, and the indigenous IP question
For MedTech zones to evolve from import-substitution platforms into genuine innovation hubs, the startup ecosystem within them is a critical test.
Dr Sharma and Patil describes what AMTZ has built, “MedTech zones such as Andhra Pradesh MedTech Zone are creating an integrated innovation ecosystem where startups can move from concept to commercialisation much faster. Instead of investing independently in expensive infrastructure such as cleanrooms, testing, sterilisation, precision engineering, and regulatory validation, startups can access these through shared common facilities — reducing development cost by nearly 30–40 per cent and significantly shortening time-tomarket.”
AMTZ has supported 180+ companies and incubated more than 175 startups.
Dr Arora frames the same dynamic, “MedTech zones support innovation and startups by reducing the cost of entry. For startups, it is difficult to build expensive infrastructure such as tool rooms, injection moulding facilities, testing labs, certification support, and regulatory systems on their own. When these facilities are available in a shared ecosystem, startups can focus more on product development and innovation instead of spending heavily on infrastructure.”
Suneja adds another dimension, “MedTech zones can also support innovation by addressing common barriers faced by startups and indigenous product teams: prototyping capacity, verification and validation access, regulatory guidance, and pathways to clinical evaluation. When these elements are available within a cluster, the distance between concept and compliant product reduces — improving not just speed, but also quality.”
Budramane, however, identifies a bottleneck that goes deeper than physical infrastructure, “Innovation in MedTech is easy. Compliant innovation is hard. For an Indian MedTech startup, building a working prototype of a software-driven device is only the first 20 per cent of the journey. The remaining 80 per cent is proving to CDSCO, the US FDA, or the EU MDR that the software and hardware are fundamentally safe. Indigenous developers often lack the massive, dedicated quality assurance and regulatory affairs teams that global Fortune 100 companies possess. When these startups attempt to manually test their software and build compliance documentation from scratch, their cash burn accelerates, and their time-tomarket stalls.”
His proposed solution, “If a MedTech zone provides its tenants with access to enterprise grade, AI-augmented software testing platforms and shared regulatory expertise, it fundamentally levels the playing field. By automating the generation of test cases, executing them autonomously, and producing audit-ready documentation aligned with global standards like IEC 62304 and ISO 14971, AI-led quality assurance allows a startup with a small engineering team to punch far above its weight.”
Tiwari adds that the most significant innovation opportunities now span hardware and software together, “Many of the most promising opportunities now sit at the intersection of devices, software, AI, and data analytics, particularly in diagnostics and connected healthcare, where solutions must be affordable, serviceable, and designed for Indian operating conditions. In that sense, MedTech zones are not just manufacturing hubs; they are enabling platforms for startups and companies like Truevis to build products that can serve both domestic healthcare needs and future export markets.”
Affordability and the patient at the end of the chain
Every argument about manufacturing policy ultimately has to answer one question: does it translate into better, more affordable care for Indian patients?
As per Bafna, Industry estimates suggest that even advanced Class-C devices manufactured in India can be around 10 per cent to 40 per cent more affordable than imported alternatives, demonstrating the growing maturity of domestic manufacturing ecosystems.
As per Dr Sharma and Patil, by localising manufacturing, testing, sterilisation, and component integration within a single ecosystem, infrastructure and production costs reduce by nearly 20–40 per cent. “India is now moving toward a model where high-quality medical technologies can be made more accessible at Indian price points, while also strengthening long-term healthcare security and supply-chain resilience.”
Dr Arora makes the connection between shared infrastructure and patient benefit directly, “If India is able to produce high-technology and high-quality medical devices at lower costs, the benefit can be passed on to Indian patients. Local manufacturing can also reduce dependence on imports, reduce foreign exchange risk, and make medical devices more accessible in the domestic market.”
Bafna identifies where affordability gains are most visible, “The strongest affordability gains are emerging in high-volume, standardised categories such as syringes, needles, dressings, sutures, surgical disposables, diagnostic consumables and selected implants. These products benefit significantly from localized inputs, shorter supply chains, and integrated manufacturing infrastructure, enabling faster scaleup and more efficient distribution.”
Tiwari highlights what this means for access in smaller cities, “For imaging systems in particular, local production can lower lifecycle costs significantly, while also improving service responsiveness and reducing downtime through stronger domestic support networks. Locally manufactured imaging solutions can make advanced diagnostics more viable for Tier-2 and Tier-3 cities, where patients often still have to travel to metros for scans and follow-up care.”
Suneja adds the long-term cost dimension, “A strong ecosystem that supports refurbishment and lifecycle care can reduce the total cost of ownership and help providers sustain diagnostic services over time.”
The software frontier: A gap that cannot be ignored
One of the most pointed observations to emerge from this reporting came from Radhika Bawa, Director, Esbee Dynamed Pvt. Ltd. — a company building active medical technologies with significant software components.
“As India’s MedTech ecosystem shifts from being hardware-centric to heavily software-driven, strengthening advanced digital capabilities is not just important — it is an absolute prerequisite for global survival. However, there is a stark gap between the conceptual design of centralised MedTech manufacturing zones and the operational reality for software-led innovators.”
Bawa identifies three realities the ecosystem has not yet fully addressed. On competitive standards: “To compete internationally, bulletproof software lifecycles and cybersecurity are non-negotiable. Patient safety now hinges as much on code as it does on hardware.” On skills: “While India has a massive talent pool for general software development, specialised expertise in MedTech software and standards such as IEC 62304, HL7 and FHIR is still lagging.” On structural disconnection: “Because traditional manufacturing hubs remain hardware-centric, software driven companies naturally build their own infrastructure independently. We have not explored physical MedTech zones because, frankly, they are not yet structured to cater to digital product lifecycles.”
Budramane reinforces this with regulatory urgency, “The US FDA’s evolving guidance on software-as-a-medical-device, the EU MDR’s post-market surveillance expectations, and India’s CDSCO framework are all signalling the same direction: regulators expect documented, continuous, evidence-based software validation, not a snapshot taken at the end. A manufacturer that treats software testing as a final-stage activity discovers defects at the worst possible moment — after clinical validation, after submission, or sometimes after deployment.”
He raises the cybersecurity dimension, “Connected medical devices are attack surfaces. A compromised infusion pump or a manipulated diagnostic reading is not merely a data breach; it is a patient safety event. Manufacturers that are not building cybersecurity testing into their development lifecycle today may face compliance gaps that become expensive to close later.”
Tiwari echoes the imperative from the product development side, “As MedTech becomes more software-driven, patient safety, device reliability, and regulatory compliance increasingly depend on rigorous software testing, validation, cybersecurity, and AI-led quality assurance across the product lifecycle.” His company is building “secure-by-design engineering and validated software architecture” as a core element of its next-generation imaging and therapy systems.
Dr Sharma and Patil confirms that AMTZ treats this as a priority area, “As MedTech increasingly becomes software-driven, strengthening capabilities in software validation, cybersecurity, AI-led quality assurance, and digital compliance is becoming absolutely critical. To ensure patient safety and global market acceptance, MedTech zones must build strong capabilities around standards such as IEC 62304, ISO 13485, IEC 81001, cybersecurity validation, AI model verification, and software lifecycle management.”
Industry’s expectations from the next generation of zones
With new zones in various stages of planning across multiple states, the industry’s expectations are specific and demanding.
Nath mentions, “Companies now expect fully integrated, professionally managed ecosystems that enhance innovation, reduce operational costs, and improve ease of doing business. Key expectations include shared testing and certification infrastructure-sterilisation units, validation labs, and global-standard testing facilities; plug-and-play manufacturing-ready-to-use units with utilities, cleanrooms, and compliant layouts; common tool rooms and simulation labs-essential for MSMEs and startups; vendor development and component ecosystems-to reduce import dependence; export facilitation and logistics support-bonded warehouses, customs support, and global shipping integration; singlewindow regulatory systems — faster approvals and reduced compliance burden; and stable, autonomous governance-professionally managed SPVs insulated from political cycles.”
Dr Sharma and Patil goes further in articulating what the next generation of zones must be designed for, “Industry now expects MedTech zones to evolve beyond manufacturing parks into advanced innovation ecosystems for next-generation healthcare technologies such as Biodesign, AI-driven healthcare, Robotics, Quantum technologies, Meta Materials, advanced biomaterials, and translational R&D. The future MedTech zone will integrate manufacturing, clinical innovation, digital health, simulation labs, advanced imaging, rapid prototyping, and indigenous IP development within one ecosystem.”
“We are actively developing capabilities in AI, Robotics, advanced materials, precision engineering, and next-generation imaging technologies, while integrating Alternative Investment Funds (AIFs) and innovation capital to support deep-tech healthcare technologies that typically require 5–7 years for validation and commercialisation.”
Dr Arora makes the same point in operational terms, “The expectation from newer MedTech manufacturing zones is that they should address ecosystem gaps in a more integrated way. They should not only provide manufacturing infrastructure but also support testing, validation, certification, logistics, component manufacturing, regulatory approvals, and access to shared facilities. These zones should also co-locate ancillaries, suppliers, laboratories, certification bodies, and service providers so that companies can access everything they need in one ecosystem.”
Bawa has a specific ask for software-driven companies, “For MedTech zones to deliver genuine value to the next generation of medical technology, they must evolve. They need to look beyond land and power, and begin integrating shared digital testing environments, specialised software regulatory expertise, and advanced training centers for medical-grade software development. Until that shift happens, softwarefirst innovators will continue to build and scale entirely outside traditional physical hubs.”
Tiwari mentions, “The most important ecosystem gaps these upcoming zones are expected to address include deeper component localisation, affordable compliance infrastructure, and stronger support for high-capex categories that are still heavily import-dependent. In practical terms, that means distributed manufacturing to reduce concentration risk, on-site regulatory support for faster approvals, industry academia hubs to build engineering talent, and better logistics access for export-oriented production.”
Nath summarises the principle, “Industry expects these zones to complement — not compete with — existing clusters by specialising in specific technologies, materials, and manufacturing processes.”
The export horizon: From substitution to dominance
The long-term aspiration for India’s MedTech zone ecosystem goes beyond import substitution. The goal is export leadership.
As per Bafna, “India’s domestic medical device production has expanded significantly over the last five years, with the domestic industry now addressing nearly 30 per cent of national demand compared to about 10 per cent earlier. At the same time, industry projections indicate India’s MedTech exports could reach nearly Rs 1,69,000 crore by FY30, reflecting growing global confidence in India’s manufacturing capabilities.”
Dr Arora believes the trajectory is achievable, “India’s MedTech manufacturing zones have the potential to evolve into globally competitive manufacturing and export hubs. If India can support high-quality manufacturing, regulatory readiness, international standards, and export-oriented capabilities, these zones can help the country become self-sufficient and also serve global markets.”
Nath sets out what is still required, “Component and semiconductor ecosystems, precision engineering and specialised materials, common R&D and innovation infrastructure, regulatory reform and harmonisation, financing and skilling support especially for MSMEs, and export-oriented trade diplomacy to secure market access and mutual recognition of standards. If these enablers are implemented consistently with support of tariff structuring, India can move beyond import substitution and emerge as a trusted global hub for affordable, innovative, technology-driven MedTech solutions.”
AMTZ has already taken early steps. The World Trade Center (WTC) AMTZ has initiated an export-promotion ecosystem, and AMTZ is strengthening its role as a WHO Collaborating Centre for Global Innovation. Dr Sharma’s stated vision, “Position India not just as a low-cost manufacturing base, but as a globally trusted MedTech innovation and export hub.”
Tiwari maps what policy needs to deliver, “Mutual recognition agreements with the FDA and EU MDR, lower export financing costs, faster patent approvals, more ISO 13485-certified manufacturers, stronger R&D incentives, certification subsidies, standards harmonisation, and procurement preference for locally manufactured devices.”
Budramane frames the software quality dimension as a market-access issue, “India has the engineering talent and manufacturing ambition to become a serious global MedTech player. The software quality and cybersecurity infrastructure needs to match that ambition. The MedTech zones that build this capability from the start will be better positioned to produce devices that reach global markets. The ones that treat it as a later-stage problem may find it becomes a permanent constraint.”
The long game
Six years after the pandemic exposed India’s healthcare supply chain as import-dependent and structurally fragile, the country is building something that could genuinely change the picture. The zones are real. The investments are real. The companies setting up within them are real. The localisation gains, while incomplete, are real.
As Kohli said, “Localisation is no longer a contingency strategy. It is becoming the default basis for building a credible Indian medical device industry. Hospitals and clinicians have a meaningful role in this transition. Specifying Indian-manufactured equipment where clinical equivalence is established, participating in post-market surveillance, and engaging with OEMs on real-world feedback will accelerate the ecosystem’s maturity. The capability is here. Adoption is what will make it permanent.”
India is building zone by zone, company by company, component by component, the manufacturing depth it will need when the next geopolitical disruption arrives. And in the current global environment, that is not a question of whether it will happen. Only when.
Krishnan is optimistic about where this leads, “If we continue at this pace, India will be able to reduce its dependency on imported goods and enhance the healthcare system by lowering costs, increasing participation and ensuring increased self-reliance.” The zones, if designed comprehensively and supported consistently, could be a decisive part of India’s answer.
Kalyani.sharma@expressindia.com
journokalyani@gmail.com