Make in India for Medical Devices — The Reality No One Is Talking About
Make in India for Medical Devices — The Honest Truth About What Is Working, What Is Not, and What It Will Take to Build a World-Class MedTech Industry
By Ankur Khare — Biomedical Engineer | Regulatory Affairs Specialist | Founder, MedReg Intel
India imports approximately 70 to 80 percent of its medical devices.
Read that again. The world's most populous country — a nation with one of the fastest-growing economies on earth, a massive domestic healthcare need, and a government that has made manufacturing self-sufficiency a centrepiece of national policy — still depends on foreign manufacturers for most of the devices used in its hospitals every single day.
The Make in India initiative for medical devices has been running for nearly a decade. The Production Linked Incentive scheme has committed thousands of crores in government support. CDSCO has been strengthened and modernised. Medical device parks have been established.
And yet the import dependence persists.
This is not a story of government failure or industry incompetence. It is a story of genuine complexity — of the specific challenges that make medical device manufacturing harder than most other manufacturing sectors, the real progress that has been made despite those challenges, and the specific interventions that will determine whether India builds a genuinely world-class MedTech industry or remains a large market served primarily by foreign manufacturers.
This article gives you the honest picture — the progress, the problems, and the path forward.
The Scale of India's Medical Device Import Problem
To understand why Make in India for medical devices matters so urgently, you need to understand the scale of the problem it is trying to solve.
India's medical device market is estimated at approximately USD 11 billion in 2026 and growing at 12 to 15 percent annually — one of the highest growth rates of any major medical device market globally. On that trajectory, the market will reach USD 25 billion or more by 2030.
Of that USD 11 billion, approximately 70 to 80 percent — or USD 7 to 9 billion — is served by imported devices. The import dependence is particularly acute in high-value, high-complexity categories — cardiac devices, imaging equipment, orthopaedic implants, critical care equipment, and in-vitro diagnostics.
This import dependence has several serious consequences beyond the obvious economic one of foreign exchange outflow.
Healthcare affordability is directly affected. Imported devices carry import duties, logistics costs, distributor margins across multiple supply chain tiers, and currency risk — all of which are ultimately passed on to patients. A cardiac stent manufactured in India can reach the patient at a significantly lower cost than an equivalent imported device. At the scale of India's healthcare system, the difference in patient-level costs is enormous.
Strategic vulnerability is real. COVID-19 demonstrated with brutal clarity what import dependence means when global supply chains are disrupted. India's healthcare system faced genuine shortages of critical devices — ventilators, PPE, diagnostic equipment, pulse oximeters — precisely because domestic manufacturing capacity did not exist at the required scale.
Technology transfer is stunted. When a country is primarily a consumer rather than a manufacturer of medical technology, the engineering capability, manufacturing knowledge, and innovation culture that generate the next generation of devices do not develop. India's enormous pool of biomedical engineering talent is largely employed in maintaining and servicing imported devices rather than designing and manufacturing them.
What Make in India Has Actually Achieved
Fairness requires acknowledging genuine progress before cataloguing the problems.
The Production Linked Incentive Scheme
The PLI scheme for medical devices committed ₹3,420 crore in incentives across four target segments — cancer care and radiotherapy devices, radiology and imaging equipment, anaesthesia and cardiology devices, and implants. The scheme attracted applications from both domestic manufacturers seeking to expand and foreign manufacturers seeking to establish Indian manufacturing operations.
Early results have been meaningful. Several companies have established or expanded manufacturing capacity in India under the PLI framework. The scheme has created a financial architecture that makes Indian manufacturing more commercially attractive for companies that previously defaulted to importing.
Medical Device Parks
The government has supported the establishment of dedicated medical device manufacturing parks — clusters designed to provide shared infrastructure, reducing the capital investment required for individual manufacturers to establish compliant facilities. Parks in Andhra Pradesh, Himachal Pradesh, Madhya Pradesh, and Tamil Nadu represent genuine infrastructure investment in the sector.
Domestic Manufacturer Success Stories
India does have genuine world-class medical device manufacturers. Companies producing surgical instruments, disposables, diagnostic reagents, hospital furniture, and certain categories of imaging equipment have built internationally competitive businesses. Indian surgical instruments, in particular, are exported globally and compete effectively on quality and cost.
The Indian diagnostic industry — particularly in-vitro diagnostics — has shown strong domestic manufacturing capability, demonstrated by India's ability to rapidly scale COVID-19 testing capacity using domestically manufactured test kits.
The Real Obstacles — Why Import Dependence Persists Despite Policy Support
If the policy intent is clear and the incentives are substantial, why does import dependence persist? The honest answer involves several structural challenges that policy alone cannot quickly resolve.
The Technology Gap in High-Value Segments
The medical devices that constitute the highest import value — MRI machines, CT scanners, cardiac implants, surgical robots, advanced in-vitro diagnostics — require manufacturing technology, materials science, and precision engineering capabilities that India's industrial ecosystem has not yet fully developed.
Building these capabilities takes time that policy incentives cannot compress. An MRI machine involves superconducting magnet technology, cryogenic engineering, sophisticated RF electronics, and advanced software integration — a manufacturing capability stack that major global manufacturers have spent decades and billions of dollars developing.
India is not starting from zero — the country's strength in software and electronics gives it genuine advantages in certain device categories. But the component and materials ecosystem that supports complex device manufacturing is still being built.
Regulatory Compliance Costs and Complexity
MDR 2017's manufacturing license requirements — ISO 13485 certification, facility infrastructure standards, documentation systems — represent a significant investment for companies transitioning from unregulated or minimally regulated manufacturing. Many small and medium manufacturers who could potentially produce quality devices lack the capital and expertise to achieve and maintain MDR 2017 compliance.
This creates a two-tier manufacturing landscape — a small number of sophisticated, compliant manufacturers and a large informal sector that cannot access the legitimate market. Bridging this gap requires both regulatory capacity building support for manufacturers and consistent enforcement against non-compliant products.
The Procurement Preference Problem
Despite Make in India policy intent, hospital procurement — both public and private — continues to show a preference for foreign-branded devices in many categories. This preference is partly rational — foreign devices in established categories often have longer track records, more extensive clinical evidence, and better post-sale service infrastructure — and partly habitual.
Public procurement policies increasingly mandate preference for domestic manufacturers meeting quality standards, but implementation is inconsistent. The experience of domestic manufacturers in government tenders — where the lowest price requirement often overrides quality considerations and domestic preference provisions are unevenly applied — continues to create commercial uncertainty that discourages manufacturing investment.
The Innovation Financing Gap
Building genuinely innovative medical devices — not just manufacturing equivalents of foreign products but developing new solutions for Indian healthcare challenges — requires patient capital willing to fund the long development and regulatory cycle of novel medical technology.
India's venture capital ecosystem for deep tech MedTech is growing but remains small relative to the opportunity. Most Indian MedTech investments are in distribution, digital health, and services rather than in the capital-intensive device manufacturing and development that would address import dependence at its root.
The Regulatory Dimension — How CDSCO Can Support Make in India
CDSCO's regulatory framework has a direct impact on domestic manufacturing competitiveness and the Make in India agenda deserves more regulatory support than it currently receives.
Faster Manufacturing License Processing
The time required to obtain a manufacturing license — from application submission through pre-licensing inspection to license grant — is a significant entry barrier for domestic manufacturers. Reducing this timeline, particularly for manufacturers in government-supported Medical Device Parks, would meaningfully reduce the time-to-market disadvantage that domestic manufacturers face relative to importers with existing registrations.
Technical Assistance for MDR 2017 Compliance
CDSCO could more actively support domestic manufacturers — particularly SMEs — in achieving MDR 2017 compliance. Technical assistance programs, model quality management system documentation, and compliance clinics where manufacturers can get regulatory guidance without incurring expensive consultant fees would reduce the compliance cost barrier for smaller manufacturers.
Recognition of Domestic Testing Infrastructure
Indian manufacturers seeking CDSCO registration need access to testing laboratories that can conduct device performance, safety, and biocompatibility testing to internationally recognised standards. Expanding the network of NABL-accredited testing laboratories with the specific capability to test medical devices would reduce the cost and time of testing compliance for domestic manufacturers.
Intellectual Property Protection
Medical device innovation requires confidence that intellectual property will be protected. Strengthening IP enforcement — including protection against counterfeit and imitation devices — is essential for creating the investment environment that supports genuine innovation.
The Opportunity — What a World-Class Indian MedTech Industry Looks Like
The case for building a world-class Indian medical device industry is not just about reducing imports. It is about the convergence of several genuine advantages that India possesses and that no other country in the world has in the same combination.
The Patient Population Advantage
India's 1.4 billion people represent not just a market but a clinical research and development resource of extraordinary scale. Conducting clinical investigations in India provides access to disease burden patterns, patient populations, and healthcare delivery contexts that are highly relevant for devices designed for emerging market healthcare — a growing global market segment.
A medical device company that understands how to design for Indian healthcare delivery conditions — variable power supply, limited maintenance infrastructure, diverse user training levels, tropical climate — has a product that is relevant across a much larger global market than just India.
The Engineering Talent Advantage
India produces more engineering graduates annually than almost any country in the world. The challenge is not talent availability but talent deployment — channeling a larger share of this engineering capability into medical device design and manufacturing rather than into software services and IT.
As the medical device manufacturing ecosystem grows, it will naturally attract more engineering talent. The critical intervention is creating the early-stage companies, manufacturing facilities, and research partnerships that give talented engineers genuine opportunities in MedTech.
The Software and AI Advantage
India's world-class software capability is increasingly relevant to medical devices as the line between hardware and software in medical technology blurs. AI-enabled diagnostics, connected monitoring devices, clinical decision support systems, and software as a medical device are categories where Indian companies have genuine competitive advantages.
The regulatory framework for software medical devices under MDR 2017 is still developing — CDSCO is working on guidance for AI-enabled devices — but the companies positioning themselves at this intersection of Indian software capability and medical device regulation are building businesses with both domestic and global potential.
What Needs to Happen in the Next Five Years
Building genuine manufacturing self-sufficiency in medical devices is a decade-long project. But the next five years are critical for establishing the trajectory.
Government procurement must consistently implement domestic preference provisions with genuine quality requirements rather than lowest-price procurement that undercuts quality manufacturers. This single change would do more for domestic manufacturing competitiveness than any additional subsidy.
The PLI scheme's incentive structure should be reviewed to ensure it is directing investment toward genuine manufacturing capability development rather than just assembly operations that remain dependent on imported components.
CDSCO's manufacturing license process should be streamlined with specific fast-track provisions for manufacturers in designated Medical Device Parks and for companies manufacturing devices in categories with high import dependence.
The innovation financing ecosystem needs development — specific medical device venture funds, government co-investment programs for novel device development, and research partnerships between academic institutions and device manufacturers that translate scientific capability into commercial products.
And the industry itself needs to take quality seriously as a competitive strategy rather than a compliance burden. The Indian manufacturers who will win global markets are those who use MDR 2017 compliance not as a minimum requirement to be met at minimum cost but as a quality foundation to be exceeded and leveraged as a market differentiator.
The Bottom Line — Honest Optimism
India will build a world-class medical device industry. The market size, the talent base, the government commitment, and the growing domestic manufacturing capability all point in that direction.
The timeline is longer than optimistic policy announcements suggest. The challenges are more structural than additional incentives can quickly resolve. And the gap between aspiration and current reality is larger than the industry's promotional narrative acknowledges.
But the direction is right and the momentum is real. Every domestic manufacturer that achieves and maintains MDR 2017 compliance, exports to international markets, and invests in genuine product development is building a piece of the infrastructure that India's MedTech future requires.
The import dependence of today is not the destiny of tomorrow. It is a problem being actively solved — imperfectly, incompletely, but genuinely — by companies, by regulators, and by a government that understands what is at stake.
Stay Informed on India's MedTech Regulatory and Industry Developments
MedReg Intel tracks regulatory developments, industry trends, and policy updates relevant to India's medical device sector at medregintel.com
For regulatory intelligence, compliance guidance, or industry analysis, reach out at ankur@medregintel.com
Ankur Khare is a Biomedical Engineer and Regulatory Affairs Specialist and the founder of MedReg Intel. The views expressed represent the author's professional assessment. This article does not constitute formal regulatory or legal advice.
Comments
Post a Comment