JATIN MAHAJAN

Secretary, Association of Diagnostics Manufacturers of India (ADMI)

The perception that imported products are superior to Indian-made ones is deeply ingrained in the Indian psyche, rooted more in legacy and sentiment than in objective reality. However, this perception is increasingly outdated. India has made significant advances in R&D, manufacturing standards, and regulatory compliance, and most manufacturers are now very particular about meeting and exceeding global standards.

India’s IVD and Medical Device Exports: The Big Picture

The Indian MedTech industry is growing at a steady pace, but is still heavily dependent on imports. Total medical device exports increased to $4.02 billion in FY2024-25, with in vitro diagnostics (IVD) accounting for approximately 7–8% of the export basket. Leading export markets include North America and Europe (together >50%), with the US alone accounting for ~16% of exports. However, even as exports grow, imports outpace them by a wide margin. In FY2023-24, India imported about ₹68,885 crore of medical devices (13% increase YoY) versus just ₹31,673 crore in exports. Within this trade, IVD products (diagnostic kits and reagents) illustrate the gap sharply: India imported ₹6,477 crore of IVD reagents in 2023-24 but exported only ₹1,694 crore. In other words, domestic consumption of IVD and other devices remains dominated by foreign suppliers.

Domestic Market and Government Procurement

The home market for diagnostics currently stands in billions of Dollars, but imports cater to 70–80% of this demand. Most leading diagnostic labs and hospitals rely on CE or FDA-approved kits, many of which are sourced from abroad. Imports supply 65–70% of India’s device market. This import dependence pervades both the private and public sectors. Historically, government and public health tenders often specified costly foreign certifications, effectively excluding many Indian products. (For example, during the COVID-19 crisis, guidelines for private labs mandated only US-FDA or European-CE approved tests, leaving domestically developed kits sidelined.)

However, India’s procurement policy is evolving. Under the Make-in-India order and related “preference to domestic suppliers” rules, central and state agencies must give preference to Indian-made devices when local capacity exists. The 2021 DPIIT order and subsequent judicial rulings have clarified that discriminatory tender clauses (e.g., requiring foreign certification without justification) are no longer permissible. Government schemes, such as the Production-Linked Incentive (PLI) Programme and the National Medical Device Policy 2023, explicitly aim to boost local manufacturing and give Indian firms a fair chance. Over the next few years, such policies are expected to increase the share of domestically produced devices in public procurement.

 The Trust Deficit: Why Indian Devices Lag

Despite meeting global standards, many Indian-made IVD and medical devices suffer a “trust deficit” – both abroad and at home. Abroad, stringent regulatory barriers and entrenched preferences hinder acceptance. Indian companies face high non-tariff barriers in the US and EU markets; for example, the US FDA approval process demands lengthy clinical trials and costly registration fees. AiMeD notes that FDA-related costs and trials (often taking years and millions of dollars) make it very hard for smaller Indian firms to enter the US market. In Europe, the new IVDR rules for IVDs require extensive documentation and high-level clinical evidence, which many Indian firms lack the resources to compile. In effect, major US/EU buyers default to established Western or Asian suppliers.

Domestically, perception issues compound the problem. Clinicians and procurement officers often assume imported = superior quality. Until recently, official policies implicitly reinforced this by favoring foreign approvals over Indian regulatory clearance. Even when Indian kits met WHO-PQ or CDSCO standards, buyers have hesitated. The marketing muscle and brand recall of foreign players contribute to this misperception. In short, the perception of Indian devices as “cheap and unproven” persists, even when specific products are globally competitive.

This trust gap also throttles innovation. Indian startups and MSMEs see little payoff for developing new diagnostic solutions, since hospitals often “wait for foreign approval” before buying. According to estimates, restrictive tender norms alone have cost Indian suppliers opportunities worth over ₹100,000 crore over the past decade. Thus, Indian manufacturers compete primarily on price and volume, rather than demonstrating added value or proven outcomes.

Bridging the Gap: A 5-Year Roadmap

To establish trust, all stakeholders, including policymakers, industry representatives, and exporters, must collaborate. Key steps include:

• Harmonization with global standards and data transparency. Expanding the Indian Certification for Medical Devices (ICMED) scheme and linking it with digital traceability can build confidence among large buyers. ICMED should also be harmonized with global standards so that it is considered on par with international certifications, such as CE, IVDR, and FDA. This will ensure automatic trust for ICMED-certified products in global and domestic markets
• Make procurement merit-based. Continue rolling out the Make-in-India procurement rules rigorously, so that local firms are not excluded by default. State governments and PSUs should adopt quality-based (Q1) criteria, rather than the lowest-price L1 alone, to strike a balance between value and trust. Giving weight to certified Indian products and publishing comparative performance can reassure hospitals.
• Promote exports via trade diplomacy. The government should negotiate the mutual recognition of standards (e.g., through clout at the WTO or bilateral talks to ease FDA/CE entry hurdles). We must seek reciprocal regulatory arrangements so that the U.S. and EU don’t impose onerous fees or duplicate trials on Indian products. Facilitating Indian companies’ participation in global health tenders (through Export Promotion Councils, trade fairs, and clustered PLI zones) will build visibility. For example, dedicated export incentives or a CEP (Certificate of Export Parity) could help Indian devices gain a foothold in benchmark markets.
• Invest in innovation and scale. Domestic manufacturers (especially MSMEs) need capital, R&D support, and clustering to meet global standards. PLI and similar grants should be targeted at high-value IVDs (molecular diagnostics, immunoassays, rapid tests) that fetch higher trust and margins. Shared facilities for biocompatibility testing and clinical validation (like at the Andhra Pradesh MedTech Zone) should be expanded nationwide. By 2030, India aims for a $50B medtech market, realizing that requires doubling down on quality over quantity.
• Build trust through evidence and success stories. The narrative must shift. Publishing case studies that demonstrate how Indian diagnostics have improved patient outcomes or filled critical gaps (e.g., rural TB testing, COVID-19 response) can help reshape perceptions. Government and industry awards for “Best Made-in-India Device” can spotlight excellence. Even branding matters: marketing “quality-assured Indian IVD” under a standard label (backed by a third-party seal) could elevate consumer confidence.

If these initiatives are pursued, India could significantly reduce its import dependence by 2030. Even in five years, we can expect to see a growing share of Indian diagnostics in government schemes and private hospitals (say, raising domestic procurement from ~30% today to over 50%). Export-wise, targeted support should enable Indian IVD firms to enter more stringent markets, as securing a few US-FDA/CE approvals will unlock multibillion-dollar segments. India’s National Medical Devices Policy already envisions boosting competitiveness; implementing it could see India’s MedTech exports climb toward the ambitious 10–12% global market share target cited by experts.

The path forward is clear. By aligning policy (Make in India, PLI, trade dialogues) with industry action (quality upgrades, certification, branding), India can turn the trust deficit into an opportunity. Today, the country imports the majority of its diagnostics – but with focused effort, homegrown IVDs can become “trusted brands,” both here and around the world.