2025-11-19

In this exclusive interaction, Jatin Mahajan, President of the Association of Diagnostics Manufacturers of India (ADMI) and Managing Director of J Mitra & Co., shares his insights on the evolving landscape of India’s In-Vitro Diagnostics (IVD) industry. He highlights the growing domestic and global demand for India-made diagnostics, the opportunities and challenges for local manufacturers, and the policy measures needed to strengthen competitiveness. He also outlines ADMI’s initiatives to support its members and calls on policymakers to ensure long-term sustainability of the sector. 

Q. How has the demand for India-made diagnostic devices evolved, both domestically and internationally, in recent years?

Jatin Mahajan: Domestic demand has strengthened with deeper public-health coverage and clearer test menus. The second National Essential Diagnostics List (NEDL 2025) links tests to each care level, anchoring steady public procurement and uptake. As per the India Brand Equity Foundation (IBEF) data, India’s medical devices sector (which includes diagnostics) overall has expanded to ~USD12 billion in FY24, reflecting sustained multi-year growth. Export prospects have also improved: the National Medical Devices Policy (2023) formalised a strategy and announced a dedicated Export Promotion Council for Medical Devices (EPC-MD). Market access has eased with the India–UK Free Trade Agreement (FTA) related to duty on medical devices, opening a high-value OECD market for Indian manufacturers. The latest Goods and Services Tax (GST) reform and the resultant shift to the five percent bracket will also spur growth in the sector. For IVD specifically, industry estimates vary, but recent analyses place India’s IVD market in the low-to-mid single-digit billions, growing at mid-single-digit CAGR—evidence of sustained structural demand. Preference for domestically manufactured products in public tenders, under the Department for Promotion of Industry and Internal Trade (DPIIT) Make-in-India procurement order, will further support local volumes.

Q. How are Indian-made IVD medical devices perceived in global markets? Where do we excel, and where do we still lag?

Jatin Mahajan: India is increasingly viewed as a reliable, value-driven supplier in routine and Point-of-Care (PoC) segments, which include rapid tests, ELISAs, and mid-throughput analysers, backed by expanding quality infrastructure (ISO 15189/NABL for labs; ISO-aligned QMS for manufacturers).

Where we still lag is in high-end platforms, critical raw materials (e.g. enzymes, antibodies), and a few complex chemistries, which is evident in India’s continued dependence on imports for ~70 percent of medical devices. The introduction of IS 23485 (BIS), which harmonises ISO 13485 and essential safety principles, is helping to align with global expectations and should steadily improve perception and market access. Trade openings such as the India–UK FTA, combined with EPC-MD hand-holding, will further enhance confidence in Indian IVDs as partners to mature health systems.

Q. In your view, what steps are necessary to raise the standards of the IVD industry in India to match global benchmarks?

Jatin Mahajan: First, universalise quality systems by mandating the time-bound adoption of IS 23485 (BIS) across IVD manufacturers and strengthening supplier audits for critical components.

Second, scale laboratory quality by expanding National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation coverage and External Quality Assessment (EQA) networks, ensuring that clinical performance data are comparable globally. The Government must incentivise corporates to obtain certification and strengthen India's position on the global IVD map.

Third, IMDRF (International Medical Device Regulators Forum) should, as a test, take the lead in forming joint action groups with other countries for mutual gains by promoting consistency and best practices worldwide.

Fourth, complete regulatory convergence–codify clear, risk-proportionate guidance for clinical performance evaluation, and operationalise a single-window licensing interface as envisaged in the 2023 National Medical Devices Policy.

Fifth, build domestic reagent independence through targeted PLI support and test-bed grants inside medical-device parks.

Finally, align procurement with quality—link tender eligibility to demonstrated QMS, performance data, and after-sales service levels, consistent with the Make-in-India procurement order.

Q. What are the key challenges and opportunities currently facing Indian IVD manufacturers?

Jatin Mahajan: Challenges include import dependence for platforms/bioreagents, uneven tender enforcement of local-content rules, and the need for faster, predictable approvals for innovative IVDs.

Opportunities are compelling—the diagnostics-equipment market is projected to reach ~USD6 Billion by 2027, the updated NEDL is widening public-sector testing, and entry to the UK market can accelerate exports.

The 2023 National Medical Devices Policy and EPC-MD provide a pathway to scale, branding, and market access; industry must now leverage medical devices parks, R&D incentives, and quality systems to move up the value chain. The EPC-MD should also collaborate with the Indian Embassies worldwide to establish a Medical Devices/IVD desk, promoting and facilitating the export of medical devices and IVDs in line with the existing pharma desk.

PLI version 2 must ensure that more companies with a lower threshold value can avail of the scheme, thereby creating a conducive environment for the growth of the sector.

Q. How do you assess the current regulatory environment for medical devices in India, and what improvements would you like to see?

Jatin Mahajan: India has made decisive progress—the CDSCO completed the transition of all devices to licensing–Class A/B from October 1, 2022, and Class C/D from October 1, 2023, thereby bringing IVDs firmly into a modern, risk-based regime.  

Continued improvements should focus on the following –

1. A digital, single-window interface across all regulators
2. Time-bound, risk-tiered review clocks
3. Clear guidance on clinical performance evaluation and post-market surveillance tailored to IVDs
4. Broader recognition of internationally accepted standards and quality certifications
5. At the recently concluded IMTE 2025, the future of Software as a Medical Device (SaMD) was discussed, with experts calling for robust regulatory frameworks, AI integration, and cybersecurity safeguards. This will help India capture a USD 30 Billion digital health market by 2030.

These recommendations are consistent with the National Medical Devices Policy 2023 and will enhance predictability without diluting safety.

Q. What is your perspective on the Production Linked Incentive (PLI) scheme for medical devices? To what extent has it benefitted IVD manufacturers, and what further measures are required to maximise its impact?

Jatin Mahajan: PLI has catalysed domestic manufacturing in high-end modalities. By April 2023, 14 commissioned projects were already producing 37 products, with additional investments in the pipeline. The medical devices PLI scheme provides a valuable template for PLI implementation for IVD as well.

To maximise impact for IVD, we need a sharper tilt toward reagents, enzymes, antibodies, plastics/consumables, and automation sub-assemblies; simplified disbursement for MSMEs; and alignment with testing infrastructure in device parks and NABL networks, so scale-up is faster and verifiable.

Q.  What recent initiatives has ADMI undertaken to support its members and strengthen the Indian IVD industry?

Jatin Mahajan: ADMI has prioritised the following tracks –

1. Policy and procurement—submissions urging rigorous enforcement of the Make-in-India procurement order and quality-linked tendering.
2. Export readiness—engagements with EPC-MD and trade bodies on market-entry pathways, including opportunities arising from new FTAs.

Publicly, ADMI leadership has called for strengthening EPC-MD and expanding export support in pre-budget consultations, and we continue to prioritise the advancement of these initiatives. Our proactive and concerted efforts for the reduction of GST have been successful, with the government addressing the same earlier this month. ADMI has also put its weight behind the knowledge enhancement of its fellow members. In line with this, we have started conducting knowledge series sessions around GST, and this initiative will be expanded to focus on other areas as well.

Our various interventions with the government have also borne fruit on the inverted duty structure issue, with many aspects being addressed by the government.

Q. What message would you like to give policymakers to ensure the long-term sustainability and competitiveness of the Indian diagnostics industry?

Jatin Mahajan: Stay the course on the National Medical Devices Policy and operationalise its single-window, standards, and skills pillars with clear timelines. Enforce the Make-in-India procurement order uniformly across ministries and PSUs to reward quality local capacity, and link tenders to QMS/clinical-performance evidence. Expand PLI coverage for IVD reagents, components, and automation sub-systems, while co-funding shared test labs in device parks.

There is a significant gap between policy announcements and policy implementations. The government must implement a robust monitoring mechanism and keep a close tab on the defined timelines and milestones related to various schemes and incentives. Finally, pair export promotion (EPC-MD) with strategic FTAs—like the UK zero-duty framework—to convert capability into market share.