2025-12-24

India’s MedTech industry stands at a pivotal point of growth and transformation. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), explains his vision to Pharma Industrial India for building a globally competitive, innovation-driven ecosystem. He discusses how policy reforms, skill development and quality infrastructure can help India move from being a major importer to a trusted global supplier of medical devices.

Q. India’s medical device market is projected to touch USD 50 billion by 2030, yet imports still dominate. What opportunities and risks do you see for domestic manufacturers in this transition?

Rajiv Nath: Strengthening Indian brands to compete globally is crucial for seizing this opportunity. Without predictable regulations, rational GST, nominal tariff protection and supportive procurement norms, imports will dominate as finished or CKD devices. Building infrastructure, skills and patient-focused innovation can help India become a trusted global supplier; otherwise, we risk remaining a trading nation as has been the case over decades.

Q. With global supply chains shifting, what unique strengths can India leverage to capture a bigger share of the international MedTech market?

Rajiv Nath: India’s strength lies in precise and affordable innovation without sacrificing quality or ethical standards. As global supply chains shift, India is well-positioned to offer cost-effective, and transparent manufacturing. To capitalise, we must align with international standards, speed up investment and component manufacturing, improve the Production Linked Incentive (PLI) scheme, coordinate MedTech Park execution and streamline export processes. By focusing on credibility, scale and design, India’s MedTech sector can achieve global trust like its pharma industry.

Q. Looking ahead, what further GST reforms would you recommend to create a globally competitive tax regime for medical devices?

Rajiv Nath: We urge the government to further simplify the GST framework for medical devices, as the current inverted duty structure taxes input at 18 percent and finished devices at five percent is disadvantaging domestic manufacturers. Recent GST 2.0 reforms, like assuring 90 percent upfront re funds for manufacturers, will improve liquidity and export potential. However, to fully realise GST’s goal of taxing value addition rather than working capital, India should also allow refunds on input services and capital goods. Global best practices support comprehensive refund systems, and extending relief to traders would further strengthen the economy. Completing these reforms will make GST truly effective in promoting growth and global competitiveness.

Q. Beyond GST, what policy levers are most critical to reduce import dependency and strengthen domestic value addition?

Rajiv Nath: India needs a stable, long-term policy framework that addresses the full value chain—from raw materials to procurement—and supports domestic manufacturing. Beyond GST, phased, planned tariff adjustments are needed to protect local producers from import competition. Enforcing ‘Preference to Make in India’ across ministries and hospitals will boost predictable demand and incentivise higher domestic content and value addition. Swift implementation of DOP marginal investment schemes, soft credit, faster approvals and R&D incentives is essential to spur innovation. Investment in testing labs, tool rooms and component manufacturing is crucial to reduce import dependence. Consistent policies over a decade will encourage manufacturers to invest confidently, driving real value creation.

Q. AiMeD has long advocated for a separate medical device law. What should be its defining features to truly support innovation and patient safety?

Rajiv Nath: The introduction of a dedicated Medical Devices Act is both necessary and timely and should account for the distinct characteristics of the medical devices industry, which differs substantially from pharmaceuticals. Legislation must be risk-based and patient-centric, providing a proportionate regulatory framework, streamlined pathways and reduced regulatory burdens for low-risk devices, while ensuring rigorous quality standards and heightened accountability for high-risk devices. Simultaneously, it should facilitate ease of business by establishing clear and predictable timelines for product registration and licensing.

It is advisable to separate regulatory processes from pharmaceuticals as also guided by The Parliamentary Committee on Health by requiring both overseas and Indian manufacturers to adhere to compliance obligations, with the responsibility for compliance delegated to Quality Managers (QMs), and Product Standards and Technical File Review entrusted to certification bodies, including for high-risk medical devices, as is currently done for low-risk ones.

The CDSCO and State Licensing Authorities should focus on supervising certification bodies responsible for manufacturer audits, rather than conducting direct factory inspections themselves, aligning with practices in the EU, UK, Health Canada, Malaysia and Australia. The emphasis should remain on quality, accountability and innovation, rather than merely regulatory oversight. A thoughtfully developed and consultative legal framework, as per international regulatory practices for medical devices, will foster confidence among manufacturers and patients alike, positioning India as a credible global MedTech leader.

Q. The National Medical Devices Policy 2023 was seen as a breakthrough. How effective has its implementation been so far, and where are the gaps?

Rajiv Nath: The National Medical Devices Policy 2023 represents a significant and positive development; however, effective on-ground implementation is now imperative. Although the policy demonstrated a strong commitment to making India self-reliant and globally competitive, execution has been inconsistent. Progress in areas such as streamlining regulations, attracting investments, skill development initiatives and testing infrastructure has been slow, with inter-ministerial coordination continuing to pose challenges especially in area of Quality Control orders on raw materials and intermediaries that discourage access to vital imported inputs with unmatched availability in India.

It is essential to establish measurable targets, including reducing import dependency, increasing exports and enhancing local value addition. States should assume responsibility by developing and adhering to time-bound action plans and reducing the cost of doing business. To realise the policy’s vision, continuous support for manufacturers—particularly MSMEs—is necessary. Without consistent implementation and adequate financial backing, the policy risks remain aspirational rather than impactful.

Q. The government is considering rules on refurbished medical devices. What impact could this have on affordability and patient safety?

Rajiv Nath: India bans the import of used cars and mobile phones to protect its industries. Medical devices beyond their warranty should be safely refurbished and certified, with strict regulations to prevent unsafe imports of pre-owned equipment. Refurbished equipment must meet new product safety standards and have proper performance testing and certification.

Domestic refurbishment under quality controls is supported as it creates jobs and reduces waste, but uncontrolled imports pose risks. The goal is affordable healthcare without sacrificing quality or self-reliance.

Q. How can AiMeD and the industry push back against tariff and non-tariff barriers while expanding global competitiveness?

Rajiv Nath: Non-tariff barriers such as testing norms, regulatory bias and certification challenges hinder Indian manufacturers’ access to global markets. AiMeD addresses these issues in trade discussions and via government channels. Meanwhile, India must boost its domestic capabilities by adopting international certifications, upgrading testing labs and matching global standards. Negotiating mutual recognition agreements is vital for the wider acceptance of Indian certifications like QCI’s ICMED certification, which is based on global ISO standards abroad. Global market access requires both effective advocacy and robust local systems—improving competitiveness that starts with strengthening quality at home.

Q. How can India strike a balance between enforcing quality standards and managing the realities of sourcing specialised materials globally?

Rajiv Nath: Balancing quality with uninterrupted production is challenging, especially as India still relies on imports for specialised materials due to limited local manufacturing capabilities. Before introducing Quality Control orders for raw materials and intermediates, impact assessments are crucial. The medical devices sector lacks a developed supply chain for essential inputs. Policies must allow essential imports while tracking their volume to support future domestic development. Regulations should be practical, science-based, and avoid unnecessary bureaucracy. Establishing shared national testing labs can help smaller manufacturers meet standards affordably. Excessive regulations or abrupt import bans harm legitimate businesses. While the aim is self-sufficiency, current systems should ensure the continued production of safe, high-quality devices.

Q. What is holding back R&D in MedTech, and what specific government support is needed to unlock innovation?

Rajiv Nath: MedTech R&D progress is slow due to limited rewards for innovation. To accelerate growth, India needs dedicated innovation hubs, sustained funding, predictable regulations and stronger links between academia, hospitals and industry. Government grants, tax incentives and faster validation will encourage investment. Public hospitals must validate and adopt locally developed technologies to help them scale. Public health procurement should give preference to indigenous innovation, and that should be prioritised over import substitution. With stable support, India can emerge as a global leader in affordable MedTech design.

Q. Inconsistent tariff protection and weak enforcement of the “Preference to Make in India” order have hurt domestic firms. What changes are necessary to ensure a truly level playing field?

Rajiv Nath: When tariffs on raw materials and components exceed those on imported medical devices, and when tariffs are below 10 percent, manufacturing medical devices domestically becomes less viable than importing them. An effective and predictable tariff policy supporting import substitution may help encourage entrepreneurs to engage in manufacturing. The ‘Preference to Make in India’ policy aimed to encourage domestic production, but its implementation has not consistently aligned with its intended objectives. Some government tenders include technical clauses that restrict participation from Indian manufacturers. Improved monitoring, regular audits, and a centralised body for addressing industry concerns could support fair policy enforcement. Import duties may be structured to promote domestic value addition rather than activities such as relabeling or simple assembly of imported goods. Transparent procurement systems can foster investor confidence. Achieving self-reliance requires consistent and equitable measures, enabling Indian manufacturers to have equal opportunities to compete.

Q. If you had to identify three immediate actions to make India a top-tier MedTech hub in the next five to 10 years, what would they be?

Rajiv Nath: We need a dedicated Medical Devices Act for clear regulation and industry identity. Developing technology-specific clusters as MedTech Parks with supporting testing labs and raw material hubs through public-private partnerships or simple coordination will strengthen manufacturing. Aligning tariff, GST and trade policies will support domestic innovation. These steps can reduce India’s import reliance, create global leaders and make devices accessible. The skills and vision are present; now we require focused execution.