A controversial new stent pricing policy in Gujarat has ignited a firestorm, pitting domestic manufacturers against global giants in a high-stakes fight over India's coronary stent market
The Gujarat government's recent decision to implement a dual pricing structure for drug-eluting stents (DES) has ignited controversy within India's medical device sector. Under this new policy, stents approved by the United States Food and Drug Administration (USFDA) are priced at Rs 25,000 per unit. At the same time, those sanctioned by India's Central Drugs Standard Control Organization (CDSCO) are capped at Rs 12,000. This significant price disparity has drawn sharp criticism from domestic manufacturers, who view it as a direct affront to the 'Make in India' initiative and a potential threat to the local industry's viability.
The Association of Indian Medical Device Industry (AiMeD), representing over 1,200 domestic manufacturers, has been at the forefront of this opposition. AiMeD argues that the state's pricing mechanism is inherently discriminatory, favouring multinational corporations (MNCs) and undermining indigenous production. Rajiv Nath, Forum Coordinator of AiMeD, expressed concerns that this move could facilitate American MNCs in reclaiming market dominance at the expense of Indian manufacturers, thereby jeopardising the growth and sustainability of the domestic medical device industry.
Adding another layer to the debate, the United States Trade Representative (USTR) has highlighted issues with India's price controls on medical devices. The USTR's report points out that India's price caps on coronary stents and knee implants have not been adjusted for inflation and fail to account for production costs or technological advancements. This, according to the report, discourages U.S. companies from engaging with the Indian market, potentially limiting the availability of advanced medical technologies for Indian patients.
The broader context reveals a concerning trend for India's healthcare sector. The country's heavy reliance on imports, with 80-85 per cent of medical devices being sourced from abroad, has led to a ballooning import bill, which stood at Rs 69,000 crore in the fiscal year 2023-24. This dependency not only hampers the growth of the domestic industry but also raises questions about the long-term sustainability of India's healthcare infrastructure.
AiMeD has been vocal about the need for government intervention to address these challenges. In its pre-budget recommendations, the association urged the government to implement policies that would reduce import reliance and bolster domestic manufacturing. Proposed measures include elevating quality regulations to meet global standards, providing incentives for surpassing international benchmarks, and promoting indigenous products through awareness campaigns and strategic initiatives. These steps are seen as crucial to fostering a self-reliant medical device industry that can cater to the nation's healthcare needs without undue dependence on foreign entities.
The Gujarat government's pricing policy has inadvertently spotlighted the pressing issues facing India's medical device sector. While the intention behind the policy may be to ensure cost-effective and high-quality patient care, the resultant implications suggest a need for a more balanced approach. Policies that inadvertently favour foreign manufacturers over domestic ones could stifle local innovation and production capabilities. As India strives towards self-reliance in various sectors, it becomes imperative for policymakers to craft strategies that not only attract foreign investment but also nurture and protect homegrown industries. Achieving this balance is essential for building a robust healthcare system that is both accessible and sustainable for the Indian populace.
