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Consumer Discretionary
The recent move by the Gujarat government to introduce differential pricing for stents under the Ayushman Bharat health insurance scheme has ignited a heated debate. The policy, which prices USFDA-approved stents at twice the rate of those cleared by Indian regulators, has been criticized for favoring American multinational companies over local manufacturers. This decision has prompted the Association of Indian Medical Device Industry (AiMeD) to write to Union Health Minister J P Nadda, highlighting the discriminatory nature of the policy and its potential to undermine India's own regulatory system.
The differential pricing system, announced in early March 2025, set the reimbursement price for stents approved by the US Food and Drug Administration (USFDA) at Rs 25,000, while those cleared by the Drugs Controller General of India (DCGI) were capped at Rs 12,000. This significant price disparity has raised concerns among Indian stent manufacturers, who argue that such a policy not only favors American companies but also questions the efficacy and credibility of India's regulatory framework.
Indian stent manufacturers, who currently dominate the market with over 73% share and export their products to over 100 countries, have voiced strong opposition to this pricing mechanism. They fear that the policy will lead to significant losses, potentially causing job losses and plant shutdowns. AiMeD has emphasized that Indian stents are of high quality and clinically validated, yet they are being unfairly priced lower than their USFDA-approved counterparts.
Following intense backlash from the industry, the Gujarat government has decided to put off the differential pricing policy temporarily. In a meeting of the governing body for the Pradhan Mantri Jan Arogya Yojana-Mukhyamantri Amrutam (PMJAY-MA), the state's hybrid variant of the flagship central insurance scheme, Health Minister Rushikesh Patel announced that the decision has been postponed pending further discussions. This move comes as a relief to local manufacturers but leaves the future of stent pricing uncertain.
Indian medical device manufacturers have expressed several concerns regarding the differential pricing policy:
Discriminatory Pricing: The policy is seen as discriminatory against Indian manufacturers by placing a higher value on USFDA-approved stents over those cleared by the DCGI.
Undermining India's Regulatory System: By favoring USFDA approval, the policy undermines the credibility and competence of India's own regulatory framework, potentially impacting the credibility of domestic medical devices globally.
Impact on Local Industry: The pricing disparity threatens to compromise the viability of local stent manufacturers, who are central to India's medical device industry.
AiMeD has called for a rollback of this decision and emphasized the need for a uniform pricing model that promotes fair competition and supports the 'Make in India' initiative.
Rajasthan, for instance, uses a differential pricing system based on clinical data, where stents supported by clinical evidence from globally reputed journals are priced higher than those without. However, this approach is different from Gujarat's initial plan, which focused solely on the regulatory approval body.
The differential pricing policy not only affects manufacturers but also has broader implications for consumers and the healthcare system. The Ayushman Bharat scheme aims to provide affordable healthcare coverage to millions of Indians. By favoring USFDA-approved stents, the policy could limit access to more affordable options, potentially increasing healthcare costs for those who depend on government-subsidized medical insurance.
To address these concerns, the Gujarat government is expected to form a committee to engage with manufacturers, doctors, and other stakeholders to formulate a new pricing model. The objective is to ensure that any future pricing policy supports both the quality of care and the viability of local industries. Dr. Ravi Rathod from AiMeD noted that there should be no different price caps based on the type of approval, as Indian stents are used globally without such distinctions.
The controversy surrounding Gujarat's stent pricing policy highlights the need for a balanced approach that supports both local industry development and high-quality healthcare delivery. By considering the feedback from stakeholders and ensuring that policies align with national initiatives like 'Make in India' and 'Atmanirbhar Bharat,' the government can create an environment that promotes fair competition and innovation in the medical device sector.
As discussions continue, it remains crucial to prioritize transparency, fairness, and the interests of domestic manufacturers while maintaining high standards of healthcare quality. This approach will not only safeguard India's growing stature in the global medical device market but also ensure that patients receive the best possible care without undue financial burdens.