Gujarat’s ₹25,000 stent shocker: U.S. FDA-approved devices get double the price of Indian ones

/ 2 min read

The Gujarat government has stated that the move aims to ensure "cost-effectiveness while ensuring high-quality patient care"

The directive applies to all private and public hospitals empanelled under the health insurance scheme.
The directive applies to all private and public hospitals empanelled under the health insurance scheme. | Credits: Getty Images

Even as former U.S. President Donald Trump continues to accuse India of harming the interests of U.S. companies through high tariffs and non-tariff barriers, the Gujarat state government has decided to pay more than double the price for U.S. Food and Drug Administration (FDA)-approved drug-eluting stents (DES), compared to those approved by India’s drug regulatory authority. The interim pricing structure will remain in effect until June 30, 2025.

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Companies supplying Percutaneous Transluminal Coronary Angioplasty DES for patients covered under the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) scheme in Gujarat can expect ₹25,000 per stent if it is U.S. FDA-approved, while the price for locally manufactured stents approved by India’s Central Drugs Standard Control Organisation (CDSCO) has been capped at ₹12,000 per stent. The Gujarat government has stated that the move aims to ensure "cost-effectiveness while ensuring high-quality patient care." The directive applies to all private and public hospitals empanelled under the health insurance scheme.

The decision has been criticised by the Association of Indian Medical Device Industry (AiMeD), which, in a letter to Union Health Minister J.P. Nadda, termed it a "deeply discriminatory pricing mechanism that is not only unfair and exclusionary but also undermines India’s own medical regulatory system."

"The decision penalises Indian manufacturers, who currently hold over 73% of the domestic market and export over 500,000 stents annually to more than 100 countries, including developed economies like Germany, the UK, Spain, Poland, Switzerland, Italy, and the Netherlands. These countries do not impose such artificial price differentiation based on U.S. FDA approval, so why should it happen in India?" the letter to Nadda asks.

The association argues that unless the government rolls back the decision, it will be seen as favouring American MNCs by allowing them to regain lost market share at a more favourable and profitable reimbursement rate. “We request an immediate resolution to ensure fair competition, policy transparency, and the protection of India’s medtech industry,” said Rajiv Nath, Forum Coordinator, AiMeD.

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The Gujarat government has implemented the AB-PMJAY scheme as the PMJAY-MA Yojana, integrating the state's Mukhyamantri Amrutam (MA) scheme with the central AB-PMJAY. It provides up to ₹10 lakh in annual health coverage per family for secondary and tertiary care. Beneficiaries under the scheme are entitled to receive treatment for 2,471 defined procedures as per the scheme’s guidelines.

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