Gujarat government has introduced different prices for stents to be used to treat patients under the flagship Ayushman Bharat health insurance scheme. According to a report by Indian Express, an order has revealed that stents approved by the United States Food and Drug Administration (will be priced Rs 25,000 per stent, and those cleared by the Indian drug regulator costing less than half or Rs 12,000 per stent.
Currently, all drug-eluting stents (DES), used to treat blocked heart arteries, are priced at Rs 35,000. The Indian Express report revealed that Indian medical manufacturers have now raised concerns over the new pricing policy, calling it “discriminatory” and urging the government to “ensure fair competition” in the market.
Stent implants under the Ayushman Bharat scheme in Gujarat accounted for an expenditure of Rs 429 crore since the scheme’s rollout in 2018, Indian Express reported.
The United States Trade Representation on Tuesday released a report ‘Foreign Trade Barriers’ raising concerns over price caps on coronary stents and knee implants, arguing they had not kept pace with inflation and do not account for production costs or innovation. Consequently, discouraging American companies from serving the market.
Rajasthan also offers differential pricing for stents, however this is based on clinical data. Stents supported by clinical data published in globally reputed peer-reviewed journals are priced at Rs 23,625, and those without such data at Rs 12,500, Indian Express reported.
Following Gujarat government’s decision, the Association of Indian Medical Device Industry (AiMeD) has written to the Union Minister for Health & Family Welfare J P Nadda saying this “will be seen as helping American MNCs capture back their lost market share at more favourable and profitable reimbursement”. As of now, Indian manufacturers account for nearly 69 per cent of the DES used under Ayushman Bharat in Gujarat, Indian Express reported.
Aimed has also sought Nadda’s “urgent intervention” and “roll back the unfair discriminatory notification”.
In a letter dated March 10, the Commissionerate of Health, Medical Services & Medical Education in Gujarat, told Bajaj Allianz General Insurance Company, that provides coverage for Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) in the state, that this new “interim pricing structure shall remain in effect” until June 30, 2025.
In Gujarat, the cashless and paperless scheme provides up to Rs 10 lakh annually per family, allowing beneficiaries to receive treatment for 2,471 specified procedures at nearly 2,654 empanelled hospitals.
According to the National Health Authority’s official dashboard, cardiology is among the top two specialties accessed by beneficiaries in Gujarat, second only to urology.
According to the Indian Express report, a significant Rs 650 crore has been spent on cardiology treatments. Among the top three procedures, percutaneous transluminal coronary angioplasty (PTCA)—a minimally invasive procedure used to open blocked coronary arteries, where drug-eluting stents are implanted—has accounted for Rs 429 crore in expenditure.
AiMeD has also emphasised that “if this biased policy continues, Indian stent manufacturers will suffer losses exceeding ₹2,000 crore, leading to job losses and plant shutdowns”.
The industry body also emphasised that the decision “disrespects” India’s own regulatory system. “The Drug Controller General of India (DCGI) is India’s apex regulatory body that ensures safety, efficacy, and quality of medical devices, including DES. By placing USFDA approval above DCGI approval, this policy directly questions the credibility of India’s own regulatory system. This situation is akin to requiring an Indian to seek a US driver’s license to drive in India—a blatant insult to the competence and sovereignty of Indian regulatory authorities,” AiMeD wrote as quoted by Indian Express.
