Gujarat offer for stents with USFDA nod: twice the price of stents approved by Indian regulator

In fact, in its report ‘Foreign Trade Barriers’ released Tuesday, the United States Trade Representation raised 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, and could discourage American companies from serving the market.

Calls and text by The Indian Express to Harshad Kumar Rational Patel, Commissioner of Health (Urban), Medical Services and Medical Education and PMJAY Scheme, Gujarat, did not elicit a response.

At present, Rajasthan offers differential pricing for stents, but 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.

Raising a red flag on the 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.

In a March 10 letter, the Commissionerate of Health, Medical Services & Medical Education in Gujarat, told Bajaj Allianz General Insurance Company that this new “interim pricing structure shall remain in effect” until June 30, 2025. Bajaj Allianz, a private insurer, provides coverage for Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) in the state.

The state government said the pricing changes aim to “maintain cost-effectiveness while ensuring high-quality patient care.”

“To evaluate the financial and operational impact of this pricing model, Bajaj Insurance Company will conduct a comprehensive impact assessment three months from the date of implementation. The findings from this assessment will be reviewed to determine whether the current pricing framework should be continued, revised, or discontinued beyond the stipulated period,” the Gujarat government wrote to the insurer.

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. 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.

Meanwhile, AiMeD sought Nadda’s “urgent intervention” and “roll back the unfair discriminatory notification”. “We bring to your urgent attention the deeply disturbing discriminatory pricing mechanism introduced… on March 10… the policy … ..is not only unfair and exclusionary but also undermines India’s own medical regulatory system,” Rajiv Nath, Forum Coordinator, AiMeD wrote.

“This decision penalises Indian manufacturers who hold today over 73 per cent of the domestic market and export 5 lakh stents annually to more than 100 countries, including developed economies like Germany, UK, Spain, Poland, Switzerland, Italy and the Netherlands. These countries do not impose such artificial price differentiation based on USFDA approval, so why should it happen in India,” AiMeD said in its letter.

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”.

“US MNCs have been in India for over three decades but have not set up any significant manufacturing units to make Stents etc, while Indian companies have built a world-class manufacturing ecosystem. By prioritizing foreign-made products, this decision directly contradicts the ‘Make in India’ and ‘Atmanirbhar Bharat’ initiatives led by Hon’ble Prime Minister Shri Narendra Modi ji,” AiMeD wrote.

AiMeD has also raised concerns 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.