Gujarat’s New Stent Pricing Stirs Debate

The Gujarat government has introduced a new pricing structure for coronary stents under the Ayushman Bharat scheme, setting stents approved by the United States Food and Drug Administration (USFDA) at ₹25,000 each, while those cleared by India’s Drug Controller General of India (DCGI) will cost ₹12,000. The order, effective until June 30, 2025, replaces the uniform ₹35,000 price for all drug-eluting stents (DES), sparking a mix of support and criticism.

Announced last month by the Commissionerate of Health, the policy aims to “maintain cost-effectiveness while ensuring high-quality patient care,” according to the state government. Bajaj Allianz General Insurance, the scheme’s insurer in Gujarat, will assess its financial and operational impact after three months, with findings to determine if the framework continues, adjusts, or ends.

Indian medical device manufacturers, however, have raised objections. The Association of Indian Medical Device Industry (AiMeD) labelled the move “discriminatory” and wrote to Union Health Minister JP Nadda, urging a rollback. “This will be seen as helping American MNCs capture back their lost market share at more favourable and profitable reimbursement,” AiMeD’s Forum Coordinator Rajiv Nath stated. Indian firms currently supply 69% of DES used under Ayushman Bharat in Gujarat, a dominance now at risk, they argue.

The policy follows the United States Trade Representative’s ‘Foreign Trade Barriers’ report, released this week, which flagged India’s price caps on stents and knee implants as outdated, failing to reflect inflation or innovation costs. Gujarat’s move has thus drawn scrutiny for potentially aligning with US interests, though officials have not commented directly on this link.

Health Commissioner Harshad Kumar Ratilal Patel is yet to comment on the issue. Since 2018, Gujarat has spent ₹429 crore on stent implants under Ayushman Bharat, part of ₹650 crore in cardiology treatments—the second-most accessed speciality after urology. The scheme offers up to ₹10 lakh annually per family across 2,654 empanelled hospitals. Cardiology procedures, notably percutaneous transluminal coronary angioplasty (PTCA) using DES, remain critical for beneficiaries.

AiMeD has warned of broader fallout. “If this biased policy continues, Indian stent manufacturers will suffer losses exceeding ₹2,000 crore, leading to job losses and plant shutdowns,” Nath wrote. He also questioned the policy’s implications for India’s regulatory credibility: “By placing USFDA approval above DCGI approval, this policy directly questions the credibility of India’s own regulatory system.”

Comparisons have emerged with Rajasthan, where stent pricing hinges on clinicaldata—₹23,625 for stents backed by peer-reviewed studies, ₹12,500 otherwise—rather than regulatory origin. Gujarat’s approach, however, ties pricing to USFDA or DCGI approval, a distinction AiMeD calls “unfair and exclusionary.”

The government has framed the change as a temporary measure, with Bajaj Allianz tasked to evaluate its efficacy. “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 state wrote to the insurer.

For now, the policy’s future remains uncertain, balancing patient access, industry interests, and international trade dynamics. Stakeholders await the insurer’s report, due in three months, for clarity on its long-term impact.