Gujarat Govt to Withdraw Dual Pricing Policy on Cardiac Stents, AiMeD Welcomes End to USFDA Bias

The move has been widely welcomed by domestic manufacturers and industry stakeholders, especially the Association of Indian Medical Device Industry (AiMeD), which has long advocated for equitable pricing policies that support the ‘Make in India’ initiative.

The withdrawn order, issued by the Gujarat Department of Health and Family Welfare, had set a price of Rs 25,000 per stent for those approved by the United States Food and Drug Administration (USFDA) under the Ayushman Bharat scheme, while stents approved by India’s Central Drugs Standard Control Organization (CDSCO) were to be priced at Rs 12,000. This stark difference raised concerns among domestic manufacturers and industry observers. At present, all Drug-Eluting Stents (DES) are uniformly priced at Rs 35,000.

The scale of the potential financial impact was underscored by a report that revealed stent implants under the Ayushman Bharat scheme in Gujarat have amounted to Rs 429 crore in public expenditure since the scheme's rollout in 2018.

“AiMeD is opposed to any discriminating price compensation mechanism on basis of Regulatory Approval,” said Rajiv Nath, Forum Coordinator of AiMeD.

He elaborated, “A 3-5% price preferences to motivate manufacturers to go up the value added quality and performance tree based on an objective quality voluntary certification like QCI’s Quality Management Systems Indian Certification for medical devices (ICMED) or its Products Certification scheme ICMED plus to allow manufacturers to demonstrate compliance to ISO standards to enable global competitiveness or an ISI mark for compliance to BIS Standards, is understandable instead of the L1 (lowest priced product wins) but not for a nearly double compensation just because a foreign manufacturer has an overseas regulatory approval eg USFDA.”

“It’s akin to asking an Indian driver to get a US driving licence to drive in India and then giving him additional advantage of 50% discount on any traffic fine whereas Indian licence holder pays full fine?!” he explained.

Nath warned of the broader implications such a pricing precedent could set. “This sets a bad precedent and if this is allowed to be repeated for other medical products, Make in India will be a bygone dream and our regulatory body may not be needed and might as well abdicate in favour of overseas regulator like US FDA,” he remarked.

Welcoming the Gujarat government’s decision to roll back the policy, Nath added, “We are very thankful to Govt of Gujarat and Health Minister Shri Rushikesh Ganeshbhai Patel ji for promptly acting on our request to him and Shri Mansukhbhai Mandaviya ji and assuring us that they are repealing the discriminatory differential pricing order of Cardiac Stents by Department of Health and Family Welfare, Government of Gujarat. This is a major step towards supporting Make In India efforts and instilling confidence in domestic industry that commands over 70% of Indian Stent market and more so for the many Gujarat based Manufacturers like Meril, SMT, AMS, SLTL etc. that has not only championed an Atma Nirbhar Bharat vision of the Honourable Prime Minister but proudly exported Brand India to over 100 Countries and employ thousands of Indians.”

Echoing these sentiments, Gaurav Aggarwal, Joint Coordinator of AiMeD and Managing Director of INvolution, said, “A Differential Pricing Policy between the USFDA and Indian Drug Regulators CDSCO India was going to set a bad precedent not only detrimental to strategically important domestic manufacturing interests but possibly dangerous for Patient Safety. Indian Stents are clinically validated and used in 100+ Countries including those with stringent regulations. Products no longer sold in the USA and other developed countries, were allowed to be implanted in Indian patients under the guise of premium imports and a false narrative on the quality and doubts on efficacy of Indian Stents without backing of Clinical Studies by some Doctors lobbying on behalf of these US MNCs via a lucrative kickback incentive system that needs to be investigated. This assurance given to us for revocation is a welcome relief.”

Dr. Ravi Rathod, General Manager of Innvolution and Joint Coordinator (Govt. Affairs), AiMeD, contextualised the issue further: “Actually, this is the second instance in recent history of cardiac care in Gujarat that unveils a rigged system that benefits vested interests by unethical marketing at the cost of Indian lives. India got Price Caps in Stents to safeguard patient interests in private healthcare and having lost market share in that market the US MNCs were trying to regain market share in Public Healthcare by nefarious means. We are obliged that media reporters supporting the letters written to Gujarat Health Minister Shri Rushikesh Ganeshbhai Patel, Gujarat Chief Minister Shri Bhupendrabhai Rajnikant Patel & Union Govt Minister of Health & Family Welfare Shri Nadda ji by AiMeD resulted in a quick rethinking and decision to revoke this order.”

Consumer rights representatives also voiced concern. Professor Bejon Misra, a well-known patient safety advocate, commented, “As a Patient Safety organisation, we were not in favour of the Government of Gujarat’s move that encouraged older generation USFDA Stents at higher prices, while ridiculing domestic companies to a lower cost but we are glad with their quick response to correct it.”

He added, “Today with Make in India Policy, no Government, be it State or Central, should opt for discriminatory pricing based on country of origin. A patient needs choice based on credible information and fair business practices to encourage ethical domestic competition—we have seen the negative fallout of J&J Implants that were USFDA approved. USFDA approval does not mean that a product or a supplier will be infallible. This discrimination by Government of Gujarat was a major jolt to PM’s vision of 'Atmanirbhar Bharat', which would have hampered accessibility, affordability and choice to the patients and would also retard the growth of our home grown Manufacturers, who now innovate and produce high-quality Medical Products in the interest of patients.”

“It is imperative that in future a fair pricing model reflect the product’s actual quality and technological advancements, rather than relying on outdated US products dumped in India and used on patients without their knowledge and empowerment.

It’s time for transparency, fairness, and real commitment to patient care—not country biased policies, influenced by professional overseas intermediaries.”