Indian Manufacturers Oppose Gujarat Govt’s Stent Pricing Policy

The Gujarat government has issued a notification introducing a new pricing structure for stents under the Ayushman Bharat health insurance scheme. According to the order, stents approved by the United States Food and Drug Administration (USFDA) will be priced at Rs. 25,000 per unit, while those approved by the Indian drug regulator will cost significantly less—Rs.12,000 per unit.

Currently, all drug-eluting stents (DES), used to treat blocked heart arteries, are uniformly priced at Rs. 35,000. However, the new policy has sparked criticism from Indian medical device manufacturers, who argue that it creates an unfair pricing advantage for foreign-approved stents.

Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AiMeD), expressed strong opposition to the decision. He stated, “AiMeD is against any discriminatory price compensation mechanism based on regulatory approval.”

He further explained that while offering a small price preference (3-5%) could encourage manufacturers to improve quality and adhere to globally recognized certification standards like ICMED or ISI, the nearly 50% price difference favoring USFDA-approved stents is excessive. Comparing the policy to a traffic rule, Nath remarked, “It’s like requiring an Indian driver to obtain a US driving license to drive in India and then giving them a 50% discount on traffic fines, while Indian license holders pay the full amount.”

Warning of the broader implications, Nath added that if such differential pricing extends to other medical products, it could undermine the ‘Make in India’ initiative and diminish the role of India’s regulatory authority in favor of foreign agencies like the USFDA.

Indian manufacturers are now urging the government to revise the policy to ensure fair competition and support domestic medical device production.