NEW DELHI :
The government is considering lifting price curbs on new generation of stents more than two years after its directive for a cap prompted companies to withdraw their products from the Indian market.
A newly constituted committee on the National List of Essential Medicines, headed by Balram Bhargava, director-general of the Indian Council of Medical Research, is reviewing if all drug eluting stents (DES) are the same or whether a new category needed to be added, said two people aware of the matter.
The panel has been meeting both Indian and foreign manufacturers of stents. The stent makers are of the view that quality and innovation should be rewarded and the high-end segment should be kept viable.
Meril Life Sciences Pvt. Ltd has developed MeRes100, which it claims is the country’s first locally made bioresorbable vascular scaffolds (BVS) for clearing blockages in arteries. The company has been insisting that its new-generation stents are the thinnest with high-performance delivery systems and hence should be treated separately and given an exemption from price caps.
According to the company these are advanced stents made of biodegradable material, and are an alternative to the traditional metallic stents.
“Medical device makers have been meeting the committee members and scientists in Indian Council of Medical Research, with representations on their products. They have to substantiate if their product is superior," said two people aware of the matter.
One view is that every non-metallic stent and bioresorbable stent should be categorized separately. “There is a view that a sub-categorization should be done under DES category so that products with new features and innovation are bifurcated and hence priced higher," said the first person, requesting anonymity.
In 2017 February, the government capped prices of cardiac stents—mesh tubes placed in arteries to improve blood flow—by up to 85%. Since then, many global stent makers have withdrawn their high-end devices, and have been pressing the government to create a new category of stents with advanced features.
Earlier, the National Pharmaceutical Pricing Authority had approached a sub-committee of experts after receiving representations from firms to include a ‘new generation’ of stents with added features as a category within the DES category. However, the panel said there were “no grounds" to create a new category. The firms did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES," it said in a report.