New Delhi: The government is mulling creating a separate category for advanced coronary stents and raising the price ceiling to woo stent makers who have shelved plans to launch their next generation devices in India over its price control measures, people aware of the development told ET.
Coronary stents became a part of the National List of Essential Medicines (NLEM) in 2022, which made them more affordable. This followed recommendations of an expert committee constituted to review the inclusion of stents in the list based on requirements.
Stent makers, however, have been urging the government to create a subcategory with a higher ceiling price for coronary stents that have advanced features.
The Standing National Committee on Medicines (SNCM), in its recommendation, included coronary stents in the NLEM, 2022 in two categories–bare metal stents (BMS) and drug eluting stents (DES), which include metallic DES and bioresorbable vascular scaffold (VBS)/biodegradable stents.
Aggrieved by the government decision, stent makers had approached the health ministry, the Indian Council of Medical Research (ICMR), the Drug Controller General of India, and the National Pharmaceutical Pricing Authority (NPPA), urging for “classification”, “higher ceiling prices” and trade margin rationalisation (TMR) for stents, the people cited earlier said.
The stent makers had failed to convince the SNCM for a revision of the NLEM, as the committee did not find any “therapeutic advantage” in stents that could warrant a relaxation in the price cap.
The companies made representations but did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES and, hence, no differential pricing could be recommended for those stents”, said another person aware of the matter.
While no government official was immediately available for comment, one source said the government may soon introduce a new category for advanced stents and keep the price ceiling higher.
Earlier, Meril Life Sciences, based in Gujarat’s Vapi, had developed MeRes100, which it claimed was the country’s first locally made bioresorbable vascular scaffold, or naturally dissolving stent for clearing blockages in arteries. In 2020, Meril Life Sciences had received a rare exemption of five years from the price caps set by the government after it provided adequate justification to the government for launching the product at “any price” it wants.
The exemption expired after which the company had again approached the government with the plea to keep its biodegradable cardiac scaffolds out of price control for longer than the exemption granted. However, it was turned down by the government. Meril’s stent was approved by the DCGI in 2017, the same year when the government capped the price of stents–a mesh tube placed in arteries to improve blood flow–forcing manufacturers to cut prices by up to 85%. This prompted Meril to hold back from launching its stents in the Indian market.
Since then, many global stent makers have withdrawn their high-end devices from India, and have been pressing to create a new category of stents with advanced features.
