New Delhi: Stent makers have approached the government demanding creation of a separate subcategory and higher ceiling prices for coronary stents with advanced features. This follows several companies shelving plans to launch their next generation stents after major price cuts by the government.
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.
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, the stent makers have approached the health ministry, Indian Council of Medical Research (ICMR), the Drug Controller General of India and National Pharmaceutical Pricing Authority (NPPA) urging for “classification”, “higher ceiling prices” and Trade Margin Rationalisation (TMR) for stents, people in the know told ET.
Gurmit Singh Chugh, co-founder of Translumina said there is a major problem in the market currently due to the huge proliferation of low quality and unproven drug-eluting stents (DES).
“They are exploiting the current lacuna of loan licencing in our regulatory system under which any distributor can label themselves as a manufacturer of a DES by taking a loan licence of any third-party manufacturer without applying any quality management systems,” he said. He said DES cannot be placed in a single category to make any pricing decision as it would wipe out all quality manufacturers of DES from India as cost structures of maintaining quality and clinical evidence is very high compared to manufacturing them under loan licencing without any investment in quality or clinical trials.
The issue has been going on for a long time. The stent makers had failed to convince the Standing National Committee on Medicines for a revision of NLEM.