Stent manufacturers are lobbying the government for separate NLEM categories and higher price caps for next-generation devices, citing industry stagnation following price cuts mandated under the essential medicines list. The push comes after coronary stents were included in the National List of Essential Medicines (NLEM) in 2022, aiming to improve affordability. The decision followed an expert committee's recommendation to incorporate stents as essential healthcare tools.
The Standing National Committee on Medicines (SNCM) categorized stents as Bare Metal Stents (BMS) and Drug Eluting Stents (DES), which included both metallic DES and Bioresorbable Vascular Scaffolds (BVS)/biodegradable stents. Sources tell PTI that manufacturers, unhappy with this classification, have approached the Health Ministry, ICMR, DCGI, and NPPA seeking distinct categories, "higher ceiling prices," and Trade Margin Rationalization (TMR) for different stent types.
Translumina co-founder Gurmit Singh Chugh flagged a concerning trend of low-quality DES flooding the market due to regulatory loopholes. "Distributors can be DES manufacturers by mere loan licenses from actual manufacturers, bypassing quality systems," he said, advocating for a nuanced DES classification to avoid penalizing genuine manufacturers. Highlighting the cost disparity between maintaining quality and relying on loan licenses, Chugh emphasized the need for differentiated pricing. "This issue has been raised with SNCM, but without success," a source added.