Should Next Gen DES Stents be removed from Price Cap- Govt Panel to Decide
NEW DELHI: In a bid to re-enter the market with advanced drug-eluting stents (DES), various medical device makers are in talks with the Government to categorise newly manufactured stents with advanced features separately and to go easy with the price control mechanism of the fresh generation of stents.
In 2017, the prices of cardiac stents were capped by 85%, which came as a major setback to several global stent makers and many expensive stents were retracted from the market. Since then the stakeholders have been pressing the government to create a new category of stents with advanced features.
It is learnt that Gujarat based global medical device manufacturer, Meril Life Sciences Pvt Ltd has been pressing upon the fact that its newly developed stents are the thinnest with a high-performance delivery system. Meril Life claims that the material used in making the stents are biodegradable in nature and can be used as a replacement for the metallic stents.
Stressing on the same, Meril Life has insisted that the product should be deal distinctly and exempted from the price cap. The stent makers are of the opinion that quality and creativity should be recognized and the high-end segment should be kept feasible.
Prior to this, the apex drug regulator National Pharmaceutical Pricing Authority(NPPA) had refused to give relief of price cap exemption for Meril Life's biodegradable stent and constituted a Standing National Committee on Medicines for revision of NLEM to examine the biodegradable stents from the perspective of any significant therapeutic advantage and increased efficacy that may merit an exemption under para 32 of DPCO, 2013.
Recently, the Government has been considering the proposal and has constituted a new committee on the National List of Essential Medicines led by Indian Council of Medical Research (ICMR) director Dr Balram Bhargava. The committee is reviewing whether all DES are the same or there is a need to add a new category.
The committee has been meeting manufacturers and stakeholders from India as well as abroad, who are supposed to provide adequate evidence if their product is superior.
“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," sources told Live Mint.
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," sources added.
Prior to this, NPPA had approached a sub-committee of experts to include a ‘new generation’ of stents with added features as a category within the DES category.
However, the panel dismissed the same stating that 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," stated the panel report.