NPPA fixes ceiling price of two coronary stents

According to the new prices notified by the drug price regulator, the ceiling price of one unit of Bare Metal Stents is Rs 9373.03 while Drug-Eluting Stents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BVS)/ Biodegradable Stents is Rs 34128.13 per unit.

This came in line with the Wholesale Price Index (WPI) data provided by the Office of the Economic Advisor, Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry whereby the annual change in the WPI works out as 10.76607% during the calendar year 2021 over the corresponding period in 2020.

Earlier the Medical Dialogues Team had reported that in line with the wholesale price index for the year 2020 over 2019, the National Pharmaceutical Pricing Authority had approved a hike in prices of two Coronary stents by 0.53638 per cent. Accordingly, the ceiling price for a unit of bare metal stents was Rs 8,462, and the ceiling price for a unit of Drug-Eluting Stents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BVS)/Biodegradable Stents was Rs 30,811.

Bare-metal stent is a stent without a coating or covering (as used in covered stents drug-eluting stents). It is a mesh-like tube of thin wire. The first stents licensed for use in cardiac arteries were bare metal – often 316L stainless steel. More recent stents use cobalt chromium alloy.

A drug-eluting stent (DES) is a peripheral or coronary stent placed into narrowed, diseased peripheral or coronary arteries that slowly release a drug to block cell proliferation. This prevents fibrosis that, together with clots (thrombi), could otherwise block the stented artery, a process called restenosis. The stent is usually placed within the peripheral or coronary artery by an interventional cardiologist or interventional radiologist during an angioplasty procedure.

Drug-eluting stents are often preferred over bare-metal stents because the latter carry a higher risk of restenosis, the growth of tissue into the stent resulting in vessel narrowing.

In continuation of the notifications issued by National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemical and Fertilizers vide S.O. 639(E) dated 12.02.2018, S.O. 1464(E) dated 02.04.2018, S.O. 1488(E) dated 29.03.2019, SO. 1217(E) dated 25.03.2020 and S.O. 1334(E) dated 25.03.2021 regarding the fixation of ceiling price of the Coronary Stents as specified in column no. (2) mentioned in the table below; after considering the Wholesale Price Index (WPI) @10.76607% for the year 2021 over 2020, it has been decided to revise the ceiling prices of Coronary Stents as mentioned in column no. (4) in the table below, exclusive of Goods and Services Tax as applicable, and unit specified in column (3) with effect from 01.04.2022, as under:

The notification further added;

(a) All the existing manufacturers/importers of Coronary Stents having MRP lower than the ceiling price specified in column (4) in the above table (plus Goods and Services Taxes as applicable, if any), may revise the existing MRP of Coronary Stent, on the basis of WPI @ 10.76607% for the year 2021 over 2020 in accordance with Paragraph 16(2) of DPCO, 2013, read with Para 13(2) of DPCO, 2013.

(b) The manufacturers/importers of Coronary Stents may add Goods and Services Taxes only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (4) of the aforesaid table.

(c) As per Para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer/importers, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

(d) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.

To view the official notice, click the link below:

https://www.nppaindia.nic.in/wp-content/uploads/2022/03/1502E_Stent_Eng.pdf