On February 13, 2017, the National Pharmaceuticals Pricing Authority (‘NPPA’), Ministry of Chemicals and Fertilizers (‘MoCF’) published an order fixing the ceiling prices of coronary stents, by way of a Gazette Notification., pursuant to which the price of bare metal stents has been capped at INR 7,260 (approximately US$ 110) per unit and the price of drug eluting stents (‘DES’) (including metallic DES and Bioresorbable Vascular Scaffold / Biodegradable stents) has been capped at INR 29,600 (approximately US$ 450) per unit, exclusive of value added tax. This has primarily been done by the NPPA as it found that huge and unethical mark-ups were being charged throughout the supply chain of coronary stents resulting in irrational, exorbitant and unaffordable prices of coronary stents in India. Earlier, by way of a notification dated July 19, 2016, the Ministry of Health & Family Welfare had added ‘coronary stents’ to the National List of Essential Medicines, 2015 and subsequently the MoCF, by notification dated December 21, 2016, had amended Schedule I of the Drug Price Control Order, 2013 (‘DPCO 2013’) such that ‘coronary stents’ were classified as ‘scheduled formulations’ under the provisions of the DPCO, 2013.
By an Office Memorandum dated February 20, 2017, the NPPA, MoCF has also fixed a trade margin of 8% on coronary stents, which will apply across the trade channels viz. from manufacturer/importer to the end consumer and will include hospital handling fees. The NPPA has also clarified that the 8% trade margin has been built into the ceiling price of coronary stents.