NPPA revises ceiling price of coronary stents for the year 2018
Further to the update shared in the trail mail, the National Pharmaceutical Pricing Authority (“NPPA”) has revised the ceiling prices of coronary stents vide notification dated 12th February, 2018. The ceiling prices are applicable from 13th February, 2018.
The notification has been issued under paragraph 19 of the Drugs (Prices Control) Order, 2013 (“DPCO, 2013”) and the ceiling prices as given below are exclusive of local tax applicable:
|Sl. No.||Coronary Stents
(Sl. 31 in Schedule I of DPCO, 2013)
|Unit (In Number)||Ceiling Price (In Rs.)|
||Bare Metal Stents||1||7660|
||Drug Eluting Stents (“DES”) including metallic DES and Bioresorbable Vascular Scaffold (BVS) / Biodegradable Stents||1||27,890|
It is important to note that the aim of DPCO, 2013, issued under section 3 of Essential Commodities Act, 1955, is to ensure that essential drugs are available to all at affordable prices.
Pursuant to Supreme Court’s direction to the Government to ensure that lifesaving drugs do not fall out of price control, the issue regarding essentiality of Coronary Stents had been considered by the Government and it was observed that there is very high incidence of coronary artery disease (“CAD”) in India associated with high morbidity and mortality. In such circumstances, where CAD has become a major public health problem; and Percutaneous Coronary Intervention (“PCI”) procedure requiring coronary stent implantation is an important treatment modality for the management of CAD; coronary stents have become ‘essential’ for public health.
Further, it was observed that huge unethical markups were being charged at each stage in the supply chain of Coronary Stents resulting in irrational, restrictive and exorbitant prices pushing patients to financial misery. Therefore, there was an urgent necessity, in public interest, to fix ceiling price of Coronary Stents to bring respite to patients.
Notification dated 12th February, 2018:
Pursuant to the above, key highlights of the notification:
i. The ‘manufacturer’ for the purpose of this order means any person who manufactures or imports or markets Coronary Stents for distribution or sale in the country.
ii.The ceiling prices will be applicable from 13thFebruary, 2018 and will also be applicable to all the stocks of Coronary Stents available for sale in the trade channel.
iii. All manufacturers of Coronary Stents, selling branded or non-branded or both versions of stents at prices higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, must revise the price of all such stents downward not exceeding the ceiling price specified in the above table, plus local taxes as applicable and paid, if any.
iv. All manufacturers/marketers of Coronary Stents having MRP lower than the ceiling price specified in the above table plus local taxes as applicable and paid, if any, will continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
v. The manufacturers may add goods and services tax and no other charges in the calculation of MRP, if they have actually paid such taxes or if it is payable to the Government on the ceiling price specified in the above table in paragraph (13) of this order.
vi. The ceiling price for a pack of coronary stent will be arrived at by the concerned manufacturer/importer in accordance with the ceiling price specified in the above table as per the provisions under DPCO, 2013.
vii. The manufacturers under Paragraph 24 of DPCO, 2013 have to issue price list in Form–V as prescribed in Schedule II of the DPCO, 2013 to the National Pharmaceuticals Pricing Authority (“NPPA”) online through Integrated Pharmaceutical Database Management System (IPDMS) and submit a copy to all State Drug Controllers and all distributors/dealers/retailers.
viii. As per paragraph 24(4) of DPCO 2013, every retailer and dealer must display price list and the supplementary price list, if any, as furnished by the manufacturer/importer, 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.
ix. Wherever institutions such as hospitals/nursing homes/clinics performing cardiac procedures using Coronary Stents are billing directly to the patients, they are required to comply with the ceiling prices as notified above and follow the applicable provisions of the DPCO, 2013. No healthcare institutions such as hospitals/nursing homes/clinics performing angioplasty procedures coronary stents shall solicit any patient to purchase coronary stents from it, in case, the patient is interested to procure the same from any third party source.
x. Institutions such as hospitals/nursing homes/clinics utilizing Coronary Stents will specifically and separately mention the cost of the coronary stent along with its brand name, name of the manufacturer/importer/batch no. and other details, if any, in their billing to the patients or their representatives.
xi. Any manufacturer or institution or person not complying with the ceiling price and notes specified hereinabove will 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.
xii. The ceiling price fixed above will be maintained for a period of one year from the date of this notification, unless revised by another gazette notification.
xiii. Any manufacturer intending to discontinue production or import of Coronary Stents is required to furnish information to the NPPA, in respect of discontinuation of production and / or import in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation as prescribed under paragraph 21(2) of the DPCO, 2013 and follow the ceiling price till clearance from the Government.
For further details, please refer to the hyperlink given below.