Executive Summary:
This document is an addendum to the National Pharmaceutical Pricing Authority's (NPPA) order S.O. 412(E) dated February 13, 2017, concerning the ceiling price fixation of coronary stents. It clarifies the application of ceiling prices, trade margins, and consequences for violations. Effective March 31, 2017, this order is issued under paragraph 19 of the Drugs Price Control Order (DPCO), 2013.
Key Points / Main Content:
Ceiling Price Applicability:
* The ceiling prices specified in Para 12 of the original order also apply to covered coronary stents.
Trade Margin Clarification:
* The ceiling prices include a maximum trade margin of 8%, which is considered fixed.
* No charges exceeding the specified ceiling price can be levied on consumers, except for applicable local taxes/VAT.
* Stent manufacturers/importers can decide on the distribution of the 8% trade margin based on their business model.
Violation and Consequences:
* Trade margins exceeding the specified 8%, in any form, will be considered a violation.
* Persons/institutions/manufacturers/importers/distributors/hospitals involved in transactions exceeding the trade margin are jointly and severally liable.
* Violators are subject to appropriate action, including prosecution, under the Essential Commodities Act, 1955, and the DPCO, 2013.
Impact Analysis:
Manufacturers/Importers:
* Impact: Must adhere to the ceiling prices for both standard and covered coronary stents and ensure trade margins do not exceed 8%.
* Action Required: Adjust pricing strategies to comply with the regulations and decide on the distribution of the 8% trade margin.
Distributors/Hospitals:
* Impact: Must ensure that stent prices charged to consumers do not exceed the ceiling price, inclusive of the maximum 8% trade margin.
* Action Required: Review pricing structures to align with the new regulations and avoid any additional charges beyond local taxes/VAT.
Consumers/Patients:
* Impact: Benefit from regulated pricing of coronary stents, ensuring affordability and transparency.
* Action Required: Be aware of the ceiling prices and report any instances of overcharging.
National Pharmaceutical Pricing Authority (NPPA):
* Impact: Responsible for enforcing the order and taking action against violations.
* Action Required: Monitor compliance with the regulations and investigate any reported violations.
Key Entities Referenced
National Pharmaceutical Pricing Authority: A regulatory body in India responsible for price control of pharmaceuticals.
Drugs Price Control Order (DPCO), 2013: An order issued by the Government of India to regulate the prices of drugs.
Coronary Stents: Medical devices used to treat narrowed or blocked coronary arteries.
Essential Commodities Act, 1955: An act of the Parliament of India that seeks to control the production, supply, and distribution of certain essential commodities.
Ministry of Chemicals and Fertilizers: A ministry in the Government of India responsible for the chemical and fertilizer industries.
Covered Coronary Stents: A type of coronary stent with a covering or membrane.
New Delhi: The capital of India, where the notification was issued.
A. K. Khurana: Director at Department of Pharmaceuticals.
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1844 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ADDENDUM
New Delhi, the 31st March, 2017
S.O. 1029(E).— In continuation of National Pharmaceutical Pricing Authority’s Order S.O. 412(E)
dated 13th February, 2017, published in the Gazette of India, Extraordinary, related to ceiling price fixation of
Coronary Stents under paragraph 19 of the Drugs (Price Control) Order (DPCO), 2013, notes (l), (m), (n)
and (o) are hereby inserted after note (k) of para 12 of abovesaid order, as follows:
(l) The ceiling prices specified in Para 12 of this order shall also apply to ‘Covered Coronary Stents’.
(m) The ceiling prices as specified in Para 12 of the order are inclusive of maximum 8% trade margin which
is sacrosanct and no additional charge, whatsoever, over and above the ceiling price specified
hereinabove, in the price notification shall be charged from the consumer/patient except applicable local
taxes/VAT, if any, paid in actual or payable.
(n) The inter-se distribution of abovesaid 8% trade margin could be decided by the stent
manufacturers/importers, as the case may be, depending upon their business model.
(o) Trade margin in excess of 8% specified above, in whatsoever form, shall be construed as
‘violation’ by the ‘person/institutions/manufacturers/importers/distributors/hospitals’ involved in the
transactions, jointly and severally, and shall be liable to appropriate action including prosecution, for
violation of the provisions of the DPCO, 2013 under the Essential Commodities Act, 1955.
[P N/175/43/2017/F. No. 8(43)/2017/DP/NPPA/DIV. II]
A. K. KHURANA, Director
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.