**Executive Summary**
This report details the regulatory measures taken by the National Pharmaceutical Pricing Authority (NPPA) to control the prices and trade margins of essential medical devices under the DPCO, 2013. Key actions include fixing ceiling prices for coronary stents and knee implants, as well as capping trade margins for essential monitoring devices. The Department of Pharmaceuticals also clarified that no "One Nation, One Price" framework is currently under consideration.
**Key Points / Main Content**
**Price Regulation of Scheduled Devices**
* The NPPA establishes ceiling prices for medical devices listed in the National List of Essential Medicines (NLEM) and Schedule-I of the DPCO, 2013.
* Coronary stents have specific applicable ceiling prices: ₹10,692.69 for Bare Metal Stents (BMS) and ₹38,933.14 for Drug Eluting Stents (DES).
* Ceiling prices for Orthopaedic Knee Implants have been extended until 15th November 2026.
**Trade Margin Rationalisation**
* During the COVID-19 pandemic, the NPPA capped trade margins on five essential devices: Pulse Oximeters, Blood Pressure Monitoring Machines, Nebulizers, Digital Thermometers, and Glucometers.
**Regulations for Non-Scheduled Devices**
* For medical devices not listed in the schedule, manufacturers are prohibited from increasing the Maximum Retail Price (MRP) by more than 10% within any 12-month period.
**Monitoring and Enforcement**
* The NPPA monitors prices for both scheduled and non-scheduled devices via State Drugs Controllers and Price Monitoring and Resource Units.
* Action is taken against companies found overcharging based on market samples, database reports, and consumer grievances.
**Institutional Billing Requirements**
* Hospitals and clinics performing angioplasty must comply with notified ceiling prices when billing patients directly.
* Invoices must specifically itemize the stent category, brand name, manufacturer/importer details, batch number, and technical specifications.
**Impact Analysis**
**Manufacturers, Marketers, and Importers**
**Impact**
They are legally restricted from selling scheduled devices above the ceiling price and are limited to a 10% annual price increase for non-scheduled items.
**Action Required**
Ensure all product pricing remains within the NPPA-notified limits plus applicable GST.
**Healthcare Institutions (Hospitals, Nursing Homes, and Clinics)**
**Impact**
Institutions are mandated to follow strict price compliance and transparency standards for coronary stents.
**Action Required**
Must provide itemized billing to patients, separately mentioning the cost, brand, category (BMS/DES), and manufacturer details of the stents used.
**National Pharmaceutical Pricing Authority (NPPA)**
**Impact**
Charged with the oversight of the medical device market to prevent consumer overcharging.
**Action Required**
Continue monitoring price data from the open market and state units, and address overcharging through established grievance redressal channels.
Key Entities Referenced
National Pharmaceutical Pricing Authority (NPPA): The regulatory body responsible for fixing and notifying ceiling prices for formulations and essential medical devices.
Drugs (Prices Control) Order, 2013 (DPCO, 2013): The primary legal framework that empowers the NPPA to regulate prices and monitor overcharging of scheduled and non-scheduled medical devices.
National List of Essential Medicines (NLEM): The reference list published by the Ministry of Health and Family Welfare used to identify medical devices for incorporation into price control schedules.
Trade Margin Rationalisation: A regulatory initiative used to cap trade margins on essential medical devices such as pulse oximeters and glucometers to ensure affordability.
Department of Pharmaceuticals (DoP): The administrative department under which the NPPA operates and which oversees the implementation of pricing orders for medical devices.
Ministry of Chemicals and Fertilizers :
Department of Pharmaceuticals
Issue of high trade margins in essential medical
devices
Posted On: 17 MAR 2026 3:27PM by PIB Delhi
The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals (DoP)
fixes ceiling prices of formulations and medical devices included in the National List of Essential
Medicines (NLEM) published by the Ministry of Health and Family Welfare and incorporated by the DoP
in Schedule-I to the Drugs (Prices Control) Order, 2013 (DPCO, 2013). Coronary stents [Bare Metal
Stents (BMS) and Drug Eluting Stents (DES)] are included in Schedule-I of the DPCO, 2013 and
accordingly NPPA fixes their ceiling prices as per the provisions of DPCO, 2013. The present applicable
ceiling price for BMS is ₹10,692.69 and for DES ₹38,933.14. The prices fixed under DPCO, 2013 are
applicable across the country. All manufacturers, marketers and importers of stents are required to sell
their products within such ceiling price (plus applicable Goods and Service Tax). Also, NPPA issued a
notification dated 12.2.2018, requiring that institutions such as hospitals, nursing homes and clinics
performing angioplasty procedures using coronary stents who bill patients directly, shall comply with the
ceiling prices notified in the said notification. Further, the said notification also requires such institutions
to specifically and separately mention in their estimate / proforma invoice / final billing, etc. the cost of
the coronary stents, its category like bare-metal stent (BMS) or drug-eluting stent (DES), brand name,
name of the manufacturer / importer / batch number / specifications and other details.
In addition, NPPA, in public interest, fixed and notified the ceiling prices for Orthopaedic Knee Implants
for knee replacement system in August 2017 and which has been extended up to 15th November, 2026, or
until further orders.
Further, during the COVID-19 pandemic, NPPA, in public interest, capped the trade margin on certain
essential medical devices i.e. Pulse Oximeter, Blood Pressure Monitoring Machine, Nebulizer, Digital
Thermometer, and Glucometer under the “Trade Margin Rationalisation” in accordance with the relevant
provision of Drugs (Prices Control) Order (DPCO), 2013.
In case of non-scheduled formulations / medical devices, manufacturers are required to not
increase the maximum retail price (MRP) of such formulations / medical devices by more than 10% of
MRP during preceding 12 months. NPPA monitors the prices of both scheduled and non-scheduled
formulations/medical devices and takes action in accordance with the provisions of DPCO, 2013 against
companies that are found as overcharging consumers, based on references received regarding
overcharging from any source, including Price Monitoring and Resource Units set up in States (including
Maharashtra), State Drugs Controllers, samples purchased from open market, reports from market
database and complaints lodged through grievance redressal channels.There is no proposal of “One Nation, One Price” framework or nationwide price cap for essential medical
devices currently under consideration of the Department.
This information was given by Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a
written reply in the Rajya Sabha today.
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