From 709% TO 70% - NPPA Caps the trade margin for oxygen concentrator, pulse
oximeter, blood pressure monitoring machine, nebulizer, digital thermometer and
glucometer with an aim to make these medical devices affordable during the
evolving situation of the covid pandemic.
The National Pharmaceuticals Pricing Authority (NPPA) invoked its extraordinary
powers under Paragraph 19 of the Drugs (Prices Control) Order, 2013 (DPCO), to
put a cap on the trade margin of the following medical devices — oxygen
concentrators, pulse oximeters, glucometers, BP monitors, nebulizers and digital
thermometers with an aim to make these medical devices affordable during the
evolving situation of the COVID pandemic and to regulate the trade margin on
these medical devices. NPPA is formed under the Department of Pharmaceuticals
which is a division of the Ministry of Chemicals and Fertilizers to regulate and
monitor prices of drugs/formulations and oversee the implementation of the DPCO.
Earlier, NPPA vide its Office Memorandums dated June 29, 2020, and February 16,
2021, decided to seek information from the manufacturers about the Maximum
Retail Price (MRP) of pulse oximeters, oxygen concentrators, nebulizers, blood
pressure monitoring machines, digital thermometers, and glucometers.
Based on the information gathered by NPPA, it was noted that the trade margins
of these medical devices ranged from 3% to 709%, therefore, NPPA invoked its
extra ordinary powers under the provisions of Paragraph 19 of the DPCO to
regulate the price of these medical devices through the ‘Trade Margin
Rationalisation Approach’ in public interest.
NPPA by its Order dated June 3, 2021, capped the trade margin for oxygen
concentrators and by its Order dated July 13, 2021, capped the trade margin for
pulse oximeters, blood pressure monitoring machines, nebulizers, digital
thermometers and glucometers (“Orders”), up to 70% under the Trade margin
Rationalisation Approach. This move will result in significant savings to the
consumers and rationalization in the price of these medical devices.
The manufacturers of these medical devices have to adhere to the following
compliances under both the Orders:
For more detailed please follow these links for Order copies:
- In case a manufacturer is intending to launch oxygen concentrators,
pulse oximeters, nebulizers, blood pressure monitoring machines, digital
thermometers and glucometers, the MRP will be fixed as per the formula at
Table-A of the Orders based on current Price To Distributor (PTD).
- The revised prices for oxygen concentrators shall come into effect from
June 09, 2021.
- The revised prices for pulse oximeters, blood pressure monitoring
machines, digital thermometers, nebulizers and glucometers shall come into
effect from July 20, 2021.
- The manufacturers of these medical devices selling at a price higher
than the MRP so computed as per Table-A, shall revise the prices downward, not
exceeding the MRP computed by using the formula provided in the said Orders.
- The manufacturer shall issue a price list in Form–V as per Paragraph
25 of the DPCO to NPPA and submit a copy to the State Drug Controller and
Dealers by June 07, 2021 for oxygen concentrators and by July 20, 2021 for pulse
oximeters, blood pressure monitoring machines, nebulizers, digital thermometers
- As per Para 25(3) of the DPCO, every retailer, dealer, hospital and
institution shall display the price list and the supplementary price list, as
furnished by the manufacturer, on a conspicuous part of the business premises in
a manner so as to be easily accessible to any person wishing to consult the
- The manufacturers not complying with the MRP so computed as per Table-A
and notes specified hereinabove shall be liable to deposit the overcharged
amount along with 15% interest p.a. from the date of increase in price in
addition to a penalty of upto 100% of the overcharged amount under the
provisions of the DPCO read with the Essential Commodities Act, 1955.
- The price so fixed shall remain in force upto November 30, 2021, for
oxygen concentrators and upto January 31, 2022 for pulse oximeters, blood
pressure monitoring machines, nebulizers, digital thermometers and glucometers.
Order for oxygen concentrators dated June 3, 2021 - https://www.nppaindia.nic.in/wp-content/uploads/2021/06/227375.pdf
Order for pulse oximeters, blood pressure monitoring machines, nebulizers,
digital thermometers and glucometers dated July 13, 2021 - https://www.nppaindia.nic.in/wp-content/uploads/2021/07/Notification-TMR-5-Medical-Devices.pdf
Written By: Pradnesh Warke
, Associate Partner
Email: [email protected]