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:

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

Author:

Pradnesh Warke

Associate Partner

[email protected]