The capped prices will be effective from June 9
NPPA directs manufacturers of medical oxygen concentrators to submit the applications about MRP calculated as per new formula by June 7
Considering Medical Oxygen as an essential life saving drug and critical for Covid-19 Management, The National Pharmaceutical Pricing Authority (NPPA) has capped the price of oxygen concentrator through trade margin rationalisation approach at first point of sale of product, referred as Price to Distributor. The Gazette Notification says, “The clinical protocols all over the world recognise the role of medical Oxygen as an essential medical therapy in clinical management of moderate and severe cases of Covid-19. With the sudden spurt in cases in COVID-19 second wave in the country, demand for Medical Oxygen has gone up considerably. With the increase in demand for medical oxygen, there is a surge in demand for oxygen concentrators in the country.
Due to the global demand supply mismatch and related issues, the prices of the oxygen concentrators have recently shown substantial voracity in domestic market. This is the reason, it is essential to cap the prices.” NPPA has capped the prices and given a prescribed formula by invoking Paragraph 19 of Drugs Prices Control Order (DPCO) – 2013 in wake of increase in demand due to pandemic. The formula prescribed for the Maximum Retail Price (MRP) is Price to Distributor (PTD) + (PTD x TM) + Applicable GST, where TM = Trade Margin not exceeding 70%. It has also directed manufacturers to fix MRP of oxygen concentrators and submit the information containing details of PTD, Retail Price, existing and revised MRP, by using the formula prescribed and other details for oxygen concentrator to NPPA by June 7, 2021. The revised prices shall come into effect from June 9, 2021. The price so fixed shall remain in force up till November 30, 2021 or until further orders, whichever is earlier. Oxygen concentrator is a non-scheduled drug and presently under the voluntarily licensing framework of the Central Drugs Standard Control Organization (CDSCO). State Drug Controllers shall ensure compliance of this Order.
The manufacturers/ dealers/hospitals/medical institutions shall assist the State Drug Controllers in verifying the compliance to this Order. Any violation of this Order is required to be brought to the notice of NPPA. Union health ministry dated February 11, 2020 notified all the medical devices intended for use in human beings or animals as Drugs under the Drugs and Cosmetics (D&C) Act 1940 with effect from April 1, 2020. NPPA has accordingly vide SO. 1232(E) dated March 31, 2020 notified that all medical devices (including oxygen concentrator) shall be governed under the provisions of DPCO 2013 w.e.f April 1, 2020.
