The National Pharmaceutical Pricing Authority (NPPA) has capped the price of five medical devices namely Pulse Oximeter, Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer and Glucometer under “Trade Margin Rationalisation Approach” by invoking the provisions of Paragraph 19 of the Drugs Prices Control Order (DPCO) – 2013.
“With the aim of making these medical devices affordable, it was necessary to regulate their prices as per a prescribed formula in the wake of increase in demand due to pandemic,” stated NPPA.
The revised prices shall come into effect from July 20, 2021. The price so fixed shall remain in force up to January 31, 2022 or until further orders, whichever is earlier. State Drug Controllers shall ensure compliance of this Order.
The Pulse Oximeter is under the voluntarily licensing framework of the Central Drugs Standard Control Organization (CDSCO). Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer, Glucometer are under compulsory licensing framework under CDSCO with effect from January 1, 2021.
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 the five medical devices and submit the information containing details of PTD, Retail Price, existing and revised MRP, by using the formula prescribed to NPPA by July 20, 2021.
The manufacturers of these five medical devices selling at price higher than the Maximum Retail Price shall revise the prices downward, not exceeding the MRP computed by using prescribed formula. All the existing manufacturers of Pulse Oximeter, Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer and Glucometer having MRP lower than the MRP, shall maintain the existing MRP, subject to the provisions of Para 20 of the DPCO- 2013 and not increase the price on the basis of formula.
The manufacturer shall submit a price list in Form–V as per Paragraph 25 of the DPCO- 2013 to NPPA and submit a copy to State Drug Controller and Dealers by July 20, 2021. As per Para 25(3) of DPCO- 2013, every retailer, dealer, hospital and institution shall display 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 same.
The manufacturers not complying with the MRP so computed as and notes specified shall be liable to deposit the overcharged amount along with 15% interest per annum (PA) from the date of increase in price in addition to penalty upto 100% of the overcharged amount under the provisions of the DPCO -2013 read with Essential Commodities (EC) Act, 1955.
No manufacturer, distributor, retailer shall sell these five medical devices to any consumer at a price exceeding the revised price, as submitted in Form-V, or price indicated on the label of the container or pack thereof, whichever is less.
