The National Pharmaceutical Pricing Authority (NPPA) has capped the price tag of 5 health-related devices namely Pulse Oximeter, Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer and Glucometer beneath “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 costs shall come into impact from July 20, 2021. The price tag so fixed shall stay in force up to January 31, 2022 or till additional orders, whichever is earlier. State Drug Controllers shall guarantee compliance of this Order.
The Pulse Oximeter is beneath the voluntarily licensing framework of the Central Drugs Standard Control Organization (CDSCO). Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer, Glucometer are beneath compulsory licensing framework beneath CDSCO with impact from January 1, 2021.
The formula prescribed for the Maximum Retail Price (MRP) is Price to Distributor (PTD) + (PTD x TM) + Applicable GST, exactly where TM = Trade Margin not exceeding 70%.It has also directed producers to repair MRP of to submit the information and facts containing information of PTD, Retail Price, current and revised MRP, by employing the formula prescribed to NPPA by July 20, 2021.
The producers of these 5 health-related devices promoting at price tag greater than the Maximum Retail Price shall revise the costs downward, not exceeding the MRP computed by employing prescribed formula. All the current producers of Pulse Oximeter, Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer and Glucometer obtaining MRP reduced than the MRP, shall retain the current MRP, topic to the provisions of Para 20 of the DPCO- 2013 and not improve the price tag on the basis of formula.
The manufacturer shall submit a price tag 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 single retailer, dealer, hospital and institution shall show price tag list and the supplementary price tag list, as furnished by the manufacturer, on a conspicuous portion of the organization premises in a manner so as to be conveniently accessible to any individual wishing to seek advice from the identical.
The producers not complying with the MRP so computed as and notes specified shall be liable to deposit the overcharged quantity along with 15% interest per annum (PA) from the date of improve in price tag in addition to penalty upto one hundred% of the overcharged quantity beneath the provisions of the DPCO -2013 study with Essential Commodities (EC) Act, 1955.
No manufacturer, distributor, retailer shall sell these 5 health-related devices to any customer at a price tag exceeding the revised price tag, as submitted in Form-V, or price tag indicated on the label of the container or pack thereof, whichever is much less.