NPPA has taken five more medical devices into DPCO 2013. NPPA has notified that all medical devices including Pulse Oximeter, Blood Pressure Monitoring Machine, Nebulizer, Digital Thermometer, and Glucometer shall be governed under the provisions of DPCO, 2013.
NPPA is entrusted with the mandate to ensure the availability of essential drugs at affordable prices, and keeping in view the evolving Covid 2.0 pandemic, it is necessary to regulate the prices of these medical devices. Drug Controller General Of India (DCGI), Director General of Health Service (DGHS) and National Pharmaceutical Pricing Authority (NPPA) are in consensus that these medical devices are essential for COVID Management.
NPPA collected data regarding the Trade Margins for these five medical devices from the manufacturers/ marketers/ importers and noted that margins ranging up to 709% from Price to Distributor to MRP level have been reported.
These medical devices are Non-Scheduled Medical Devices/ Drugs. Because all the medical devices intended for use in human beings or animals are regarded as “Drugs” under the Drugs and Cosmetics Act 1940 from April 2020.
NPPA said that, "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 w.e.f. 01.01.2021. With the aim of making these medical devices affordable during the evolving situation of Covid pandemic, it is felt necessary to regulate the trade margin on these medical devices."
NPPA has notified that Trade Margin must not exceed 70%. NPPA set maximum retail price should be the sum of Price to Distributor (PTD) with (PTD x trade margin) with Applicable GST.
