NPPA to regulate MRP of non-scheduled medical devices, asks manufacturers to submit price details
New Delhi: In a major development regarding medical devices, the National Pharmaceutical Pricing Authority (NPPA) has decided to monitor and regulate the Maximum Retail Price (MRP) of Medical Devices notified as Drugs under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. For this, the Authority has given three weeks' time to manufacturers and importers of 24 categories of medical devices to furnish pricing details of all such products.
NPPA has rolled out a memorandum directing all non-scheduled medical device manufacturers and importers to mandatorily submit the price list and supplementary price list in a given format to the dealers, State Drug Controllers, and the Government.
The manufacturers or importers of all 24 non-scheduled Medical Devices are bound to submit price-related information in the given prescribed formats within 21 days ie. before March 9, 2021. In a directive on February 16, NPPA said,
The Maximum Retail Prices (MRP) of non-Scheduled Medical Devices notified as 'drugs' under Drugs and Cosmetics Act,1940 are governed under the provisions of Para 20 of the Drugs(Price control) Order, 2013. By implementing the Para 20 provision of the DPCO, 2013, dated 12th May 2017, all the price-related data had been gathered for all the 19 categories of non-scheduled Medical Devices for the years from 2014 to 2017.
Moreover, the Ministry of Health & Family Welfare had added four more Medical Devices including Nebulizer, Blood Pressure Monitoring Machine, Digital Thermometer, Glucometer under the category of non-scheduled Medical Devices, regulated as "Drugs" with effect from 01.01.2021.
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