The National Pharmaceutical Pricing Authority (“ NPPA”) has in an Office Memorandum (OM) dated 16th February 2021, directed all manufacturers / importers of the 24 non-scheduled medical devices (mentioned in Annexure I & II of the OM) to submit price related information in the formats as given in Annexure III & Annexure IV of the OM. The information must be duly certified by a practicing Chartered Accountant / Cost Accountant and must be submitted within 9th March, 2021.
A soft copy of the same in excel format must also be sent to medicaldevices-nppa@gov.in
Background :
The Maximum Retail Price (“MRP”) of non-scheduled medical devices are regulated as drugs under the Drugs and Cosmetics Act, 1940 which is also governed under the provisions as mentioned in the Drugs (Price Control) Order, 2013 (“DPCO”). Further Para 25* of the DPCO, 2013 provides that every manufacturer / importer will issue a price list and a supplementary price list in Form -V to the dealer, State Drugs and Controllers and the Government from time to time.
In order to monitor, MRP of the non scheduled medical devices under DPCO, 2013, the NPPA had collected price related information for all the 19 categories of Non-Scheduled Medical Devices from 2014 to 2017.
Presently, 28 categories of Medical Devices are under mandatory regulation as drugs as per the Drugs and Cosmetics Act, 1940 , out of which Coronary Stents, Drug Eluting Stents, Condoms, Intra Uterine Devices falls under Medical Devices.
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*25. Display of prices of non-scheduled formulations and price list thereof.–
(1) Every manufacturer of a non-Scheduled formulation intended for sale shall display in indelible print mark, on the label of container of the formulation and the minimum pack thereof offered for retail sale, the maximum retail price of that formulation with the words “Maximum Retail Price” preceding it and the words ‘inclusive of all taxes’ succeeding it.
(2) Every manufacturer shall issue a price list and supplementary price list, if required, of the non-Scheduled formulations in Form-V to the dealers, State Drugs Controllers and the Government indicating changes, from time to time.
(3) Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.
Source: National Pharmaceutical Pricing Authority
