Last Updated on January 8, 2024 by The Health Master
The National Pharmaceutical Pricing Authority (NPPA) has extended deadline till April 15, 2021 for medical devices manufacturers of all non-scheduled medical devices covering 24 categories to submit price related information for price monitoring exercise from the earlier deadline of March 11, 2021.
NPPA on Februray 16, 2021 had issued an office memorandum (OM) wherein it was directed to submit price related information in the prescribed format for 24 categories of non-scheduled medical devices.
“In this connection, NPPA has received representation from various companies and industry associations seeking extension of the date for the submission of the requisite date.
A consultation was held with the industry associations on March 11, 2021 in the matter and it was agreed to extend the timeline upto April 15, 2021 for submission to be made in compliance to the OM,” as per the notice of NPPA.
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The NPPA in exercise of powers of para 29 of Drugs Prices Control Order (DPCO)-2013 had directed manufacturers and importers of all non-scheduled medical devices of 24 categories to submit price related information in the prescribed format duly certified by practicing chartered accountant (CA) within 21 days of issue of this office memorandum (OM) price monitoring exercise.
The maximum retail price (MRP) of non-scheduled medical devices notified/regulated as drugs under Drugs and Cosmetics (D&C) Act, 1940 are governed under the provisions of Para 20 of the DPCO-2013.
Also read: Latest notifications – DPCO /NPPA
Further Para 25 of DPCO-2013 provides that every manufacturer/importer shall issue a price list and supplementary price list in Form-V to the dealer State Drugs Controllers (SDCs) and the government from time to time.
NPPA had earlier notified all medical devices as drugs under the provisions of the DPCO-2013 with effect from April 1, 2020 in pursuance of notification dated February 11, 2020.
In order to monitor the MRP of the non-scheduled medical devices under para 20 of DPCO 2013 vide OM dated May 12, 2017, NPPA had collected price related information for all the 19 categories of non-scheduled medical devices for the year 2014 to 2017.
Further Union health ministry vide notification dated December 3, 2018 and December 27, 2019 had notified four medical devices. “Thus, with effect from 1st April, 2020, all medical devices shall be regulated by the government as drugs for quality control and price monitoring.
Therefore, the MRPs of all the medical devices would be monitored by the government under the provisions of Para 20(1) of the DPCO, 2013 to ensure that no manufacturer or importer increases the MRP of a drug more than ten percent of MRP during preceding twelve month and where the increase is beyond ten per cent of maximum retail price, it shall reduce the same to the level of ten per cent of maximum retail price for next twelve months,” NPPA in its notification had stated.
Further, as per Para 20(2) of the DPCO, 2013 read with the Essential Commodities (EC) Act, 1955, the manufacturer/importer shall also be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to penalty.
Government is today regulating 24 categories of medical devices which have been notified or regulated as drugs under D&C Act, 1940 and D&C Rules, 1945. Of the above, four medical devices viz. (i) Cardiac Stents (ii) Drug Eluting Stents (iii) Condoms and (iv) Intra Uterine Device (Cu-T) are scheduled medical devices for which ceiling prices have been fixed.
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