Mumbai : The National Pharmaceutical Pricing Authority (NPPA) in exercise of powers of para 29 of Drugs Prices Control Order (DPCO)-2013 has directed manufacturers and importers of all non-scheduled medical devices 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.
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 percent 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.