Mumbai : The Association of Indian Medical Device Industry (AiMeD) has hailed the National Pharmaceutical Pricing Authority (NPPA)’s price monitoring exercise on medical devices to rein in irrationally high trade margins to appease healthcare providers and retailers.
All medical devices are today regulated under the Drugs Act but only 37 medical devices have been notified for compliance to Medical Device Rules (MDR)-2017.
According to Rajiv Nath, Forum Coordinator of AiMeD, “It’s currently common place to artificially inflate maximum retail price (MRP) to satisfy excessive margin needs of the healthcare providers or retailers which is not only harmful to consumers but also ethical manufacturers lose out on competitiveness.”
“While the NPPA is seeking to monitor MRP of the products covered under its jurisdiction, it should be more prudent to capture import landed price on which GST is paid first that is at the first point of sale and similarly seek ex-factory price (post discount) on which GST is charged first time that is again at the first point of sale. This unethical practice need to be regulated and price monitoring is a start but it should not be from price to stockist by an importer but from the first point of sale when the goods enter the country,” emphasized Nath.
In exercise of powers of para 29 of Drugs Prices Control Order (DPCO)-2013, NPPA recently 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 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.