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Parliamentary panel recommends DoP to work on inclusion of more medical devices into NLEM
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Gireesh Babu, New Delhi
February 19 , 2024
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The Parliamentary Panel that looked into the promotion of medical devices industry in the country has recommended to the Department of Pharmaceuticals (DoP) to take up the inclusion of medium and high-end medical devices used for critical care under the National List of Essential Medicines (NLEM) with the ministry of health and family welfare (MoHFW), in public interest.
The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers in its 50 report on promotion of medical devices in the country was exploring the National Pharmaceutical Pricing Authority's (NPPA) plan to expand its price regulation on other medical devices in coordination with ministry of health and family welfare that are being used widely for treatment in government hospitals.
The Panel noted that there are only four medical devices - cardiac stents, drug eluting stents, condoms and intra uterine devices - that have been included in the NLEM by the MoHFW, and hence covered under Schedule-I of the Drugs (Prices Control) Order, 2013. The ceiling prices of these four scheduled medical devices are notified by NPPA.
In 2017, the NPPA had fixed the ceiling price of knee implants to control the excessive trade margins of orthopedic knee implants under extraordinary circumstances. Later, during the post-Covid crisis, a Delhi High Court judgement dated May 17, 2021 directed NPPA to regulate the prices of medical devices and on June 3, 2021 and July 13, 2021 the price regulator issued notifications to cap the Trade Margin at Price to Distributor (PTD) at 70% for medical devices namely, oxygen concentrators, pulse oximeter, blood pressure monitoring machine, nebulizer, digital thermometer and glucometer.
The Committee opined that the devices which are required for critical care to the patients should be listed under NLEM.
"The Committee, therefore, strongly recommends that the Department of Pharmaceuticals should take up the matter with NPPA, for inclusion of other medium and high-end medical devices which are used for critical care of the patients, at the highest level with the ministry of health and family welfare, in public interest," said the report.
The mandate of the NPPA is to implement and enforce the provisions of the Drugs (Prices Control) Order, 2013 promulgated under the Essential Commodities Act, 1955. NPPA monitors the availability of drugs including medical devices, identifies shortages, if any, to take remedial steps.
With regard to the non-scheduled medical devices, which are notified as drugs, NPPA is currently monitoring Maximum Retail Prices (MRPs) under Para 20 of the DPCO, 2013 to ensure that no manufacturer/importers increase the price by more than ten percent of the MRP during preceding twelve months.
The Committee asked the DoP on whether NPPA plans to expand its price regulation on other medical devices in coordination with the Ministry of Health and Family Welfare that are being used widely for treatment in government hospitals, the department stated that NPPA’s mandate is to ensure the availability and affordability of drugs/medical devices.
The inclusion of drugs including medical devices in NLEM is dealt with by the ministry of health and family welfare. NLEM issued by MoHFW is the basis for Schedule-I of DPCO for regulation of price of formulations and medical devices by NPPA. Expansion of price regulation to other drugs/medical devices is dependent on its inclusion in NLEM which comes under the purview of MoHFW, informed the Department.
The Committee further asked whether NPPA can regulate the prices of other medical devices under Para 19 of DPCO, 2013 in public interest like it is doing for knee implants since 16.08.2017. In reply, the Department stated that Para 19 of the DPCO, 2013 inter-alia authorizes the government, in extraordinary circumstances, if it considers necessary to do so in the public interest, to fix the ceiling price or retail price of any drug/medical devices for such period, as it deems fit. NPPA has invoked Para 19 from time to time, in extraordinary circumstances (eg. oxygen concentrator & five medical devices) in view of public interest.
With regard to the number of complaints that NPPA has disposed with respect to shortage of medical devices and overcharged medical devices since the implementation of DPCO, 2013 and action that has been taken on those complaints, the Department has informed that from 2018 to till date, 24 complaints/grievances pertaining to overcharging and 10 cases pertaining to shortage of medical devices were received by NPPA.
The complaints of overcharging cases are analyzed and notices are issued in the cases, where necessary. The monitoring of over charge cases of medical devices is being carried on at NPPA which is a continuous ongoing process.
In addition to this, shortage of medical devices was also reported during Covid pandemic (2020-2021). The Delhi High court vide judgment dated 17.05.2021 had also directed the NPPA to regulate the prices of medical devices, essential for diagnostic purposes, in general, and specifically for Covid-19 management.
Taking cognizance of the various report and the High court directions, prices of medical devices, essential for Covid-19 management, NPPA capped Trade Margin at Price to Distributor (PTD) at 70% for medical devices, namely, oxygen concentrators, pulse oximeter, blood pressure monitoring machine, nebulizer, digital thermometer, and glucometer.
The Committee also enquired on the steps being taken to increase awareness among the general public in various states/districts/blocks/village level about the existing complaint redressal mechanism for overcharged medical devices.
The Department has stated that to spread awareness, the NPPA, the Department implements the “Consumer Awareness, Publicity and Price Monitoring (CAPPM)” Scheme. The Scheme has a National component and a State component. The National component covers the expenditure for publicity through print and electronic media, organizing seminars for consumer awareness, purchase of samples, etc. Under the State Component of the Scheme, Price Monitoring and Resource Units (PMRUs) are set up in the states. PMRU is a registered society under the Chairmanship of the State Drug Controller and aims to create public awareness so that benefits of the DPCO (revised from time to time) trickle down to the grassroots level. NPPA has also launched the Pharma Jan Samadhan portal and the updated version of the Pharma Sahi Daam App which has a public complaint redressal mechanism, to promote ease of access, it informed the Panel.
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