Last Updated on March 1, 2024 by The Health Master
Medical Devices
In a groundbreaking move, the Department-related Parliamentary Standing Committee on Chemicals and Fertilisers has recently presented a comprehensive report on the promotion of the medical devices industry in the country.
The focal point of their recommendations lies in urging the Department of Pharmaceuticals (DoP) to collaborate with the Ministry of Health and Family Welfare (MoHFW) to include medium and high-end medical devices essential for critical care under the National List of Essential Medicines (NLEM).
Exploring the Current Scenario
Limited Inclusion in NLEM
The report highlights that currently, only four medical devices – cardiac stents, drug-eluting stents, condoms, and intrauterine devices – find a place in the NLEM.
These devices, covered under Schedule-I of the Drugs (Prices Control) Order, 2013, have their ceiling prices regulated by the National Pharmaceutical Pricing Authority (NPPA).
Historical Perspective on Price Regulation
The NPPA, tasked with implementing and enforcing drug pricing regulations, has a history of intervention in pricing.
Notably, in 2017, knee implant prices were capped to curb excessive trade margins.
Subsequently, during the post-Covid crisis, a Delhi High Court judgment prompted the NPPA to regulate prices for various medical devices crucial in the pandemic, such as oxygen concentrators and pulse oximeters.
Committee’s Strong Recommendations
Inclusion of Critical Care Devices in NLEM
The Parliamentary Panel asserts that medical devices crucial for critical care should be listed under NLEM.
The report strongly recommends the DoP to engage with the NPPA for the inclusion of other medium and high-end medical devices in the highest public interest.
NPPA’s Mandate and Scope
The NPPA’s mandate, rooted in the Essential Commodities Act, involves monitoring drug and medical device availability and taking remedial steps for shortages.
However, the inclusion of drugs and medical devices in NLEM falls under the purview of MoHFW.
Addressing Queries on Price Regulation
Expanding Price Regulation
The Committee queries the DoP on whether NPPA plans to expand its price regulation on widely-used medical devices in government hospitals.
The response clarifies that NPPA’s focus is on ensuring the availability and affordability of drugs and medical devices.
Regulation under Para 19 of DPCO, 2013
The Department explains that NPPA can invoke Para 19 of the Drugs (Prices Control) Order, 2013, in extraordinary circumstances to fix ceiling prices for drugs or medical devices in the public interest.
Handling Complaints and Shortages
The report delves into the number of complaints received by NPPA regarding overcharging and shortages.
From 2018 to the present, 24 overcharging and 10 shortage complaints have been addressed.
The NPPA takes necessary actions, including issuing notices, to rectify overcharging cases.
Crisis Response during Covid-19
Recognizing the challenges during the Covid-19 pandemic, the NPPA, guided by a Delhi High Court judgment, capped Trade Margin at Price to Distributor (PTD) at 70% for crucial medical devices, including oxygen concentrators and pulse oximeters.
Public Awareness Initiatives
Spreading Awareness
The Committee inquires about steps taken to increase awareness about the complaint redressal mechanism for overcharged medical devices.
The Department outlines the “Consumer Awareness, Publicity and Price Monitoring (CAPPM)” Scheme, covering both national and state components, to educate the public.
Additionally, the Pharma Jan Samadhan portal and Pharma Sahi Daam App provide a platform for public complaints.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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