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Parl Panel Urges DoP to Include Medical Devices in NLEM

Written by : Aishwarya Sarthe

February 19, 2024

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This recommendation was made in collaboration with the Ministry of Health and Family Welfare (MoHFW), focusing on public interest.

The Parliamentary Panel has recommended the Department of Pharmaceuticals (DoP) to include medium and high-end medical devices essential for critical care into the National List of Essential Medicines (NLEM).

This recommendation was made in collaboration with the Ministry of Health and Family Welfare (MoHFW), focusing on public interest.

The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers, in its 50th report, focused on promoting medical devices. The report explored the National Pharmaceutical Pricing Authority's (NPPA) plans. These plans aim to expand price regulations to cover other medical devices widely used in government hospitals.

Currently, only four medical devices, namely cardiac stents, drug-eluting stents, condoms, and intrauterine devices, have been included in the NLEM by the MoHFW.

Consequently, these devices fall under Schedule-I of the Drugs (Prices Control) Order, 2013, with ceiling prices notified by the NPPA.

Backstory: Regulatory Measures by NPPA

In 2017, the NPPA intervened to regulate the prices of knee implants due to excessive trade margins. Subsequently, amidst the post-Covid crisis, the Delhi High Court directed the NPPA to further regulate the prices of essential medical devices.

This led to notifications issued by the price regulator on June 3, 2021, and July 13, 2021, capping the trade margin at Price to Distributor (PTD) at 70% for medical devices such as oxygen concentrators, pulse oximeters, blood pressure monitoring machines, nebulizers, digital thermometers, and glucometers.

Expressing their stance, the Committee emphasized the significance of including medical devices crucial for critical care in the NLEM. In the eir report, they stated, "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 the public interest."

The NPPA's mandate is to enforce the provisions of the Drugs (Prices Control) Order, 2013, focusing on ensuring the availability and affordability of drugs, including medical devices. However, the inclusion of drugs and medical devices in the NLEM falls under the jurisdiction of the MoHFW.

Moreover, the Committee queried the DoP about NPPA's potential expansion of price regulation on other widely used medical devices in government hospitals. The DoP clarified that NPPA's role primarily revolves around ensuring availability and affordability, while inclusion in the NLEM is under the purview of the MoHFW.

Additionally, the Committee sought information on the steps taken to increase awareness about existing complaint redressal mechanisms for overcharged medical devices among the general public. The DoP, further, highlighted initiatives such as the Consumer Awareness, Publicity and Price Monitoring (CAPPM) Scheme, the Pharma Jan Samadhan portal, and the Pharma Sahi Daam App, aimed at promoting ease of access and transparency in the medical device market.

Recommendations for Supporting Domestic Manufacturing

Furthermore, Parliament’s Department-related Standing Committee on Chemicals and Fertilizers recently proposed measures to support domestic manufacturing of medical devices. Recommendations include reducing GST rates, providing short-term custom-duty concessions on imported components, and extending the Phased Manufacturing Programme (PMP) to cover a broader range of medical devices.

The Parliamentary Panel's recommendations underscore the importance of expanding the inclusion of critical medical devices in the NLEM to ensure their accessibility and affordability for the public.

The proposed measures by the Standing Committee aim to bolster the domestic manufacturing of medical devices, thereby contributing to the overall healthcare infrastructure of the nation.


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