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Parl Panel Calls for Increased Oversight of Medical Devices Industry

Written by : Aishwarya Sarthe

February 28, 2024

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The panel emphasized the necessity of expanding the pool of notified bodies and equipping them adequately to ensure quality and safety standards are met.

A recent parliamentary panel report has highlighted concerns regarding the oversight of medical device manufacturing in the country, urging the government to take proactive measures to enhance regulatory mechanisms.

The Department-related Parliamentary Standing Committee on Chemicals and Fertilizers, chaired by Lok Sabha member Dr Shashi Tharoor, expressed dissatisfaction with the limited number of bodies available to audit and inspect medical device manufacturing sites. The panel emphasized the necessity of expanding the pool of notified bodies and equipping them adequately to ensure quality and safety standards are met.

According to the report, the Department of Pharmaceuticals informed the committee that only 13 Notified Bodies were registered under the Medical Device Rules, 2017, to audit Class A&B medical device manufacturing sites. This raised concerns among the panel members regarding the adequacy of oversight for ensuring the quality and safety of medical devices.

Call for Prompt Action to Enhance Oversight

The parliamentary panel urged immediate action to increase the number of Notified Bodies and enhance their technical infrastructure and manpower. It emphasized the critical role of these bodies in ensuring the quality, safety, and efficacy of medical devices manufactured in the country.

In a statement, the panel underscored the importance of expediting the process of issuing licenses to manufacturers of all kinds of medical devices within a time-bound framework. It called upon the Department of Health & Family Welfare to ensure that Central Medical Device Officers are well-equipped and trained to conduct audits of Class C&D medical devices effectively.

Regulatory Framework & Licensing Process

The report highlighted the regulatory framework governing the medical devices industry, with the Department of Health and Family Welfare responsible for regulating medical devices' quality, safety, labeling, and performance under the Medical Device Rules, 2017. The Central Drugs Standard Control Organization (CDSCO) oversees the import and manufacture of Class C&D medical devices, while State Licensing Authorities regulate the manufacture, sale, and distribution of Class A&B medical devices.

As per the report, the Department of Health has received 3,413 manufacturing license applications, with 2,262 applications approved to date. The panel welcomed the assurance that manufacturers with pending applications would be allowed to sell their products for the next six months without penalty.

Focus on National Standards & Essential Medical Devices

In addition to regulatory concerns, the Parliamentary Panel urged the Department of Pharmaceuticals and the Bureau of Indian Standards to accelerate the establishment of National Standards for medical devices. The absence of such standards for domestically produced medical devices has been identified as a barrier to exports and limits opportunities for Indian manufacturers.

Moreover, the Committee recommended the inclusion of medium and high-end medical devices essential for critical care into the National List of Essential Medicines (NLEM). In collaboration with the Ministry of Health and Family Welfare, this recommendation underscores the public interest in ensuring access to essential medical devices.

Furthermore, the panel proposed measures to support domestic manufacturing of medical devices, including reducing GST rates, providing custom-duty concessions on imported components, and extending the Phased Manufacturing Programme (PMP) to cover a broader range of medical devices. These recommendations aim to bolster the domestic medical devices industry and enhance access to quality healthcare equipment.

The parliamentary panel's report underscores the importance of strengthening oversight and regulatory mechanisms in the medical devices industry to ensure the quality, safety, and efficacy of healthcare products. 

By addressing key concerns and proposing actionable recommendations, the panel aims to promote the growth of the medical devices sector and improve healthcare outcomes for all citizens.


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