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Parliamentary panel concerned about inadequate regulatory framework for used medical devices

The Parliamentary Standing Committee on Chemicals and Fertilisers has voiced apprehensions about the inadequate regulatory framework concerning the assessment of quality, safety, and efficacy of second-hand or used medical devices. This deficiency, the panel asserts, compromises the standard of healthcare services in the nation. In response, the committee strongly advocates for government intervention to ensure the safety, quality, and efficacy of imported second-hand medical devices.

Urgent calls for regulatory actions by parliamentary committee
The committee, led by Dr Shashi Tharoor, urges immediate measures to regulate imported second-hand medical devices under the Medical Device Rules of 2017. Emphasizing the need to safeguard the interests of domestic manufacturers, the committee underscores the necessity of restricting the import and usage of such products manufactured within India. The Department of Pharmaceuticals is urged to address these concerns with the Ministry of Health & Family Welfare/CDSCO promptly.

Current regulatory gaps highlighted by the committee
Presently, the Medical Device Rules of 2017 lack specific provisions to regulate refurbished or pre-owned second-hand medical devices. While the Ministry of Environment, Forest and Climate Change oversees the import and usage of such devices under the Hazardous and Other Waste Management Rules of 2016, concerns persist regarding safety and quality standards. Additionally, the Central Drugs Standard Control Organisation (CDSCO) lacks data or records concerning the safety and quality standards of these products, highlighting regulatory deficiencies.

Impact on healthcare and ‘Make in India’ initiative
The lax regulatory framework not only compromises healthcare standards but also undermines the ‘Make in India’ initiative. Easy importation of refurbished medical devices poses challenges to domestic manufacturers. Despite the cost-effectiveness of refurbished devices in price-sensitive markets like India, concerns are raised about fair competition and the need for regulation to ensure market fairness.

Advocacy for fair market practices
The Association of Diagnostic Manufacturing of India (ADMI) has raised concerns about the unregulated usage of second-hand medical devices in the country, advocating for regulations to prevent unfair market practices. The recent amendments to the Hazardous and Other Waste Management Rules of 2016 have further liberalized the import of high-end used medical equipment.

Lack of information and regulatory measures
However, the Department of Health and Family Welfare acknowledges the absence of specific data on the percentage of the market comprising refurbished medical devices and the steps taken to ensure their safety and quality standards. Furthermore, details regarding assessment centers for measuring the residual shelf life of refurbished medical devices remain unavailable, underscoring the need for enhanced regulatory measures and transparency in the healthcare sector.

Operon Strategist, a leading medical device regulatory consulting firm, addresses concerns raised by the Parliamentary Standing Committee on the safety and quality standards of medical devices in India. With a team of experts, they navigate complex regulations, ensuring compliance and facilitating license acquisition. Operon Strategist promotes transparency and regulatory compliance, playing a vital role in advancing healthcare objectives. Operon Strategist

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