Parl Panel Raises Concerns Over Regulatory Gap for Refurbished Medical Devices

The panel emphasized the urgent need for government intervention to ensure the safety and efficacy of such imported devices.

The parliamentary panel has raised concerns over the need for a robust regulatory framework for assessing the quality, safety, and efficacy of refurbished or pre-owned medical devices. 

The Department-related Parliamentary Standing Committee on Chemicals and Fertilisers highlighted that the current laxity in regulation is compromising the standard of health services in the country. 

The panel emphasized the urgent need for government intervention to ensure the safety and efficacy of such imported devices.

Calls for Immediate Regulatory Action

The Committee, chaired by Dr Shashi Tharoor, strongly recommended that regulatory measures be implemented swiftly to address the issue. 

It asserted, "The needful should be done at the earliest to ensure safety, quality, and efficacy of imported second-hand medical devices by regulating them under the Medical Device Rules, 2017, in the public's best interest."

Furthermore, the Committee stressed the importance of safeguarding the interests of domestic manufacturers by restricting the import and use of such products manufactured in India. 

It urged the Department of Pharmaceuticals (DoP) to take proactive steps in this direction.

Committee’s Critical Observations

The Committee noted the absence of specific provisions under the Medical Device Rules 2017 to regulate refurbished or pre-owned medical devices. 

While the Ministry of Environment, Forest and Climate Change (MoEF&CC) oversees the import and use of these devices under the Hazardous and Other Waste (Management and Transboundary Movement) (HOWM) Rules, 2016, concerns remain regarding safety and quality standards.

The Committee expressed deep concern over the lack of data maintenance by the Central Drugs Standard Control Organisation (CDSCO) regarding refurbished medical devices' safety and quality standards. 

It highlighted the adverse impact of lax regulatory frameworks on public health and the 'Make in India' initiative.

Market dynamics, particularly in developing countries such as India, where price sensitivity is high, have led to a significant demand for refurbished medical devices. 

While these devices offer cost savings for patients, concerns persist regarding their safety and quality.

The Association of Diagnostic Manufacturing of India (ADMI) underscored the need for regulation to prevent unfair competition posed by imported or dumped second-hand instruments. This regulation, it argued, would ensure a level playing field for Indian manufacturers and imported products.

The Ministry of Environment, Forest and Climate Change (MoEF&CC) amended the HOWM Rules, 2016, in December 2022, allowing the import of high-end and high-value used medical equipment under specific conditions. 

However, the Committee noted a lack of clarity regarding the percentage of the medical device market occupied by refurbished devices and laboratory instruments.

The Department of Health and Family Welfare acknowledged the absence of specific details regarding separate assessment centers for measuring the residual shelf life of refurbished medical devices. 

This lack of information underscores the need for comprehensive regulatory oversight and data management in the healthcare sector.

Focus on National Standards & Essential Medical Devices

In addition to regulatory concerns, the Parliamentary Panel urged the DoP 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 on 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.