PSAIIF Files PIL Over Illegal Import of Refurbished Medical Devices

PSAIIF has pointed out that many refurbished medical devices entering the Indian market lack the necessary approvals and certifications, posing a significant risk to patients.

The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL) in the Delhi High Court, raising serious concerns about the growing trend of refurbished medical equipment imports in India.

The petition highlights the potential risks these devices pose to patient safety and questions their reliability. PSAIIF argues that the illegal import of refurbished medical devices, such as CT scanners, MRI machines, ultrasound equipment, and surgical robotics, threatens the integrity of India’s healthcare system.

PSAIIF has pointed out that many refurbished medical devices entering the Indian market lack the necessary approvals and certifications, posing a significant risk to patients.

This trend has increased in recent years, with associations such as the Association of Indian Medical Device Industry (AiMeD), the Federation of Indian Chambers of Commerce and Industry (FICCI), and several domestic companies urging the government to take immediate action.

They argue that the influx of these devices undermines the country's efforts toward self-reliance and jeopardizes patient safety by allowing substandard equipment into healthcare facilities.

Response from Government Agencies

In compliance with the directions issued by the Delhi High Court, PSAIIF recently received responses from the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest, and Climate Change (MoEFCC).

These responses addressed the issue of unauthorized imports of refurbished medical equipment without appropriate certifications. The PSAIIF petition emphasized that such imports compromise safety standards established under the Medical Device Rules, 2017, which aim to ensure that only safe and effective medical devices are sold in India.

The PSAIIF also brought attention to the fact that the import of refurbished devices, including high-end and high-value (HEHV) medical equipment, poses a substantial threat to patient safety and the domestic medical device manufacturing industry.

This issue is central to the PIL, which names several government agencies and private companies as respondents, including the Central Board of Indirect Taxes and Customs (CBIC), DGHS, MoEFCC, Directorate General of Foreign Trade (DGFT), and Intuitive Surgical India.

Illegal Import of HEHV Medical Equipment

The petition specifically highlights the case of Intuitive India, a subsidiary of Intuitive Surgical Inc. The company has allegedly imported refurbished medical equipment worth over INR 250 Cr since 2019 without obtaining the necessary approvals from MoEFCC.

According to PSAIIF, these devices were imported illegally, as the rules governing such imports were not relaxed until 2023 when a DGHS notification allowed select refurbished devices to be imported under strict conditions.

However, MoEFCC’s approval was still mandatory for all imports, a requirement that the petition claims Intuitive India has ignored.

Professor Bejon Kumar Misra, Founder of PSAIIF, stated, “The petition has been filed seeking the issuance of directions to the Respondents to identify and furnish a list of all second-hand and refurbished High-End and High-Value (HEHV) medical equipment, other than critical care medical equipment, that have been imported into India since 2019 without the permission of the Ministry of Environment, Forest, and Climate Change (MoEFCC).”

He further urged that companies, including Intuitive Surgical, immediately recall all refurbished HEHV medical equipment installed without prior approval and stop importing these devices until a clear policy framework regulating their importation is implemented.

Conflicting Approvals & Regulatory Issues

While the petition raised serious concerns, PSAIIF acknowledged that the MoEFCC’s 133rd meeting in May 2024 revealed that Intuitive India had received approval to import one refurbished Da Vinci X robot in 2019.

However, the company allegedly continued importing equipment worth over INR 250 Cr in subsequent years without securing the required approvals from MoEFCC.

Despite these concerns, MoEFCC granted additional approvals in 2024, which contradicts DGHS's stance. The DGHS has maintained that the import of refurbished devices should not be permitted if similar devices are being manufactured in India, in line with the “Make in India” initiative.

This inconsistency between the positions of MoEFCC and DGHS undermines domestic manufacturers’ confidence and threatens the success of the government's policy to promote local manufacturing.

Professor Misra described this situation as an “Un-make in India” campaign, pointing out that allowing these imports could damage the domestic medical device manufacturing industry. He further emphasized the need for better regulatory oversight to ensure the safety and efficacy of medical equipment entering the Indian market.

Call for Immediate Action

PSAIIF has called for immediate action to enforce compliance with India's regulatory framework and prevent the illegal import of refurbished medical devices.

The foundation has also stressed the importance of raising public awareness about the risks posed by these devices, as patient safety could be compromised by using equipment that does not meet safety and quality standards.

The Delhi High Court directed PSAIIF to submit representations to the concerned respondents. The HC further allowed to approach it again if the responses are found unsatisfactory.

Professor Misra noted, “Since the responses have been received pursuant to a court order, no statements can be made on the same until conclusive legal advice is taken.”

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