New Delhi: A Public Interest Litigation (PIL) filed by the Patient Safety and Access Initiative of India Foundation (PSAIIF) has raised serious concerns over the illegal import of refurbished medical devices into India, highlighting potential risks to patient safety and violations of the country’s medical regulatory framework. Filed before the Delhi High Court, the PIL targets the unregulated influx of second-hand medical equipment, such as CT scanners, MRI machines, and surgical robots, which allegedly bypass crucial safety certifications and environmental clearances.
According to the PIL, the import of refurbished devices into India has surged, with many entering the market without approval from the Ministry of Environment, Forest, and Climate Change (MoEFCC). This includes high-end and high-value (HEHV) medical equipment, which poses significant risks to patients if not properly vetted. PSAIIF’s petition has garnered responses from key regulatory bodies, including the Directorate General of Health Services (DGHS) and the MoEFCC, as part of the Court’s directives.
Medical devices, including refurbished ones, are governed under India’s Medical Device Rules, 2017, ensuring that all products meet rigorous safety and performance standards before being made available. However, PSAIIF’s investigation has found that critical medical devices, such as refurbished CT scanners and surgical robots, have entered India without the required approvals, threatening patient safety in healthcare settings.
Professor Bejon Kumar Misra, Founder of PSAIIF, commented, “The illegal importation of refurbished HEHV medical equipment without the necessary MoEFCC permissions jeopardizes patient safety and violates India’s regulatory standards. We have requested that all such equipment imported since 2019 without MoEFCC approval be recalled immediately and that a policy framework be established to regulate these imports.”
The petition specifically cites Intuitive India Private Limited, a subsidiary of Intuitive Surgical Inc., which reportedly imported over Rs 250 crores worth of refurbished medical equipment between 2019 and 2024 without proper MoEFCC clearances. While the company was granted approval in 2019 to import a single refurbished Da Vinci X surgical robot, it allegedly continued to import additional devices without seeking further permissions.
Despite the DGHS’s 2023 notification allowing the import of select refurbished devices under strict conditions, MoEFCC approvals remain mandatory. PSAIIF’s petition points to inconsistencies in the government’s approach, with MoEFCC recently granting more approvals in 2024 despite DGHS objections based on the “Make in India” policy, which promotes the use of domestically manufactured devices.
The PIL highlights the need for stricter enforcement of India’s regulatory framework for medical devices, emphasising the importance of public awareness and stakeholder cooperation to ensure that only certified, safe equipment is used in healthcare settings.
