- Calls for clear guidelines to ensure refurbished devices meet stringent safety and performance standards, protecting patients and healthcare providers
- Regulatory gaps leave refurbished equipment inadequately monitored, posing risks to patient health in critical medical settings
- Import of refurbished devices, including surgical robots, into India without MoEFCC approvals poses serious regulatory violations and risks to patient safety
New Delhi 16 October 2024: The growing trend of refurbished medical equipment presents significant risks to patient safety and raises important questions about the reliability and effectiveness of these devices, which are vital to the healthcare system. The Patient Safety and Access Initiative of India Foundation (PSAIIF) had filed a Public Interest Litigation (PIL) in the High Court of Delhi, citing numerous violations and non-compliances in the import of refurbished medical devices. As per the directions passed by the Court, recently PSAIIF received responses from the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest, and Climate Change (MoEFCC).
Medical devices, including refurbished ones, are governed by stringent regulatory vigil under the Medical Device Rules, 2017, in India. These regulations aim to ensure that medical devices meet rigorous safety and efficacy standards before entering the market. However, a growing trend of importing refurbished devices, such as CT scanners, MRI machines, ultrasound equipment, laboratory devices, and surgical robotics, without appropriate certifications has been observed. This creates a loophole that compromises India’s self-reliance and poses potential risks to patient safety. Associations such as AiMeD, FICCI, and several domestic companies opposed the import of refurbished medical equipment in India, urging the government to take decisive action.
The illegal import of refurbished medical devices into India without obtaining the necessary approvals is a pressing issue that raises significant concerns for public health, regulatory integrity and India’s self-reliance. This practice not only undermines the established medical device framework but also poses serious risks to patients who rely on these products for their health and well-being. In response, PSAIIF had initially filed a Writ Petition before the Delhi High Court highlighting these issues. The petition had impleaded several respondents, including the Central Board of Indirect Taxes and Customs, DGHS, MoEFCC, DGFT, and Intuitive Surgical India Pvt Ltd.
Speaking on the matter, Professor Bejon Kumar Misra, the Founder of PSAIIF, said, “The petition had been filed seeking issuance of directions to the Respondents to identify and furnish a list of all second-hand and re-furbished High-End And High-Value (HEHV) Used Medical Equipment other than Critical Care Medical Equipment that have been imported into India since 2019 without permission of the Ministry of Environment Forest and Climate Change (MoEFCC) and for directions to Companies including the Intuitive Surgical to immediately recall all such Refurbished HEHV Medical Equipment that are installed without prior approval as per the Rules and Regulations and stop the import of Refurbished HEHV Medical Equipment including the systems that are at customs cleared and not installed at customer locations until the Government inter-ministerial committee of Respondents decides on implementation of policy framework that would regulate the import of such devices.”
The petition presented substantial evidence, citing one company—Intuitive India Private Limited, a subsidiary of Intuitive Surgical Inc.—which allegedly imported refurbished equipment worth over INR 250 crores since 2019, presumably without the required MoEFCC approval. The petition’s core contentions stress that the import of medical devices, particularly refurbished HEHV devices, was not permitted before 2023. Even after the DGHS notification in June 2023 that allowed for the import of select devices under strict conditions, the approval of MoEFCCwas mandatory.
The Delhi High Court had directed PSAIIF to file representations with the respondents, granting the liberty to approach the court again if the responses were unsatisfactory. Professor Misra confirmed that PSAIIF recently received responses from both MoEFCC and DGHS. According to MoEFCC’s 133rd meeting in May 2024, Intuitive India received approval to import only one refurbished Da Vinci X robot in 2019, yet continued to import equipment worth over INR 250 crores in subsequent years without approval.Professor Misra further stated, “Since the responses have been received pursuant to court order, no statements can be made on the same until conclusive legal advice is taken on the same.”
Further, MoEFCC recently granted more approvals in 2024, despite DGHS’s stance that imported equipment should not be allowed if equivalent devices are manufactured in India under the “Make in India” policy. Professor Misra pointed out that this inconsistency undermines domestic manufacturers’ confidence and threatens the government’s “Make In India” policy, leading to what he terms an “Un-make in India” campaign.
This illegal importation not only violates India’s regulatory standards but also jeopardizes patient safety. Immediate action is needed to enforce compliance, raise public awareness, and encourage cooperation among stakeholders to ensure that only safe, certified medical devices are available in the Indian market.
