PIL filed on illegal import of refurbished medical devices into India

The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL) in the Delhi High Court, raising concerns about the growing trend of refurbished medical equipment imports in India. The petition highlights the significant risks posed to patient safety and questions the reliability of these devices. PSAIIF pointed out 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.

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). The responses address the issues surrounding the unauthorised import of refurbished medical equipment without appropriate certifications. This trend compromises the safety standards set under the Medical Device Rules, 2017, which are designed to ensure that only safe and effective medical devices enter the market.

India has seen an increase in the import of refurbished medical devices without necessary approvals, with associations such as AiMeD and FICCI, along with several domestic companies, urging the government to take action. They argue that these imports undermine the country’s self-reliance and pose potential risks to patients.

The illegal importation of refurbished devices, including high-end and high-value (HEHV) medical equipment, has been a focus of the PIL filed by PSAIIF. The petition names several respondents, including the Central Board of Indirect Taxes and Customs, DGHS, MoEFCC, DGFT, and Intuitive Surgical India Pvt Ltd.

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 points to 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 notes that prior to 2023, the import of refurbished medical devices, particularly HEHV devices, was not permitted. Even after the DGHS notification in June 2023 allowed select devices under strict conditions, MoEFCC’s approval remained mandatory.

The Delhi High Court directed PSAIIF to submit representations to the concerned respondents and granted permission to approach the court again if the responses were deemed unsatisfactory. Recently, PSAIIF received responses from both MoEFCC and DGHS. According to MoEFCC’s 133rd meeting in May 2024, Intuitive India had approval to import one refurbished Da Vinci X robot in 2019. However, the company allegedly continued importing equipment worth over INR 250 crores without the required approvals in subsequent years. Professor Misra 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.”

Despite these concerns, MoEFCC granted further approvals in 2024, which is in conflict with DGHS’s position that imported devices should not be allowed if similar devices are manufactured in India under the “Make in India” initiative. Professor Misra noted that this inconsistency undermines domestic manufacturers’ confidence and threatens the success of the government’s policy, describing the situation as an “Un-make in India” campaign.

The illegal import of refurbished medical devices without proper certification and oversight not only violates India’s regulatory framework but also jeopardises patient safety. PSAIIF calls for immediate action to enforce compliance and increase public awareness to ensure that only safe, certified medical devices are available in the Indian market.