PIL Filed on Illegal Import of Refurbished Medical Devices into India: Concerns and Policy Violations

By Our Correspondent

New Delhi, Oct 24 :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 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 MoEFCC was 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.