A Public Interest Litigation (PIL) has been filed in the Delhi High Court by the Patient Safety and Access Initiative of India Foundation (PSAIIF) over the illegal import of refurbished medical devices into India. This growing trend of importing devices such as CT scanners, MRI machines, and surgical robotics without proper certifications raises significant concerns for patient safety and undermines India’s self-reliance in the medical sector.
The PIL highlights numerous violations of the Medical Device Rules, 2017, which regulate the safety and efficacy of medical devices entering the Indian market. PSAIIF has accused companies, including Intuitive India Private Limited, of importing equipment worth over Rs 250 crores since 2019 without the necessary approvals from the Ministry of Environment, Forest, and Climate Change (MoEFCC).
According to the PIL, this practice poses risks to patient health, violates regulatory standards, and threatens domestic manufacturers working under the “Make in India” initiative. The Delhi High Court has directed PSAIIF to file representations with the concerned authorities, allowing them to return to the court if the responses are unsatisfactory.
The PSAIIF, led by Professor Bejon Kumar Misra, continues to advocate for strict action to stop these illegal imports and ensure that only certified, safe medical devices are available in India’s healthcare system.