PSAIIF

The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL) in the Delhi High Court, raising alarms over the growing trend of illegal imports of refurbished medical devices into India. PSAIIF expressed concern that these imported devices—such as CT scanners, MRI machines, surgical robots, and ultrasound equipment—pose significant risks to patient safety due to the lack of appropriate certifications and regulatory approvals.

The petition emphasizes that these unauthorized imports undermine India’s healthcare standards by introducing equipment that may not meet safety norms established under the Medical Device Rules, 2017. PSAIIF asserts that these imports jeopardize the country’s efforts to promote self-reliance and local manufacturing, in line with the “Make in India” initiative.


Several industry stakeholders, including AiMeD, FICCI, and various domestic companies, have urged the government to take decisive action against these illegal imports. PSAIIF argues that allowing the use of uncertified medical equipment could compromise patient care and diminish trust in healthcare services.

Responses from Government Agencies

Following a court directive, PSAIIF has received responses from the Directorate General of Health Services (DGHS) and the Ministry of Environment, Forest, and Climate Change (MoEFCC). The responses acknowledged issues surrounding the unauthorized imports but revealed conflicting stances between government agencies. While the DGHS has opposed the import of refurbished devices if locally produced alternatives are available, the MoEFCC has issued selective approvals, raising concerns over regulatory inconsistencies.

The PIL specifically mentions Intuitive India, a subsidiary of Intuitive Surgical Inc., which allegedly imported refurbished medical equipment worth ₹250 crore since 2019 without necessary permissions from MoEFCC. PSAIIF has demanded that the company recall all unapproved devices installed in India and halt further imports until clear policy guidelines are implemented.


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Impact on the Domestic Medical Device Industry

Professor Bejon Kumar Misra, Founder of PSAIIF, highlighted that the inconsistent regulatory framework could harm the domestic medical device manufacturing industry. “The lack of cohesive oversight risks turning ‘Make in India’ into an ‘Un-make in India’ campaign,” he cautioned, calling for stricter regulatory controls to ensure all imported equipment complies with safety and quality standards.

PSAIIF has stressed the need for immediate action to prevent the influx of unauthorized refurbished devices, ensure compliance with existing regulations, and protect patients from the potential hazards of substandard medical equipment. The Delhi High Court has allowed PSAIIF to submit additional representations to concerned government bodies and re-approach the court if responses are unsatisfactory.

This case highlights the urgency for robust regulatory oversight in India’s healthcare sector to strike a balance between patient safety and local industry growth, ensuring only safe and certified devices are deployed in healthcare settings.


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