Severe risk with import of second hand CT scanners, MRI machines, surgical robots, warns industry body, files PIL
New Delhi: Medical device manufacturers in India are sounding alarms over the unregulated import of refurbished medical devices, emphasizing serious potential risks to patient safety and alleged violations of regulatory standards. As per various media reports, industry groups have reached out to Health Minister JP Nadda, urging him to withdraw a recent policy that permits the entry of second-hand equipment like CT scanners, MRI machines, and surgical robots without stringent regulatory controls.
The Ministry of Environment, Forest, and Climate Change recently expanded a list of high-end, high-value used or refurbished medical equipment permitted for import. Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AiMeD), called this development a direct violation of the National Medical Devices Policy, 2023. He expressed concerns that Indian and foreign companies investing in high-tech manufacturing under the "Make in India" initiative face significant risks, as recent investments might now turn into non-performing assets due to this policy shift.
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“The ministry’s expansion of this equipment list creates an unpredictable environment for investors who are considering bringing advanced medical manufacturing technology to India,” Nath was quoted as saying by the Economic Times. He added that the revised policy not only endangers new domestic manufacturing projects but also exposes patients to the risk of treatment with potentially non-calibrated, unregulated equipment.
Nath further warned that India could become a dumping ground for obsolete equipment from overseas, while foreign manufacturers exploit this scenario to double their sales.
Meanwhile, the Patient Safety and Access Initiative of India Foundation (PSAIIF), a non-profit organization focused on improving healthcare quality, has also voiced objections. In May, PSAIIF filed a Public Interest Litigation (PIL) with the Delhi High Court, challenging the import of used medical devices and questioning the effectiveness of the regulatory framework. The petition emphasizes that unregulated second-hand medical devices compromise safety, efficiency, and quality standards intended to protect patients.
In its ongoing PIL, PSAIIF has specifically named Intuitive Surgical Inc.’s subsidiary, Intuitive India, alleging the company imported refurbished medical devices worth over INR 250 crore since 2019 without securing necessary approvals from the Ministry of Environment, Forest, and Climate Change (MoEFCC). PSAIIF argues that these imports bypassed the 2023 rules that mandate MoEFCC approval for all such devices. The foundation has called on Intuitive India and similar companies to recall these devices and halt further imports until a robust regulatory policy is in place.
Professor Bejon Kumar Misra, founder of PSAIIF, urged authorities to create an exhaustive list of all imported second-hand and refurbished High-End, High-Value (HEHV) medical equipment brought in without MoEFCC authorization since 2019. He suggested that unapproved devices, especially non-critical care equipment, should be removed from the market until they meet strict standards.
The conflicting stance between the MoEFCC and the Directorate General of Health Services (DGHS) further complicates the issue. Despite recent MoEFCC approvals, DGHS has maintained that importing refurbished devices undermines the "Make in India" initiative, particularly if similar equipment is already manufactured locally. Professor Misra criticized this situation as counterproductive to the country’s goal of self-reliance, coining it an “Un-make in India” scenario.
Amid these developments, PSAIIF has stressed the urgency of regulatory consistency and enforcement to safeguard public health and support the growth of India's medical device manufacturing industry. The Delhi High Court has directed PSAIIF to submit its concerns to the relevant agencies and allowed it to seek further judicial intervention if the agencies' responses are unsatisfactory.
“Since we’ve received responses as per court order, we will wait for complete legal advice before issuing any formal statements,” Professor Misra told Digital Health News, noting that the issue could have long-term implications for patient safety and healthcare quality in India.
