A Union environment ministry panel’s approval for the import of refurbished medical equipment — despite a ban by India’s apex regulator — has drawn objections from domestic medical device makers who say it risks turning India into a dumping ground for outdated equipment.

Domestic device makers questioning such imports have also cautioned that patients remain unaware when diagnosis and treatment are performed using refurbished systems acquired at discounts because healthcare institutions typically do not disclose such information.

The ministry’s expert committee, which evaluates applications for the import of hazardous and other wastes, had on November 12 approved the import of 16 CT scanners, 10 MRI systems and 10 surgical robotic units from different companies, according to government documents.

Domestic companies say those approvals conflict with a January 10 “clarification” from the Central Drugs Standard Control Organisation (CDSCO), the national regulator, which said refurbished medical devices cannot be imported because there are no provisions to regulate them.

India had, in 2023, outlined rules for certain categories of “pre-owned and refurbished” high-end and high-value medical equipment, allowing refurbished systems when new options are unavailable or unaffordable. The eligible list spans 38 categories, from CT and MRI scanners to radiotherapy systems, ophthalmic lasers, endoscopic cameras and surgical robots.

“India does not allow the import of pre-owned or refurbished cars or phones — the same principle should apply to medical equipment,” said Rajiv Nath, forum coordinator with AIMED, an umbrella group of domestic device makers.

Domestic industry executives say the dispute is also about competitiveness.

In a December 6 letter to the expert committee and other government departments, Srinivasa Reddy, senior vice-president at SS Innovations, an Indian manufacturer of surgical robots, warned that approvals to refurbished equipment would erode domestic firms’ competitiveness and deepen dependence on “outdated foreign technologies”.

“Allowing refurbished imports, particularly when similar devices are already being manufactured domestically, creates an uneven playing field and weakens India’s self-reliance and technological advancement,” Reddy wrote in the letter, also sent to health and trade departments.

He urged the committee to revoke the clearances and align with the CDSCO clarification, arguing that domestic manufacturers cannot compete with heavily depreciated systems first sold, used and refurbished for developing-country markets.

Documents show the committee had also cleared similar high-end equipment on May 22, June 6, August 29 and October 10.

Queries sent by this newspaper to the environment ministry asking how the expert committee was approving imports of refurbished equipment despite the CDSCO’s January 10 note have not evoked a response.

The dispute has also moved to the courts.

A consumer rights group last year petitioned Delhi High Court for stricter oversight of refurbished medical equipment imports. “Not only are Indian patients exposed to medical equipment discarded in other countries, we’re taking on the burden of disposal of medical electronic waste,” said Bejon Misra, founder of the group that filed the petition.

The committee’s clearances specify that refurbished products are “for re-use purposes and not to be re-exported” and must be disposed of under rules for hazardous wastes at the end of their life.

Reddy has questioned the committee’s decisions in the midst of the high court proceedings. The court has issued notices to the health ministry, the CDSCO and the environment ministry, among other departments.

One of the companies that has received approvals has defended the imports.

Intuitive Surgical India, which has clearance to introduce refurbished surgical robotic units, said reconditioned systems had “safely expanded access to advanced surgical care” worldwide, including in India, the company told this newspaper via email.

The company did not respond to questions about what proportion of its India installations are refurbished or
how much lower such units cost buyers.

Intuitive said its refurbished systems followed the same standards of quality, performance and safety as new devices and are used by surgeons across the US, Europe and Asia-Pacific. Developing reconditioned systems, the company said, is part of its commitment to “responsible innovation”.