Concerns Raised For Import Of Refurbished Medical Equipment

New Delhi, Oct 26 (KNN) Indian medical device manufacturers have raised strong objections to the recent government move permitting the import of pre-owned, refurbished high-end and high-value (HEHV) medical equipment, such as CT scanners, MRI machines, and robotic assistance systems.

They argue that the policy endangers the nascent domestic industry, which is striving to align with the Aatmanirbhar Bharat vision of self-reliance.

The concerns follow an office memorandum (OM) issued by the Ministry of Environment, Forest, and Climate Change, revising the list of HEHV medical devices allowed for import. 

The updated list now includes 38 devices, down from the earlier 50, but notably removes a crucial clause that previously prohibited imports of refurbished equipment already manufactured within India.

Industry groups warn that this policy shift undermines local manufacturers' efforts and could jeopardise recent investments. “Many domestic projects launched to manufacture high-end equipment are now at risk, while patient safety is compromised by the use of non-calibrated or inadequately regulated devices,” said Rajiv Nath, forum coordinator at the Association of Indian Medical Device Industry (AIMED). 

He also pointed out that this move conflicts with the goals of the National Medical Devices Policy 2023, launched by Prime Minister Narendra Modi.

Manufacturing associations have requested Union Health Minister J.P. Nadda’s intervention, urging the withdrawal of the policy. They argue that while Indian companies have successfully developed devices meeting international standards, allowing refurbished imports creates unfair competition, disincentivizing further domestic innovation and investment.

“Indian manufacturers are actively developing advanced medical solutions aligned with the Make in India initiative,” said Sudhir Srivastava, former chair of the medical device committee at the PHD Chamber of Commerce and Industry (PHDCCI). 

“Refurbished devices often lack the latest technological upgrades, offer limited warranties, and have inadequate service support, all of which impact care quality and surgical outcomes.”

Industry representatives further expressed concern that startups and MSMEs in the sector may struggle to survive if refurbished imports flood the market, leading to potential shutdowns of local production units.

The debate around these imports has also reached the legal arena. In May, the Patient Safety and Access Initiative of India Foundation (PSAIIF) filed a Public Interest Litigation (PIL) in the Delhi High Court, demanding stricter regulations on second-hand medical devices to ensure patient safety and quality control.

As stakeholders await the government’s response, the future of India’s domestic medical device industry hangs in the balance.

(KNN Bureau)