Medtech industry flags risks of importing refurbished medical devices

Medical device manufacturers' and industry bodies have raised concern over a recent memorandum by the Union Environment Ministry that allows the import of refurbished medical devices, highlighting potential risk to patients and undermining India’s push towards self-sufficiency.

The ministry has issued a revised list of refurbished equipment, including devices like MRI and CT scan machines, high-end operating microscopes and 34 other devices.

Industry experts highlight that while the industry has developed devices meeting international quality standards, it is irrational to permit refurbished medical devices to compete with locally made new products.

They also urged Prime Minister Narendra Modi to order a ban on the import of refurbished devices that are manufactured locally.

The Association of Indian Medical Device Industry (AiMeD) warned that imported devices were often inaccurately labelled, posing a significant risk to safety. The lack of clear refurbishment guidelines in India allowed unscrupulous traders to import substandard equipment.

Rajiv Nath, forum coordinator, AiMeD said, “The Office Memorandum (OM) issued by the Environment Ministry undermines the National Medical Devices Policy 2023, which was launched by Prime Minister Narendra Modi. It allows the import of pre-owned medical equipment into India, putting the investments made by Indian and overseas manufacturers under the "Make in India" initiative at risk of becoming non-performing assets (NPAs), some of which are ironically subsidised by the Government of India under its PLI scheme.”

He said the investors would only bring manufacturing technologies to India if the policy environment was predictable, adding that India must not become a dumping ground for obsolete medical equipment.

Chandra Ganjoo, Chief Executive Officer of Trivitron Healthcare, said, “The import of refurbished medical devices will have a long-term impact on the Indian healthcare ecosystem and pose a direct threat to India’s vision of Atmanirbhar Bharat. The refurbished equipment will be a hindrance to the growth of India’s medical device industry. This approach discourages focus on research and development and limits innovation, which are crucial for driving the country's healthcare forward.”

Viswanathan Santhanagopalan, CEO and MD, Sequoia Healthcare, pointed out that hospitals and diagnostic centres charged patients the same fee, regardless of whether they used new or refurbished equipment, which meant no cost benefit was passed on to patients, while outdated technology was employed.