Make or unmake in India. Fault lines persist on the reuse of pre-owned medical devices

A fortnight ago, a forum representing Indian makers of medical devices put out an explosive statement against what they called the “unmake in India” drive.

Pointing to the Centre’s decision to allow the import of pre-owned medical devices, the Association of Indian Medical Device Industry (AIMED) said, the move would hurt local entrepreneurs investing in manufacturing devices. And, it would put patient safety at risk, as it remained unclear who would regulate the import of these refurbished products, they said.

AIMED’s statement alleging that industry platforms like FICCI’s Medical Devices Committee (MDC) did not stand by local entrepreneurs was followed by a flurry of counter statements from the MDC and others, dismissing the allegations. A clear indication that the issue simmers, with some legitimate concerns still in need of scientific answers.

Substantial need

Chaitanya Sarawate, President and Chief Executive, GE HealthCare South Asia and Managing Director, Wipro GE Healthcare, explains, India has a high disease burden and there is a “substantial need” to bring in high-quality refurbished products to bridge the gap that exists in availability.

Only those products refurbished by the original equipment manufacturer (OEM) in the same facility and with the same components would be imported, he said, addressing fears that India could become a dumping ground for substandard, cheap and unsafe (even radioactive) products that could be brought in by traders.

Not all healthcare institutions in the country can buy new products and some centres may not need all features in a medical equipment. Refurbished products can be purchased in smaller centres at a 35 per cent lower cost, he estimates. At present, the country has kept critical care products out of the purview.

So why don’t hospitals or countries take back their own refurbished medical devices? Developed regions including the US, Europe, Japan and Singapore accept refurbished products, he said. But individual institutions may have their own rules (on equipment replacement) and requirements. Some regions have mandatory obsolescence limits, he points out, that would require replacing existing medical equipment.

Sarawate believes that GE Healthcare has a “unique perspective” on the issue as they are a multinational, and they design and manufacture components in India. “We are a local manufacturer and exporter as well,” he added. In fact, the refurbishment business was already a $400 million business for the company when it started the same in India (2009), he says.

“There is enough space in the market for refurbished and new products,” he says, allaying concerns of local manufacturers getting elbowed out of the marketplace. Further, he adds, only products not presently being made in India are being allowed and the imports will be governed by “multiple entities”, he said, even as the medical devices sector pushes for a consolidation of regulatory authorities.

Some industry representatives say, the focus should be on weeding out unscrupulous traders who bring in cheap and unsafe medical devices. Allowing OEMs will help the country transition to a time when more local manufactures populate the local marketplace and bring in competition, helping to bring down prices.

Risk to patients

AIMED’s Rajiv Nath says patient safety is clearly at risk as the refurbished products allowed are not regulated. Presently only Class A and B devices (low to moderate risk) are regulated. The rest are to be covered only by October, he says, cautioning on the risk of contaminated products coming into the country. Concern on re-use comes-up even as aggrieved patients point to faulty original products — the hip implant controversy, being a case in point.

Disagreeing that products not made in India are being allowed as refurbished imports, Nath says, a large number of the listed products have local manufacturers. Allowing a refurbished product will discourage local entrepreneurs investing and making products here, he says, pointing to the evolution of the automobile and telecom sectors that have a thriving local market.

He says countries such as China, Vietnam, Egypt, Peru do not allow refurbished products in their country. And on cost, he asks, if the private hospital buying the equipment will pass on the price-cut to consumers depending on whether they were tested using a new or refurbished product.

The reuse decision conflicts with India’s approach to become self-reliant and export to the world, Nath says, adding that it goes against the National Medical Device Policy, 2023, and the PLI (production linked incentive) scheme to encourage local manufacturing.

“India needs to stand on her own feet. This move makes her stumble,” he says, calling for a recall of the official memorandum that green-lit the imports of refurbished medical devices.

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