Surgeons raise questions about clearance given to ‘made in India' ear implant

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Surgeons raise questions about clearance given to ‘made in India’ ear implant
© Provided by The Times of India

It is touted as the first cochlear implant to be manufactured in India. It was approved by the Central Drugs Standard Control Organisation (CDSCO) in May 2021. However, several cochlear implant surgeons and association have raised questions regarding safety and effectiveness as the new device has no publications on its performance or safety in any peer reviewed journal and doesn’t have approval in any other country.

The new implant, called Neubio Bold, is supposed to be the product of a technology transfer from Swiss company Neubio AG, set up in 2017, to its Indian arm SwitzNeubio, set up in 2019. Though it is a Swiss company, its product is used neither in Switzerland nor anywhere in Europe. One of the company directors, Parveen Khurana, in response to TOI’s queries, said the company has applied for approval in Europe.

As per CDSCO’s classification of devices based on risk, a cochlear implant is a class D device, which are high risk surgically implanted devices that would remain in the body for at least 30 days and can be removed only through medical or surgical intervention. CDSCO, when contacted, said they had well defined rules in place and that medical devices were approved subject to compliance of these rules. The company admitted to Cochlear Implant Group of India, the largest association of cochlear surgeons, that its implant has been approved only in India.

CDSCO approval to a device can be given without clinical investigation if it’s based on an approved device already in the market with similar intended use, material of construction and design characteristics. The company has to establish substantial equivalence with such a “predicate device” with respect to intended use, chemical composition, manufacturing process, performance, safety, effectiveness etc. In this case, none of these are available in public domain or to surgeons.

Switz Neubio said implant components are manufactured in Switzerland and shipped to India to be assembled, with only the electrodes being made in its Gurgaon unit, which has been inspected and approved by CDSCO. It claimed that around 300 of its devices were implanted in Pakistan and Iraq. Anecdotally, the outcomes have been very good, the company said, adding that there were no adverse events. The company said it intended to collect data from these nations and do studies and generate data to be published in peer reviewed journals.

“Even the government’s own DRDO-researched cochlear implant system, Sravan, is undergoing DCGI approved clinical trials, as we speak. When we are so by-the-book with our own product, how did this new device get licenses from CDSCO,” said CIGI president Sunil Narayan Dutt.

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