Innovation regulator

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Innovation regulator

Thursday, 25 April 2019 | Pioneer

Innovation regulator

Medical devices have saved or improved millions of lives but their unregulated use has become a concern

There is little doubt that medical devices such as cardiac stents or implants for damaged bones and cosmetic improvements have had an impact on people’s lives. Cardiac stents and their ease of implantation have made major operations for blocked arteries a thing of past. Hip and knee implants have allowed millions of people with degenerative bone diseases to walk without pain again. Cosmetic implants have been around for a few decades and have improved the self-esteem of millions. However, a rash of cases in India and across the world have shaken the faith of people in implants and increased the calls for regulation in this sector. The Government has taken some steps in response. For example, the move to dramatically reduce the price of stents was seen as a way to prevent unnecessary procedures by hospitals seeking to line their pockets. However, there have also been cases where implants, hip and breast ones, have gone faulty. With the lack of tort law in India or the ability to have class-action lawsuits against manufacturers, many impacted individuals, particularly after the recent case involving faulty hip implants from American healthcare multinational Johnson & Johnson, have demanded that a regulator with the ability to fine and punish companies be established. This also highlights a bit of the ‘wild west’ nature when it comes to medical devices that are on the edge of technical innovation. India is a critical emerging market with a growing population that can afford the implants and other aids. However, with few rules and regulations, there have been rampant imports of pre-used devices and a lack of incentives for domestic manufacturing. At the same time, there were few legal remedies for patients impacted by poor quality devices or botched installations.

Given that medical devices are a rapidly emerging field of technology, it is vital that the government and the recently reconstituted Medical Council of India (MCI) work towards developing not just a scheme to compensate individuals but also have a regulator for them. While we can all see progress on smartphones, medical device technology is a rapidly evolving field whose capabilities are growing day after day. It is also a sector where major frauds have been perpetrated such as the former Silicon Valley darling Theranos. In India, we should not let our patients be bamboozled by technology and suffer as a result. The hoops through which many of the patients of faulty implants have had to jump through cannot be allowed to continue. There is no doubt that those impacted by poor devices are a fraction of those who have gained, but that does not mean that they fall by the wayside and suffer because something that was supposed to improve their lives has cursed them.

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