Medical devices regulation welcome

The government’s move to bring medical devices under a regulatory framework is welcome as it will ensure that some essential norms and rules are followed in this important area of medical treatment. The plan is to notify them as drugs and bring them under the purview of the Drugs and Cosmetics Act. The Central Drugs Standard Control Organisation (CDCSO) will act as the regulatory body. This is expected to ensure that medical devices meet certain accepted standards of quality and efficacy. The move is actually late. Many medical devices which are commonly used are known to be deficient in quality and cause harm or unintended side-effects to those who use them. Some of the issues related to medical devices came into the public domain recently in the wake of reports about some faulty hip implants supplied by Johnson & Johnson. The company had to withdraw the devices after cases of adverse effects and high failure rates were reported.

Concerns over patient safety and the need to make device manufacturers accountable for their products have increased after such incidents. More and more devices are being used in medical operations and it is right to treat them as drugs. This is in line with international practices. There is a large number and variety of devices and many kinds of materials with which they are made. There are also varied processes that are used to make them and different software codes that run them. The regulatory standards have to cover all of them. The devices range from simple blood pressure checking instruments to complex diagnostic or robotic machines. The regulatory norms may not be the same for all of them, but the rules will have to ensure the best standards of quality in all of them.

The entire system of registration, approval and introduction into the market of medical devices may change with the new regime coming into effect. It is important that the regulatory authority has the requisite skills and expertise in different fields like medicine, mechanics, electronics, etc., which go into the making and applications of the devices. There should also be a sound legal basis for the regulatory functions and actions. At present only a few devices have been notified. But in course of time, all the existing devices, about 6,000 in number, and those that will come into the market in future will have to be brought under the regulatory framework. India’s medical devices market is worth about $10 billion and is growing fast. Millions of people use them. Ensuring their safety and well-being should be the first priority of the regulatory regime, especially because people who use them often have little knowledge about them.