The Centre has notified four medical devices as drugs bringing them under the ambit of regulation. According to a notification issued by the Union ministry of health and family welfare, effective from January 1, 2020, nebulisers, blood pressure monitoring devices, digital thermometers and glucometers will be classified as "drugs" under the Drugs and Cosmetics Act, 1940.
Currently, only 23 categories of medical devices are regulated as drugs, and their import, manufacture and distribution is regulated under the Drugs and Cosmetics Act, 1940. These include catheters, cardiac stents, drug eluting stents, intra-ocular lenses, disposable hypodermic syringes, heart valves and orthopaedic implants, among others. Besides these, other devices such as X-ray and CT scan equipment are also on the list of devices that are to be brought under the ambit of regulation.
"Devices such as nebulisers, glucometers and thermometers have been brought under the ambit of regulation since they are routinely used in households and affect people at large. For instance, glucometer will determine how much insulin you take, and a faulty reading could mean that you could be taking excess or even lesser dose of insulin. Similarly, a faulty reading on a BP device, or even a digital thermometer has the potential of causing harm to the patient," Dr S. Eswara Reddy, Drug Controller General of India, told THE WEEK. "We are planning to notify more devices as drugs depending on their risk factor," Reddy said. In May this year, a proposal to regulate high-end medical devices such as implantable medical devices, CT scan equipment and X-ray machines was cleared by the Drugs Technical Advisory Board.
While the notification to regulate the BP monitors and thermometers has come through, the same has not been done for other important devices such as implants and heart valves. “The government seems to be taking a piecemeal approach in the matter by bringing low risk, non-controversial devices such as thermometers and BP monitors, instead of say, implants. Regulation will ensure that both the quality and the pricing aspect of devices is brought under check,” said Malini Aisola, co-convenor, All India Drug Action Network.
However, the Indian medical device industry remains largely unregulated. The Medical Device Rules, 2017 (under the Drugs and Cosmetic Act, 1940) the rules define devices based on risk factor, among other specifications on certification that came into force this year, is being seen as beginning in the right direction. However, the medical devices industry has been asking the government for a new law to specifically govern medical devices, as opposed to being categorised as "drugs".
