A regulation has been passed by Union Health Ministry under which all medical devices used either on human beings or animals would be treated as drugs from April 1 this year, and would be dealt under Section 3 of the Drugs and Cosmetics Act.
Through a gazette notification, the ministry also released the Medical Devices Amendment Rules, 2020, for mandatory registration of all medical devices. In order to bring all the medical devices under the ambit of the new law, the ministry has defined medical device in such a way that no device can now escape from government regulation.
Various devices, including instruments, apparatus, appliances and implants, whether used alone or in combination for various purposes like diagnosis, prevention, monitoring, treatment, alleviation of any disease, investigation, replacement or modification or support of the anatomy among others, will be regulated under the new legislation. The ministry has made it amply clear that all the devices used for diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder will also be considered as medical devices. Besides, all devices used for diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability will also be considered as medical device.
Further, the government has brought all the devices which are used for supporting or sustaining life; disinfection of medical devices; and control of conception under the definition of medical devices.
Behind this amendment, the government’s intention is to ensure that all medical devices sold in the country meet certain standards of quality and efficacy. Besides, the new regulation will make medical device companies accountable for quality and safety of their products. At present, only 23 categories medical devices are regulated under the law and the remaining categories were being added in piecemeal. But, now the government has done well by bringing all devices under the ambit of the new law. The government’s welcome move in this regard is laudable as there are thousands of medical devices which are not regulated in the country at present. As the majority of medical devices are completely unregulated, there is always a question mark over the quality of these devices which are critical from a patient safety perspective.
Earlier from 1st April, the Central Drugs Standard Control Organisation will be the approving authority for import, manufacture and sale of all the medical devices in the country. Besides, the CDSCO will be the nodal authority to investigate complaints related to the quality and safety aspects of medical devices and can suspend the registration or cancel licences of firms. But, all said and done, the government should heed to the views of the experts that medical devices, if strictly speaking, cannot be treated as drugs. It needs a separate regulatory framework. So, this new ‘arrangement’ should be a temporary measure until the Centre’s policy think-tank NITI Aayog drafts a new Bill to regulate medical devices separately from drugs.