As the government continues to chart plans to regulate the production, sale and import of all medical devices, clouds of confusion hover over the need for regulation, on whether to enact separate laws and the possible impact on the medical device industry.
The ministry of health and family welfare recently proposed to notify or include all medical devices under the Drugs and Cosmetics Act, 1940, to regulate them as per the provisions of that Act and the Medical Devices Rules, 2017. According to the draft notification, devices intended for use on human beings or animals should be treated as drugs with effect from 1 December 2019.
“We have proposed to include all devices, including an instrument, apparatus, appliance, implant, material or other article; whether used alone or in combination, including software or an accessory,” said a senior official at the Central Drugs Standard Control Organisation (CDSCO) under the ministry of health and family welfare.
Public health experts are, however, of the view that medical devices cannot be treated as drugs and the need to regulate all the devices should be seriously reviewed. The NITI Aayog, the government’s policy think tank, is also working on a proposal to classify medical devices on the basis of their usage and risk to human health. It has also proposed a separate body to regulate devices stating that authorities handling it should also have special expertise, which the CDSCO doesn’t have. – Livemint