Commonly used medical devices such as nebulizers, blood pressure monitors, digital thermometers and glucometers have been notified as drugs under the Drugs and Cosmetics Act, a step which will enable the government to ensure their quality and performance.
The Drug Controller-General of India (DCGI) would regulate the import, manufacture and sale of these devices from January 1, 2020.
All these devices will have to be registered under the quality parameters prescribed under Medical Devices Rules 2017 and other standards set by the Bureau of Indian Standard (BIS) certification.
The Drug Technical Advisory Body (DTAB), the country’s highest drug advisory body, had approved the proposal to include nebulizers, blood pressure monitoring devices, digital thermometers and glucometers under the purview of the Drug Law.
“The Ministry of Health has through a notification dated December 3, specified devices intended for use in humans for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, to be included in the definition of drug under the Drugs and Cosmetics Act, 1940; effective from January 1, 2020,” the notification read.
Currently, only 23 medical devices are monitored for quality by the country’s drug regulator. With four new devices being notified, 27 medical devices now fall under the definition of drugs under the Act. The other medical equipments are sold without any quality checks or clinical trials.