Thermometer, glucometer among four devices notified as drugs for regulation

Commonly used medical devices like 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.

The health ministry has proposed expanding the list of devices in eight new categories, under the definition of 'drugs' to bring them under the purview of the Drugs and Cosmetics Act, 1940.

The eight categories include implantable medical devices, MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator.

The proposal to bring high-end medical devices like implants, X-ray machines , MRI and CT scan equipment, dialysis machines under the purview of the drug law is

under consideration.

Once the proposal gets approved, it would mean companies which are engaged in manufacture and import of these equipment will have to seek necessary permission or license from the Drug Controller General of India.