09 Dec 2018
Nebulizers, blood pressure monitors, digital thermometers, glucometers notified as drugs
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.
Here is more.
DTAB has approved proposal to include devices under Drug law
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 had issued the notification on December 3
"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 definition of drug under the Drugs and Cosmetics Act, 1940," the notification read.
"It's effective from January 1, 2020," it added.
Ministry may expand list, include devices in eight new categories
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 proposed eight categories by the ministry include implantable medical devices, MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines, and bone marrow cell separator.
If proposal gets approved, necessary permission/license would be mandatory
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 that are engaged in manufacture and import of these equipment will have to seek necessary permission or license from the Drug Controller General of India.
Medical devices monitored by drug regulator now increased to 27
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 equipment are sold without any quality checks or clinical trials.