The Union Government has notified four commonly used medical devices including nebulisers, blood pressure monitors, digital thermometers and glucometers as drugs under the Drugs and Cosmetics Act.
The decision will enable the government to ensure their quality and performance. The Drug Controller General of India (DCGI) will regulate the import, manufacture and sale of these devices from January 2020.
The DTAB, the country’s highest drug advisory body, had approved the proposal to include the four medical devices under the purview of the 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.
Till recently, only 23 medical devices were monitored for quality by the nation’s drug regulator.
With the addition of these four new devices, the number of medical devices that will now fall under the definition of drugs under the Drugs and Cosmetics Act add up to 27.
The other medical equipments are sold without any quality checks or clinical trials.
The Union Ministry of Health had 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, to be effective from January 1, 2020.
The ministry had 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 included 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 the required approval, the companies engaged in manufacture and import of these equipment will have to seek necessary permission or license from the Drug Controller General of India.