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Govt notifies commonly used medical devices as drugs

Govt notifies commonly used medical devices as drugs

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.

Highlights of the decision

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 equipment are sold without any quality checks or clinical trials.

Road Ahead:

The Indian government is also planning 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.

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.

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