Health Ministry notifies four more devices under Drugs and Cosmetics Act

Overview: 

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.

Influence:

• 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.
• Also, companies which are engaged in the manufacture and import of these equipment, will have to seek the necessary permission or license from the Drug Controller-General of India.
• 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.

Behind the scene:

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.

Know more about DTAB:

• Drugs Technical Advisory Board (DTAB) is the highest decision-making body under the Union health ministry on technical matters.
• Director General of Health Services (DGHS) is the ex-officio chairman of this statutory body which is constituted by the ministry under section 5 of the Drugs and Cosmetics Act.

Sources: the hindu.