Health Ministry notifies four more devices under Drugs and Cosmetics Act

•  Recently Government has notified commonly used medical devices such as nebulizers, blood pressure monitors, digital thermometers and glucometers under the Drugs and Cosmetics Act.
• 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 is sold without any quality checks or clinical trials.

Impact:

• 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.

About DTAB:

• DTAB is highest statutory decision-making body on technical matters related to drugs in the country.
• It is constituted as per the Drugs and Cosmetics Act, 1940.
• It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.

Functions:

• Laying down the safety and quality standards for drugs, cosmetics, diagnostics, and devices. Regulatory the marketing of new drugs.
• Publishing and updating the Indian Pharmacopoeia.
• Guiding on technical matters and monitoring adverse drug reactions.
• Screening the drug formulations that are available in the Indian market.

By: Vishal