Blood pressure monitors, nebulizers other medical devices may cost less

Blood pressure monitors, nebulizers other medical devices may cost less

News:

Medical devices like nebulizers, blood pressure monitors, notified as drugs under Drugs and Cosmetics Act Facts:

• The Drug Technical Advisory Body (DTAB) had cleared the proposal to include blood pressure monitoring devices, nebulizers, digital thermometers and glucometers under the purview of the Drug law.
• After the proposal medical devices may cost less.
• The Drug Controller General of India (DCGI) would regulate the import, manufacture and sale of these devices from January 1, 2020.
• As of now, just 23 medical devices are monitored for quality by DGCA. With the inclusion of four new devices, there will be 27 medical devices under the definition of drugs under the Act.
• Other medical equipment is currently sold without any clinical trials or quality checks.
• 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 ministry has also proposed to expand the list of devices in eight new categories, including MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator, under the purview of the drug law.

Additional Information:

• About Drug Technical Advisory Body (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.