Medical Equipment Notified as ‘Drugs’

WHY IN NEWS?

The Ministry of Health and Family Welfare has notified that medical equipment would qualify as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act (D & CA), 1940 from 1st April, 2020.

ABOUT NOTIFICATION

• The Medical Devices Amendment Rules, 2020 were also released. The rules will also come into force from 1st April, 2020.
• The Rules state that the medical devices shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO).
• Such registration is voluntary for a period of 18 months, after which it will be mandatory.
• At present, only 23 medical devices have been classified as drugs. The latest notification gives a wide definition of the term medical devices.
• The devices used for diagnosis, monitoring, treatment, assistance for any injury or disability, investigation, replacement or modification or support of the anatomy or of a physiological process will come within the scope of the definition of ‘Drugs’.
• Medical equipment under this definition include implantable medical devices such as knee implants, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine etc.
• Primary intended action of the device in or on human body or animals should not be pharmacological or immunological or metabolic.
• The manufacture, import and sale of all medical devices will now need to be certified by the Central Drugs Standard Control Organisation.

DRUG TECHNICAL ADVISORY BOARD

• Drugs Technical Advisory Board is a statutory body constituted under the Drugs and Cosmetics Act, 1940.
• The function of DTAB is to advise the Central government and State government on technical matters related to drugs and cosmetics.

Prelims Question

Q. Consider the following statements regarding Drugs and Cosmetics Act (D & CA), 1940:
1.Medical equipment would also qualify as ‘drugs’ under Section3 of the Drugs and Cosmetics Act (D & CA), 1940.
2.Medical equipment under this definition does not include CT scan and MRI equipment.
Which of the statements given above is/are correct?
a)1 only
b)2 only
c)Both 1 and 2
d)Neither 1 nor 2

Answer to the Prelims Question