Four new devices notified as drugs for regulation

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level:  Not much

Mains level: Issues related to medical devices, implants etc.


News

  • 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 Drugs and Cosmetics Act, 1940.

Why such move?

  1. The Drug Controller General of India (DCGI) would regulate the import, manufacture and sale of these devices from January 1, 2020.
  2. 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.
  3. This is a step which will enable the government to ensure their quality and performance.
  4. Once the proposal gets approved, it would mean companies which are engaged in manufacture and import of this equipment will have to seek necessary permission or license from the Drug Controller General of India.
  5. With this there are only 27 medical devices monitored for quality by the country’s drug regulator.

Expanding list of devices

  1. The health ministry has proposed expanding the list of devices in eight new categories, under the definition of ‘drugs’ to bring them under the purview of the Drugs and Cosmetics Act, 1940.
  2. The eight categories include implantable medical devices, MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator.
  3. The proposal 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 is under consideration.
Health Sector – UHC, National Health Policy, Family Planning, Health Insurance, etc.
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