All Medical equipment notified as drugs

Note4Students

Mains Paper 2: Governance | Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level:  Not Much

Mains level:  Regulating medical and diagnostics devices & services


News

  • All implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator have been notified as drugs with effect from April 1, 2020.
  • The Central Drugs Standard Control Organization (CDSCO) is the national medical device regulator for its sale and use.

Why such move?

  1. A majority of medical devices are unregulated in India.
  2. These eight medical equipments have been notified as ‘drugs’  under Section 3 of the Drugs and Cosmetics Act, 1940.
  3. This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.
  4. This will regulate medical and diagnostics devices in the country.
  5. It will create a new regulatory marketing approval system and the government can keep a tab on importers as well as manufacturers.

Criticisms

 

Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.
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