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