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All medical devices to be treated as ‘drugs’ from April 1

Topics covered :Statutory, regulatory and various quasi-judicial bodies. Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

All medical devices to be treated as ‘drugs’ from April 1

What to study?

For Prelims: The announcement.

For Mains: Why treat medical devices as drugs- need, concenrs and significance.

Context: The central government has notified all medical devices as ‘drugs’, effective from April 1, bringing a range of products from instruments to implants to even software intended for medical use in human beings or animals under the purview of the Drugs and Cosmetics Act, 1940. At present, only 37 medical devices are notified as drugs. The health ministry made some amendments to the Medical Devices Rules, 2017.
Significance and implications of this move:

  • Apart from expanding the scope of regulation to ensure safety and efficacy, the move may pave the way for regulation of prices under the Drugs Price Control Order (DPCO).
  • It will also make companies, in case of violations, liable to be penalised in a court of law.
  • Companies will now have to seek approval from the drug controller to manufacture, import and sell any medical device in the country.
  • 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.
  • The manufacturer of a medical device shall upload the information relating to that medical device for registration on the “Online System for Medical Devices” established by the CDSCO. Importers too will be required to do the same.

Sources: the Hindu.