Medical devices which do not fall under the Drugs and Cosmetics Act are currently sold without quality checks by the government. When the proposal to add the four devices to the list of "drugs" gets accepted, it will mean that they will need to get approval or a license from the Drug Controller General of India.
The medical equipment used by patients to monitor their health at home is all set to go through mandatory quality checks before it can be purchased from a store.
Currently, 23 medical devices fall under the definition of drugs under the Drugs and Cosmetics Act, and soon, nebulisers, blood pressure monitors, digital thermometers and glucometers will be added to the list. Here’s what this means:
1. When the proposal to add the four devices to the list of “drugs” gets accepted, it will mean that they will need to get approval or a license from the Drug Controller General of India (DGCI). This will be effective from January 2020 onwards.
2. Nebulisers, blood pressure monitors, digital thermometers and glucometers will have to be registered under and abide by the quality parameters that are prescribed under the Medical Devices Rules, 2017.
Apart from this, they will also have to follow the standards set by the Bureau of Indian Standard (BIS) certification.
3. Medical devices which do not fall under the Drugs and Cosmetics Act are currently sold without quality checks or clinical trials by the government. This proposal promises these tests by the DGCI, ensuring that the devices you use at your home give reliable and consistent results.
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4. A notification by the ministry of health sent out on December 3 reads, “[The ministry]… has specified devices intended for use in humans for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, to be included in the definition of drug under the Drugs and Cosmetics Act, 1940.”
5. The ministry has also proposed to expand the list from 27 devices into eight categories.
These will include MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines as well as bone marrow cell separators. Whether to get these devices under the drug law is still under purview.
6. When the devices come under the Drugs and Cosmetics Act, they may also cost less than what they do now.
(Edited by Gayatri Mishra)