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Medical devices to come under drug regulator
Why is it in the news?
- According to credit rating agency ICRA, the Centre’s decision to notify all medical devices as drugs and bringing them under purview of the Drugs and Cosmetics Act, 1940,from April is bound to push up the cost.
More in the news
- Background:
(1) The government has recently issued a notification to consider all medical devices as drugs.
(2) It would bring the devices under the purview of the drugs regulator and tightening regulations for them to improve safety and quality.
- Re-categorization:
(1) The notification will also re-categorize medical devices that are used for life support, diagnosis, treatment or alleviation of any disease or disability.
(2) These effectively cover all medical devices that are sold in the market.
- Currently,
(1) Medical devices are classified under four categories.
(2) Class A and B medical devices are low-risk ones like surgical dressing, alcohol swabs, thermometers, blood pressure monitoring devices among others.
(3) Class C and D are high-risk devices like implants, hemodialysis catheters, angiographic guide wire and heart valve.
- Under medical devices rules,
(1) Low risk-devices are inspected by private notified bodies while licenses were given by CDSCO.
(2) For high-risk devices, inspection and licensing are both done by CDSCO.
(3) The increased scrutiny on medical devices comes in the aftermath of Johnson & Johnson’s faulty hip implants.
Source
The Hindu, LiveMint