India’s central government to regulate all medical devices as drugs

All medical devices in India will be regulated as drugs under Drugs and Cosmetic Act of 1940 with effect from April 2020.

This regulation would focus on ensuring all medical devices in India meets certain standards of efficacy and quality.

The current statistics showed that only 24 out of over 6,000 medical devices are regulated and being notified as drugs.
This change would potentially lead to a higher input cost, especially for local start-ups.

On the flip side, once devices are regulated they would give investors and surgeons the extra confidence to invest and try the products on patients. It will also inspire start-ups to do further research and innovation on medical devices.


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