Safety with affordability: New rules on medical devices should balance them

Imports should be restricted to original manufacturers or certified partners, while devices that are too old or have exceeded usage thresholds should be barred

An interdepartmental high-level committee of the central government is reported to have begun discussion on framing rules to regulate the entry of refurbished medical devices into India. The pre-owned equipment market, valued at about ₹1,500 crore, accounts for nearly 10 per cent of India’s medical-device sector. These machines help hospitals in small cities keep costs down, but at present, the Medical Devices Rules, 2017, do not differentiate between new and refurbished devices. Nearly 75 per cent of medical devices in India are imported, and shortages of MRI (magnetic resonance imaging) machines, CT (computerised tomography) scanners, ventilators, and dialysis equipment remain