India Lets Hospitals Skip Import Licenses for MRI, CT Scanners

India's drug regulator is proposing a rule change that would let hospitals import advanced medical equipment like MRI and CT scanners directly, bypassing the current license system. The stated goal is faster access to newer technology.

The domestic medical device industry is pushing back. Trade groups argue that licensed importers have the specialized expertise to handle high-risk equipment and verify quality. Hospitals, they say, do not.

The Drugs Controller General of India has floated the proposal for public comment. No timeline has been set for a final decision.

The change would cover equipment classified as medical devices under the Drugs and Cosmetics Act, a category that includes imaging machines, ventilators, and implantable devices. Current rules require an import license for each shipment, a process that can take weeks.

Hospitals have long complained that the licensing system delays upgrades and raises costs. The new proposal would allow institutions with a valid wholesale or retail drug license to import directly, cutting out the middleman.

Industry groups counter that the safety risks are real. A faulty MRI machine or a counterfeit component is harder to catch without a dedicated importer's quality checks, they say. The Association of Indian Medical Device Industry has asked the regulator to keep the license requirement in place.

The regulator has not indicated whether it will modify the proposal before issuing a final notification.