India’s drug regulator is considering a proposal that would allow hospitals to directly import high-end medical equipment, eliminating the need to route purchases through conventional procurement channels and licensed importers.
According to ET, the proposed framework covers around 80 sophisticated medical devices, including MRI machines, CT scanners, PET-CT systems, SPECT/SPECT-CT and Gamma cameras, mammography units, and advanced X-ray equipment.
The Central Drugs Standard Control Organisation (CDSCO) said the initiative is intended to help hospitals gain quicker access to cutting-edge medical technologies. However, the proposal has raised concerns among domestic medical device manufacturers.
At present, hospitals whether private institutions or major government facilities such as AIIMS must obtain import licences through the CDSCO, similar to authorised distributors. Government hospitals also face additional restrictions, as they can procure only those devices included in the global tender exemption list. CDSCO has invited stakeholder feedback on the proposal until June 22 and has also sought suggestions on additional devices that could be included.
Industry representatives opposing the move argue that the current system provides important safeguards. Licensed importers are responsible for ensuring regulatory compliance for high-risk Class C and D medical devices, securing approvals, verifying quality and performance standards, and offering installation and after-sales support.
“Licensed importers possess specialised expertise that most hospitals do not have,” said a medical device manufacturer who requested anonymity. Rajiv Nath, Forum Coordinator of the Association of Indian Manufacturers of Medical Devices (AiMeD), cautioned that bypassing authorised importers is not merely a procedural change but could pose significant safety concerns.