New Delhi: India’s drug regulatory authority has floated a proposal, seeking to create a framework under which hospitals would be permitted to directly import high-end and sophisticated medical equipment, bypassing conventional procurement and regulatory channels.
The proposed list has 80 items, including MRI machines, CT scanners, PET-CT systems, SPECT/SPECT-CT/Gamma cameras, mammography units and high-end X-ray equipment, according to documents seen by ET.
As per the Central Drugs Standard Control Organisation (CDSCO), the proposal is aimed at giving hospitals faster access to advanced medical technology. The move, however, has left the domestic medical device industry worried.
Under the existing regulatory framework, hospitals cannot import medical equipment directly. Institutions from private hospitals to leading government hospitals like the All India Institute of Medical Sciences must apply for an import licence through the CDSCO, just as licensed distributors do. Public hospitals face an additional layer of restriction, as they can only procure equipment that are on the global tender exemption list. The regulator, which made the proposals recently, has asked stakeholders to share their inputs by Monday and suggest more medical devices that could be put on the list.The existing system has several advantages, said local industry executives who oppose the proposal.
“Licensed importers who understand compliance requirements are responsible for handling high-risk Class C and D devices. They secure approvals, verify quality and performance and also provide installation and after-sales support. Hospitals, by and large, lack this specialised expertise,” said a manufacturer who did not wish to be named.
“Bypassing licensed importers is not just a procedural shortcut, it is a safety risk,” said Rajiv Nath, forum coordinator of the Association of Indian Manufacturers of Medical Devices (AiMeD).
