In a recent notification, the Central Drugs Standard Control Organisation (CDSCO) said that software using artificial intelligence to detect or diagnose cancer through X-rays, CT scans, and other medical images will now be treated as Class C medical devices, a category reserved for moderate-to-high risk products.
With this move, hospitals and diagnostic centres using such AI tools will no longer be able to deploy them freely. They will require official approval, safety validation and ongoing monitoring before widespread clinical use. Developers will also have to follow quality standards and report any problems linked to patient safety.
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Since India has seen a rapid rise in startups offering AI-driven cancer screening solutions, which often claim early detection benefits. Regulators said the framework intends to ensure such claims are scientifically validated, and patient safety is not compromised. The risk classification list, CDSCO said, will be reviewed periodically as technology evolves.
Welcoming the move, Dr Pallavi Shukla, associate professor of Preventive Oncology at AIIMS New Delhi, told TOI, "A clear regulatory framework is essential to ensure ethical use of AI and protect patients. While AI shows promise in cancer screening — particularly for cervical, lung and breast cancers — most such tools in India remain in the research phase due to limited Indian datasets and are not yet ready for routine clinical application. The regulatory step is timely and beneficial as it will provide oversight of a rapidly evolving field before wider adoption."
Health experts said, "The move is significant as AI tools increasingly influence decisions on cancer screening and diagnosis."
Officials added that the step could set a precedent for bringing other AI-based medical devices and software under formal regulatory oversight as their clinical role expands.
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