NEW DELHI: In a move aimed at protecting patients as artificial intelligence increasingly enters healthcare, govt has brought AI-based cancer detection and diagnostic software under formal regulatory oversight, treating them on a par with medical devices.According to a notification issued by Central Drugs Standard Control Organisation (CDSCO), software that uses artificial intelligence (AI) to detect or diagnose cancer by analysing X-rays, CT scans and other medical images will now be regulated as Class C medical devices, a category reserved for moderate-to-high risk products.The decision means that such AI tools — already being used in some hospitals and diagnostic centres — 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.Welcoming the move, Dr Pallavi Shukla, associate professor of Preventive Oncology at AIIMS New Delhi, said 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 — she noted that 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, she said, 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 the step could set a precedent for bringing other AI-based medical devices and software under formal regulatory oversight as their clinical role expands.India has seen a rapid rise in startups offering AI-driven cancer screening solutions, often claiming 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.
