Centre Brings AI-Based Cancer Detection Tools Under Regulatory Oversight

According to a notification issued by the Central Drugs Standard Control Organisation (CDSCO), software that uses artificial intelligence to detect or diagnose cancer by analysing medical images such as X-rays, CT scans, and other radiological data will now be regulated as Class C medical devices.

In a move aimed at strengthening patient safety amid growing use of artificial intelligence in healthcare, the Centre has brought AI-based cancer detection and diagnostic software under formal regulatory oversight, placing them on par with medical devices.

According to a notification issued by the Central Drugs Standard Control Organisation (CDSCO), software that uses artificial intelligence to detect or diagnose cancer by analysing medical images such as X-rays, CT scans, and other radiological data will now be regulated as Class C medical devices.

The category is reserved for products considered to carry a moderate-to-high risk to patients.

The classification brings such AI tools under the purview of mandatory regulatory approvals, safety validation, and post-market surveillance before they can be deployed widely in clinical settings. Developers and manufacturers will also be required to adhere to prescribed quality standards and report any adverse events or safety-related issues linked to their use.

The notification applies to AI-driven software currently being used or proposed for use in hospitals and diagnostic centres for cancer screening and diagnosis. Officials said the regulatory framework is intended to address the growing influence of algorithm-based tools in clinical decision-making.

Welcoming the move, Dr Pallavi Shukla, associate professor of Preventive Oncology at AIIMS New Delhi, said a structured regulatory framework is necessary to ensure ethical use of AI in healthcare and protect patient interests. She noted that while artificial intelligence shows potential in cancer screening—particularly for cervical, lung, and breast cancers—most AI tools in India are still in the research phase.

Dr Shukla added that the limited availability of Indian datasets has restricted the readiness of such technologies for routine clinical application, making regulatory oversight essential as the field evolves.

Health experts said the decision is significant as AI systems are increasingly being integrated into cancer screening and diagnostic workflows. Officials indicated that the move could also set a precedent for bringing other AI-based medical devices and software under formal regulation as their clinical use expands.

India has witnessed a rise in startups offering AI-driven cancer screening solutions, often promoting early detection capabilities. Regulators said the new framework seeks to ensure that such claims are supported by scientific validation and that patient safety remains central. CDSCO added that the risk classification list will be reviewed periodically to keep pace with technological developments.

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