In a significant move to safeguard patients as artificial intelligence becomes more prevalent in healthcare, the government has brought AI-based cancer detection and diagnostic software under formal regulatory control. Authorities will now regulate these technologies on par with medical devices.
CDSCO Classifies AI Cancer Software as 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 X-rays, CT scans, and other medical images will now fall under the Class C medical device category. This classification applies to products considered to carry moderate to high risk.
Mandatory Approval, Validation, and Monitoring
As a result of the new classification, hospitals and diagnostic centres using such AI tools will require official regulatory approval before wider clinical deployment. Developers must conduct safety and performance validation, comply with quality standards, and report any adverse events linked to patient safety. Additionally, regulators will subject these tools to ongoing monitoring throughout their lifecycle.
Experts Welcome Timely Regulatory Clarity
Welcoming the move, Dr Pallavi Shukla, Associate Professor of Preventive Oncology at AIIMS New Delhi, said a clear regulatory framework is critical to ensure ethical AI use and protect patients. While AI shows promise in cancer screening—particularly for cervical, lung, and breast cancers—she noted that most AI tools in India remain at the research stage due to limited availability of Indian datasets. Consequently, they are not yet ready for routine clinical use.
She added that the regulatory step is timely, as it provides oversight of a rapidly evolving field before large-scale adoption.
Growing Role of AI in Cancer Screening and Diagnosis
Health experts pointed out that AI tools are increasingly influencing decisions related to cancer screening and diagnosis. Therefore, bringing these technologies under regulation marks an important step in strengthening patient safety and clinical accountability.
Setting the Stage for Broader AI Regulation in Healthcare
As reported by TOI, officials indicated that this move could set a precedent for regulating other AI-based medical devices and software as their clinical applications expand. India has also witnessed a surge in startups offering AI-driven cancer screening solutions, often claiming early detection advantages. Regulators clarified that the new framework aims to ensure such claims undergo scientific validation and do not compromise patient safety.
Dynamic Framework to Evolve With Technology
Finally, CDSCO stated that the risk classification list will undergo periodic review to keep pace with rapid technological advancements, ensuring that regulation remains relevant and responsive as AI continues to evolve in healthcare.