In a significant step for healthcare safety, the Indian government has formally placed artificial intelligence (AI) software used for detecting and diagnosing cancer under strict regulatory oversight. This move treats these advanced digital tools with the same seriousness as traditional medical devices.
New Regulatory Framework for AI in Healthcare
The Central Drugs Standard Control Organisation (CDSCO) issued a notification that brings AI-based software analysing X-rays, CT scans, and other medical images for cancer under its purview. These tools will now be regulated as Class C medical devices, a category designated for products posing a moderate-to-high risk to patients.
This decision mandates that AI tools, which are already in limited use in some hospitals and diagnostic centres, must obtain official approval from regulators. Developers will be required to provide robust safety validation and their products will be subject to ongoing monitoring before they can be deployed for widespread clinical use. Furthermore, manufacturers must adhere to strict quality standards and report any incidents related to patient safety.
Expert Applauds Timely Move for Patient Safety
Health experts have welcomed this regulatory intervention. Dr. Pallavi Shukla, Associate Professor of Preventive Oncology at AIIMS New Delhi, stated that a clear regulatory framework is crucial to ensure the ethical use of AI and to safeguard patients.
While acknowledging the promise AI holds in screening cancers like cervical, lung, and breast cancer, Dr. Shukla pointed out a key challenge. Most such AI tools in India are still in the research phase, partly due to a lack of extensive Indian-specific datasets, and are not yet fully ready for routine clinical application. She described the regulatory step as both timely and beneficial, as it establishes oversight in a rapidly evolving field before these technologies see wider adoption.
Setting a Precedent for Future AI Medical Tools
The implications of this move are far-reaching. Health officials and experts believe it is a landmark decision because AI tools are increasingly influencing critical decisions related to cancer screening and diagnosis. The step is also seen as setting a potential precedent for bringing other AI-based medical devices and software under formal regulatory scrutiny as their role in clinical practice expands.
India has witnessed a rapid surge in startups offering AI-driven solutions for cancer screening, many promoting benefits like early detection. Regulators have clarified that the new framework aims to ensure that such claims are backed by scientific validation and that patient safety is never compromised. The CDSCO has also stated that the risk classification list will be reviewed periodically to keep pace with technological advancements.
This proactive stance by Indian health authorities marks a crucial effort to balance innovation with responsibility, ensuring that the integration of artificial intelligence into healthcare prioritises patient well-being above all.
