DCGI warns of regulatory challenges as AI enters healthcare

Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), has raised concerns regarding the regulatory challenges posed by the rapid adoption of artificial intelligence in healthcare and pharmaceuticals. Speaking at the IIMA Healthcare Summit in Ahmedabad, Raghuvanshi noted that as AI moves closer to making patient-facing medical decisions, existing regulatory frameworks may be insufficient.

A primary concern involves the accountability of AI-driven recommendations. While AI currently serves as a support tool for diagnosis, analysis, and drug development, its evolution into systems that provide direct recommendations to consumers creates ambiguity. Raghuvanshi highlighted the difficulty in determining whether certain AI solutions fall under the current definition of medical devices and emphasized the need for clear frameworks to establish responsibility when AI influences treatment decisions.