As artificial intelligence (AI) rapidly gains ground in healthcare and pharmaceuticals, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi raised concerns about the regulatory challenges that could emerge as AI moves closer to patient-facing medical decisions. Speaking at the third edition of the IIMA Healthcare Summit in Ahmedabad, Raghuvanshi highlighted the need for greater clarity around AI-powered healthcare technologies, particularly when they begin influencing treatment decisions.
‘AI Doctor’ Exhibit Raises Regulatory Questions
During a walkthrough of the exhibition stalls at the summit, Raghuvanshi encountered an exhibit promoting an “AI Doctor”. The demonstration prompted him to question how regulators should approach AI systems that increasingly perform functions traditionally associated with healthcare professionals. According to Raghuvanshi, AI already supports healthcare in multiple ways. However, its rapid evolution presents significant regulatory challenges, particularly because it is not always clear whether certain AI-powered solutions fall within the existing definition of medical devices.
AI in Healthcare Is Already Underway
Raghuvanshi stressed that the question is no longer whether AI will enter healthcare. Instead, the focus should be on how AI will be regulated as its role expands. Currently, healthcare professionals use AI as a supporting tool for tasks such as analysis, diagnosis and drug development. However, the regulatory challenge becomes more complex when AI starts providing recommendations directly to consumers. As a result, regulators may need to establish clearer frameworks governing AI-driven healthcare applications and their responsibilities.
Accountability Becomes a Key Concern
One of the DCGI’s primary concerns is accountability when AI provides medical recommendations. In conventional healthcare, a prescription creates a clear chain of responsibility. A doctor evaluates the patient, makes a clinical decision and prescribes the appropriate treatment. This establishes professional accountability for the medical advice provided. However, if a mobile application independently recommends what a consumer should take or do, that accountability becomes less clear. Raghuvanshi questioned where responsibility would lie if an AI-powered application effectively dictated a patient’s course of treatment without direct involvement from a doctor.
Need for Clear AI Regulations in Pharma
The rapid adoption of AI across the pharmaceutical and healthcare sectors therefore creates a need for clear regulatory guidelines, defined accountability and appropriate safeguards. As AI technologies become increasingly sophisticated, regulators will need to determine how these systems should be classified, evaluated and monitored. In particular, applications that directly influence diagnosis or treatment may require closer regulatory oversight.
Balancing AI Innovation with Patient Safety
AI has the potential to transform healthcare by improving efficiency, supporting drug development and assisting medical professionals. Nevertheless, the technology also introduces new challenges when it begins influencing patient decisions directly. Therefore, as reported by thehindubusinessline.cm, the healthcare industry and regulators will need to work together to establish a framework that encourages AI innovation while protecting patient safety and maintaining accountability.
