The Drugs Controller General of India, Rajeev Raghuvanshi, said AI's rapid evolution is a "moving target" for regulators, making it difficult to set fixed safety guidelines for healthcare and pharmaceutical applications. Speaking at the Indian Institute of Management Ahmedabad Healthcare Summit on Saturday, he said traditional frameworks built for static products cannot keep pace with AI systems that update continuously.
Raghuvanshi pointed to the range of AI uses in the sector, from diagnostic algorithms to drug discovery models, as evidence that regulatory approaches need to change. He said the situation demands adaptive rules that respond to iterative software updates without weakening patient safety or data protections.
Bias and accountability concerns
The DCGI also raised concerns about algorithmic bias, transparency, and accountability in AI-driven medical tools. He urged stakeholders to work together on validation standards and post-market surveillance so problems can be caught after deployment, not just before approval.
He called for a multi-disciplinary task force of technologists, clinicians, ethicists, and policymakers to build a forward-looking regulatory system. The proposal reflects a broader global debate about AI governance, with India trying to position itself as a leader in digital health while still protecting public health.
For professionals working in healthcare, the practical question is how to integrate AI tools when the rules around them remain unsettled. Courses such as AI for Healthcare can help clinicians and administrators understand the capabilities and limits of these systems. Those in compliance roles may find AI for Regulatory Affairs Specialists useful as they track shifting expectations from agencies like the CDSCO.
Why this matters for healthcare professionals
If you work with AI-assisted diagnostics, clinical documentation, or drug development, expect validation requirements to tighten as regulators catch up. The DCGI's remarks signal that India's oversight of AI in health is moving from informal guidance toward structured review - and that means your organization should document how its AI tools are tested, monitored, and updated. Start building an audit trail now, before compliance becomes mandatory.
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