India is at a critical point in leveraging artificial intelligence (AI) for biotechnology innovation, aiming to become a global leader in AI-driven biomanufacturing. Initiatives like the BioE3 Policy and the IndiaAI Mission exemplify this ambition but face challenges from fragmented regulations and outdated safeguards. While India has a strong history in generic medicine and vaccines, the integration of AI is poised to revolutionize biomanufacturing, enhancing efficiency through predictive analytics and real-time monitoring. Companies like Biocon and Strand Life Sciences are already optimizing processes using AI. However, India’s regulatory framework struggles to keep pace with these advancements, raising concerns about reliability and safety. A call for context-aware, risk-based regulations akin to those in the EU and U.S. is crucial to ensure public trust and effective oversight. If India addresses these challenges promptly, it could secure a dominant role in the future of global healthcare and biomanufacturing.
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Aligning Ambitions: Can India’s Policies Support AI and Biomanufacturing Growth?

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