Regenerative medicine in India: A landscape review of scientific progress, regulatory pathways, and future opportunities

• Author Details:   
• Rakesh Pandit ^*
• Ashutosh Shukla
• Nikita Paliya

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India stands at a unique and pivotal crossroads in the global landscape of regenerative medicine. With its vast patient population, skilled scientific workforce, and burgeoning biotechnology sector, the nation holds immense potential to become a leader in this revolutionary field. This comprehensive review synthesizes the current state of regenerative medicine in India, examining the three core pillars that will define its future: scientific progress, regulatory pathways, and persistent challenges. We analyze the significant advancements in stem cell research, particularly with Mesenchymal stem cells (MSCs) across various clinical applications including orthopedics, cardiology, and dermatology and also discuss the emergence of other advanced cell-derived therapies. We then delineate the evolution of India's regulatory framework, from its early, ambiguous phase to the current dual-pronged structure governed by the National guidelines for stem cell research (NGSCR) and the New drugs and clinical trials rules (NDCTR, 2019). This framework critically distinguishes between minimally manipulated cells for autologous use and substantially manipulated cell-based products classified as "drugs." However, significant hurdles remain, including the persistent ethical quandary of "stem cell tourism," a critical deficit in GMP-certified manufacturing facilities, and the "valley of death" in funding that stalls the translation of promising research into clinical therapies. The high cost and affordability of these novel therapies also pose a significant challenge to widespread access. This review concludes that for India to realize its potential, a concerted effort is required from policymakers, scientists, clinicians, and industry stakeholders to strengthen regulatory enforcement, build indigenous manufacturing capacity, foster an ecosystem for innovation streamline commercialization processes, and ultimately ensure that advanced therapies are safe, effective, and accessible to its population.