STEM CELL THERAPY AND ITS EVOLVING REGULATORY LANDSCAPE: PERSPECTIVES FROM INDIA, USA, AND EUROPE

Neha Chaudhary, Arpana Rana**, Shivali Rahi 

ABSTRACT

Stem cells are unspecialized cells with the ability to self renew and differentiate into specialized cell types, positioning them at the forefront of regenerative medicine. Their therapeutic potential offers new hope for conditions once considered incurable, including leukemia, Parkinson’s disease, and multiple sclerosis. However, the clinical translatio n of stem cell therapies is constrained by ethical concerns, manufacturing challenges, and divergent regulatory frameworks. This article provides a comparative overview of the current regulatory systems in India, the United States, and Europe. By analyzing similarities and differences in approval pathways, oversight mechanisms, and compliance requirements, it underscores the need for harmonized global standards to ensure both patient safety and the advancement of innovation in regenerative medicine.

Keywords: Stem cells; Stem cell therapy; Regulation; India; USA; Europe; Regulatory pathway