Strategic integration of 3D Cell culture and regenerative biomedical technologies in India's biomedical ecosystem: Aligning with the global transition toward human-relevant drug development.

Three-dimensional (3D) cell-culture and organ-mimetic systems are transforming biomedical research by offering physiologically relevant models for drug screening, toxicology and regenerative medicine. With enactment of the U.S. FDA Modernization Act 2.0 (2022) and the introduction of Act 3.0 (2024), the European Medicines Agency (EMA)'s endorsement of new approach methodologies (NAMs) and UK government's roadmap to replace animal testing (2025) the regulatory science has shifted toward human-relevant models. However, the development of these technologies in India remains limited to a few leading institutes. This manuscript presents a perspective on adoption of a national strategy for popularizing 3D culture and regenerative biomedical solutions within Indian institutions, with the long-term goal of integrating them into the central drugs standard control organisation (CDSCO), biotechnology for economy, environment, and employment (BioE3) and anusandhan national research foundation (ANRF) mandates, thus aligning them with the India Vision 2047. It reviews Indian and global landscape, identifies skill and infrastructure gaps, and proposes policy and implementation frameworks, emphasizing on capacity building, regulatory incentives and industry-academia collaboration. A roadmap for establishing regional hubs and harmonized standards has been proposed to enable India to emerge as a Global South leader in ethical and cost-effective alternatives-to-animal testing.