Abstract

Nanotechnology has catalyzed a paradigm shift in biomedicine by enabling manipulation of materials at the 1–100 nm scale where unique physicochemical properties emerge. Nanocarriers (liposomes polymeric nanoparticles dendrimers micelles) inorganic platforms (gold silica iron-oxide) and biologically inspired systems (exosomes) are reshaping drug delivery onco-therapeutics diagnostics and regenerative medicine. This paper synthesizes state-of-the-art advances and barriers in nanomedicine focusing on translational pipelines safety-by-design and regulatory science. Special attention is given to India’s ecosystem (CSIR labs IITs DBT/ICMR programs startups) and global comparators. While meta-analyses show improved therapeutic index and reduced systemic toxicity for approved nanoformulations challenges persist around immunogenicity long-term biodistribution scale-up quality-by-design manufacturing and ethical concerns including equity of access and data/privacy risks in nano-enabled diagnosti