Deependra Nath Pathak, Radha Ranjan, Ms. Anupam Sinha, Pushpendra Kumar Anuragi, Dr. Govind Prasad, Vyas Kumar Yadav
The rapid evolution of advanced drug delivery technologies — encompassing nanotechnology-based carriers, artificial intelligence (AI)-guided therapeutics, combination products, and personalised medicine platforms — has fundamentally outpaced the regulatory and legal architectures designed to govern pharmaceutical innovation. This paper undertakes a comparative analytical examination of the legal frameworks applicable to advanced drug delivery technologies across three principal jurisdictions: the United States of America (USA), the European Union (EU), and the United Kingdom (UK). Drawing on doctrinal legal methodology, the study interrogates how existing pharmaceutical law, product liability doctrine, intellectual property regimes, and emerging AI governance instruments intersect — and often conflict — when applied to novel drug delivery systems. Key findings reveal structural fragmentation in regulatory classification, unresolved liability attribution in AI-integrated drug delivery, substantial intellectual property challenges unique to nanomedicine, and the legal inadequacy of emergency authorisation frameworks originally designed for conventional pharmaceuticals. The paper concludes with a call for adaptive, technology-neutral legislative reform and stronger international regulatory harmonisation, particularly under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).