<p>This review explores the regulatory challenges and opportunities for the development of drug delivery systems (DDS) in emerging markets such as India, China, and Brazil. It highlights the evolving regulatory frameworks, the harmonisation of national standards with international guidelines, and the rapid growth of healthcare infrastructure in these regions. Despite challenges like resource constraints, the lack of specialised regulations for novel DDS technologies, and the prevalence of counterfeit drugs, the increasing demand for advanced therapies presents significant opportunities for pharmaceutical companies. Regulatory reforms, including fast-track approval processes and investment in healthcare, create a conducive environment for the growth of DDS, especially in chronic disease management, targeted drug delivery, and biologics.</p>