Published Paper Details:

This research provides comparative examination of requirements for prescription labelling in three regulatory super jurisdictions: the United States of America, the European Union, and India. Labelling on drugs is a vital communication means that facilitates proper use of medicine safely and effectively by communicating core information to prescribing physicians and patients. The research comprehensively analyses the regulatory directives for labelling exercises in these regulatory super jurisdictions, which include the guidelines of the U.S. FDA, the European Medicines Agency (EMA), and India's Central Drugs Standard Control Organization (CDSCO). Regulatory expectations regarding key components such as labelling formats, required content, language, and patient safety and risk communication strategies are found to be majorly similar and divergent, depending on differing public health priorities, legal requirements, and cultural norms. This study identifies regulatory gaps, industry challenges, and potential harmonization strategies to facilitate global trade and enhance consumer confidence. By understanding these frameworks, stake holders can navigate compliance more efficiently, fostering growth in labelling practices across the USA, Europe, and India. The conclusions highlight the necessity of balancing some labelling components to ensure global drug safety while acknowledging the necessity of local adjustments.