Regulatory Affairs Department, Dayanand Education Society’s Dayanand College of Pharmacy, Latur, India
*Corresponding author. E-mail address: pradnyashinde951@gmail.com (P L Shinde)
Online Published on 02 February, 2026.
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.
This research aims to provide comparative examination of requirements for prescription labelling in three regulatory super jurisdictions: The United States of America, the European Union, and India.
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. This study identified regulatory gaps, industry challenges, and potential harmonization strategies to facilitate global trade. By understanding these frameworks, stakeholders can navigate compliance more efficiently, fostering growth in labelling practices across the USA, Europe, and India.
Drug Labelling, Label, Package insert, SmPC, US FDA, CDSCO, EMA
