Comparative Study of Regulatory Guidelines for Over-the-Counter (OTC) Drugs in India, the United States, and Europe

Abstract

The regulation of over-the-counter (OTC) medicines plays an important role in ensuring consumer safety and
healthcare accessibility. This review compares OTC regulatory frameworks in India (CDSCO), the United
States (FDA), and the European Union (EMA), focusing on legislation, classification systems, labelling, and
pharmacovigilance. The analysis highlights that India lacks a formal OTC category, a defined Rx-to-OTC
switch pathway, and a robust surveillance system for non-prescription medicines. In contrast, the USA's
CARES Act (2020) modernised the OTC Monograph System, while the EU maintains a comprehensive
regulatory framework through EMA and national authorities. The review identifies key regulatory gaps in
India and proposes reforms to improve consumer safety and align with international standards