THE RECLASSIFICATION OF RX TO OTC DRUGS IN BRAZIL: PERSPECTIVES, CHALLENGES AND OPPORTUNITIES

Abstract

The reclassification of prescription-only medicines (RX) to over-the-counter (OTC) drugs is a growing trend in the global pharmaceutical market, driven by patient autonomy, health system relief, and industry expansion. This article examines the regulatory, economic, and social aspects surrounding drug reclassification in Brazil, highlighting the ongoing debate on drugs such as proton pump inhibitors (PPIs), which are currently under evaluation by ANVISA. Based on a literature review, document analysis, and updated market data, the study identifies opportunities and insights regarding the expansion of the OTC market in the country.