PACKAGING AND LABELING REQUIREMENTS OF PHARMACEUTICALS IN REGULATED MARKETS LIKE U.S.A. AND INDIA

Abstract

In pharmaceutical industry packaging and labeling plays a very important role. This article provides an overview of regulatory requirements and tests for Quality control and suitability of packaging and labeling of prescription and Over-The-Counter (OTC) Products in USA and India. The study has been informative to understand the need and importance of the labeling requirements of pharmaceuticals to protect the consumers by providing the suitable instructions for the use of the drug product at suitable place and suitable format. KEYWORDS: Innovator, Generics, PLR (Physician Labeling Rule), OTC, FPL (Final Printed Labeling), Testing of packages, ANDA, Regulatory requirements, USA, India Market.