Open AccessPACKAGING AND LABELING REQUIREMENTS OF PHARMACEUTICALS IN REGULATED MARKETS LIKE U.S.A. AND INDIA
Author(s) -
Sakshi Agarwal,
D. B. Singh,
Sandeep Kumar Voore
Publication year - 2019
Publication title -
journal of biomedical and pharmaceutical research
Language(s) - English
Resource type - Journals
eISSN - 2589-8752
pISSN - 2279-0594
DOI - 10.32553/jbpr.v8i2.589
Subject(s) - innovator , business , product (mathematics) , quality (philosophy) , packaging and labeling , medical prescription , risk analysis (engineering) , control (management) , marketing , computer science , pharmacology , medicine , finance , mathematics , artificial intelligence , philosophy , geometry , epistemology , entrepreneurship
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.