Regulatory Requirements for Packaging and Labeling of Pharmaceuticals in India and USA

Author(s)

Kashyap, R.

Author's Affiliation

Abstract

In pharma industry Packaging and Labeling plays very important role for improvements of attraction to human beings. This study 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 had been in formative 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. Guidance provides the recommendations for submission.

Keywords

Innovator, Generics, PLR (Physician Labeling Rule), OTC, FPL (Final Printed Labeling), Testing of packages, ANDA, Regulatory requirements, USA, India Market

Cite This Article

Kashyap, R. (2016). Regulatory Requirements for Packaging and Labeling of Pharmaceuticals in India and USA, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(1), 23-49.