V. Narasimhulu*, J. Praveen Kumar, P. Jaya Chandra Reddy
Krishna Teja Pharmacy College, Tirupathi, Andhra Pradesh, India
ABSTRACT
Regulatory affairs professionals are key players in drug development for obtaining approvals and maintaining life cycle management of both branded and generic drugs. Packaging has been around for many hundreds of years in some shape or form, from the early days of using wooden barrels to transport water to today’s rather sophisticated methods. For identification purposes packaging must be labelled in some way and the traditional methods for doing so would be to print and apply a label to the product. Packaging also plays an important role for portraying information about the product. Outside packaging may contain directions on how to use the product or make the product. Packaging can also differentiate one brand of product from another brand. Regulatory issues around packaging are very complex, and you must consider them in detail with respect to each product’s unique needs and the properties of its potential package. The role of packaging and labeling in society is a vitally important one, not only in ensuring the safe delivery of products to the end-user but also in communicating the nature of the product and how it should best be utilized. With the increased importance placed on self-service marketing, the role of packaging and labeling is becoming quite significant.
Keywords: Regulatory affairs, Packaging, Generic drugs, Brand, Product