Abstract

REVIEW ON DRUG APPROVAL PROCESS IN KENYA, TANZANIA, INDIA, CHINA

Abhishek Mali*, Sumit Joshi, Ganesh Dama and Sanket Gavhane

Abstract

This study contains comparison of drug approval requirements between various regulated and non-regulated markets that could result in a clear understanding of the market positions of different countries and most importantly revise regulations for a healthier tomorrow. The overall objective of a stringent drug approval system is to ensure that medicinal products of acceptable quality and efficacy are manufactured. The pharmaceutical industry is one of the highly regulated industries, to protect the health and well-being of the masses This topic aims to explain and compare the different processes and regulations for approval of drugs in regulated and non-regulated market. As per law, all new drugs must first be shown to be safe and effective before they can be approved for marketing. Many of the generics produced are now constitute in all parts of the world. A regulated market is the regulations of services that is regulated by a government authorization body. Drug authorization standards in regulated countries are considered by many to be the most exacting in the world. Discovering a new drug, and crafting it through various review process, can take many years. To a large degree, these costs are mostly associated with the clinical testing. Coming to authorization of drugs in typical non-regulated markets, they are becoming an important player in drug manufacture, in particular, the production of generics.

Keywords: To a large degree, these costs are mostly associated with the clinical testing.