Regulatory Requirements for Drug Product Registration in West and South African Countries

Author(s)

Venkatesh, M.P., Sur, S., Kulshreshtha, C.

Author's Affiliation

Abstract

The Indian pharmaceutical industry is one of the major manufacturers and exporters of multi-source generic drugs to world countries. Traditionally, the prime targets for Indian pharmaceutical companies were US, Europe and other regulated markets. But in recent years, there is remarkable decline in export to these countries. The present focus is on ‘Emerging markets’ and one such option is Africa, which have larger market share and appreciable rate of growth. Africa is the 2^nd largest and 2^nd most populous continent in the world. Africa is world’s second fastest growing pharmaceutical market and is expected to reach US 30$ billion by 2016. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient to meet the demand of such diseased condition and so Africa relies heavily on externally developed and procured drugs. This combination of economic strength and prevalence of diseases is already driving a demand for medicines across Africa. The objective of this study is to delve in various parameters required for registration for externally developed pharmaceutical product among west and South African countries. A comparative study will help the sponsor to file the dossier in many countries simultaneously; which can save time and money. Thus knowledge of guideline specific for individual country becomes important to determine the most stringent member, which shall ease approval process in other target countries in the region.

Keywords

Generic Drugs, Regulatory Strategies, Dossier Submission, African Countries

Cite This Article

Venkatesh, M.P., Sur, S., Kulshreshtha, C. (2016). Regulatory Requirements for Drug Product Registration in West and South African Countries, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(2), 173-188.