Mon, 18 Dec 2017

Regulatory Requirements for Registration of Multi Source Anti Retro Viral Medicinal Products in Zimbabwe

Pasumarthy N V Gopal1, Lakshmi T*2, P Anusha2, M V Nagabhushanam2, D Nagarjuna Reddy2

1. Departments of Pharmaceutical Biotechnology, Hindu College of Pharmacy, Guntur, AP, India-522002.

2. Departments of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Guntur, AP, India-522002.


ABSTRACT

In 2013 world health organization concluded that approximately around 35.0 million people have been infected with HIV and about 1.5 million people have died of AIDS. Most of the people infected with HIV particularly African regions. World health organization continuous to bear the burnt of HIV epidemic in sub Saharan African region like Zimbabwe. This country is experiencing one of the harshest HIV/AIDS epidemics in the world .So according to performance of ART program estimated that percentage of eligible adulates 76.9% and children’s around 46.12 % in 2013. The statistical information about Global economic environment in ARV business has continued to grow in the generic-accessible market. So it is an essential need for quality assured ART’s with proper regulatory control and evolution procedures. In this paper work it involves how will the Anti Retroviral generic drugs filing have been processed based on Medicinal Control Authority of Zimbabwe [MCAZ].

Keywords: HIV/AIDS, ART, MCAZ.


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