Dynamics of Pharmaceutical Quality Systems for the Export of Pharmaceuticals from India to Africa

India’s pharmaceutical industry of more than 10,000 manufacturing sites is estimated to generate US$ 22 billion in revenue , half of which is exported to more than 150 countries across the globe. Exports to countries with Stringent Regulatory Authorities (SRAs) are estimated to be nearly 50% of the overall pharmaceutical exports, while exports to African countries are estimated to be a quarter of the total pharmaceutical exports from India. With these pharmaceutical exports, India has been contributing to public health globally and is often referred to as the ‘pharmaceutical factory’ to the world. For example, India has a dominant global market share of anti-retrovirals (80%) and paediatric ARVs (90%) in the world4 . Some studies estimate that Indian companies account for more than 50% of the pharmaceutical market in several African countries. India also has one of the largest numbers of high quality United States Food and Drug Administration (USFDA)/United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved manufacturing plants5.However, at the same time, India also has thousands of manufacturing units with weak manufacturing standards.