Karen Maigetter
Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute (Swiss TPH), Basel, Switzerland | University of Basel, Basel, Switzerland
[ 1 ] - Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality Medicines
Background Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified by national committees since 1975. The growth of India’s pharmaceutical industry and its large export market makes the problem more acute. Methods The foc...
[ 2 ] - Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements
Background Pharmacovigilance (PV) data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI) interviews and compares them with the World Health Organization’s (WHO’s) minimum PV requirements for a Functional National PV Syste...
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