Original Articles
Ajay Malik, Vipin Kumar, Sande
Abstract
The purpose of this study is to understand the process of prequalification of medicinal products followed by World Health Organization for inclusion of product in WHO Model List of Essential Medicines. WHO undertakes a comprehensive evaluation of the quality of medicinal products, based on information submitted by the manufacturers of such products or other applicants, and on an inspection of the corresponding manufacturing facilities and clinical sites. This is done through a standardized quality assessment procedure which is based on WHO-recommended quality standards.