Drug Recalls: Trend analysis of Recalls by Indian Pharmaceutical Industry during the period 2013-2023

Abstract

With the advanced technologies, increasing complexities of the manufacturing processes, more stringent inspections, and dynamic regulatory environment under which manufacturers work, there are high possibilities that a pharmaceutical firm will undergo a recall of one of its products. A recall can impact a company in product exposure, sales, manufacturing costs, and patients trust. The study presented here explored the drug recalls made by Indian Pharmaceutical Industry during the period of 2013 – 2023. There is an increasing trend in number of recalls post 2017 which could be due to the new regulations and, scientific discoveries. The major reasons for recalls primarily included cGMP deviations, failure to comply with approved specification, labeling mix ups. The study enlists the expectations of US FDA from Indian Pharmaceutical sector. This will help Indian pharmaceutical manufacturers to adopt the strategies to minimize drug recalls.