This case is about the problems faced by India-based pharmaceutical research company GVK BIO due to the ban imposed by the European Union (EU) suspending sales and distribution of around 700 generic drugs being sold by various global pharma companies for which clinical trials were conducted at the GVK BIO facility in Hyderabad. The case focuses on the alleged manipulation of clinical trials at GVK Bio. It concludes by discussing the impact of the ban on the reputation of GVK BIO and how winning back the trust of global regulators would be a tough task for GVK BIO going forward...
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The case is structured to achieve the following teaching objectives:
Understand the importance of clinical trials in the drug discovery process.
Understand the implications of the EU ban on GVK BIO’s business.
AExplore ways in which GVK BIO can salvage its reputation and the measures it has to take to improve transparency in clinical trials.