56 pages • 1 hour read
Katherine EbanA modern alternative to SparkNotes and CliffsNotes, SuperSummary offers high-quality Study Guides with detailed chapter summaries and analysis of major themes, characters, and more.
Ranbaxy executives, as well as future CEO Malvinder Singh, communicated about how to deal with the fallout from the scrutiny of the company’s AIDS drug and its falsified data. By 2005, nearly two dozen of Ranbaxy’s drugs needed to be reregistered, which created a dilemma for the company. Most of the drugs had never been tested. Executives discussed amongst themselves how they could best fool regulators. Meanwhile, many employees felt reluctant to engage in fraud, but most employees were pressured into participating in some way. Eban describes how the company pressured executives to illegally shuttle name-brand drug samples into India via their briefcases on international trips.
In 2004, Ranbaxy’s executives decided to commit interim fraud by moving manufacturing from their Dewas plant to a newer one in Paonta Sahib and representing old data from Dewas as newer data from Paonta Sahib.
Eban describes Muralidhara Gavini, or Mike, an FDA inspector known for his leniency. Gavini did not see his role as an enforcer, but rather as a facilitator of the drug approval process. He thought it was his job to help companies become compliant, and he was open about his findings and lenient in his evaluations.
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