Americans benefit from the safest drugs and the safest drug supply chain in the world. That’s a good thing, because we also consume more drugs for more conditions than anyone else in the world. And that is precisely why everyone in the United States should read Fortune Online’s new article covering the backstory that lead to the shocking May 13, 2013 guilty plea by Ranbaxy USA, the US subsidiary of the India-based generic drug maker, to seven U.S. federal criminal counts of selling substandard and adulterated drugs with intent to defraud. Once you start reading the article, you won’t be able to stop, thanks to the skillful writing of Katherine Eban, author of “Dangerous Doses”.
The company admitted to falsifying drug test data for years and for hundreds of products sold worldwide. I was stunned by how callous company employees—from the lowest levels to the CEOs themselves—could be over the quality of their drug products. They seemed to believe that Continue reading Ranbaxy, FDA, FDASIA and Indian Pharma Credibility→
“The U.S. Congress, the U.S. Food and Drug Administration (FDA), the pharmaceutical industry and other organizations have renewed their commitments to remedy existing weaknesses. This white paper seeks to inform these efforts by presenting a holistic picture of the pharmaceutical supply chain and its problems (illustrated by case studies), and to propose a set of meaningful reforms that will better protect patients.”
The report is 77 pages of text with 24 additional pages of references. The text is peppered with numbered references for those who want more details on a particular topic.
There are three Chapters.
Pharmaceutical Manufacturing: Globalization and Quality Management
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.