Giving Compass' Take:

• Roger Bate shares key insights from Katherine Eban's new book Bottle of Lies, which unpacks the fraud committed by India's generic drug industry. 

• How can funders work to ensure generic drug safety in general? Are programs you support at risk of being impacted by this type of drug fraud? 

• Learn about the increasing frequency of drug recalls. 

I first came across substandard medicine in the early years of this century in southern Africa when HIV and malaria patients didn’t respond to their medicine.  It was obvious from the beginning that problems of quality were greater with Chinese and Indian medicine that those made in OECD, but this was not universally true and it was hard to establish why and impossible to know when it would occur.

It wasn’t until I was contacted by Dinesh Thakur in 2005 that I learned the reason for poor quality was often due to fraud rather than incompetence. Thakur was a quality control specialist at Ranbaxy, which a decade ago was India’s most important generic drug producer. Mr. Thakur became a whistleblower for the US FDA, exposing the lies and mis-directions of Ranbaxy’s management in hiding its lack of quality control. When he first contacted me he used a pseudonym since his life was at risk, as Katherine Eban explains in detail in her new book about Indian generics called Bottle of Lies.

All health advocates were delighted that Indian companies could make cheap and highly effective medication. But there is an Indian word that sums up the Indian drugs industry — Jugaad, which means ethically dubious corner-cutting to quickly achieve an objective.

After nearly a decade of investigation and delays, a US court punished Ranbaxy for seven felonies and fines and penalties totaling $500 m in May 2013. Most damning of all is Eban’s assessment of the fallout from the Ranbaxy case: “Many of Ranbaxy executives had become experts at data fraud. They had spent years immersed in the intricacies of altering test data, from the research and development phase through to commercial manufacturing, all while managing questions from skeptical regulators. They had learned a system that aimed to get drug applications approved at record speed, even before the company mastered how to make the drug in question. Now these executives were leaving Ranbaxy in droves…getting jobs throughout the industry, taking their colleagues and their skillsets with them.“

Read the full article about Bottle of Lies by Roger Bate at American Enterprise Insititute.