Dirty Medicine - Long-term criminal fraud at Ranbaxy

[AnaMariaVR2]

Dirty medicine
http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

 

[Wes Bucey]

Dirty medicine
http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

I gave you a "Thanks" but I'm not sure for what. Of the list of generic drugs made by Ranbaxy, six are "maintenance drugs" taken for years between my wife and me. We get the generics, of course, because of the disparity in cost on our insurance, but I note that, from time to time, the druggist supplies generics from different manufacturers and I never paid attention to which manufacturer (which could easily have included Ranbaxy.)

This bit

Fortune's investigation yields the first comprehensive picture of how one under-policed and far-flung generics company operated. It is not a tale of cutting corners or lax manufacturing practices but one of outright fraud, in which the company knowingly sold substandard drugs around the world -- including in the U.S. -- while working to deceive regulators. The impact on patients will likely never be known. But it is clear that millions of people worldwide got medicine of dubious quality from Ranbaxy.

certainly puts me and my wife on the list of possibles.

When I recall the pure he!! Abbott Labs, my next town neighbor, went through over its documentation procedures when inspected by the FDA, this comment seems particularly apt

The heart of good manufacturing is documentation. Without it, there is no way to verify quality, investigate problems, or know whether your drug will improve health or harm it. Because the most minuscule changes can make the difference between a robust product and one that degrades and becomes toxic, each step must be recorded and validated. Any misrepresentation, mixing of data streams, or deviation from procedure invalidates -- and potentially adulterates -- the drugs.

Particularly telling in this article is this description of the company culture by its own regulatory officer

In August 2004, as he confronted his assignment to investigate possible fraud at his own company, Thakur gave each of his project managers a part of the world and asked them to compare Ranbaxy's manufacturing data against the claims made to regulators. His own efforts began with a visit to a company regulatory official.
It was a depressing conversation. The official explained, Thakur says, that the company culture was for management to dictate the results it wanted and for those beneath to bend the process to achieve it. He described how Ranbaxy took its greatest liberties in markets where regulation was weakest and the risk of discovery was lowest. He acknowledged there was no data supporting some of Ranbaxy's drug applications in those regions and that management knew that, according to Thakur. After initially discouraging him, the official grudgingly directed him to begin his inquiry with the Africa portfolio. (The official, who has since left, disputes Thakur's account, asserting that management launched an investigation because it didn't know about the misconduct. He says Ranbaxy's conduct was "checked out" internally at that time, and he shared that information with the company.)

In my consulting practice, I practically tear out what remaining hair I have when I hear versions of this when I make my various "walk arounds" during the course of an assignment. Yet, the sad truth is that many companies are still ruled by FEAR and the underlings are often willing to be the "townspeople who turn a blind eye to the emperor's new clothes" lest they find themselves without a job.

Thanks for bringing this very disturbing article to my attention.

 

[kgott]

Dirty medicine
http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

I read about this on another website and I find this kind of thing horrendous and I cant believe why they have not been charged with some kind of criminal offence.

It bothers me somewhat that corporations cannot be found gulity of crimiminal offences that put the board and the CEO in gaol for life.

I can believe there is no such law as corporate assualt, corporate manslaughter and other charges that individuals are subject to.

 

[Ajit Basrur]

Dirty medicine
http://features.blogs.fortune.cnn.com/2013/05/15/ranbaxy-fraud-lipitor/

Yes I had also read this article ... shocking indeed

 

[Wes Bucey]

I read about this on another website and I find this kind of thing horrendous and I cant believe why they have not been charged with some kind of criminal offence.

It bothers me somewhat that corporations cannot be found gulity of crimiminal offences that put the board and the CEO in gaol for life.

I can believe there is no such law as corporate assualt, corporate manslaughter and other charges that individuals are subject to.

In addition to the corporate honchos of the offending company, why not some charges against the regulatory bodies and THEIR honchos for misfeasance in office for turning a blind eye to these egregious offenses and allowing these miscreants to sell adulterated products to their citizens and residents?

In my state, maligned as we are for political skullduggery, we STILL manage to put TOP government officials behind bars when their greed and incompetence allows the vultures and pirates to inflict harm on our citizenry.

 

[kgott]

In addition to the corporate honchos of the offending company, why not some charges against the regulatory bodies and THEIR honchos for misfeasance in office for turning a blind eye to these egregious offenses and allowing these miscreants to sell adulterated products to their citizens and residents?

In my state, maligned as we are for political skullduggery, we STILL manage to put TOP government officials behind bars when their greed and incompetence allows the vultures and pirates to inflict harm on our citizenry.

Excellent point Wes