Ranbaxy Accused By Feds Of Falsifying Records
7 CommentsBy Ed Silverman // July 11th, 2008 // 7:21 pm
Federal prosecutors are investigating the Indian generic drugmaker for allegedly falsifying records that resulted in the production and sale of generic meds that didn’t meet FDA standards, The Star-Ledger of New Jersey reports.
The feds allege officials at Ranbaxy’s plant in northern India used raw chemicals from unapproved sources, fabricated in-house test data to meet FDA standards and attempted to conceal the ruse from FDA inspectors, according to court documents cited by the paper. The Parexel consulting firm is also named in connection with its audits of Ranbaxy facilities, some of which Ranbaxy refused to produce, claiming attorney-client privilege.
The “pattern of systemic fradulent conduct,” left an untold portion of tablets and capsules made by Ranbaxy too weak, too potent or lacking the advertised shelf life, the government said in its papers filed in US District Court in Maryland, the paper writes. In November, Ranbaxy recalled 73 million doses of generic Neurontin, which is used to treat seizures and nerve pain. The FDA, you may recall, raided Ranbaxy offices in New Jersey early last year as part of its investigation.
“Specific allegations under investigation include fabricating bioequivalence and stability data to support…(HIV/AIDS) drugs to be paid for by the President’s Emergency Plan for AIDS Relief program (PEPFAR) and distributed to foreign countries,” according to the court filing, which also states “the government is also investigating whether Ranbaxy committed contract fraud and caused the submission of false claims to Federal health benefit programs under the False Claims Act.”
The investigation of Ranbaxy comes shortly after Daiichi Sankyo announced plans to acquire Ranbaxy, one of the world’s largest generic drugmakers with global sales of $1.5 billion last year, including $390 billion in the US. So do you think this was disclosed to Daiichi? Maybe Daiichi’s lawyers want to look at the court documents.
Chuck Caprariello, a Ranbaxy spokesman at its US offices in Princeton, tells the paper: “We’re still working with food and drug and the other authorities to resolve any questions. We’ve been conscientious in trying to provide information to the government. At this point and time, we’re conducting bsuiness as normal until we address these questions.”
Anne PME
“At this point and time, we’re conducting business as normal until we address these questions.”
Chuck Caprariello, Ranbaxy spokesman
Perhaps Mr. Caprariello would elaborate on what he means by “conducting business as normal”.
Dr. Sal Giorgianni
Wow - how could this happen.
If folks are worried about QC in companies with huge brand-name reputations just wait. You ain’t seen notning yet. As the commoditization of medicines continues to push to the lowest price point I fear a lot more reports such as these will surfact.
What’s that old joke about not feeling too comfortable about flying in a plane built with parts that went to the lowest-bidding government contractor? Food for some uncomfortable thought.
Jaynesday
Dr. Sal
Near as I can tell practically every industry on the planet (maybe with the exception of pharma) has already begun to push for the lowest price point and those that succeed also maintain or increase their level of quality. Yes it can be done. Especially when we face a crisis point. Pharma is at that do or die point in my humble opinion.
I have no facts to base this next statement on but here goes -
I suspect their are *billions* of dollars of fat of all kinds in the pharma industry. If properly organized and streamlined I would also predict that pharma *could* provide a much better product (as a whole) at a lower cost. Actual I honestly feel they are going to have to. Business as usual is going to have to come to an end.
SeenThisBefore
This should NOT surpise anyone familiar with how Indian companies do business. Their sense of “ethics” is vastly different than the Western culture. For example, Wockhardt (another Indian generic company) was issued a Warning Letter in 2006 for peristent fabrication of data despite multiple FDA inspections and meetings (http://www.fda.gov/cder/warn/2006/320-06-01.pdf). In the past two years, a number of Chinese drug substance manufacturers have been issued Warning Letters, and there is the recent heparin raw materials issues. These are not isolated incidents - they are a culturally problemmatic pattern of behavior. Cheating will continue to be a problem for US companies that have outsourced to “emerging markets.”
Jaynesday
SeenThisBefore - your comment “they are a culturally problematic pattern of behaviour.”
As in they are incapable of doing better? Don’t kid yourself.
Chris
SeeThisBefore: You take an amazing swipe at ‘Indian companies’ in general and beieve that their sense of “ethics” is vastly different to the Western culture: Apart from the rather offensive tone of your comments I think you may be surprised at how wrong you are. As Jaynesday (and a lot of other people) recognise the Indians, SE Asians and Chinese are well on their way to dominating many industries through ingenuity, hard work and rigorous education. Not all obviously, and no doubt ethical violations occur as they do anywhere (Transkaryotic anyone?) but ignoring that and lumping “Indians” under one heading risks having your you know what handed to you in a sling.
Sumanth
SeeThisBefore:
Not to say that Ranbaxy is clean-I’m making my case on the premise that you’re not guilty until proven to be.
On the other hand, if you’re even remotely related to the pharmaceutical community (and I believe you are)- you will be aware of enough and more instances where Western companies have been been proven guilty for business malpractices.
The fact is- and try challenging this-Indian and Chinese companies are an integral part of the supply chain of companies worldwide. For every such accusation, I’m sure there are a few hundred instances of how Indian players have contributed to the success of Western pharma.
And If culture and business ethics were ever an issue, would the West ever have come to India?