The Ranbaxy story: why we still can't trust our medications

It isn't just China that struggles with counterfeit and defective medications.

India's Ranbaxy makes much of the generic Lipitor consumed in the US -- and today a Pulitzer prize quality Fortune investigation makes it clear that Ranbaxy is a criminal enterprise.

Ranbaxy has been fined $500 million (no criminal prosecutions) in the US, but most of its crimes took place in weaker nations and during a time when America's regulatory agencies were reeling under GOP attack (emphases mine) ...

Dirty medicine - Fortune Features

.... On May 13, Ranbaxy pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud, failing to report that its drugs didn't meet specifications, and making intentionally false statements...

...  the sixth-largest generic-drug maker in the country, with more than $1 billion in U.S. sales last year ...

... we simply don't know what we're dealing with," says Dr. Roger Bate, an international pharmaceutical expert. "No one has actually gone into these sites to expose what's going on."...

... Drug applications work on the honor system: The FDA relies on data provided by the companies themselves....

... Ranbaxy took its greatest liberties in markets where regulation was weakest and the risk of discovery was lowest...

... The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line...

.... directed to substitute cheaper, lower-quality ingredients in place of better ingredients, to manipulate test parameters to accommodate higher impurities, and even to substitute brand-name drugs in lieu of their own generics in bioequivalence tests to produce better results...

.... the majority of products filed in Brazil, Mexico, Middle East, Russia, Romania, Myanmar, Thailand, Vietnam, Malaysia, African Nations, have data submitted which did not exist or data from different products and from different countries...

... drugs for Brazil were particularly troubling. The report showed that of the 163 drug products approved and sold there since 2000, only eight had been fully and accurately tested...

... deceptions greatly accelerated the pace of the company's FDA applications. They were also a grave public-health breach...

... the drugs Ranbaxy was actually selling on the U.S. market were an unknown quantity...

... Thakur knew the [HIV] drugs weren't good. They had high impurities, degraded easily, and would be useless at best in hot, humid conditions. They would be taken by the world's poorest patients in sub-Saharan Africa, who had almost no medical infrastructure and no recourse for complaints. The injustice made him livid...

 ... The inspectors also took and tested samples of Sotret, Ranbaxy's version of the acne drug Accutane, and found that it degraded far in advance of its expiration date....

[In 2006] ... the FDA ... did nothing to stop all the drugs that were already on the market,... .... Ranbaxy got six new approvals....

... September 2008, [the FDA] announced it was restricting the import of 30 drug products made by Ranbaxy (11 of which had been approved after Thakur's first contact with the FDA three years earlier). The agency still did nothing to recall the very same drugs on pharmacy shelves all over America, despite finding that Ranbaxy had committed fraud on a massive scale....

... many of Ranbaxy's senior executives were expected to ... carry suitcases full of brand-name drugs ... former employees suspect that the company used the brand-name drugs as a substitute for its own in testing...

The company is still in business, Tempest and Sigh aren't in prison, and the recent $500 million fine will soon be forgotten. In the meantime, does anyone imagine Ranbaxy is the only fraudulent manufacturer of generic drugs? And will Americans ever wake up?

We're wasting our time GOP scandal-theater, and ignoring the real scandal in front of us.

See also

• Ranbaxy: Looking Under the Rock. In the Pipeline 5/13 
• FDA Fails to Catch Generic Drug Disasters - The People's Pharmacy 5/2013
• FDA Let Drugs Approved on Fraudulent Research Stay on the Market - ProPublica (Cetero Research - 4/2013)
• We really need to panic more - FDA inspection of Chinese drug suppliers 2/2008
• Pet food poison and pithed America 3/2008 -- melamine poisoning
• The case of the curious silence: Counterfeit Heparin killed 62+ 4/2008
• Fraud and global supply chains - unanticipated consequence 5/2007
• Poisoned medicine: Even I am stunned. 5/2007

Update: The People's Pharmacy has five responses I liked, I omitted the one I disliked

1) Country of origin labeling. You should know where your medicine comes from!
2) The name of the manufacturer of your medicine should be on the label.
3) The FDA should release its bioequivalence curves for all generic drugs. These data should not be kept secret, as they currently are.
4) We must demand unannounced inspections in all countries that wish to export pharmaceuticals to the U.S. market.
5) Every foreign drug manufacturing company must be inspected every two years, just as U.S. manufacturers are inspected.