"Who cares?" he said "It's just blacks dying."

[True Earthling]

Ranbaxy an India based generic drug maker sold substandard drugs worldwide and lied to FDA for years...One of the most outrageous cases of outright fraud and deception I've ever seen...putting millions of lives at risk. Ranbaxy, the 6th largest generic drug manufacturer in the U.S., fabricated test data, substituted formulations with cheaper ingredients, and lied to regulators at every turn...

Edit - BTW...this is the company that makes generic Lipitor - Atorvastatin.

Fortune's account of what occurred inside Ranbaxy and how the FDA responded to it raises serious questions about whether our government can effectively safeguard a drug supply that last year was 84% generic, according to the IMS Institute for Healthcare Informatics, much of that manufactured in distant places. More than 80% of active pharmaceutical ingredients for all U.S. drugs now come from overseas, as do 40% of finished pills and capsules. (Click here for a list of Ranbaxy products in the U.S.) Today's global market for generic drugs is $242 billion and growing. In America we have embraced generics as a vital way to control costs, a trend likely only to accelerate as health reform extends treatment to millions and our population ages.

Ranbaxy was the first foreign generics manufacturer to sell drugs in the U.S. and rose rapidly to become, today, the sixth-largest generic-drug maker in the country, with more than $1 billion in U.S. sales last year (and $2.3 billion worldwide). The company, now majority owned by Japanese drugmaker Daiichi Sankyo, sells its products in more than 150 countries and has 14,600 employees. 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.

Sometimes all the data were made up. In India and Latin America, the report noted the "non-availability" of validation methods, stability data, and bio-equivalence reports. In short, Ranbaxy had almost no method whatsoever for validating the content of the drugs in those markets. The 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. The rest had been filed with phony data because they had been only partially tested, or not at all. No market or type of drug was exempt, including antiretrovirals purchased by the U.S. and WHO as part of a program to fight HIV in Africa. In Europe, for example, the company used ingredients from unapproved sources, invented shelf-life data, tested different formulations of the drug than the ones it sold, and made undocumented changes to the manufacturing process. Ranbaxy executives didn't care, says Kathy Spreen, and made little effort to conceal it. In a conference call with a dozen company executives, one brushed aside her fears about the quality of the AIDS medicine Ranbaxy was supplying for Africa. "Who cares?" he said, according to Spreen. "It's just blacks dying."

Six other pharma veterans who worked for Ranbaxy in the U.S. as recently as 2010 tell Fortune they found themselves in a corporate culture like nothing they'd ever experienced. Executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators. Until 2005 the company didn't even have a functioning patient-safety department, and patient complaints piled up in boxes, ignored, uncategorized, and unreported to the FDA as required.

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

[Tx4obama]

1. Reminds me of a film I recently saw...

The Constant Gardener: http://www.imdb.com/title/tt0387131/?ref_=sr_1

The film is not much about gardening, it's more about drug companies and drug testing.

[The Magistrate]

2. Very Good Movie, Ma'am

[Egalitarian Thug]

7. A much better book. n/t

[Hekate]

3. 5th Rec

Good gods.

[True Earthling]

4. Here's a list of Ranbaxy's generic drugs

If you use any of these I would be very cautious... ask your pharmacist who the supplier is then ask for an alternate suppliier if it's Ranbaxy. I would not trust this company...

http://fortunefeatures.files.wordpress.com/2013/05/ranbaxy-products.pdf

[PotatoChip]

5. Thank you for that link.

My blood pressure medication is on that list. Hope the stuff is ok.

[Elwood P Dowd]

6. Damn, Lisinopril is on that list. I used to take it for high blood pressure but

had to change after a few months because it made me feel terrible and also made me cough all the freaking time.

[YeahSureRight]

10. Good luck getting your Insurance Company to cover the name brand

Even if your DR writes a prescription for a name brand most insurance companies can and will substitute the lowest cost generic they can find. Yes Dr’s can do battle with the insurance companies to cover the med but they should not have too. About every 3 months the manufacture of my BP med changes to another manufacture in India that will charge a lower price. My prescription coverage is 10/15, max of $10 for generics and max of $15 for name brand. 2 years ago the generic version of my med was made in the USA and cost me $10 per month, today my med is made in India and costs me $2.35 per month.

I think soon prescription coverage will consist of them telling you to go eat some grass, you will feel better it works for dogs so it will work for you too.

[HiPointDem]

8. upper class libs don't care about third world drug trials

[Quantess]

9. Thanks for posting it!