Tuesday, November 12, 2013

Ranbaxy......Fraud

Prescription drugs made in India and China.  Contaminated…. Illegal….potentially dangerous…… but sold to you and your family anyways. 

It makes corporations a ton of money.  Isn’t that great.


Among the drugs prescribed to Americans, 80 percent are generic drugs, and 40 percent of drugs are now made overseas in countries such as China and India where U.S. oversight is weaker. (They meant to say oversight is non-existent.)

Dinesh Thakur, an American-educated chemical engineer, was hired by Ranbaxy, back in 2003. He would later become a whistleblower, exposing massive fraud by the generic pharmaceutical giant, a company that sold Americans drugs like the generic version of Lipitor. His information led to Ranbaxy pleading guilty to seven felonies in a U.S. court in May, and pay $500 million in fines and settlements.

"The expectations is the drug's supposed to work as intended," Thakur said. "What we saw in this particular case is that trust was broken."

Thakur reported his findings to the Food and Drug Administration in 2005. Their investigation found Ranbaxy had a "persistent" "pattern" of submitting "untrue statements." On at least 15 new generic drug applications, auditors found more than 1,600 data errors. This meant their drugs were "potentially unsafe and illegal to sell."

 "In essence, they used the fraud as a competitive advantage to build and grow the business here in the U.S." (That is what Capitalism is all about…God Bless America)

"Let's say you're treated with a generic cancer drug and -- and your cancer -- progresses. Is it because of the drug? Is it because of the disease process? No one would know. 

In 2008, shortly after Ranbaxy came under new ownership, the FDA blocked 30 Ranbaxy drugs from coming into the United States from two Indian plants. But the company continued to sell drugs in the U.S. from other Indian facilities.

Then in 2011, while one arm of the FDA was investigating Ranbaxy for serious criminal violations, another arm of the FDA was approving Ranbaxy for the exclusive rights to make the generic version of one of the most popular pharmaceuticals of all time: Lipitor. That decision by the FDA would earn the company a reported $600 million in the first six months.  (Awesome)

CBS News traveled to India to visit the rural Toansa facility. Active pharmaceutical ingredients -- the key ingredient that makes a drug work -- are made there. Despite the manicured grounds and catchy safety slogans, the facility has run into serious problems with the FDA.

In 2012, Ranbaxy issued a recall after finding glass particles in raw ingredients for generic Lipitor. Later that year at another Ranbaxy plant, FDA inspectors found faulty cleaning records and a failure to investigate problems. (Make sure you take your Lipitor with a large glass of water….It helps digest the GLASS)

"Ranbaxy is committed to providing high quality affordable drugs to patients in the U.S." and "will take all measures to keep our facilities in full compliance to all regulations..." (Clearly)

As for Thakur, his findings led Ranbaxy to plead guilty to seven felonies. For exposing the company, he was awarded $49 million in a U.S. court.  (Good for him)

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