Here’s an excellent, detailed look from Fortune at how things went off the rails at Ranbaxy and their generic atorvastatin (Lipitor). The company has been hit by a huge fine, and no wonder. This will give you the idea:
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 to the government. Ranbaxy agreed to pay $500 million in fines, forfeitures, and penalties — the most ever levied against a generic-drug company. (No current or former Ranbaxy executives were charged with crimes.) Thakur’s confidential whistleblower complaint, which he filed in 2007 and which describes how the company fabricated and falsified data to win FDA approvals, was also unsealed. Under federal whistleblower law, Thakur will receive more than $48 million as part of the resolution of the case. . .
. . .(he says that) they stumbled onto Ranbaxy’s open secret: The company manipulated almost every aspect of its manufacturing process to quickly produce impressive-looking data that would bolster its bottom line. “This was not something that was concealed,” Thakur says. It was “common knowledge among senior managers of the company, heads of research and development, people responsible for formulation to the clinical people.
Lying to regulators and backdating and forgery were commonplace, he says. The company even forged its own standard operating procedures, which FDA inspectors rely on to assess whether a company is following its own policies. Thakur’s team was told of one instance in which company officials forged and backdated a standard operating procedure related to how patient data are stored, then aged the document in a “steam room” overnight to fool regulators.
Company scientists told Thakur’s staff that they were 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.”
You name it, it’s probably there. Good thing the resulting generic drugs were cheap, eh? And I suppose these details render inoperative, as the Nixon staff used to say, the explanations that the company used to have about talk of such problems, that it was all the efforts of their big pharma competitors and some unscrupulous stock market types. (Whenever you see a company’s CEO going on about a conspiracy to depress his company’s share price, you should worry).
The whole article is well worth reading – your eyebrows are guaranteed to go up a few times. This whole affair has been a damaging blow to the whole offshore generics business, India’s in particular, and does not help them wear their “Low cost drugs for the poor” halo any better. Not when your pills have glass particles in them along with (or instead of) the active ingredient. . .