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Pharmaceutical Gone Wild; Ranbaxy Exposed

June 8, 2013

You have probably never heard of Ranbaxy Pharmaceuticals. But I bet you are familiar with the drug Lipitor. Ranbaxy makes Lipitor, and is the world’s sixth largest producer of generic drugs. They serve customers in 150 countries and have manufacturing plants around the world.

Ranbaxy was recently fined $500 million dollars, and charged with seven counts of the following:

  • Selling adulterated drugs with intent to defraud
  • Failure to report its drug did not meet specifications
  • Making intentionally false statements to the government

The Department of Justice wrapped up a nearly 10 year case about their illegal, fraudulent and corrupt business practices. A former employee, who is receiving $48 million as a whistle-blower, bolstered the case against Ranbaxy.

Fortune magazine recently published this story, an impeccably researched long-form article by Katherine Eban about Ranbaxy’s case.

You should take the time to read it. It is lengthy, but reads like a novel. Unfortunately, it is not fiction

It is hard to imagine a drug manufacturing company doing anything more egregious.

I worked in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research for a year, and many of the technical aspects of this story were familiar to me. We interacted with Indian generic drug companies frequently, but I refuse to lump all generic drug companies together as corrupt. I am sure there are plenty who follow the laws and procedures, developing wonderful products that benefit humanity.

Ranbaxy was the opposite. They were phenomenally, sickeningly, awful.

The generic drug industry is booming. 84 percent of the drugs you and I take are generic.

The vast majority (80 percent) of all drug ingredients come from foreign facilities. If you take any prescription drugs, they were likely produced in a foreign lab in India or elsewhere.

However, only 11 percent of foreign drug plants even receive FDA inspections. Compare that to FDA inspections at 40 percent of manufacturing facilities in the U.S., and the problem becomes evident. Even 40 percent is quite low. Unfortunately, the FDA does not have the money or the employees to conduct the inspections it should to ensure all drugs are safe.

Ranbaxy’s crimes astound me.

The article repeatedly details how Ranbaxy laboratories completely made up statistics and tests about their drugs. They wrote numbers down on paper that seemed legitimate and no one knew the difference. They submitted false safety documents to regulators.

To put it another way, there was no scientific proof that many of their drugs were safe for human consumption.

They fabricated figures, but then had the gall not only to claim they had tested the drugs and they were not harmful, but also to aggressively market said products all across the world.

We have all seen and heard about certain drugs, which give a disclaimer about their side effects, but we know the risks before we take them. We know about the possible dangers, because they were examined. However, Ranbaxy was not actually testing their drugs as required by law. There may have been serious complications from their products, possibly even leading to death. We will never know. They never bothered ensuring that their globally selling drugs were not harmful. That is abominable.

I realize we enter a slippery slope to start waxing about all the products that we use daily, which could be unsafe. However, when we are talking about pills and pharmaceutical drugs, learning a company systematically and repeatedly lied about their drugs safety is especially jarring.

As this story demonstrates, we take for granted that government is ensuring drugs have passed safety tests. The FDA expects the pharmaceuticals to police themselves. That is a bad idea generally and definitely in this case. Ranbaxy cared about their “bottom-line;” they did not care about their patients.

The article details “systemic fraud in Ranbaxy’s worldwide regulatory filings.” 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.”

If you are not appalled, you should be.

In another section of the article, was this doozy: “In a report to the board in 2004, more than 200 different products, in 40 separate countries were found to have either ‘no data,’ ‘little data’ or ‘compromised lab data.’”

Certainly among the worst individual cases of fraud was an anti-HIV drug marketed for Africa that was NEVER tested. The World Health Organization endorsed it throughout sub-Saharan Africa generating $600 million in sales.

On the rare occasion that I take pills, I do not think twice about whether that drug is safe. I bet you do not either. That attitude makes this story particularly terrifying. Hundreds of millions of people all across the globe take drugs we believe are tested, will heal us, and are safe for consumption. Nevertheless, as this story demonstrates, do we really know if that is the truth?

We expect agencies like the FDA to protect us. When they do not, what is our recourse?

People around the world took those drugs, millions of folks, like you and I, some of them received Ranbaxy drugs at a discount, because they could not pay full price for them. Where are they now? The stories of people who used their products went unmentioned in the story.

Meanwhile, Ranbaxy paid their fine and continues to put drugs on the market. People probably died resulting from the pharmaceuticals crimes, but Ranbaxy’s punishment is paying $500 million. That punishment is a farce. Ranbaxy’s sales were twenty times that in 2012.

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