I had heard rumblings about some US regulatory bodies taking action on Ranbaxy. At first, I was not interested in the details – it sounded too much like American protectionism. But this article on Firstpost was an eye-opener.
However, after five years of legal battle, now Ranbaxy has pleaded guilty of the same wrong doings that it was exonerated of. The company has admitted to selling adulterated drugs from the two plants and submitting false statements to the FDA.
Take a minute. Step back from the screen. This is not financial fraud. Not an industrial espionage or a patent litigation case. We are talking about medicine. Make no mistake – flooding markets with cheap generics is good. But what sort of sick psychopath floods the market with adulterated, untested drugs? It is right out of a Bond film.
I followed a link and came upon one of the worse indictments possible for a pharmaceutical company. Do yourself a favour and read the report. Some highlights of report are listed below. Text in italics is quoted directly from the article.
- Standard operating procedures for clinical studies and drug testing, manufacturing and storage facilities were violated – sometimes, the company would create its own SOPs to prove compliance on paper.
- senior managers of the company, heads of research and development, people responsible for formulation … clinical people – all were “in” on this game.
- Drug tests were carried out with actual brand-name drugs substituted in place of the generics meant to be tested.
- Drug degradation (“expiry date”) was almost always under-reported. This means medicines would expire sooner than mentioned on the label.
- crucial testing data for many of the company’s drugs did not actually exist and submissions to regulators had been forged.
- “There was a total lack of understanding,” Dr. Kathy Spreen (former executive director of clinical medicine and pharmacovigilance, Ranbaxy U.S.) says, “of what it meant to be ethical and what it meant to actually protect the patient.”
- 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.
- 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.
- In entire markets—including Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Vietnam, Peru and the Dominican Republic—the company had simply not tested the drugs and had invented all the data.
- The company had a “reputation for threatening people, bullying people,” Dinesh Thakur (former global head of psychiatry for clinical research and development, Ranbaxy) recalls.
- Ranbaxy used its international staff as drug mules to bring brand-name drugs to India – violating import-export laws of multiple nations.
- “Every single inspector that went to India said they would never take a Ranbaxy drug,” says David Nelson (former senior investigator, House Energy and Commerce Committee), “like eight out of eight.”
- One by one, each of the former Ranbaxy executives Fortune interviewed had determined, while still at the company, to stop taking Ranbaxy drugs.
- Ranbaxy has been recalling its blockbuster drugs at an alarming rate in the US.
Dinesh Thakur – the whistle-blower.
The question remains – why are Indian regulators moving so slowly? Why is Indian media – print, TV, Internet – silent? Ranbaxy should be splashed on the front page of every newspaper and news portal. The intent here should not be to protect Ranbaxy but the Indian generic drugs industry and patients – both Indian and international – who depend on generics for their medical needs. Only by taking Ranbaxy to task and verifying that its systems and processes are in order can confidence be restored.
I don’t know about you, but from now on, I will be assiduously avoiding the Ranbaxy brand. The pity is I can do so only if there is an alternative that I know about.
What about the millions who do not have the means to search for and procure alternatives?