Like many people, I have grown blasé about the successive waves of corporate scandal that have broken since the financial meltdown of 2008, but Fortune’s account of the crimes of Indian generic drug maker, Ranbaxy, is quite astonishing.
Ranbaxy boasts that it “is a research based international pharmaceutical company serving customers in over 150 countries… providing high quality, affordable medicines trusted by healthcare professionals and patients across geographies.” Its business is conducted with the “highest standards of professional integrity and ethical behavior,” it says.
What a joke.
According to Fortune, Ranbaxy deliberately and systematically faked quality tests in order to gets its products licensed across the world. Here’s what a new Ranbaxy employee, Dinesh Thakur, found when he investigated his employer’s fraudulent behaviour:
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.
Thakur reported his findings to the company’s bosses, who took no action. Another executive – Kathy Spreen – found that Ranbaxy was submitting patented drugs – the ones it was copying – for testing, not its own. She too reported her concerns:
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.”
Both ended up resigning.
In recent years, USA regulators have made some attempts to pursue Ranbaxy and while no individual has yet been prosecuted (how can that be?), the company recently agreed to pay a huge fine ($500m or so), with Thakur receiving in excess of $48m as a whistle-blower. Ranbaxy is still in business, however, and is strengthening its position in drugs markets around the world.
Why hasn’t this been a bigger story? The BBC gave it a couple of hundred words. I think the Guardian may have briefly carried the wire story but, if so, it’s now gone from its website. The FT managed a blog post which focused mainly on whether the settlement would be good for the company’s share price. In the grand scheme of things, that’s diddly-squat.
Two reasons for the radio silence, I think. The current media narrative focuses heavily on the myriad of sins of Western companies – if this had been GlaxoSmithKline, you can be sure it would have dominated the front pages. There’s much less interest in how lax regulation elsewhere in the world is corrupting globalisation.
Second, many – me included – are heavily invested in generic drugs as a vital weapon in the battle to improve health standards in the poorest countries. In 2004, the Guardian carried an interview with Dr Brian Tempest, a Brit who was then Ranbaxy’s CEO (and who Fortune puts at the heart of the company’s reckless cover-up). For the generics industry, AIDS drugs were a route to respectability, with Ranbaxy swiftly becoming an aid industry favourite.
“We don’t make a lot of money out of selling our Aids treatments cheaply. I tell all the analysts that this is really out of social responsibility because we are based in the developing world and have all its issues on our doorstep.”
We can’t be sure that Tempest knew his company’s drugs were dirty when he gave the Guardian that quote, but later that year, Fortune reports that he attended a meeting of its scientific committee and heard that “the company had simply not tested the drugs and had invented all the data” for entire markets, including Brazil, Kenya, Ethiopia, Uganda, Egypt, and Thailand.
Perhaps it is time for Randeep Ramesh, the Guardian’s social affairs editor, who talked to Tempest in 2004, to follow up on his story. After all:
- Ranbaxy’s drugs continue to be consumed by British patients – in just twelve months, the NHS saved £350m by using a generic cholesterol-reducing drug it buys from the Indian firm. Last year, it was forced to admit that it had shipped batches of the drug contaminated by fragments of glass.
- The British regulator seems to have taken barely any action against Ranbaxy when compared to its American counterpart. Parliament has also ignored the scandal, although ministers have met regularly with Ranbaxy both in the UK and in India.
- The American investigation tells us nothing about the standard of drugs sent to Africa and other developing countries, including those funded by the British taxpayer. In 2011, for example, DFID lauded Ranbaxy for its “leadership and foresight” in driving down the price of anti-AIDS drugs for the poor. Can we be sure the generic drugs it is now buying are safe?
- We also don’t know whether this is a one-off or other generic manufacturers have indulged in similar behaviour. The pattern in banking and other industries, however, suggests that if one company can evade regulation, then others will also have been up to the same tricks. That’s extremely worrying, given that the generic drug industry is expected to be worth $169bn in 2014.
- It would be good to hear more about Tempest – dubbed the ‘benign buccaneer’ in the Guardian profile. He was with Ranbaxy until 2008 and now holds a string of non-executive directorships. He is still involved with Ranbaxy’s founding family, serving on the board of Fortis Healthcare, which is chaired by Malvinder Mohan Singh, one of India’s richest men, who sold out his Ranbaxy shareholding to a Japanese drug-maker as scandal engulfed the company. He also chairs the advisory board of Lancaster University Management School. Tempest was too busy to speak to Fortune’s reporter.
Maybe the Fortune story is overblown. I hope it is. But eight Food and Drug Administration inspectors went to look at Ranbaxy factories in India. All of them came back saying they would never, ever, take a Ranbaxy drug.