Wednesday, February 26, 2014

More trouble for Ranbaxy

Ranbaxy Laboratories, once one of India's great pharma success stories, continues to be in trouble. Shipments of active pharmaceutical ingredients (APIs) from all four of its Indian plants, meant for export to foreign markets, have now been suspended. In effect, Ranbaxy can no longer export drugs to its biggest market, the US.

The bans were put in place by the US Food and Drug Administration (FDA), after Ranbaxy failed to meet FDA quality standards for their products. On a recent visit to India, FDA commissioner Margaret Hamburg made it clear that Indian pharma companies wanting to do business with the US will have to play by their rules. 
"If Indian pharmaceutical companies want to sell in the US, they need to comply with our standards, practices and expectations."
In case anyone thinks the FDA's being unnecessarily harsh, let me direct you to this excellent and painstakingly researched article that explains, in frightening detail, exactly what was going wrong at Ranbaxy's manufacturing plants.
"...Ranbaxy had to recall millions of pills after tiny glass particles were discovered in some of them."
"...the company culture was for management to dictate the results it wanted and for those beneath to bend the process to achieve it." 
"Lying to regulators and backdating and forgery were commonplace..." 
"The company not only invented data but also fraudulently mixed and matched data..." 
If these statements are true (and given the amount of research that's gone into the article, I think they are), I'm not touching a Ranbaxy-made tablet with a ten-foot barge pole until they clean up their act.

Sadly, this attitude of "regulations are meant to be bent and/or broken" is something I've come across before. When you're making medicines that are meant to cure sick people, those regulations are there for a reason. There are plenty of Indian pharma companies who rigorously follow all the rules relating to good manufacturing practices. But bad apples like Ranbaxy, who not only break the rules but thumb their noses at them, make the Indian generics industry look very bad indeed, and that's the kind of negative publicity we really don't need.

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