AMERICAN.COM

The saga over the quality of medicines produced by Indian company Ranbaxy looks to be coming to a close. Back in 2004 and 2005, a Ranbaxy whistleblower contacted me to provide information about quality infringements at one of Ranbaxy’s plants. Despite FDA warnings and the WHO’s awareness of the problem, the problem was not fully resolved.

Ranbaxy is a good company and it is endeavoring to set things right. But its problems demonstrate the cost of not successfully inculcating good standards through all levels of management. My reading of the infringements made by Ranbaxy staff suggests that they may have saved the company at most a few thousand dollars from their regulation-infringing cost-cutting. Yet the loss of business has now run in the millions of dollars—and who knows what the cost of poor quality medicines has been to patients. It should be noted that none of the drugs the FDA tested failed quality control. But, as drug experts explain to me, there are some flaws it is hard to test for; it is possible dangerous products slipped through, especially if the production processes are careless.

The United States now sources 80 percent of its intermediate drug chemicals from overseas, a growing number from China. Chinese companies probably suffer worse quality control problems than most of the large Indian companies—but so far no whistleblowers have emerged. I expect many more Ranbaxy-type problems to crop up in the near future, with the likelihood of serious implications for at least some American patients.