FDA Halts Import of 30 Generic Drugs from India

US News ran a story today called "Generics: Cheaper, but Not Identical," written by Bernadine Healy MD who cited a Harvard study of 47 articles about generic drug studies that found the generic versions bioequivalent, then noted that a great majority of the drug studies were supported by generic drug companies. The concern arises from generic drugs manufactured in cheap labor and overhead countries like India and China, already involved in scandal over contaminated heparin that caused deadly allergic reactions in the US.

The Government Accountability Office reports that foreign companies escape FDA testing, documentation and monitoring, yet the problem has been swept aside as more companies in China ramp up generic drug production. Not specifying dates of when the GAO report was released, it said that the FDA halted the import of 30 generic drugs from Ranbaxy Laboratories in India (pictured above). The list includes simvastatin, pravastatin, clarithromycin, lamivudine, zidovudine, metformin and penicillin. Of the drugs listed, the FDA kept one antiviral off the list that is important to AIDS treatment, saying the US would suffer a shortage of the drug if import was halted. Healy states her concern thusly:

As China, India, and other countries with cheap labor compete to take up more of U.S. drug manufacturing, will quality and regulatory standards, which make domestic production of lifesaving drugs more costly, be held hostage by a foreign company that controls so much of the market it can tell our government to take a hike?

Healy calls for quality control of imported drugs in the form of random inspection and labels that identify the country of manufacture.

Call me gullible, but I have always thought that drugs sold at a pharmacy as prescribed by a medical doctor were far more potent, effective, monitored, rigorously tested, etc. I was naive enough to think that the reason you can only buy certain drugs over-the-counter was to prevent overmedication and addiction, yet I never understood the need to require a prescription for Tylenol or broad spectrum antibiotics. Besides, any doctor I've ever seen never batted an eye about whether any script I had was filled with name or generic drugs. Insurance demands the generic anyway. Still, that the drugs came from a pharmacy seemed to guarantee quality and effectiveness. My wallet demands the purchase of generic OTC drugs as well, whether I doubt their quality or not.

This very well may be just the tip of an iceberg. Like the tobacco industries and the anti-tobacco factions illustrate very different study results to the point where it's impossible to glean the truth, drug makers are proving they learned from the best and perfected the practice of deniability. But, drug manufacturers are "untouchable" way beyond the scope of tobacco's standing as a major US industry. In the end, it's the consumers who pay with their lives again.