In 2011, over 3.7 billion retail prescription drugs were filled in U.S. retail pharmacies, according to health statistics compiled by the Henry J. Kaiser Family Foundation. So with such a large number of scripts issued, it becomes even more imperative to ensure drug quality. But a new Reuters investigation finds that pharmaceutical quality control may not be at the top of the list for many manufacturing plants in China.
As the Reuters report finds, some Chinese chemical companies are manufacturing poor quality active pharmaceutical ingredients (API) with little to no government regulation. And these suppliers account for the large majority of our prescription drugs.
In fact, some companies build immaculately clean showroom factories with perfect inspection records. These, however, are just fronts for the real, behind- the-scenes factories that crank out impure drugs under substandard conditions.
Though regulated markets in the U.S. and Europe have a certain number of safeguards in place to protect against such inferior drugs, these measures are far from foolproof. In 2008, for instance, 149 Americans died after taking a contaminated supply of the blood thinner heparin, which was produced in China. Since then, Beijing authorities mandated API manufacturers to obtain a license before selling any products. But, as current API operations demonstrate, such rules are not difficult to get around.
When 70 to 80 percent of all APIs originate in China (with a small fraction coming from India), however, the issue becomes more pressing. If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty, notes Guy Villax, chief executive of Hovione, an API supplier based in Portugal with factories there and in China.
It is one thing to rely on China to make TV sets, says ACSH's Dr. Josh Bloom. But to count on them to not only do our new drug research, but to also support our entire pharmaceutical infrastructure isn t especially comforting. The FDA reports that it is now helping to oversee the Chinese industry, but with a total of three offices there, it is hard to see how much this will help. He adds, It is clear that the FDA is drastically shorthanded in inspecting foreign plants, some of which they can t even find. This is also one of the contributing factors to the ongoing hospital drug shortage crisis.