When a serious discussion of counterfeit drugs is held, China and India invariably come up in the conversation. That is not a surprise. The FDA says those two countries now account for 80% of the drugs and ingredients now sold in the U.S. And both are known to have lax regulatory systems.
China, egged on by local media, has been making some high-profile efforts. Earlier this year it announced that it had sent out 18,000 Chinese police officers to round up nearly 2,000 drug counterfeiting suspects. They were said to have destroyed 1,100 production plants. The fake drugs they confiscated were valued at $182 million. The Ministry of Public Safety said the counterfeits had been advertised to treat everything from hypertension to cancer and rabies.
While an impressive display of might, the bigger problem is that China and India are believed to account for about 80% of APIs sold in the U.S. and both countries are known to have lax oversight. An investigation by Reuters recently found that drugs that are still protected by patents, or worse yet, have been banned in the U.S., can be found for sale in China over the Internet. A consultant who audits Chinese API makers for drugmakers told the news service that it is not uncommon to find plants, with biosuited employees and manufacturing equipment, which are obvious fronts for companies that buy cheap APIs, substandard or worse, and offer them for sale.