Of the nearly 80% of pharmaceutical ingredients and 40% of the finished product of prescription drugs sold in America, half are supplied by China and India. Yet the majority of those drugs and drug ingredients that are coming from these coundtries are not regulated and their safety, quality, and proper labeling are not ensured. In a recent article, The Kansas City Star reported that China has captured 20% of the U.S fish oil market – the third most popular dietary supplement used in the U.S. – and that the label on those supplements did not show that they were from China. But Chinese officials and businesses are defending the quality of their products, according to The Star, stating that their defect rates have been decreasing.
According to the Washington Post, “Over the past seven years, amid explosive growthe in imports from India and China, the FDA conducted only about 200 inspections of plants in those countries…The agency, which is responsible for ensuring the safety of drugs for Americans wherever they are manufactured, made 1,222 of these quality-assurance inspections in the United States last year. In India, which has more plants making drugs and drug ingredients for American consumers than any other foreign nation, it conducted a handful.”
Joseph Famulare, Deputy Director for the FDA, said that “The FDA does the best it can to regulate overseas good manufacturing practices and do inspections, given the limited resources we have. If we had more resources, we would get more inspections done. A bill has been offered in Congress that could assist the FDA in inspecting more plants in China and would bolster their authority to regulate overseas factories.