Active Pharmaceutical Ingredients: Made in China

API China refers to a leading exhibition for pharmaceutical companies to display drug substances, raw materials, and processing machinery. The exhibition takes place in China, and it is where numerous companies purchase products, such as APIs, for distribution. An “API” refers to an active pharmaceutical ingredient. Currently, the U.S. Food and Drug Administration (FDA) has faced great difficulty in monitoring APIs that are sold to the U.S. Only two FDA officials are responsible for overseeing the shipping of APIs from over 4,000 companies based in China.

Increasing the Number of FDA Officials in China

In a recent congressional hearing, China’s chief FDA agent revealed that he hopes to increase the number of individuals working to inspect APIs in the country. Christopher Hickey, the chief agent, has described monitoring the shipping of drug substances as a “challenge.” Despite the shutdown of a few drug substance manufacturing plants in China, the FDA still faces numerous hurdles in improving the safety of APIs that make their way into the U.S.

China’s Stake in the API Industry

China currently produces about 25 percent of the world’s drug substances. In the U.S., about 75 percent of all drug substances used to create medicine are imported from the international community. China stands as a major producer of drugs due to affordable labor and a lack of stringent regulations.

Posing Risks to U.S. Consumers

U.S. consumers may be left facing the risks of using APIs imported from China. Chinese drug pharmaceutical companies do not use the same quality assurance methods that U.S. companies use. This could mean that harmful residue or impurities could be found within APIs shipped from China. Heavy metals may be some of the impurities found in the drug substances.

Sources:
http://www.in-pharmatechnologist.com/Ingredients/USCC-making-sure-Chinese-APIs-are-safe-is-hopeless-task-for-US-FDA
http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/Events/DSP_AfterHeparinAndre.pdf