U.S. Opens the Door to Chinese Pills

October 9, 2007--Perhaps for the first time, a Chinese generic drug maker (Zhejiang Huahai Pharmaceutical Co.) got FDA approval to export finished pills to the US (the AIDS drug nevirapine). Because China is already the world’s largest producer of raw drug ingredients, many more Chinese drug makers could be poised to receive similar approvals for the export of finished medicines. Though current concerns over the safety of products imported from China could challenge a budding generic drug-export industry, the approval for Huahai’s AIDS drug, the continual flow of raw materials, and the backing given by major companies to their Chinese sourcing all give China’s drug-export industry impetus to grow. The Wall Street Journal (Registration required)

Also: A 10/5 U.S. News & World Report article on drug safety takes a look at how the US government is working to beef up its monitoring of raw drug ingredients and finished products that are imported from other countries. According to the article, Chinese pharmaceutical imports into the US have more than doubled in the past five years. The article also says India and China make about 20% of generic and over-the-counter drugs sold in the US and at least half of the active pharmaceutical ingredients for pills made within the US.