China: not required to meet even minimal drug-manufacturing standards, there is little to stop them from exporting unapproved, adulterated or counterf

Chemicals Flow Unchecked From China to Drug Market | By WALT BOGDANICH | Published: October 31, 2007

At least 82 Chinese companies at a Milan trade show, none of them certified, said they made pharmaceutical ingredients.
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MILAN — In January, Honor International Pharmtech was accused of shipping counterfeit drugs into the United States. Even so, the Chinese chemical company — whose motto is “Thinking Much of Honor” — was openly marketing its products in October to thousands of buyers here at the world’s biggest trade show for pharmaceutical ingredients.

... Also attending were two exporters owned by China’s government that had sold poison mislabeled as a drug ingredient, which killed nearly 200 people and injured countless others in Haiti and in Panama.

Yet another chemical company, Orient Pacific International, reserved an exhibition booth in Milan, but its owner, Kevin Xu, could not attend. He was in a Houston jail on charges of selling counterfeit medicine for schizophrenia, prostate cancer, blood clots and Alzheimer’s disease, among other maladies.

While these companies hardly represent all of the nearly 500 Chinese exhibitors, more than from any other country, they do point to a deeper problem: Pharmaceutical ingredients exported from China are often made by chemical companies that are neither certified nor inspected by Chinese drug regulators, The New York Times has found.

Because the chemical companies are not required to meet even minimal drug-manufacturing standards, there is little to stop them from exporting unapproved, adulterated or counterfeit ingredients. The substandard formulations made from those ingredients often end up in pharmacies in developing countries and for sale on the Internet, where more Americans are turning for cheap medicine. ...
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At their worst, uncertified chemical companies contribute to China’s notoriety as the world’s biggest supplier of counterfeit drugs, which include unauthorized copies as well as substandard, even harmful, formulations. “Underregulated manufacturers are increasingly becoming the source of A.P.I.’s used in the production of counterfeit medicine,” R. John Theriault, until recently Pfizer’s head of global security, said in a statement to Congress. ...