Chinese Chemicals Flow Unchecked Onto World Drug Market (1)
Pigi Cipelli for The New York Times
At least 82 Chinese companies at a Milan trade show, none of them certified, said they made pharmaceutical ingredients.
By WALT BOGDANICH
Published: October 31, 2007
This article was reported by Walt Bogdanich, Jake Hooker and Andrew W. Lehren and written by Mr. Bogdanich.
Du Bin for The New York Times
The Changzhou Kangrui Chemical Company in Changzhou, China, is one of a number of concerns selling uncertified drug ingredients. It sent representatives to a trade show in Milan this month.
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.
Other Chinese chemical companies made the journey to the annual show as well, including one manufacturer recently accused by American authorities of supplying steroids to illegal underground labs and another whose representative was arrested at the 2006 trade show for patent violations. 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.
In Milan, The Times identified at least 82 Chinese chemical companies that said they made and exported pharmaceutical ingredients — yet not one was certified by the State Food and Drug Administration in China, records show. Nonetheless, the companies were negotiating deals at the pharmaceutical show, where suppliers wooed customers with live music, wine and vibrating chairs.
One of them was the Wuxi Hexia Chemical Company. When The Times showed Yan Jiangying, a top Chinese drug regulator, a list of 186 products being advertised by the company, including active pharmaceutical ingredients and finished drugs, Ms. Yan said, “This is definitely against the law.”
Yet in China, chemical manufacturers that sell drug ingredients fall into a regulatory hole. Pharmaceutical companies are regulated by the food and drug agency. Chemical companies that make products as varied as fertilizer and industrial solvents are overseen by other agencies. The problem arises when chemical companies cross over into drug ingredients. “We have never investigated a chemical company,” said Ms. Yan, deputy director of policy and regulation at the State Food and Drug Administration. “We don’t have jurisdiction.”
China’s health officials have known of this regulatory gap since at least the mid-1990s, when a chemical company sold a tainted ingredient that killed nearly 100 children in Haiti. But Chinese regulatory agencies have failed to cooperate to stop chemical companies from exporting drug products.
In 2006, at least 138 Panamanians died or were disabled after another Chinese chemical company sold the same poisonous ingredient, diethylene glycol, which was mixed into cold medicine.
China has an estimated 80,000 chemical companies, and the United States Food and Drug Administration does not know how many sell ingredients used in drugs consumed by Americans.
The Times examined thousands of companies selling products on major business-to-business Internet trading sites and found more than 1,300 chemical companies offering pharmaceutical ingredients. How many others sell drug ingredients but don’t advertise this way on the Web is not known.
If the Milan show is any guide, most, if not all, are not certified by China’s drug authorities.
China exports drug ingredients to customers in 150 countries, said Sun Dongliang, a Chinese trade official who helped organize his country’s Milan exhibitors. Many suppliers have passed inspections by drug authorities and sell active pharmaceutical ingredients, or A.P.I.’s, of high quality, buyers say.