Published: October 31, 2007

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When The Times pointed out that many uncertified chemical companies openly advertise active ingredients, Ms. Yan said that was illegal. “If there are in fact chemical companies that are making drugs without certification then this is very serious,” she said. “These companies are not qualified to make medicine. They make chemicals.”

Wang Siqing, managing director of the Changzhou Yabang Pharmaceutical Company, estimated that uncertified chemical companies make half the active pharmaceutical ingredients sold in China. “The stuff produced by chemical plants is clearly counterfeit medicine, but they aren’t investigating,” Mr. Wang said in an interview at his office. “This has been happening in a regulatory void.” He added that most chemical company exports go to unregulated markets in Africa or South America. “That’s not to say these products don’t enter the United States through these other countries,” he said.

To find out how well American consumers are being protected from unsafe imported drugs, investigators from the House Energy and Commerce Committee recently accompanied F.D.A. officials on inspections of drug plants in China and India.

In a letter to the F.D.A. commissioner, the committee said that the agency was unable to provide such basic information as the number of firms exporting to the United States, and that overseas F.D.A. inspectors lacked necessary logistical support. A House hearing on F.D.A. oversight of foreign drug manufacturers is scheduled for Thursday.

“China alone has more than 700 firms making drug products for the U.S., yet the F.D.A. has resources to conduct only about 20 inspections a year in China,” said Representative John D. Dingell, the Michigan Democrat who is the chairman of the House Energy and Commerce Committee. The F.D.A. said it would answer the committee’s questions at the hearing.

Poisonings in Haiti

United States officials learned of problems with China’s chemical companies in the mid-1990s while investigating the fatal poisonings in Haiti. Chinese authorities took no action against the uncertified chemical company that made the poison, diethylene glycol, or the giant state-owned trader, Sinochem International Chemicals, that exported it.

A decade later another state-owned trading company, CNSC Fortune Way, exported the diethylene glycol — also from an uncertified chemical company — that ended up in the deadly Panamanian cold medicine in 2006.

Chinese officials have known for years that uncertified chemical companies are producing active pharmaceutical ingredients. In 2004 the Chinese drug authority’s newspaper cited complaints that some licensed companies “affiliate” with unlicensed ones to hide their illegal purchases, while others buy only a token amount from certified suppliers to pass inspection. “The impact of chemical products on the bulk pharmaceutical market hints at a much larger problem: a huge hole in drug safety,” the drug agency publication stated.

Since the Panama poisonings, China is considering ways to corral the chemical industry. At Panama’s request, Michael O. Leavitt, the secretary of health and human services, has pressed the Chinese government to step up regulation of chemical companies selling pharmaceutical ingredients.

American and Chinese health officials held their first high-level meeting in May, and hope to sign a memorandum of agreement in December. “The Chinese have finally come to the realization that their regulatory system needs repair,” said William Steiger, director of international affairs for Mr. Leavitt’s agency. But meaningful change will be difficult. Chinese authorities may not have enough investigators to weed out the many small chemical companies that are making drug ingredients.

And efforts to close the regulatory gap must overcome one particularly thorny issue: some uncertified companies accused of selling counterfeit drugs are owned by the government itself.