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Chinese chemical companies evading the law, still actively pushing drugs

(Image via RSC.org)Another front page story in the New York Times today about blind spots in the global supply chain leading to devastating consequences in consumer product safety.

Chemicals Flow Unchecked From China to Drug Market
By Walt Bogdanich
New York Times
October 31, 2007

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.

How is it possible that chemical companies can get away with openly marketing counterfeit drugs?

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.”

Here’s a list of criminal activity in China’s pharmaceutical industry, as identified by the New York Times:

• Honor International Pharmtech was accused of shipping counterfeit drugs into the United States
• One manufacturer recently was accused by American authorities of supplying steroids to illegal underground labs.
• Another manufacturing representative was arrested at the 2006 trade show for patent violations. (For examples, see this story about a supposedly stolen cancer treatment, and another story about counterfeit Viagra.)
• Two exporters owned by China’s government sold poison mislabeled as a drug ingredient, which killed nearly 200 people and injured countless others in Haiti and in Panama. (In the aftermath, former high-ranking official, Cao Wenzhuang, from China’s top food and drug watchdog agency, was sentenced to death for corruption and approving counterfeit drugs.)
• 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.

Here are some reasons why Chinese chemical companies can get away with actively marketing and selling unregulated drugs:

• The rapid growth of China’s chemical suppliers makes it difficult for federal regulators to track raw materials and protect consumers from illegal products.
• Chinese chemical companies often lack the resources or means to produce high-quality medicine.
• Some uncertified chemical companies selling active pharmaceutical ingredients pose as manufacturers, thus making it difficult to track a drug’s origins.
• Some uncertified companies accused of selling counterfeit drugs are owned by the government, which makes it even more difficult to crack down on the problem.

[tags]China, pharmaceuticals, drug safety[/tags]

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