Chinese Chemicals Flow Unchecked Onto World Drug Market (3)
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“We do make grape seed extract,” the company’s managing director, Nie An, said in a telephone interview. He denied shipping counterfeit Viagra, but he acknowledged other indiscretions: making false advertising claims, using another company’s import-export license and creating a fake corporate name.
“We don’t really have a factory,” Mr. Nie said, even though he advertised that he did. Honor International is just a trading company, he said, adding, “As a trading company, saying you can manufacture attracts business. It was fake advertising.”
The Times found several other companies posing as manufacturers, thereby obscuring a drug’s provenance. In a recent joint statement, chemical associations in the United States and Europe cautioned that globalization has led to a rise in complexity in supply chains, “increasing the potential for contamination, mislabeling or substitution.”
Pharmaceutical ingredients can pass through three or four trading companies, none of which check their quality. The ultimate manufacturer may not realize the ingredients came from an uncertified chemical company.
Mr. Nie, for example, said he markets Viagra’s main ingredient, sildenafil, through a partnership with a chemical company in a distant region that he has never visited. “We met them at a trade fair,” he said. “This company didn’t even have a booth at the fair. They were standing outside the entrance to the exhibition center, and they handed us a flier with a menu of their products.”
He said he was trying to the reach the factory, which has no Web site, to fill a Croatian company’s order.
“Our main markets are in Latin America — Brazil, Argentina, Uruguay,” he said. “A little in Canada, a little in the United States. In Europe, we export to Germany, Russia, Italy.”
But Mr. Nie faces an uncertain future. He said that Chinese investigators had recently visited his office, and that they knew about the seizure in Ohio.
Viagra is hardly the only drug that companies try to copy. The French drug maker Sanofi-Aventis grew weary of watching other companies sell knockoffs of its new diet drug, Acomplia, and alerted French authorities that three Chinese companies were marketing their own version of the product at the 2006 pharmaceutical ingredient trade show, held in Paris. Six Chinese company officials were arrested.
One of those arrested in Paris was Jin Lijie, managing director of the Wuxi Hexia Chemical Company. Still, Wuxi Hexia showed up in Milan in 2007 selling a line of pharmaceutical ingredients.
Its representatives declined to be interviewed in Milan, or at its offices in the boomtown of Wuxi. “We are all young college graduates and we are still learning about the market,” said an employee named Du Yanqun.
Factories on the Yangtze
A good place to find companies selling uncertified drug ingredients is Changzhou in the Yangtze delta, where the raw materials for chemical production are readily available and easily transported by canals and roads.
Several factories there sent representatives to Milan, including the Changzhou Kangrui Chemical Company. It makes pharmaceutical ingredients in an old converted steel plant. “I’m afraid it will leave you with a bad impression,” said Zhou Ladi, a sales representative, as she gave a tour. She said Kangrui Chemical hopes to move into a new plant by early 2009.
“As long as we don’t export products that are under patent in other countries, the government encourages us to export,” she said.
To help find customers overseas, smaller factories enlist the services of people like Bian Jingya, export manager for a trading company called the Changzhou Wejia Chemical Company.
Ms. Bian said chemical companies are involved in all phases of drug manufacturing, including making finished products. Some, she said, “are under patent in other countries.”
Ms. Bian, who was also in Milan, said the government should spell out more clearly what companies may and may not do. “If you want to be regulated, they will regulate you,” she said. “If you don’t want to be regulated, they don’t.”
The Chinese drug agency does not oversee the making of pharmaceutical raw materials, called intermediates, which are the building blocks for active pharmaceutical ingredients. “It is unrealistic for us to certify all factories that make intermediates and regulate them like medicine products,” said Ms. Yan, the agency official. But if companies make active ingredients, a more refined product, then they must be regulated by drug authorities, she said.