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Chinese Chemicals Flow Unchecked Onto World Drug Market
Key Excerpts from Article on Website of New York Times
Posted: November 18th, 2007
http://www.nytimes.com/2007/10/31/world/asia/31chemical.html...
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. [At a pharmaceutical trade show 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. 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 [Jiangying], deputy director of policy and regulation at the State Food and Drug Administration. We dont have jurisdiction. 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 [Chinese] chemical companies offering pharmaceutical ingredients.
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