CHINA: Manufacturer Closed Over Tainted Drugs

SHANGHAI, China (The Associated Press - The Seattle Times), December 14, 2007: China's food-and drug-safety agency has revoked the license of a company responsible for making tainted leukemia drugs blamed for causing leg pains and paralysis among dozens of patients. State-owned Shanghai Hualian Pharmaceutical Co., a unit of China's biggest drug maker, Shanghai Pharmaceutical (Group) Co., will also be fined and profits from the sale of the contaminated drugs will be confiscated, the State Food and Drug Administration (SFDA) said on its Web site Thursday. A report in the state-run newspaper Shanghai Daily said the maximum fine for a breach of regulations was only $4,000. Some Shanghai Hualian executives were detained by police on suspicion of deliberately withholding information about violations of production standards, the SFDA said. The investigation was one of a slew of cases involving contaminated or bogus drugs and foods that have prompted tighter enforcement of safety regulations. Authorities banned the sale and distribution of the drugs in early July after some patients complained of adverse reactions. In September, the SFDA ordered the company to stop production of the drugs involved — methotrexate and cytarabin hydrochloride. The investigation found that the drugs were contaminated with vincristine sulfate — another cancer-fighting chemical — during production. China has taken steps to crack down on tainted drugs and other unsafe products after various foods, medicines and other items were found to contain potentially deadly substances. At China-U.S. economic talks this week in Beijing, the governments signed deals on safeguarding food, drugs and medical devices, and setting up mechanisms for sharing information on goods exported to the U.S. China's former top drug regulator was executed in July for taking millions of dollars in bribes to approve substandard medicines. By Elaine Kurtenbach Copyright © 2007 The Seattle Times Company