China shuts down leukemia drug maker

China shuts down leukemia drug maker
SHANGHAI, China - 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 partial 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 the highest amount allowed under law and profits from the sale of the contaminated drugs will be confiscated, the State Food and Drug Administration said in a statement on its Web site seen Thursday.
Some Shanghai Hualian executives were detained by police on suspicion they deliberately withheld information about violations of production standards during the investigation, the SFDA's statement said.
A report in the state-run newspaper Shanghai Daily said the maximum fine for a breach of regulations was only $4,000.
Shanghai city government officials said they were cooperating with the SFDA in resolving the case.
Calls to Shanghai Pharmaceutical rang unanswered Thursday morning. Calls to numbers listed for Shanghai Hualian Pharmaceutical were answered with a "this number does not exist" recording.
The investigation into Shanghai Hualian Pharmaceutical was one of a slew of cases involving contaminated or bogus drugs and foods that have prompted tighter enforcement of safety regulations.
The food and drug agency described the company's actions as a "systematic" cover-up.
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 — and withdrew most of the product from the market.
The investigation found that the drugs were contaminated with vincristine sulfate — another cancer-fighting chemical — during production, the drug safety agency's statement said. Investigators did not say how the contamination occurred.
The agency put the number of patients affected at "more than a hundred." Local news reports said "several hundred" were thought to have suffered bad reactions to the medicines.
Shanghai Hualian was founded in 1939 and is one of the country's top drug makers. It exported to more than 70 countries and regions around the world, according to information on its Web site.
China has taken a series of steps to crack down on tainted drugs and other unsafe products after various foods, medicines and other items ranging from toothpaste to seafood were found to contain potentially deadly substances.
The issue of safety was on the agenda of high-level China-U.S. economic talks this week in Beijing.
The governments signed deals on safeguarding the quality of food, drugs and medical devices, and setting up bilateral mechanisms for sharing information on goods exported to the U.S., officials said.
In China's harshest action on safety so far, the country's former top drug regulator was executed in July for taking millions of dollars in bribes to approve substandard medicines, including an antibiotic that killed at least 10 people.
Earlier this week, the SFDA announced a new procedure for drug recalls that is expected to encourage pharmaceutical manufactures to take such actions voluntarily.
Companies that issue recalls on their own will face no penalties or less stringent penalties for safety violations, the new law says. Those who knowingly fail to do so will face heavier punishment and possibly lose their licenses.