China Cracks the Whip Against Drug Manufacturers Who Fail Quality Norms

by Gopalan on  July 8, 2007 at 3:39 PM Drug News   - G J E 4
China Cracks the Whip Against Drug Manufacturers Who Fail Quality Norms
As reports of the allegedly substandard Chinese products make constant headlines in the western media, the emerging Asian giant has decided to crackdown.

For starters it has suspended the sale of a drug used to treat acute leukemia and rheumatoid arthritis.

In the past week alone, a former department head at the State Food and Drug Administration was sentenced to death on bribery charges, and it was announced that production licenses of five drug makers had been pulled over the last year and that 128 others had been penalized.

The moves come as U.S. regulators ordered a recall of three more Chinese-made products deemed dangerous to children, part of a lengthening list of recent U.S. government actions to ban, recall or restrict Chinese imports — from juice to toothpaste — suspected of containing high levels of toxins.

China's pharmaceutical industry is lucrative but poorly regulated. Some companies try to cash in by substituting fake or substandard ingredients.

The latest U.S. recalls announced Thursday by the U.S. Consumer Product Safety Commission covered jewelry the agency said could cause lead poisoning. They also covered a magnetic building set and plastic castles with small parts, which it said could choke children.

Chaotic food and drug safety mechanisms, murky laws, corruption, and intense competition among government agencies are among the ills supposedly afflicting the country.

But China retaliates such criticisms are only a ruse for protectionism. All the same it has stepped up enforcement of health and safety rules in the export industries that drive its economic growth.

In a notice posted late Saturday on its Web site, the State Food and Drug Administration said it had suspended the sale of methotrexate made by Shanghai Hualian Pharmaceutical Co. Ltd.

The statement said it caused adverse reactions in several young leukemia patients in hospitals of Guangxi autonomous region in southern China and the eastern financial center of Shanghai.

"Some of the children have felt pain in their legs and some have experienced difficulty in walking after being injected with the methotrexate drug numbered 070403A and 070403B," the statement said.

"Local drug regulators have been ordered to re-evaluate the drug," it said.

On Friday, a Beijing court sentenced Cao Wenzhuang, a department director at the State Food and Drug Administration, to death with a two-year reprieve on charges of accepting bribes and neglecting official duties, according to his lawyer, Gao Zicheng.

Such suspended death sentences are usually commuted to life in prison if the convict is deemed to have reformed.

Cao, who oversaw the pharmaceutical registration department, was secretary to Zheng Xiaoyu, the head of the agency, in the 1980s. Zheng was sentenced to death in May for taking bribes to approve substandard medicines, including an antibiotic blamed for at least 10 deaths.

In the pharmaceuticals department, Cao, 45, had the power to approve pharmaceutical production in China from 2002 to 2006.

The sentencing was followed a day later by a report in the official China Daily that the food and drug watchdog had pulled the production licenses of five drug makers over the last year, and penalized 128 other companies.

Source: Medindia

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