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Illegal Blood Procurement in Hepatitis C Scandal
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Local health authorities in south China's Guangdong were aware that the company responsible for the China's Hepatitis C scandal had illegally procured blood stocks, Thursday's China Business News (CBN) reported.

Last August, Guangdong health department found Guangdong Bioyee Pharmaceutical Co, Ltd had been collecting blood plasma illegally to make immunoglobulin and other drugs, the newspaper quoted an industry insider as saying. It ordered the company to halt any illegal practices but did not suspend production or impose any punishment, CBN said.

An unnamed official from the Shaoguan City drug and food bureau told CBN an inspection team from a "related department" had carried out another inspection in November and had discovered "illegalities" in the company's manufacturing processes, without elaborating.

Despite these two failed inspections, the source from the Shaoguan bureau said Bioyee had still managed to obtain a Good Manufacturing Practice (GMP) certificate, which is usually granted by the State Food and Drug Administration (SFDA), valid from November 24.

However, another investigation was launched in December by the SFDA, which reported that the company was unable to provide a record of production and testing of its drugs, and was using faked licenses for some batches of pharmaceuticals. It is not clear why the investigation was launched so soon after Bioyee secured the GMP certificate.

On January 16, the MOH revoked Bioyee's GMP certificate and license. The unnamed Shaoguan official was quick to try and absolve his department from responsibility for the scandal.

He told CBN, "We did not find any irregular practices by the company ourselves. Although Bioyee is located in Shaoguan, the main supervisory responsibility lies with the State Food and Drug Administration. ”

"Our daily inspections are not very careful or thorough," he admitted.

The Ministry of Health (MOH) issued an urgent statement on Wednesday ordering all medical institutions to register patients who have used the drug.

Those who have used the intravenously administered drug must be given blood tests for hepatitis C nucleic acid and antibodies, and should be put under close observation, the MOH said.

Almost 90,000 doses of the drug produced by Guangdong Bioyee Pharmaceutical Co, Ltd, have been recalled, said the officials.

(Xinhua News Agency January 25, 2007)

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