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Guangdong authorities aware of illegal blood procurement in Hepatitis C scandal
www.chinaview.cn 2007-01-25 14:11:59

    BEIJING, Jan. 25 (Xinhua) -- 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.

    In Beijing 68,558 bottles of the drug have been recalled, along with 20,000 bottles in Guangdong Province.

    The officials did not reveal how many people taking the drug had been infected with hepatitis C antibodies but said the tainted drugs produced after last September had been sold in twelve provinces and regions.

    Doctor Jia Jidong, of the Beijing Friendship Hospital, estimated that about 50 to 85 percent of patients who have tested positive for antibodies would end up contracting the disease.

    Jia said patients could be confirmed as being infected with Hepatitis C just one to three weeks after receiving the injection. However, no results have been released.

    If the tests show the Hepatitis C antibodies to change from positive to negative in two to eight weeks, the patients are not infected with the virus, he confirmed.

    Jia said if Bioyee had followed proper manufacturing procedures the hepatitis C antibodies would have been killed and users would not have been infected.

    Hepatitis C is a liver diseases and although symptoms are relatively mild compared with other types of hepatitis, it can become chronic and lead to liver cancer.

Editor: Ling Zhu
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