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)