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August 19, 2014

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3 top drug officials faulted for regulatory wrongdoings

A WEEK after the former chief of China’s drug watchdog was accused of favoring special interest groups, three other regulatory officials face accusation of wrongdoings.

Ma Wenfang, a village doctor in Henan Province who is a deputy of the National People’s Congress, and Zhang Yi, an executive of Henan Yisheng Pharmaceuticals, have levelled accusations of unfair practices against three top officials.

Ma and Zhang have accused the trio — Wu Zhen, deputy director of China Food and Drug Administration, Yin Hongzhang, deputy director of the administration’s drug evaluation center, and Shen Qi, senior official with the administration-affiliated National Institute for Food and Drug Control — of injustice, the 21st Century Business Herald reported.

Ma alleged the trio were a “barrier against technological innovation,” the paper said.

Zhang, meanwhile, bought a lawsuit on June 3 against the China Food and Drug Administration at the Beijing No.1 Intermediate People’s for dereliction of duty.

Zhang, who is also the executive of Liaoning Yisheng Biological Pharmaceuticals, which owns Henan Yisheng, has been demanding answers from regulatory officials for more than a year, China National Radio reported yesterday.

From 2012-end to August 2013, Liaoning Yisheng had sought regulatory approvals for 120 batches of rabies vaccines. But it was not until last summer that the National Institute for Food and Drug Control responded by saying three batches had failed sterility tests, CNR reported.

On December 24 last year, the institute told the company that it would not issue certificates to the remaining 117 batches because the “risks still existed,” CNR reported.

“If they are qualified, then you issue certificates. If they are not qualified, you give us detailed reports. But we don’t have any explanations,” Zhang said.

“Since three batches were found to be contaminated, others were very likely to be hazardous as well,” Wu Zhen reportedly told Zhang when he visited Wu’s office.

Shen Qi meanwhile told Zhang that “the company did not provide any documents on contamination.”

But Liaoning Yisheng claims it had provided reports of quality control and risk evaluation.

The Jilin Provincial food and drug testing authority found the 117 batches safe but it still did not issue the necessary certificates, CNR reported.

Liaoning Yisheng said the company would lose nearly 400 million yuan (US$65.09 million) because of the stalemate, CNR reported.

On August 12, Lu Quan, a Party official from Hunan Province alleged that Shao Mingli, the former chief of China Food and Drug Administration, amended the Chinese Pharmacopoeia in favor of honeysuckle producers in his hometown in Shandong Province, resulting in huge economic losses for other growers of the herb.


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