China tells med institutions to stop using ‘Huahai drug’
Chinese parents protest
SHANGHAI, July 30, (Agencies): China’s health regulator has ordered local medical institutions to stop using a heart drug from Zhejiang Huahai Pharmaceutical Co Ltd, in a directive that comes just days after another case of a tainted medical product.
Public confidence in domesticmade drugs has been shaken since Huahai’s case came to light at the beginning of July, followed by a government investigation concluding Changsheng Bio-technology Co Ltd sold a substandard rabies vaccine. The prices of healthcare shares have since dropped.
In the Huahai case, the European Medicines Agency found the firm’s valsartan blood and heart drug tainted with an impurity linked to cancer, saying the issue likely dated to changes in the firm’s manufacturing processes in 2012.
Huahai has since halted production and recalled the product. On Monday, it said its other products did not contain the impurity — NDMA — and that there was not enough data to categorically conclude it has carcinogenic effects on humans.
China’s National Health and Family Planning Commission, also on Monday, said on its website that the drug must not be used for diagnosis or treatment. It was not clear whether medical institutions could be penalised for noncompliance.
The regulator also said six local firms used the drug in their own products, of which five have issued recalls. It said the sixth, a subsidiary of Zhuzhou Qianjin Pharmaceutical Co Ltd , had not distributed its products.
Qianjin in a statement said it returned its stock of valsartan after Huahai halted production, and that none of its products were affected by Huahai’s recall.
Alex Jiang, a Hong Kong-based analyst at UOB Kay Hian, said the Huahai incident could affect China’s roughly three-year effort to export locally made drugs, impacting not just drugmakers but also other firms involved in the push.
Stronger
“Their drug products could receive stronger supervision from the (United States’) Food and Drug Administration,” he said.
An index tracking the share prices of major Chinese healthcare firms closed 2.9 percent lower on Monday, for the index’s third consecutive day of loss.
In the Changsheng case, police on Sunday said it had applied for arrest warrants for 18 people at the firm, which the government investigation found had falsified data and sold ineffective vaccines for children.
Changsheng previously apologised for the incident. Calls to the company seeking comment on Sunday went unanswered.
About a dozen people held a rare protest outside China’s Health Ministry to demand action over a vaccine scandal that has inflamed public fears over the safety of domestically produced drugs.
Video clips of the daring demonstration in front of the ministry were widely circulated on Twitter and other social media on Monday, showing the protesters holding banners urging accountability and justice in the latest case.
“Legislation for vaccines is imperative! Handle this properly and responsibly!” they shouted in the footage.
Social media posts said the demonstration took place on Monday but AFP was unable to independently confirm that.
The fate of the protesters, whose banners described them as parents, was not known. An AFP journalist who arrived later at the location found no one there.
Chinese security personnel typically react quickly to shut down public expressions of dissent, often detaining those involved.
China’s latest product-safety scare emerged more than a week ago with news that major pharmaceutical manufacturer Changchun Changsheng Biotechnology had fabricated records and was ordered to cease production of rabies vaccines.
The government has said the suspect vaccine did not enter the market, but the case has provoked unusually strong outrage from Chinese consumers fed up with recurring safety scandals.
The protester’s banners bore headlines saying “Vaccines?” and messages including “Please give the victims justice”.
As information about the vaccine scandal emerged over the past two weeks, parents vented anger online, prompting the ruling Communist Party’s internet censors to swoop in and purge mention of the issue.
The anger was exacerbated by the additional revelation that Changsheng’s vaccine for diphtheria, pertussis and tetanus (DPT) had also failed to meet quality standards, but that 250,000 doses were nonetheless sold last year.