China orders medical institutions to stop using recalled Huahai-made drug

Shanghai, July 30

China’s health regulator on Monday said all domestic medical institutions must cooperate with authorities and not use the valsartan blood and heart drug made by Zhejiang Huahai Pharmaceutical Co Ltd that could pose cancer risks.

The bulk manufacturer of the drug said earlier this month that it was recalling the valsartan drug sold in the United States after the European Medicines Agency found that it was tainted with an impurity linked to cancer.

In a notice posted on its website, China’s National Health and Family Planning Commission said the recalled drug, commonly used to treat patients with high blood pressure, should not be used for the diagnosis and treatment of diseases.

European regulators have said that the problem likely dates to changes introduced into manufacturing processes at the company in 2012, suggesting that many patients could have been exposed to cancer risk.

The drug has already been withdrawn in the United States and Europe and China’s drug regulator said on Sunday that Huahai had completed the withdrawal in China of the raw materials used to produce the drug.

The case is one of two involving tainted medical products that Chinese health regulators have had to deal with in recent days. On Sunday, police said it was applying for arrest warrants for 18 people at Changsheng Bio-technology Co Ltd, a vaccine maker which was found to have falsified data and sold ineffective vaccines for children.

Shares in Chinese drug makers have since slumped, with an index tracking major Chinese healthcare firms trading 3 percent lower on Monday, putting it on track for its third consecutive day of loss.

The Chinese health regulator also said there were six local companies that used valsartan made by Huahai. Five of these companies had products on the market and have since issued recalls, it added.

The sixth firm, the Hunan branch of Zhuzhou Qianjin Pharmaceutical Co Ltd, had not yet shipped out its products, the regulator said. The company in a statement said it returned Huahai’s valsartan earlier this month and that none of its products were affected by the product recalls.

Huahai on Monday said its other products did not contain the impurity known as NDMA, which is classified as a probable human carcinogen, and that it would continue to improve its systems to prevent similar incidents from happening. — Reuters.