Watchdog eyes safety check on drug ingredients

SEOUL, July 20 (Yonhap) — South Korea’s drug safety watchdog said Friday it will check the safety of all active pharmaceutical ingredients following a global scare over a Chinese drug tainted by a cancer-causing substance.

Zhejiang Huahai Pharmaceutical, a listed Chinese firm that makes and sells generic drugs to the global market, has recently recalled some of its products containing the active ingredient valsartan after detecting an impurity known as N-nitrosodimethylamine (NDMA).

Valsartan is used to make a generic blood pressure drug. NDMA is classified as a probable human carcinogen, which may cause cancer with long-term use according to results from laboratory tests.

The Ministry of Food and Drug Safety said it will investigate whether other active drug ingredients made by Zhejiang Huahai contain NDMA.

The ministry said it plans to look at data received from the Chinese company to check the safety of its manufacturing process while sharing related information with European regulators.

“The safety check will be carried out as a precaution since NDMA was produced during Zhejiang Huahai’s manufacturing process,” a ministry official said.

In addition, the ministry plans to check whether valsartan manufactured by domestic pharmaceutical companies may contain the probable carcinogen, he said.

The ministry added that Zhejiang Huahai’s manufacturing changes introduced in 2012 are believed to have produced NDMA as a by-product.

Following the safety scare, South Korea has suspended the sale of 115 high blood pressure treatments containing valsartan made by Zhejiang Huahai.


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