Govt urged to strengthen supervision on drug exports

By Cao Siqi Source:Global Times Published: 2018/8/8 23:18:40

Improved clinical tests ensure drug standards

Chinese experts on Wednesday called on government agencies to strengthen the supervision of exports of domestic medicine and ingredients, after several Chinese drug makers reportedly recalled their products over safety concerns that triggered a global alert.

"Drugs are a special product linked to people's health. China should better supervise medicine quality and prohibit substandard drugs from entering the domestic and overseas markets," Tian Guangqiang, an expert on medicine at the Chinese Academy of Social Sciences, told the Global Times on Wednesday.

Chinese drug manufactures should raise their awareness of quality control, while the government should establish a strict approval system and impose severe penalties on violators, Tian said.

Tian's opinion was echoed by Zhou Zijun, a professor at Peking University's School of Public Health, who said it is normal for medicines to sometimes react abnormally in clinic tests. However, the quality of ingredients should be treated seriously as ingredients affect the quality of a wide range of medicines.

"If there is something wrong with the ingredients, medicines using them face a possible recall," Zhou told the Global Times on Wednesday.

Experts made the appeal after China initiated protocols on Tuesday to recall fake rabies vaccines sold in other countries and regions amid the recent vaccine scandal.

On July 29, Zhejiang Huahai Pharmaceutical, a major Chinese producer of Valsartan ingredients, halted shipments and ordered a recall in the domestic and overseas markets after realizing that the active pharmaceutical ingredient N-nitrosodimethylamine (NDMA), a known carcinogen, poses a cancer risk.

NDMA is classified as a 2A carcinogen by European and other drug regulators, which means there is limited evidence that it could cause cancer to humans. Measures, including a halt to sales and recalls, are taken as a precaution but drugs with NDMA are not expected to pose a severe health risk, according to a State Drug Administration statement on August 2. 

The National Health Commission on July 30 required medical institutions of all kinds and at all levels to stop using medicines containing Valsartan.

Valsartan, a common drug used to control hypertension and heart failure, is being recalled worldwide. In addition to the European Union, other countries affected by the recall include Canada, the United Arab Emirates, and South Korea, media reported. 

The recall triggered a global alert over a similar issue. Two other drug makers from the Chinese mainland, Tianyu Pharm and Rundu Pharma, recalled blood-pressure products, which had been sale to the island of Taiwan, because of a potential impurity linked to cancer, Hong Kong-based news website Asia Times reported Tuesday.

Tianyu Pharm issued a statement Monday at the Shenzhen exchange, where both Tianyu and Rundu are listed, while Rundu issued a similar statement, AFP news agency reported.

"Chinese drug companies and drug-related government departments should do more to ensure that the medicines, especially the ingredients, meet standards set by government agencies. Improving detection methods are the key," Zhou said.

Analysts noted that the recall will strike a heavy blow to the country's drug exports, and will also damage the international image of Chinese drug companies.

China-made medicines are in demand in overseas markets because of their reasonable price, but the recall will make overseas markets more cautious with China-made medicines.

It will give other countries a chance to get a slice of the China-made medicines' market share, Tian said.

In 2017, exports of Chinese medicines and health products reached $60.7 billion, an increase of 9.44 percent from the previous year, China Customs data shows.

The China Chamber of Commerce for Import and Export of Medicine and Health Products said that medicine exports faced 15 anti-dumping investigations in 2017. The chamber said India initiated the most anti-dumping claims against Chinese medicines, National Business Daily reported in February.

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