China’s recalling of the defective vaccines and special category drugs from home and abroad, including India, over safety concerns will strike a heavy blow to drug exports and damage the country’s international image, Chinese experts have said.
China initiated protocols on Tuesday to recall fake rabies vaccines sold in other countries and regions amid the recent vaccine scandal.
Changchun Changsheng Biotechnology Corporation, the Chinese company which manufactured the vaccines, has been accused of producing ineffective vaccines and violating immunity standards.
The Indian authorities have ordered an immediate withdrawal of rabies vaccines from the market and have also banned its imports from a Chinese manufacturer that allegedly fabricated records.
Chinese 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, state-run Global Times reported.
The experts have 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 newspaper.
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.
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.
Tian’s opinion was echoed by Zhou Zijun, a professor at Peking University’s School of Public Health, who said it was normal for medicine to sometimes react abnormally in clinical tests, but the ingredients should be treated seriously as they affect the quality of a wide range of medicines.
“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.
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 realising 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, the daily report said.
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 statement issued last week by China’s State Drug Administration.
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 UAE and South Korea, media reports said