Drug Safety Concerns Spark SFDA Inspections Of Chinese Manufacturers
China ramped up inspections of its pharmaceutical industry during the first half of June in response to heightened concerns over drug safety, according to State Food and Drug Administration reports.
Although a great deal of attention has recently been paid to problems with Chinese exports, domestic issues have been even more widespread, according to experts. Under current SFDA regulations, exported pharmaceutical products must comply with other countries’ manufacturing practice standards, which may be higher than in China.
“The inspections are in response to a series of serious incidents within the pharmaceutical industry,” Hao Junbo, an attorney with the Beijing-based legal firm Lehman, Lee and Xu, told PharmAsia News.
“Supervision should be done in advance because it’s critical to people’s lives. We can’t just wait until every time something bad happens before we go in and fix it.”
In Qiqihar in northeast China, eleven people allegedly died last May and many others became sick after receiving injections of counterfeit Armillarisin A, a treatment for gall bladder, liver and gastric disorders manufactured by Qiqihar No. 2 Pharmaceutical Co., according to the state-owned Xinhua newswire. Three months later, the antibiotic Xinfu (clindamycin phosphate glucose injection) manufactured by Anhui Huayuan Worldbest Biology Pharmacy Co., also allegedly caused 11 deaths.
At the 22nd International Medical Summit Forum in Haikou, in March, SFDA Deputy Director Wu Zhen acknowledged that “Serious incidents related to drug safety have been happening non-stop in China since last year,” according to Xinhua.
More recently, the SFDA said June 11 that thousands of counterfeit bottles of human albumin had turned up in eight provinces across China.
The agency is expected to soon publish revised good manufacturing practices standards to strengthen drug safety regulations, according to the China Pharmaceutical Industry Association.
Wu told Xinhua that GMPs are an effective system to guard drug safety, but that problems sometimes arise from violations of the regulations and the SFDA’s failure to enforce them effectively.
“Drug safety has been a more severe problem in mainland China than in other countries,” David Zweig, director of the Center for China’s Transnational Relations at the Hong Kong University of Science and Technology told PharmAsia News. “Drug safety regulations are still developing. Enforcing the law is important for mainland China.”
From June 5 to June 8, SFDA Deputy Director Zhang Jinli led an inspection team in Shanxi province in central China. This team visited the cities of Taiyuan, Changzhi, Datong and Jinzhong, met with local officials, and reviewed company inspection files.
In addition, the team conducted on-the-spot inspections of several local pharmaceutical firms, including the Shanxi Taisheng Pharmaceutical Co., the Shanxi Taihang Pharmaceutical Co., the Shanxi Yabao Pharmaceutical Co., and the Shanxi OsteoRad Biological Materials Co.
The inspectors reviewed drug production and medical device manufacturing procedures and investigated the quality of ingredients that went into the drugs, according to SFDA reports.
By mid-June, inspection teams were scheduled to visit 15 Chinese provinces, out of a total of 32 province-level divisions.
- Rachel Liu
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