Scandals keep blindsiding China’s food and drug regulator, so what’s the missing ingredient?
For more than 15 years, Beijing has been pushing the public safety watchdog through rounds of reforms, but health scares continue to sweep the country. The problem, say experts, is that oversight remains in the hands of local officials
Recent health scares have once again prompted concerns that China’s food and drug regulator, despite decades of reform, still lacks the bite to effectively police the rapidly expanding sectors.
Confidence in the China Food and Drug Administration has been shaken by news that for years a mother and daughter in Shandong province had sold improperly stored or expired vaccines worth more than 570 million yuan (HK$680 million).
Last month, mainland media reported that dozens of eye patients suffered serious side effects, including blindness, after operations involving a medical gas.
Experts say that although the regulator has made huge strides over the past decade, it continues to face challenges, including a lack of manpower and a pharmaceutical market growing more complex and diverse by the year.
The government is trying to balance vigilance and efficiency, they say, but some drugmakers complain the approval process is too inflexible and long.
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“The mainland’s top drug regulatory body is still adjusting to social and economic developments and department adjustments have not yet been completed yet,” said Hu Yinglian, an associate professor at the Chinese Academy of Governance, who has been researching drug administration for several years.
“Since it was established ... China’s pharmaceutical industry has changed greatly and people’s demand for medicine has substantially changed,” he said.
The central government created the State Drug Administration (SDA) in 1998 by merging the State Pharmaceutical Administration, the Ministry of Health’s drug administration department and some of the functions of the State Administration of Traditional Chinese Medicine.
The new authority was in charge of overseeing research, licensing applications, production and distribution. At the time, more than 7,000 pharmaceutical producers and 760,000 distributors were under its radar.
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Five years later the SDA expanded its authority to licensing approval of food, cosmetics and health supplements, and adopted a new name, the State Food and Drug Administration (SFDA).
A slew of corruption cases involving licensing approvals were exposed in ensuing years.
Zheng Xiaoyu, who led the administration since its inception, was sentenced to death in 2007 for negligence and taking 6.5 million yuan in bribes
The following year, the State Council put the body under the health ministry’s authority, which was made responsible for drafting standards on food safety.
But loopholes in oversight remained. Other government bodies, tasked with commerce, health and quality inspection, continued to play a role.
This arrangement lasted until 2013 when the State Council decided to merge the state quality inspector and the commerce administration’s food safety oversight duties with the State Food and Drug Administration to form the China Food and Drug Administration, taking an approach also found in the United States.
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Gu Hai, a professor of public administration at Nanjing University, said food and drug safety supervision had been strengthened as each division was more aware of the boundaries of their power, while the task force had been bolstered.