Drug-makers must recover dangerous or deadly medication from end-users within 24 hours of a recall order under a draft regulation by China's top drug watchdog.
The 24-hour rule will take effect during a Class 1 recall under a new three-tier recall system devised by the State Food and Drug Administration (SFDA). The draft is based on international practices.
In response to a question about the feasibility of the one-day recall, the administration's spokes-woman, Yan Jiangying, said: "Because the people who buy medication are scattered across the country and are hard to keep track of, companies probably will face difficulties recovering their drugs."
"The regulation is still in draft form, and we are soliciting feedback from stakeholders, including drug companies," Yan said. "The final version will be released and implemented on October 8."
According to the draft, a Class 2 recall involves a situation in which the use of or exposure to a problem product could cause temporary or medically reversible adverse health consequences, or in which the probability of serious adverse health consequences is remote. A Class 3 recall takes place when the use of an unsafe product is not likely to cause adverse health consequences.
"The system will be applied to recalls that are either conducted under a firm's own initiative or by order of the SFDA," Yan said.
The top drug watchdog and its provincial branches will order recalls if companies fail to do so, according to the draft.
In such situations, the companies will also face fines of up to three times the value of the drugs involved and a possible revocation of their licenses.
"The regulation is intended to strengthen the accountability of pharmaceutical companies in case of health scares triggered by problematic drugs," Yan said, urging drug makers to both work with the recall system and self-regulate.
Drug-makers will have to shoulder any expenses incurred during recalls, the draft said.
Under the existing system, the authorities rely on administrative measures such as seizures and the destruction of problem drugs while handling recalls.
Retailers and hospitals that uncover problems with drugs must immediately stop selling and prescribing them, inform the makers and distributors and submit a report to quality supervision authorities, said the draft.
If they fail to do so, they face fines ranging from 1,000 ($132) to 50,000 yuan, or a revocation of their licenses in serious cases.
On Tuesday, the Shanghai drug watchdog ordered the recall of tainted leukemia drugs that had been blamed for causing leg pains and other problems.
(China Daily September 21, 2007)
