China's drug safety watchdog has issued a new drug recall
method, which encourages pharmaceutical manufacturers to recall
unsafe drugs voluntarily.
The regulation, promulgated Monday by the State Food and Drug
Administration (SFDA), says that enterprises, which voluntarily
recall unsafe drugs, will be subject to lower, or even be exempted
from, administrative punishment.
Those who are aware of problems with their drugs but fail to
issue voluntary recalls, will face heavy fines or even be deprived
of drug manufacturing licenses, according to the regulation.
"Fines will be three times the value of the recalled drugs," Yan
Jiangying, spokeswoman of the SFDA, told a press conference
Wednesday.
China has witnessed a series of drug safety scandals over the
past years. The move by the SFDA comes in the wake of pressure on
the Chinese government to overhaul the country's food and drug
safety system.
One of the most notorious cases of substandard drugs was that of
Anhui Huayuan Worldbest Biology Pharmacy Co., whose antibiotic
injections had been blamed for six deaths last year.
The problem injections, produced in June and July last year,
were found to be not properly sterilized, with both sterilization
temperature and time being below the state-required safety level.
The producer was then given two weeks by the SFDA to retrieve all
its problem drugs.
Yan said most drug recalls in the past in China, like the
substandard injection case, were compulsory recalls issued by the
government.
"The new recall methods emphasize the primary responsibility of
pharmaceutical manufacturers in drug safety," Yan said.
According to the regulation, manufacturers must set up and
improve their quality monitoring systems, promptly analyze
information and feedback from hospitals, retailers and users, and
to investigate and evaluate potentially unsafe drugs.
It classifies the problem drugs that must be recalled into three
categories, with the first being potentially fatal and harmful
drugs, which must be recalled within 24 hours of the recall
announcement.
The second category is drugs that may cause temporary or
reversible health problems and producers have two days to recall
these.
The third category involves drugs that must be recalled within
three days for reasons other than safety, such as improper
packaging.
Yan said the new regulation also applies to overseas
pharmaceutical enterprises, which export drugs to China. "Their
legal obligations are the same as domestic drug makers," said
Yan.
To improve risk control on imported drugs, Yan said the
regulation also requires overseas manufacturers to report promptly
to the SFDA when they decide to recall products outside China.
The new regulation also requires that drug retailers and users
cooperate with manufacturers in retrieving drugs.
Drug retailers and users should stop using the drugs once
problems occurred, inform producers and suppliers of the problems
promptly and report to drug safety administrations, according to
the regulation.
Drug safety administrations at all levels should improve
monitoring capacity, publicize drug safety information regularly
and make sure that such information could reach the public, the
regulation says.
"Compared with previous drug recall rules, which were rather
general in wording, the new regulation is more specific, scientific
and applicable," Yan said.
(Xinhua News Agency December 13, 2007)
