Producers must recall deadly drugs within 1 day
2007-09-20 03:31:07 Shanghai Daily
DRUG producers must recall products within one day if they could severely harm patients' health or lead to death, the State Food and Drug Administration has said.
The administration published the draft regulation on the management of drug recalls yesterday on its Website to collect public opinions.
The draft said producers must recall drugs within three days if they could harm users' health and within one day if the damage is serious.
They can recall the drugs within seven days if not related to health problems, such as problematic design or content on packages, the draft said.
The producers can correct the packages and then put the drug on shelves again, the draft said.
Problematic drugs must be destroyed under the supervision of authorities.
Provincial drug authorities will conduct assessment on the drug recall and will require producers to expand recall if the result is not satisfactory, the draft said.
Opinions and suggests can be sent to the administration's regulation department by September 27.
China is tightening inspection of pharmaceuticals to improve drug safety after the state's former top drug regulator Zheng Xiaoyu was executed on July 10 for taking bribes and allowing substandard medicines onto the market, including Xinfu antibiotic injections.
Xinfu antibiotic injections, manufactured by Anhui Huayuan Worldbest Biology Pharmacy Company, have been blamed in the deaths of at least 10 patients and severe reactions in more than 80 others last July.
The administration halted production and sales of two leukemia drugs produced by Shanghai Hualian Pharmaceutical earlier this month after some users reported adverse reactions.
Some leukemia patients in Shanghai said they suffered pain and fatigue in their legs and retention of urine after they were injected with Cytarabine Hydrochloride and Methotrexate.
In a crackdown last month, Heilongjiang food and drug supervisors confirmed that 10 out of the 67 drugs they seized in a major drug haul were counterfeit.
The fake drugs, including human serum albumin, rabies vaccines and cefalexin tablets, were sold in the rural areas of Harbin and Mudanjiang in the province.
China will invest 8.8 billion yuan (US$1.17 billion) in the next three to five years on infrastructure for a nationwide food and drug safety system, Yan Jiangying, spokeswoman of the administration, said last month.
