Drugmakers in China may be set a 24-hour deadline to recall dangerous medicines or lose their licences, according to a proposal from the country’s healthcare regulator.
The State Food and Drug Administration has published a draft plan which advocates a rapid recall of products, according to China’s official Xinhua News Agency, and proposes a three-tier system for withdrawals; “potentially fatal and harmful drugs” must be recalled in one day, those that could cause “temporary health problems” should be recalled after three days and in the third category, which can include problems such as faulty packaging, drugmakers have seven days to rectify the situation.
The proposal, which the SFDA says is based on international practices, requires manufacturers to promptly analyse information about potentially unsafe drugs and inform the public immediately. If they do not, the government can revoke a drugmaker’s manufacturing licence.
Also, if retailers and hospitals find problems, they must immediately stop selling the product, inform the makers and providers, plus “submit a timely report to the quality supervision authorities”. Failure to do so could lead to fines ranging from 1,000 yuan, about $132, to 50,000 yuan and the revocation of licences in serious cases.
Yan Jiangying, a spokeswoman for the SFDA, told China Daily that the regulation is still in draft form, and we are soliciting feedback from stakeholders, including drug companies". The final version will be implemented as soon as October 8 and the proposal “is intended to strengthen the accountability of pharmaceutical companies”, she added.
The planned move is the latest in a number of measures that China has been taking. In July, a day after the execution of its former chief Zheng Xiaoyu for corruption, the SFDA announced plans to tighten approval regulations and strengthen the penalties for producing counterfeit drugs. Indeed, this week Shanghai Hualian Pharmaceutical Co was told to recall the oncology agents methotrexate and cytarabine after they had caused adverse reactions, while earlier in the summer Guangdong Baiyi Pharmaceutical Co lost its production licence was pulled for making blood-based products from a donor infected with hepatitis C.