Vaccine firms at fault face hefty fines
CHINESE vaccine manufacturers who falsify test results or break other rules could be fined up to 5 million yuan (US$720,000) under a new law proposed after a scandal that fueled public fears over domestically made medicine.
The law would regulate areas including production, distribution and use of vaccines, according to a draft posted on Sunday on the website of China’s market regulator.
China’s State Administration for Market Regulation published a draft law on vaccine management on its website to solicit public opinions for half a month. The 11-chapter draft law stipulates that supervision and management of vaccines’ market access should be tightened.
The draft law requires stricter management on vaccine production, research, after sales, distribution and vaccination.
The country was earlier this year rocked by a scandal that saw a manufacturer of rabies vaccines fabricating records.
While authorities say the affected vaccines did not enter the market, the consumers were fed up with product safety scandals. Under the proposed law, those who flout the rules can be fined up to 5 million yuan for offenses including submitting false test results, not recalling problematic batches and other illegal acts.
“Those who participate in illegal behavior, shield or connive with violators, hide the facts through fabrication, or impede investigation will receive severe punishment,” the draft said.
This is the first time a law has targeted vaccines, which were previously covered by regulations controlling medicine.
Changchun Changsheng Biotechnology company was slapped with a massive US$1.3 billion in penalties over the rabies vaccine scandal.