Tougher rules set to control vaccine makers

China will intensify supervision of vaccines, including inspection of the products, to ensure safety of public health this year, the top drug regulator said.

The National Medical Products Administration will urge its branches across the country to improve supervision, and will supervise handling of cases involving legal violations or irregularities, Jiao Hong, head of the administration, said at a national conference on drug supervision that concluded on Friday. Improving supervision of vaccines will be a priority for the administration for the new year, she said.

Li Li, deputy chief of the administration, said the administration will impose the strictest standards on drug supervision and give the most severe punishment to violators.

It will take more effort to eliminate risks, focusing on high-risk products including vaccines, to ensure drug safety, he said.

Safety of vaccines was a hot topic last year that garnered much public attention after a major vaccine producer was found to have fabricated production records and used expired materials over four years in the production of vaccines that prevent rabies, a potentially fatal disease.

The company, Changchun Changsheng, based in Changchun, Jilin province, also was found to have produced and sold substandard DTaP vaccines, which protect against diphtheria, tetanus and whooping cough. Another vaccine producer in Wuhan, Hubei province, was also found to have produced and sold substandard DTaP vaccines.

Following the incidents, top officials vowed harsh penalties and the reform of supervision of the vaccine industry to eliminate loopholes. A new law proposing harsher penalties was drafted and submitted to the top legislature for first review at the end of last year.

In Jinhu, Jiangsu province, local authorities have confirmed 145 children had received expired polio vaccines at Licheng Health Center in the county. Polio vaccine is a Category One vaccine in China, which means it is provided by governments for free.

The Jiangsu Health Commission dispatched a team on Tuesday to the county to supervise an investigation into the case, it said in a statement released on Friday.

The commission has intensified supervision and inspection of vaccination across the province, and ordered local authorities to do thorough inspections to eliminate risks in vaccination.

Pu Rongcao, deputy publicity chief of Jinhu, told China Daily on Friday that a lack of a sense of responsibility among staff in the health center caused the incident, and chief officials of the county's center for disease control and prevention have been removed from office.

The county government will provide free physical checkups to the children, or they can choose to go to major hospitals outside the county at the expense of the county's health authority, he said. The authority will pay all medical costs for children who suffered health damage due to the vaccination, he said.

Ru denied media reports that children in the county have received some other kinds of expired vaccines, saying there is no evidence of that.