China widens vaccine scandal probe, vows tough penalties

SHANGHAI (Reuters) – China's drug watchdog published on Tuesday from an investigation into a second pillar of vaccines.

Public Confidence in Domestic-Made Drugs medical products has been shaken by such scandals in China.

China has already ordered the arrest of 18 people at Changsheng Bio-technology Co Ltd, the vaccine maker at the heart of the scandal, including its chairwoman Gao Junfang.

The vaccine was found to be ineffective and vaccinated. It also produced and inspected records relating to rabies vaccine used for infants. Changsheng has apologized publicly for the incidents.

A meeting of the State Council chaired by Premier Li Keqiang on Monday said companies and individuals should be severely punished and banned from the pharmaceutical industry for life.

Changed the case for other cases in the Changsheng case, according to a notice posted late on Monday.

The State Council also called for a full investigation into any potential regulatory failings, including the possibility of public safety and security.

A special cabinet investigation team said on Friday. Changsheng had systematically falsified production and testing records to avoid regulatory scrutiny, and had also 252,600 doses of ineffective DPT vaccines to inoculate children against diphtheria, whooping cough and tetanus.

The China Food and Drug Administration, published in Wuhan Institute of Biological Products, which, with Changsheng, was found to be producing inferior vaccines in November 2017.

The regulator said on its website the cause of Wuhan's substandard vaccines was accidental because of its packaging equipment experienced a temporary malfunction that was originally distributed.

The company recalls and destroyed all 400,520 inferior doses on May 4 and was also approved.

It said that Wuhan was considered to have its production issues after passing inspections in March.

The company did not respond immediately to requests for comment.

China's pharmaceutical companies, which focus primarily on the bulk production of a small number of products, making them vulnerable to safety incidents.

"Concentration on low-quality generic drugs, high product concentration and heightened regulatory risks will continue to constrain most Chinese drug makers' business profiles to non-investment grade levels," it said.