Chinese pharma contaminated with scandals


Another batch of vaccines have been found “substandard”, just days after the second-largest pharmaceutical company in China admitted to falsifying test results and producing hundreds of thousands of fake new-born rabies shots.

Authorities from Chinese province Jilin announced classifying a batch of Changshen Biotechnology diphtheria, tetanus and pertussis (DTaP) vaccines produced in 2017 as substandard.

DTaP vaccines are fully subsidised by the Chinese government and are widely given to infants across the country in the first weeks of their life.

According to state media outlet CGTN, more than 250,000 doses of DTaP had already been sold to disease control and prevention centres in eastern China, however, there is no evidence or estimates on how many of them have been used.

This information further increased public fury and health scare as just a few days ago executives from the same pharma company admitted to falsifying production documents related to a rabies vaccine that is also routinely given to Chinese babies as young as three months.

The official Chinese news agency Xinhua reported last week that president Xi Jinping launched police and China’s State Drug Administration (SDA) investigation into Changsheng Biotechnology Co, its chairwoman and four senior executives over suspected criminal behaviour.

Vaccines provided for Chinese children, manufactured by Changshen, have been found to be faulty, inciting widespread fury and prompting the country's president to describe this incident as "vile and shocking."

Chinese Premier Li Keqiang urged severe punishment for the people involved, saying the incident had "crossed a moral line".

"We will resolutely crack down on illegal and criminal acts that endanger the safety of peoples' lives, resolutely punish lawbreakers according to the law, and resolutely and severely criticise dereliction of duty in supervision," he said.

The Chinese drug maker has apologised publicly, saying that it was "guilty and embarrassed" and would co-operate with drug regulators to carry out a comprehensive internal investigation.

According to the SDA despite finding the vaccines “substandard” there is no evidence of any children falling ill or reports of any sicknesses related to the vaccines.

Changshen has been ordered to stop any production, recall all vaccines circulated in the healthcare system and pay a 3.4m yuan fine ($510,000). Company shares went down by 47% since the first information about vaccines surfaced in media.

Unfortunately, these two incidents are not new to the Chinese pharma market. Wuhuan Institute of Biological Products went through similar DTaP vaccines issues in 2016 and just two weeks ago most of the European regulators recalled a common blood pressure and heart drug manufactured by Zhejiang Huanhai Pharmaceutical over possible cancer link.

As much as the Chinese pharma might recover, Changshen will have to forget about its aspiration of becoming the global vaccines manufacturer.

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Piotr Wnuk

24 July, 2018