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Chinese leaders promised to impose tough penalties on drug companies that break the law, after a large firm was accused of falsifying its records. Here, a child receives a vaccine against vaccination at a hospital in south China's Guangxi region on Monday.
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Chinese leaders promised to impose tough penalties on drug companies that break the law, after a large firm was accused of falsifying its records. Here, a child receives a vaccine against vaccination in a hospital in southern Guangxi, China, on Monday
AFP / Getty Images
President Xi Jinping ordered an investigation – and promised serious punishment – after a pharmaceutical firm falsified the production records of an anti-rabies vaccine and sold more than 250,000 doses of vaccine. an infant vaccine that does not meet medical standards.
The regulators said that the major drug manufacturer, Changchun Changsheng Life Sciences Limited, had arbitrarily changed the way it produced freeze-dried human rabies vaccines, as well as falsified records and inspection reports. The government says it's ordered the company to stop producing the vaccine.
Problems with rabies vaccine were discovered on July 5th. Food and Drug Administration and a local agency to hold an on-site inspection, Xinhua reports run by the state. The president of the pharmaceutical company and four senior officials are now under criminal investigation
The public outrage has steadily grown, the news echoing a major recall late 2017, when Changsheng recalled 252,600 DTP doses for infants (against diphtheria, whooping cough). and tetanus). Despite not meeting the standards, the drug was sold to the Shandong Disease Prevention and Control Center.
Outlining public reaction, the South China Morning Post reports:
"Fury and fear filled Chinese social media this weekend." On WeChat, the country's most popular email service, the word Chinese for the vaccine appeared in 321 million articles and research, 80 times the number of times it appeared on Friday. "
The recall of DPT also included another company, the Wuhan Institute of Biologics – a subsidiary of the Chinese national pharmaceutical group China State Pharmaceutical Group – which was producing even more of the wrong doses. 000 doses of DPT to governments of cities and provinces that were subsequently recalled.
Regarding the potential effects of the wrong DTP vaccine, the quotes from China News Service a medical website that says that even though the vaccine does not should not pose a threat to safety in itself, it will "reduce the expected immune effects."
A plan for the inoculation of newborns was done in February, says the CNS
. provoked an uproar in social media and threatened confidence in health regulators in China, two years after the discovery of the country's national vaccine market fraud. s have dismantled a network of criminals for illegally reselling millions of vaccines without following proper conservation and refrigeration protocols, leaving many parents worried that their children will be sick or left unprotected from future disease
. According to NPR's Anthony Kuhn, many consumers are angry because they believe the government would pamper pharmaceutical companies and regulators, while punishing whistleblowers who bring scandals to light.
Pharmaceutical companies are also subject to scrutiny and potential spot checks, especially after some of them have run into their own problems.
Earlier this month, the US Food and Drug Administration drugs for the heart, if their active ingredient valsartan was produced by Zhejiang Huahai Pharmaceutica of China ls. The reason: The products have been contaminated with a potentially carcinogenic impurity.
The FDA said the problem was related to a change in the manufacturing process in China – and that the impurity may have gone unnoticed for "up to four years". "
The current vaccine case" has crossed a moral line, "said Chinese Premier Li Keqiang over the weekend, adding," Any wrongdoing will be severely punished, no matter who is involved. "
The scandals have cast a horrible scourge on the Chinese public vaccination system, which has already been credited with reducing the number of cases of polio, hepatitis B and tetanus
Several Chinese vaccine companies fell by 10% on Monday, the Wall Street Journal reports, adding that Changsheng's stock price fell by more than 40% last week.
The setbacks come months after the central government Chinese has announced that it is changing the structure of its drug regulatory agency – the latest in a series of changes since the agency's inception in 1998, according to the journal Pharmaceutical Technology. [19659026]
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