[ad_1]
BEIJING • China is investigating a manufacturer of medical products following reports that it has sold human immunoglobulin injected intravenously and that may have been contaminated with HIV, although the authorities have stated that tests had not revealed any signs of the virus.
Beijing has repeatedly pledged to step up surveillance and crackdowns on companies and officials after scandals surrounding food and drug safety sparked public outrage, including one of the polio vaccines expired on the month last and another against rabies last year.
Human immunoglobulin, made from human blood plasma, is used to treat various conditions, but the number of people who may have received an injection of the suspect lot has not been clearly defined. This media consisted of 12,226 units whose expiry date was 2021.
The tests on the suspected batch have proved negative for HIV, officials said Wednesday, following a comment from the National Health Commission of China that the risk of HIV infection was "very weak".
The Shanghai Medical Products Administration said in a statement that the batch, identified as number 20180610Z, had been manufactured by China Meheco Xinxing Pharma, a unit of China Meheco Group under state control.
Reuters could not get any comment from the manufacturer because most of the offices in China were closed for the Chinese New Year holiday week.
According to China Economic Observer, the investigation began after an HIV test on a baby in the southeastern province of Jiangxi had initially given a "weak" positive result that had been attributed to the batch under investigation. The baby was then tested negative for HIV, he added.
"The Shanghai authorities have tested for HIV, hepatitis B and hepatitis C on the lot in question and they all gave a negative result," said National Medical Products Administration. He asked the medical institutions to stop using the lot and seal the remaining stocks for further investigation.
The Shanghai Medical Products Administration said that it had ordered the manufacturer to stop production.
Last month, the National Medical Products Administration of China asked manufacturers to add warnings against the potential risks badociated with frozen human immunoglobulin and human immunoglobulin products injected intravenously, claiming that the raw materials were derived from human blood.
In 2016, the regulator of medical products in Shanghai warned the same company about changes in the manufacturing process of certain products based on human fibrinogen, without evaluating the potential risks, revealed the website of the regulator.
REUTERS
[ad_2]
Source link