Investigation of the party of immunoglobulin with antibodies to hiv
Recently, news of an immunoglobulin batch with antibodies to HIV swept across China.
The authorities are investigating the evidence that antibodies to HIV may be contained in a batch of human immunoglobulin produced in Shanghai for intravenous injections, according to a statement by the State Food and Drug Administration of China.
The Office on Tuesday received a notification from the Committee on Health and Planned Childbirth of China that in the party 20180610Z, produced by Shanghai-based Meheco Xinxing Pharma, there may be antibodies to HIV. After that, an investigation began, during which inspections were carried out at the plant itself, as well as with suppliers of raw materials, including blood plasma and other components of the substance.
The authorities issued a notice informing them that the use of the company’s products, distribution and further production was immediately ceased. Meheco Xinxing Pharma should quickly and promptly withdraw the entire batch from the market for further investigation.
In the state laboratories of Shanghai and Jiangsu Province, where the company mainly distributed its products, an independent examination of the immunoglobulin batch for antibodies to HIV, hepatitis B and C was carried out, the results were negative in all cases.
In addition, tests for the corresponding diseases were taken from a number of patients who received the immunoglobulin of this lot. All the results of the checks are also negative. However, it has not yet been possible to establish and verify all those who received the appropriate injections, so the authorities are in no hurry to draw conclusions and close the investigation.
The investigation began after HIV was discovered in a child in Jiangsu Province during a physical examination. Further checks have shown that the child is healthy. In connection with this situation, the authorities decided not to put the inhabitants of the country at risk and initiated a full-scale investigation.