- The Chinese FDA is reportedly investigating three drugmakers for illegal production methods and has ordered some of their products pulled from the market, Reuters reports.
- Hebei Yongfeng Yaoye, Gansu Dadeli Pharmaceutical, and Guizhou Shouxian Pharmaceutical are all subject to the criminal probe.
- China is still dealing with the fallout from the discovery of nearly $90 million blackmarket for vaccines against a wide range of diseases. The vaccines are thought to have been illegally sold in provinces through China since 2010.
Last week, the Chinese government announced plans to punish 357 officials tied to the ongoing vaccine scandal. Already, over 200 people have been detained as part of the investigation.
The WHO has urged China to apply the same high standards used for public vaccine distribution to the private market. Standards which are in place for public distribution of vaccines apparently have been disregarded once the products reach the private market, leading to improper storage and sales of expired vaccines.
As the government works to restore faith in the public health system, it is also moving to reform its $60 billion plus biopharma market. The Chinese FDA has said it will accelerate approval of new medication but is also seeking to crack down on corruption and quality control.
The U.S. FDA is also closely watching the Chinese market. Last week, three other Chinese pharmaceutical companies were added to an import alert list for manufacturing violations, Regulatory Focus reports, bringing the list total to 44 firms.
With large populations and growing domestic markets, quality control will likely continue to be a major issue in Chinese and Indian biopharma markets for some time.