21 Apr 2010 10:43

Vaccine cases expose lapses in China's inspection system

By Yin Guo'an

Shanghai. April 21. INTERFAX-CHINA - Four months ago, the State Food and Drug Administration (SFDA) suspended production and sale of human rabies vaccines produced by Jiangsu Ealong Biotech Co. Ltd. and Hebei Fu'er Biopharmaceutical Co. Ltd. The two companies had produced vaccines that were later linked to adverse drug reactions. To date, the relevant government agencies have yet to announce the outcome of their investigation into the companies' products.

The biggest concern among the Chinese public is that under the existing inspection system for biological products, substandard vaccines have been able to bypass supervisory controls and enter the market.

The current inspection system was introduced in 2002, with guidelines stipulating that authorities must inspect samples from every batch of vaccines produced. Batches that fail to pass inspection will not be distributed.

Under this system, vaccines which did not meet standards should have been restricted from entering the market. This begs the question, how did the problematic rabies vaccines become available in 27 provinces, autonomous regions and municipalities across China?

The evidence strongly suggests that problems lie in the inspection process. In practice, the system has evolved into one where manufacturers submit samples to authorities instead of one where authorities conduct inspections of random samples taken on factory grounds. Industry insiders said that the quality of vaccine samples submitted to government agencies for examination may not be consistent with the quality of the majority of vaccines actually produced. In addition, we cannot rule out that government agencies may have made mistakes when evaluating the quality of the vaccines.

Unfortunately, no one knows for certain how the substandard vaccines managed to enter the market. Either way, government agencies must share the responsibility. I believe there is a lack of regulatory oversight in the inspection system for biological products - at present, there are no government agencies tasked with monitoring the regulatory agencies.

The above is a personal opinion piece by the author. Its publication in no way implies that Interfax shares the views expressed in the article.