Effective drug regulation takes time. In the U.S., the foundation for the USP, and with it, safe drug standards, was laid shortly after the first Continental Congress, yet it wasn't until 1938 that FDA took its modern form. So it's easy to imagine the challenges that China faces. After all, China's SFDA is only seven years old, and operates in a huge and populous country. Yet, insiders acknowledged that the Agency has been "rotten from top to bottom," according to an article in the International Herald Tribune.
Under the circumstances, the recent death sentences issued for its top officials (with life prison terms for some underlings) are part of "a harsh but probably necessary strategy to re-establish control over an under-regulated sector," said David Zweig, a professor at the Hong Kong University of Science & Technology quoted in the article. (For more, read the entire article ).
The sentences are meant to send a message that the government is serious about reform to China's citizens, the victims of unsafe drugs or snake oil products (at least one of which, the Chelsea Clinton Slimming Patch , was advertised as coming from the U.S.) For those who study absurd scams, see the blog Shanghaiist for more on this little product, designed to "suck the fat" out of the afflicted area. )
But China is also the focal point of a huge and growing counterfeit drug export industry. What message is being conveyed to those outside of China?
It's one thing to take dramatic steps against a handful of scapegoat government bureaucrats and quite another to take action "on the ground." What penalties will be enforced for the managers of drug or food manufacturing companies who are found guilty of bribery or of selling intentionally fake, substandard or untested products? How will China enforce laws against individual counterfeiters?
(Drugs are only part of a rising tide of poorly made or dangerous counterfeit Chinese goods, which now includes exploding cell phone batteries, according to the New York Times)
This year, SFDA says it has increased the number of GMP inspectors for drug factories and monitored production quality of narcotic drug manufacturers.
Since July, the Agency claims that it has also:
- Revoked the production licenses of five drug manufacturers
- Withdrawn GMP certificates from 128 drug makers, mainly in Jilin, Henan, Hainan, Sichuan and Anhui provinces
- Revoked the production licenses of three factories in Fujian, Henan and Hebei provinces.
- Suspended methotrexate, a drug manufactured by Shangai Hualian Pharmaceuticals and used to treat acute leukemia and rheumatoid arthritis, after several adverse reactions were reported.
