When it comes Chinese-made APIs, Western drugmakers are between a rock and a hard place. They know Chinese oversight of bulk APIs is insufficient to snuff out substandard producers, but since China produces more APIs than any other country, they can't live without them.
"If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty," Guy Villax, CEO of Hovione, tells Reuters. The Portuguese API supplier has factories in China, as well as the U.S. and Ireland.
After 80 U.S. patient deaths were tied to tainted Chinese heparin in 2008, Chinese authorities pledged to crack down on API suppliers. But a Reuters investigation finds that while China is doing more, the fact that many Chinese APIs are substandard or counterfeit is an open secret. "Illegal ingredients in bulk are a big problem, but nobody talks about it," Villax says.
One gaping loophole in China's regulatory arsenal, the news service found, is that the State Food and Drug Administration (SFDA) regulates pharmaceutical manufacturers, but not chemical makers. Yet the unregulated chemical makers produce many of the APIs, which are chemicals. The fact that many non-Chinese companies must rely on brokers who know the language and the regulations, to source their APIs, also creates an environment that allows some bad players to fly under the radar.
Philippe Andre, whose company audits Chinese API suppliers for drugmakers, tells Reuters that he finds fraud in maybe a quarter of the plants he audits. In one, 8 years of logs had been written in one person's handwriting, indicating that they were fraudulent, and while workers wore bio suits, drugmaking equipment wasn't vented, indicating that it was for show. "If you can substitute an API that is expensive to make and manufactured at a high level with something that costs much less, then that can happen," Andre said.
It is not that there are no safeguards. Without admitting defeat, the SFDA is instituting regulations Oct. 1 that put the responsibility to audit excipient suppliers on the drugmakers themselves. The FDA has three offices in China now, and with passage of the Generic Drug User Fee Amendments, it will have more funds for inspections and require that they be carried out at least one every two years in generic drug manufacturing facilities. It also looks to add a new heparin molecular weight determination procedure and already asks heparin makers to test crude heparin to make sure the ingredient comes only from pig intestines.
Many experts say the West has the resources and knowledge to generally protect against bad players, while developing areas like Africa are vulnerable. Still, with price pressures building on drugmakers and China's API market still producing most of the products, some experts tell Reuters that the unregulated makers pose a threat globally.
Edward Sagebiel, a spokesman for Eli Lilly ($LLY), says even with the high standards Lilly places on its products, it is aware that there are unauthorized Chinese companies making and selling copies of some of its APIs. "We see this as a global crime against public health," Sagebiel says. "Because these bulk chemicals are unregulated, they are inherently unsafe."
- read the Reuters story
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