Despite risks, drug makers must rely on Chinese ingredients to make their medications. APIs, or active pharmaceutical ingredients, are produced in greater quantities in China, leaving Western producers with little or not options. In fact, some 70-80 percent of the world’s supply of APIs are manufactured in China or India, according to a recent Reuters report.
Unfortunately, China’s oversight of bulk APIs is not sufficient to eliminate producers who use substandard processes and ingredients. The issue is significant, noted FiercePharmaManufacturing. According to Guy Villax, CEO of Hovione, speaking to Reuters, “If China, for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty.” Hovione is a Portuguese API supplier with factories in China, the United States, and Ireland.
The fatal heparin contamination in 2008, which led to many U.S. patient deaths, highlighted some of the issues with API suppliers in China, with Chinese authorities promising to increase oversight on its API suppliers, said FiercePharmaMaufacturing. As we’ve written, more than 150 people died in the U.S. after they received heparin that contained a counterfeit API. “Illegal ingredients in bulk are a big problem, but nobody talks about it,” Villax said. In fact, noted FiercePharmaManufacturing, although China is working harder, it remains widely known that Chinese APIs are substandard or counterfeit.
One problem is that China’s State Food and Drug Administration (SFDA) regulates pharmaceutical manufacturers and not chemical makers; however, many of the unregulated chemical makers are producing many APIs, which are chemicals, noted FiercePharmaManufacturing. Because nonChinese firms are at the mercy of brokers who speak the language and understand the laws for API sourcing, they are, sometimes, unaware that they may be dealing with less-than-reputable brokers.
The Chinese have gone to great lengths creating a facade designed to fool would-be inspectors. As we’ve explained, in one case, alongside Reuters reporters, the Belgian head of a pharmaceutical auditing firm based in Tianjin, China, visited one of these so-called “showroom” factories designed to fool inspectors. Figuratively and literally, there seemed to be no signs of anything amiss. Workers donned safety gear and the floors, walls, and manufacturing equipment were immaculate. Certainly, this was not a facility that manufactured contaminated or counterfeit APIs. In reality, the factory did nothing other than provide a ruse. Machines were not connected to anything that allowed them to vent outside and inspection records appeared to have been written all at once even though they were supposed to have covered a span of eight years.
Some safeguards are in place and the SFDA is implementing regulations Monday to make drug makers responsible to audit excipient suppliers (suppliers who provide inert carriers for APIs). The U.S. Food & Drug Administration (FDA) maintains three offices in China; passage of the Generic Drug User Fee Amendments, will provide additional inspection funds with mandates that inspections be conducted no less than once every two years in generic drug manufacturing facilities, said FiercePharmaManufacturing. The Fee Amendments also seek to add a new heparin molecular weight determination procedure and does ask heparin makers to test crude heparin to ensure the ingredient comes from pig intestines.
The World Health Organization admits it is aware of the problem with pharmaceutical counterfeiting but appears powerless to alter this trend at the moment.
