Four years ago China promised to clean up its act and do better after a counterfeit heparin incident took 149 American lives, but ultimately have they? According to a special news report from Reuters, there are still some alarming things happening in the Chinese pharmaceutical industry.
Philippe Andre, a detective in the murky world of Chinese pharmaceuticals, set out to see exactly what was going on, and he found some very alarming things.
In May last year, he visited a factory an hour outside Shanghai that supposedly produced a pharmaceutical ingredient. While shown around by men wearing protective clothing and spotless hard hats, Andre noticed oddities: the floor was immaculately clean and some workers sat around idle.
The factory had an inspection log that spanned eight years with perfect record-keeping, but the handwriting was the same for all those years and not a single page was dog-eared. What’s more, while the factory had equipment to dry its product, there were no connecting pipes to funnel steam or waste gases out of the plant.
“Obviously the product was not made there,” said Andre, a Belgian who runs a pharmaceutical auditing firm in the eastern Chinese city of Tianjin that advises foreign drug companies buying ingredients in China. The building, he says, was just one of the “showroom” factories intended to disguise China’s thriving industry in substandard and counterfeit drugs.
An examination by Reuters also found that unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling their products on the open market with few or no checks.
Interviews with more than a dozen API producers and brokers indicate drug ingredients are entering the global supply chain after being made with no oversight from China’s State Food and Drug Administration (SFDA), and with no Good Manufacturing Practice (GMP) certification, an internationally recognized standard of quality assurance.
“There is falsification of APIs going on, we know it,” said Lembit Rago, coordinator for Quality Assurance and Safety in Medicines with the World Health Organisation (WHO). “The regulated markets like Europe and the United States are relatively safe because they have well-resourced regulatory authorities. But the situation is different in places like Africa, where there are a lot of local medicine manufacturers who all use APIs from China.”
The export of unregulated drug ingredients may be putting lives at risk, particularly in poor countries where local pharmaceutical controls are minimal. Medicines containing faulty active ingredients or the wrong dose do not work properly and can contribute to the emergence of drug-resistant strains of dangerous diseases, such as malaria.
“We see this as a global crime against public health,” said Edward Sagebiel, a spokesman for Eli Lilly and Co, a multinational pharmaceutical company that says it imposes high standards on its own products, but has seen the unauthorized production of the active ingredients for its drugs by unsupervised Chinese firms. “Because these bulk chemicals are unregulated, they are inherently unsafe.”
China’s dominant position in the global market for pharmaceutical ingredients makes the issue both pressing and hard to tackle.
“Illegal ingredients in bulk are a big problem, but nobody talks about it,” said Guy Villax, chief executive of Hovione, an API supplier based in Portugal with factories there and in China, the United States and Ireland.
About 70 to 80 percent of all active drug ingredients – the biologically active component in medicines – originate in China and India, estimate industry experts, with China accounting for the lion’s share. Its export market in these products is worth $22 billion in annual sales, according to the China Chamber of Commerce for Import and Export of Medicines and Health Products.
“If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty,” said Villax.
Andre, the drug detective, estimates he has uncovered fraud or misrepresentations in as many as 25 percent of cases where he has been hired to audit China factories. “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’s impossible to give an exact number, but it’s not rare. It’s a minority, but not tiny minority.”
In August, Chinese authorities arrested nearly 2,000 people in a nationwide crackdown on counterfeit drugs, seizing more than $180 million worth of fake products.
By 2015, China hopes to be able to electronically track different types of drugs from their production to end-market to prevent counterfeit and inferior drugs from being distributed, although this will only apply to products traded inside the country.
At the U.S. FDA, Commissioner Margaret Hamburg said her agency now had three offices in China and had identified a number of other products, in addition to heparin, where there could be particular “vulnerabilities”.
She declined to give further details. However, she did say, “We do think there’s more work to be done in this area and we’re very interested in working closely with China.”
The United States and Europe are both planning to tighten regulations to control API quality better.