Fake that

It is a nation of 1.2 billion as well as the workshop of the world, so everything happens on a bigger scale in China. Even so some of the numbers involved in the latest crackdown on counterfeit pharmaceuticals there are staggering.

In late July (though news didn’t emerge until August), police seized fake drugs worth about €148 million. Over 18,000 officers were deployed, around 2,000 people suspected of being involved in drug counterfeiting rings were arrested and 1,100 production facilities were destroyed.

Let’s go over that last one again: 1,100 production facilities were destroyed. These were not large-scale manufacturing facilities, one imagines. More likely, many of them were small workshops that should never have been linked to pharmaceutical manufacturing in the first place.

Likewise in the scandal over chromium in drug capsules back in May, when the State Food & Drug Administration (SFDA) announced that 254 companies, 12.7% of all China’s drug capsule makers, had been producing unsafe capsules and that over 50 arrests had been made. It subsequently tested 11,561 batches of drugs, of which 5.8% contained excessive levels of chromium.

The fake edible gelatin found in the investigation was apparently made from industrial gelatin recovered from waste leather produced during the manufacture of clothing. These were treated with industrial chemicals containing high levels of chromium to extract the gelatin, which was then sold on to the capsule manufacturers. Showing the scale of it all points to another major issue. The supply chain in the world’s workshop is vast, free-wheeling and out of control.

It is not yet clear whether the drugs involved in this latest case were for the domestic or the international market - or more likely both - but fake drugs are a massive problem in either case. The scandals that have rocked the wider world, most obviously heparin, are well known enough but even without having precise statistics to hand, it is certain that the majority of victims have been Chinese.

Some of those involved had apparently advertised their drugs online, in newspapers and on television. These included drugs sold on the regulated market to treat diabetes, high blood pressure and rabies. Many contained toxic substances that caused liver and kidney damage and even heart failure.

A Chinese ministry commented: "The criminals' methods were despicable and have caused people to boil with rage." That should be correct, assuming that the people have not simply descended into weary cynicism about it all. Certainly it should cause everyone alarm that four years on from heparin, the risks are still as bad as ever.
 

As Rx-360, the pharmaceutical supply chain consortium that has campaigned for restrictions on fake and sub-standard drugs, noted back in May: “It is not just expensive APIs or drug products that are faked. Inexpensive raw materials like sodium chloride and glycerin have caused many deaths around the world, once contaminated, adulterated or counterfeited.”

There is no doubt that the Chinese authorities are determined to stamp this out and there is no lack of will to do so. New draft regulations were rushed through shortly after both scandals and there has been a new guidance document on pharmaceutical excipients that will usher in Western-style quality requirements.

Officials admit, however, that the problem of fake drugs is “still far from eradicated … Criminals are coming up with new schemes, becoming craftier and better able to deceive,” a public security statement said. Above all, with market forces and regulation pulling in different directions, the incentive for criminals to try their luck will still be there.