It was always a question of ‘when’ rather than ‘if’. After the scandals over contaminated heparin and baby milk adulterated with melamine, it was really only a matter of time until the next major episode of counterfeiting emerged in China.
Local police are investigating 43 capsule manufacturing companies in Xinchang and 53 individuals have been arrested for allegedly producing and selling the counterfeit capsules to pharmaceutical companies.
Fortunately, it seems as if the offending products – capsules made from industrial gelatin containing carcinogenic chromium 90 times above safe levels – have been detected and removed from circulation before any harm has been done to human health.
It is, however, too late to prevent damage to the already sullied reputation of China’s burgeoning pharmaceutical manufacturing industry. On a positive note, the State Food and Drug Administration (SFDA) acted promptly to recall the affected products and to issue warnings about the hazard. And no doubt the investigations will be thorough and the culprits severely punished.
On the other hand, it puts a serious question mark over the Chinese government’s efforts to implement new GMP regulations to which all pharma companies serving the domestic market will have to conform by 2015.
The pharmaceutical manufacturing sector in China is not only spread over an enormous geographical area, but it is also made up of thousands of small, disparate and unregulated enterprises. Monitoring the entire industry and enforcing the regulations is an insurmountable task, but this is not the main issue.
While there are those willing to put lives at risk by manufacturing toxic products, and while there are pharma manufacturers prepared to buy and use goods from suspect sources and put them into circulation, the main requirement is not for tougher regulation, but for a radical change in attitude.
Until ethical values in the industry outweigh illicit financial gain, China’s massive achievements as a major force in the pharma sector will continue to be tainted by scandal.