China’s Battle For Drug Safety

Earlier this month, $180 million worth of counterfeit pharmaceuticals were seized and nearly 2,000 people were arrested by Chinese authorities, part of an ongoing government pledge to enhance drug safety and crackdown on counterfeiting after tainted Chinese-made medicine killed users across the globe in 2007 and 2008. A post from SecuringPharma.com summarizes a report from China’s Ministry of Public Security outlining their progress in cleaning-up counterfeit food and drugs over the past year:

According to newly released figures from the Chinese Ministry of Public Security police have shut down 147,000 sites involved in the fake food and drug trade since August 2011. Over the same period the police have reportedly resolved 185,000 criminal cases linked to counterfeiting.

Information from the public played a big role in the anti-counterfeiting cases. The Ministry says the police paid 12,000 informants $4.4m for helping to identify and solve cases of fake food and drugs.

[...]Data on the success of anti-counterfeiting efforts comes as China tries to show publicly that it is taking control of the situation. From October the State Food and Drug Administration (SFDA) will blacklist manufacturers of fake drugs as part of the intensified anti-counterfeiting push.

Xinhua relays a drug safety supervisor’s forecast on what’s to come in Beijing’s campaign for drug safety:

In the latter half of this year, the SFDA will step up joint actions with other law enforcement agencies and government departments to curb counterfeit medicines, he [Yin Li, director of the SFDA] said.

Efforts will be made to improve the coordination among drug safety agencies from different regions as well as cooperation between the government and enterprises, he said.

In addition, the SFDA will start an inspection on the production of medicines listed as the national essential medicines in the next four months.

Despite Beijing’s recent efforts, China is still rife with counterfeit and contaminated drugs, and lacks the controls to keep them off the global market, according to a special report published by Reuters yesterday:

Four years ago, Beijing promised to clean up its act following the deaths of at least 149 Americans who received contaminated Chinese supplies of the blood-thinner heparin. But an examination by Reuters has 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 recognised standard of quality assurance.

[...]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.

[...]China’s dominant position in the global market for pharmaceutical ingredients makes the issue both pressing and hard to tackle.[...]

The Reuters report follows the investigations of Philippe Andre, a “Detective in the murky world of Chinese pharmaceuticals” (i.e. pharmaceutical auditor based in Tianjin). A slideshow of Andre’s, outlining the “supervision of Chinese-made drug substances“, can be found via PEW Health Group.

Also see prior CDT coverage of the 2008 herapin scandal, counterfeit medicinedrug safety, and other tainted exports.