Terra Sigillata

From today’s New York Times,

The 62-year-old former commissioner [Zheng Xiaoyu] received the unusually harsh sentence amid growing concerns about the quality and safety of China’s food and drug system following several scandals here involving tainted food and phony drugs.

China is now under mounting pressure to overhaul its food export controls after two Chinese companies were accused earlier this year of shipping contaminated pet food ingredients to the United States, resulting in one of the largest pet food recalls in American history.

The government is also investigating how diethylene glycol, a toxic chemical sometimes used to make antifreeze, ended up in cough syrup and toothpaste in Latin America.

We’ve been following the diethylene glycol adulteration of cough syrup and toothpaste as of late as a result of misrepresented glycerin exports. But the NYT article is suggestive that problems have been bad, if not worse, inside China itself:

For instance, last year 11 people died in China after being treated with an injection tainted by a fake chemical. Also, six people died and 80 others fell ill after taking an antibiotic that was produced with what regulators later said was a “substandard disinfectant.”

Mr. Xiaoyou was charged with taking bribes amounting to US$850,000 in exchange for approving licenses for drug production facilities that apparently did not meet guidelines:

Worried that some of those drugs may be substandard, China is now reviewing more than 170,000 production licenses issued by food and drug agency over the past decade.

What is shocking to me is that China has 170,000 drug manufacturing facilities. I’m having trouble digging up precise US numbers, but most pharmaceutical companies usually have a handful of production facilities each. The US Department of Labor notes, “the pharmaceutical and medicine manufacturing industry consists of about 2,500 places of employment.” Even with that number, the US FDA is already overextended (“Currently there are not enough FDA resources to audit every aspect of CGMP in every manufacturing facility during every inspection visit” from FDA’s own compliance document.).

But going back to monitor the authenticity of 170,000 production licenses seems beyond comprehension, much less inspecting whether each facility meets even the minimum of good manufacturing practices.

However, Chinese food and drug exports are garnering increasing international scrutiny and evidence of some action was inevitable. This action is bound to get attention.

Addendum: Pharmagossip posted on this story earlier this morning linking to a NASDAQ article that notes 31 others have been charged in this case, including the former commissioner’s wife and son.

Comments

  1. #1 John Melikoff
    June 24, 2007

    Hi Abet, (pharmboy?)

    Just to clarify your thinking the 170,000 drug manufacturing facilities in China produce TCM (Traditional Chinese Medical products). Almost none of them actually produce a “real” toxic drug. Maybe 500 of the 170,000.

    To put it into perspective total annual Chinese drug sales in 2005 (the last year we have a record for) amounted to US$25 billion. That is less than Canada spent that year ($28 billion). I don’t know what got spent in the USA, but no, it was not $18 per person.

    Yes the spending will now grow as already 160 million Chinese are over 70 years old. This is expected to rise to 400 million by 2015. No wonder they are now worried about about drug quality.

    John

  2. #2 oscar chidiadi iheanacho
    June 27, 2007

    i whant to complet my education there in U .S .A

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