In a mid-February post (Product Quality Issues Tied to China- More Deepening Concerns), I commented on the disturbing incident of contamination in certain supplies of the critical blood thinner drug Heparin, which were sourced within China.Since that post, there have been new press stories that the contaminated Heparin is now been linked to 19 deaths, (vs. previously indicated 4 deaths) and all imports of the drug, as well as its raw ingredients have been suspended by the U.S. government. The U.S. Food and Drug Administration found contaminant in 20 of 28 samples of raw Heparin sourced from a Chinese factory of Scientific Protein Laboratories, a primary supplier to Baxter International. Also revealed is that a different brand of Heparin has been recalled in Germany, after 80 patients were taken ill from doses. The German manufacturer is narrowing down the source of that contamination to another Chinese supplier.
Press reports will continue to hype the deepening concerns around drug safety from drug supplies manufactured in China, and no doubt, the lawyers of victims will be citing many of the past quality defect stories of Chinese goods to bolster damage claims. But there are lessons here related to supply chain strategy and risk mitigation.
It’s fairly obvious to me, and other supply chain professionals I presume, that government inspections cannot be relied upon to be the sole quality control point for drugs and medical materials imported from China. There are a reported 700 Chinese drug makers registered with the U.S. FDA, with just 14 inspections completed by the FDA last year. Quality and safety will have to come from highly controlled and monitored process, managed by brand owners themselves.
A recent Boston Globe story ( Drug makers stick by China– subscription required) indicates that U.S. manufacturers such as Iverness Medical, Covidien, as well as Genzyme are ramping-up their own manufacturing sites located in China, utilizing highly controlled processes developed, controlled and proven for all worldwide facilities. Sourcing materials solely for pure cost savings, is penny wise and pound foolish in the drug manufacturing value chain. The point here is that the sourcing or procurement group does not hold the bag for product quality, the complete value-chain, and all groups involved, collectively own that responsibility. Safety should never be compromised for the sake of singular material cost savings.