Since mid-February, Supply Chain Matters has been providing ongoing commentary on the disturbing trend of contamination of imported supply within certain pharmaceutical supply chains, namely the ongoing incident involving the life-saving drug heparin. (Drug Imports from China- Controls Are Mandatory)This contamination incident involving the drug Heparin has now been linked with 62 deaths as well as 800 allergic reactions in the U.S. Recalls involving six different countries are now in effect, and China’s drug safety agency has belatedly ordered tighter controls on the production of heparin.
According to a story posted by The Canadian Press, when U.S. FDA experts finally inspected the suspect Chinese plant last month, they found scratched holding tanks with “unidentified material” sticking to their insides. Records were also missing to identify sources of raw Heparin, and testing of these sources was incomplete. The FDA further indicated that a contaminant, identified as oversulphated chondroitin, accounted for up to half of the active ingredient in some batches of heparin from the suspected Chinese factory, but has yet to confirm whether this contaminant caused any allergic reactions. Chondroitin sulphate is made from animal or shark cartilage, and is more than seven times cheaper than heparin. Its chemical similarity to heparin makes it difficult to detect. “We (China) have an increasingly globalized supply chain…” wrote James Shen, publisher of the industry newsletter Pharma China, “It is likely we will continue to see the same problems with other drugs”.
In my view, these incidents are cause for serious concern not just in pharmaceutical, but all supply chains involving human sensitive products. The substitution of melamine for protein and diethylene glycol for glycerin led to previous product recalls involving pet food, toothpaste, and other products. In the most critical of life-sustaining products, heparin, this same trend develops.
A recent PharmaLive article comments on European and WHO officials becoming increasingly concerned of not only fake medicines in the supply chain, but expensive commodity ingredients being targeted by unscrupulous individuals out to make a quick profit, regardless of implication.
Upon reading a number of articles today on the disturbing short supplies and high commodity prices among corn and soybean products driven by the conflicting needs to supply both booming food and bio-fuel supply chains, this author is very concerned that the next contaminant trend will break out in the food supply chain.
While regulatory agencies can speak to new tools and methods to identify counterfeit supplies, we know that regulation cannot keep up with the current pace of change in global supply chains. Risk mitigation must stem from internal controls and processes that continuously certify foreign producers. Electronic track and trace technologies, such as RFID, that insure traceability of all supplies should be investigated.
The time to act is now.