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Call on chemical distributors to take extra care with cough syrup ingredients

Call on chemical distributors to take extra care with cough syrup ingredients
We remind you of the serious issue of contaminated cough syrups, about which the WHO raised the alarm after a string of tragic incidents early last year. Contaminated cough syrups killed over 300 people in Gambia, Indonesia and Uzbekistan, most of whom were children under the age of five. The contaminations can be the result of falsification of CoAs and insufficient QC testing. For more info, see here.

Each of the cases relates to the use of medicinal syrups that were manufactured using non-pharmaceutical grade excipients such as propylene glycol, glycerine, sorbitol or polyethylene glycol, all of which were contaminated with ethylene glycol (EG) and/or diethylene glycol (DEG). These chemicals are for use in industrial applications only, such as industrial solvents, coolants and antifreeze agents. 

WHO urgently called upon chemical manufacturers and distributors to do more to prevent, detect and respond quickly to contaminated medicines. Chemical distributors are specifically implored to always:
  •  distribute ingredients suitable for use in pharmaceutical products/pharmaceutical grade excipient (authorized by, and from sources approved by, competent authorities)
  • test glycerine for traces of residual EG and DEG, see here for a testing method
  • enable full traceability of the supply chain back to the original excipient manufacturer.
ICTA has cooperated with Oxford University to develop better detection methods. We continue to discuss the issue and share best practices in our SSHE committee.