26 January 2023
After handing out multiple alerts over contaminated cough syrups, the World Health Organization (WHO) is now stepping up the pressure on manufacturers and governments to prevent further instances of harm.
WHO released a statement on Monday issuing an “urgent call to action” for countries and manufacturers to prevent and respond to issues of substandard and falsified products. In the past four months, countries in Asia and Africa have reported incidents in which cough syrups meant for children had confirmed or suspected contamination with “high levels” of diethylene glycol (DEG) or ethylene glycol, both toxic substances that are mainly used in antifreeze or as industrial solvents.
Three product alerts have been issued by WHO in recent months, with one related to four products made by the India-based generic manufacturer Maiden Pharmaceuticals. WHO reported 66 deaths of children in Gambia stemming from the use of these syrups which included acute kidney injuries. More recently, two other syrups were identified in Uzbekistan and reported to WHO on Dec. 22. According to WHO, an analysis conducted by Uzbekistan’s Ministry of Health identified “unacceptable amounts of diethylene glycol and /or ethylene glycol” with another manufacturer, Marion Biotech, as the maker of these products. Another alert was issued in November for eight syrups that were distributed in Indonesia.
WHO is urging manufacturers to only purchase “pharmaceutical grade” materials from qualified suppliers as well as conduct testing upon receiving the supplies before using them in production. The global health group is also calling on manufacturers to assure the quality of products, including certificates of analysis and complete records of the purchase, testing and distribution of materials, to properly investigate any incidents that may occur.
For suppliers and distributors, WHO urges that companies check for signs of “falsification,” check the condition of products, and only distribute medicine authorized by the competent authorities. The WHO is also pushing for governments to not only remove “substandard” products, but to improve and increase the “risk-based” inspections of manufacturing sites, and boost surveillance within their respective markets, including the “informal markets.”
Endpoints News reached out to WHO for further information on how it plans to urge manufacturers and government bodies to act.Print
NovaMedica will produce migraine drug Relonova in Moscow
23 March 2023
A resource for anti-tumor drugs testing has been launched in Russia
23 March 2023
Building a Community of Trust in Epilepsy & Rare Syndromes
23 March 2023
Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone in the Treatment of Lennox-Gastaut Syndrome
22 March 2023