Following recent reports of the death of over sixty (60) and ninety nine (99) children in Gambia and Indonesia respectively, from acute kidney injury suspected to have been caused by Diethylene Glycol (DEG) and Ethylene Gylcol (EG) impurities found in pharmaceutical syrup formulations, the Food and Drugs Authority (FDA) on October 20, 2022 in a letter to manufacturers of pharmaceutical, food and cosmetic products gave directives on the importation of Gylcerin and Propylene Gylcol.
Further to those directives, the FDA wishes to direct with immediate effect that, all batches of imported Gylcerin and Propylene Gylcol raw materials should be accompanied by a certificate of analysis that have tested and limit for Diethylene Gylcol (DEG) and Ethylene Gylcol (EG) as per the second recognized official compendia.
All batches of imported Gylcerin and Propylene Glycol shall be released under detention, sampled at the port of entry and tested for the presence of DEG and EG at USP-Ghana Quality Control Laboratory at the cost of the importer.
Only tested and released Glycerin Propylene Gylcol imported raw materials shall be used in formulating products to be put on the market.
For all batches of finished pharmaceutical products (FPP) imported in the country that have Gylcerin and Propylene Glycol as excipients, the manufacturer are required to submit documentary proof of the FPP manufacturer’s control of DEG and EG in the excipients used for the FPP.
In the absence of proof of the control of DEG and EG in the excipients as indicated above, the FPP shall be sampled at the port of entry and tested for the presence of DEG and EG at the USP-Ghana Quality Control Laboratory at the cost of the importer.
Only FPP that meet the above requirements would be allowed onto the market. Importers, manufacturers, and other stakeholders are to take note of this and comply accordingly.