The Food and Drugs Authority (FDA) has announced that only Finished Pharmaceutical Products (FPP) that meet its new requirements will be allowed onto the Ghanaian market.
This follows directives on the importation of Glycerin and Propylene Glycol into the country recently after Ethylene Glycol (EG) impurities were found in pharmaceutical syrup formulations.
In a notice to Importers and Manufacturers of Pharmaceutical, Food and Cosmetic Products, the authority said “All batches of imported Glycerin and Propylene Glycol raw materials should be accompanied by a certificate of analysis that has test and limit for Diethylene Glycol (DEG) and Ethylene Glycol (EG) as per the recognised official compendia.”
It added, “All batches of imported Glycerin 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.”
FDA further indicated that only tested and released Glycerin and Propylene Glycol imported raw materials shall be used in formulating products to be put on the market.
“For all batches of FPP imported into the country that has Glycerin and Propylene Glycol as excipients, the manufacturers are required to submit documentary proof of the FPP manufacturer’s control of DEG and EG in the excipients used for the FPP,” FDA explained.
Meanwhile, the authority has cautioned that in the absence of proof of the control of DEG and EG in the excipients the FPP shall be 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.
