New Requirements For The Importation Of Finished Pharmaceutical Products Set

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FDA CEO Delese Darko. Image credit: Foods and Drugs Authority Ghana Source: Facebook Read more: https://yen.com.gh/181894-fda-approves-clinical-trial-herbal-medicine-covid-19-treatment.html
FDA CEO Delese Darko. Image credit: Foods and Drugs Authority Ghana Source: Facebook Read more: https://yen.com.gh/181894-fda-approves-clinical-trial-herbal-medicine-covid-19-treatment.html

The Food and Drugs Authority (FDA) has said only Finished Pharmaceutical Products (FPP) that meet its new requirements will be allowed onto the Ghanaian market.

This follows the FDA’s directives on the importation of Glycerin and Propylene Glycol into the country recently after Ethylene Glycol (EG) impurities were found in pharmaceutical syrup formulations.

There were reports that 60-99 children in the Gambia and Indonesia respectively had died from acute kidney injury suspected to have been caused by Diethylene Glycol (DEG) and EG impurities found in pharmaceutical syrup formulations.

In a notice to Importers and Manufacturers of Pharmaceutical, Food and Cosmetic Products, the FDA said: “All batches of imported Glycerin and Propylene Glycol raw materials should be accompanied by a certificate of analysis that have test and limit for Diethylene Glycol (DEG) and Ethylene Glycol (EG) as per the recognised official compendia.

“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.”

Also, “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 finished pharmaceutical products (FPP) imported into the country that have 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,” stated in the notice.

It continued that in the absence of proof of the control of DEG and EG in the excipients as indicated, “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.”

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