FDA Outlines 6 Directives Over The Importation Of Glycerin And Propylene
The Food and Drugs Authority (FDA) has issued a communiqué to the importers and manufacturers of pharmaceutical, food, and cosmetic products over the importation of Glycerin and Propylene Glycol to Ghana following the death of over 60 people and 99 children in the Gambia and Indonesia.
The victims were alleged to have been given Glycerin and Propylene Glycol by their parents, which contain Diethylene Glycol (DEG) and Ethylene Glycol (EG) impurities found in pharmaceutical syrup formulations and that were the cause of the kidney injuries that led to their untimely death.
According to FDA, Glycerin And Propylene Glycol are good for children, but due to the recent tragedy that happened in Gambia and Indonesia, importers and manufacturers of pharmaceutical, food, and cosmetic products are to follow the below-given directives to import the two syrups in the country.
1. 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 recognized official compendia.
2. 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.
3. Only tested and released Glycerin and Propylene Glycol imported raw materials shall be used in formulating products to be put on the market.
4. 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.
5. 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 USP-Ghana Quality Control Laboratory at the cost of the importer.
6. Only FPP that meets the above requirements would be allowed onto the market.
The Food and Drugs Authority has therefore cautioned all importers, manufacturers, and other stakeholders to take note and comply with the above-given directives.
Find The Notice From FDA Below