FDA Issues Measures After Cough Syrup Killed 159 Kids

Ghana’s Food and Drugs Authority (FDA) has instituted six measures following the deaths of hundred and fifty-nine (159) children in Indonesia and The Gambia after the consumption of some medicinal syrups.

The measures were issued to manufacturers of pharmaceutical, food and cosmetic products on the importation of glycerin and propylene glycol- the two products suspected to have caused acute kidney injury which subsequently killed the kids.

In July, The Gambia recorded high rates of acute kidney disease in children which led to the death of 66.

This was linked to a cough syrup produced by Maiden Pharmaceuticals Limited, a drug manufacturing company in Haryana, India.

Later, the World Health Organisation (WHO) flagged four products including Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makeoff Baby Cough Syrup and Magrip N Cold Syrup which were said to contain toxins related to glycerin and propylene glycol.

In October, Indonesia also reported that 99 children had died of acute kidney injury and linked it to medicinal syrups.

Following this, the FDA of Ghana has instituted the six guidelines for manufacturers of pharmaceutical, food and cosmetic products in the importation of glycerin and propylene glycol raw materials.

First, the FDA said, “all batches of imported glycerin and propylene glycol raw materials should be accompanied by a certificate analysis that has a test and limit for Diethylene 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.

“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 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

“In the absence of proof of control of DEG and EG in the excipients as indicated above, the FPP shall be sampled at the ports of entry and tested for the presence of DEG and EG at USP-Ghana Quality Laboratory at the cost of the importer.

“Only FPP that meet the above requirements would be allowed onto the market”.

In October, the FDA said the flagged medicinal products were not registered in Ghana and noted that its market surveillance had not identified any of them on the Ghanaian market

“Anyone with any information or has seen the products anywhere in Ghana, such information should be made available to the FDA”, the FDA beseeched the public at the time.

Source: opemsuo.com/Hajara Fuseini