Maiden Pharma omitted quality tests in Gambia cough syrup case: Reports

By Garima Soni  | Date: October 12, 2022

Maiden Pharma omitted quality tests in Gambia cough syrup case: Reports

Maiden Pharmaceuticals Limited, a company that is under investigation for 4 adulterated and low-grade cough syrups that are directly linked to the deaths of 66 children in The Gambia, omitted to perform quality testing on a raw material used in the manufacturing of the medicine, according to a notice sent following an official investigation.

Additionally, the purchase receipts for the materials utilized, including propylene glycol, did not include batch numbers, the name of the producer, or manufacturing and expiration dates.

Specialists opine that ethylene glycol and diethylene glycol, the two harmful substances that the World Health Organization (WHO) has identified as potential causes of the death, can be the impurities found in the propylene glycol used to make medications, which is why careful quality control is required.

Following a joint inspection with the Central Drugs Standard Control Organization, the Haryana drug authorities issued Maiden Pharmaceuticals a show-cause notice on October 7th stating that the firm has not performed the quality testing of propylene glycol for ethylene glycol and diethylene glycol. The pharmaceutical corporation is expected to respond to the warning by October 14th or else legal action may be pursued.

The notice presented that a batch of propylene glycol received and examined in March 2022 was found to be the same one that was used to make MaGrip n Cold Syrup batch in December 2021, indicating that it was likely not tested for quality and that the paperwork was not in order.

For those unaware, the four cough syrups that have been related to fatalities in the country of West Africa are Makoff Baby Cough Syrup, Kofexmalin Baby Cough Syrup, Promethazine Oral Solution, and Magrip N Cold Syrup.

Pharmaceutical professionals felt that testing should have been carried out on the propylene glycol stocks to look for contamination with ethylene and diethylene glycol. An expert claimed that because propylene glycol is expensive, it is frequently combined with ethylene and diethylene glycol by negligent pharmaceutical firms.

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Garima Soni

Garima Soni

Despite starting her career in science, Garima always had a zeal for writing. She started out her writer journey as a freelancer which eventually turned into a full-time job. Now as an upcoming MBA professional, Garima pens down articles for IBMag and several other we...

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