Maiden Pharma row: No contamination found in syrups linked to 66 children's deaths in Gambia, India tells WHO

The control samples of four cough syrups by Maiden Pharma that were linked to the death of 66 children in The Gambia have been found to be of 'standard quality', news agency Reuters reported on Thursday.

Earlier this year, Haryana-based pharmaceutical company Maiden Pharma came under scanner for its four syrup products which were linked to the deaths of 66 children in The Gambia. 

Maiden Pharma's trouble began after the WHO (World Health Organization) issued a medical product alert, asking countries not to use these substandard products. It said the cough syrups had ingredients, such as diethylene glycol and ethylene glycol, which can be toxic to human beings. 

However, India has now told the global health agency that samples taken from Maiden Pharma have been found to be within specifications. The samples had not been contaminated with ethylene glycol and diethylene glycol, DCGI chief VG Somani said in a letter to the WHO, according to Reuters. 

The WHO in its alert issued on October 5 listed the name of the syrups - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.

"The manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," it said.

The health agency said that laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.

Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal, it said, adding that toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

"All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities," the WHO then said.

However, just last month, Reuters reported that The Gambia had not yet confirmed that toxic cough syrup was the cause of the deaths of 70 children from acute kidney injury.

Tijan Jallow, an officer at Gambia's Medicines Control Agency, said that country's national regulatory body had not yet pinpointed the exact cause of the deaths. "We haven't concluded yet it is the medicine that caused it," he said, adding that a good number of kids died without taking any medications.

"Other kids died, the medication that they took, we have tested them and they are good," he said as per Reuters.

According to the report, the agency was trying to establish exactly which medications, if any, each child took. 

In Gambia, the spike in cases of acute kidney injury among children was detected in late July. A number of patients had fallen ill three to five days after taking a paracetamol syrup sold locally, the report said citing officials.