A probe report by the top public health body of the U.S., Centre for Disease Control, into the death of children in The Gambia due to kidney injury, has suggested a strong link between these deaths and consumption of allegedly contaminated cough syrup manufactured by India-based Maiden Pharmaceuticals.
A CDC report released on Friday said, “This investigation strongly suggests that medications contaminated with Diethylene Glycol [DEG] or Ethylene Glycol [EG] imported into The Gambia led to this Acute Kidney Injury (AKI) cluster among children.”
The CDC report is the third such evidence to link cough syrups manufactured in India to the deaths. Earlier, the World Health Organization (WHO) in the same case had stated that it had found DEG and EG, two industrial chemicals in tested samples in the range of 1% to 21.3%. Before this, an investigation by The Gambian parliament had said Maiden Pharma ‘should be held accountable.’
The Indian government, however, maintains that when it collected control samples from the pharma company of the same batch that was exported to The Gambia it found no contamination. “We had also requested that a team of Indian officials go to The Gambia to investigate the case, but we have been disallowed by The Gambia from conducting the probe,” a senior Health Ministry official told The Hindu.
The Indian Health Ministry has not issued any official response to the U.S.-CDC probe. Health officials have claimed it to be ‘a political ploy.’
Between July and Septmber last year, The Gambian Ministry of Health had identified that 78 children developed sudden kidney failure and up to 66 (85%) of them died. The Gambia had requested help from CDC experts to help investigate the situation.
The CDC report states that June 21 was chosen as a start date for the investigation because medications (allegedly contaminated cough syrup) suspected to cause the deaths were imported in The Gambia on that day. Up to 56 patients met the criteria for investigation and were included in the CDC analysis.
These children had developed fever, vomiting, diarrhoea, loss of appetite and an inability to pass urine. The report said that most children died within 11 days of experiencing symptoms.
The CDC team of experts interviewed caregivers of affected children who said they had given the affected children a prescription or over-the-counter cough syrup-based medication before their kids were unable to pass urine.
The CDC report pointed out that a single international manufacturer (Maiden Pharma) that produced a syrup-based medication was reported in 8 of 14 interviews in which caregivers identified the manufacturer name or at least one medication administered to their child before hospitalisation.
The report further added that lab analysis of 23 medication samples conducted by The Gambia’s Ministry of Health and the WHO confirmed that four products from Maiden Pharmaceuticals in Haryana contained DEG and EG.
Based on records from The Gambia’s Medicines Control Agency, all medications that tested positive for DEG and EG were imported into The Gambia on June 21, 2022, shortly before the occurrence of the first AKI cases.
The report says that in past DEG outbreaks, manufacturers have been suspected of substituting DEG in the place of more expensive, pharmaceutical-grade solvents, adding that testing of lab samples has supported the fact that contaminated medical syrups led to a cluster outbreak of AKI cases.
It adds, “Further support for a toxic etiology includes the wide geographic distribution of cases in the country (six of seven health regions), a common pharmaceutical manufacturer of medications reported to have been used by many patients... This intoxication appears to have only affected children, likely because medications in syrup form are most commonly used for children in The Gambia.”
This likely poisoning event highlights the potential public health risks posed by the inadequate quality management of pharmaceutical exports, highlights the CDC report. It warns against the risks of inadequate regulatory structures which make the sale of medicines from international markets a high-risk activity especially in low-resource settings like The Gambia.
“Medications for export might be subject to less rigorous regulatory standards than those for domestic use. Simultaneously, low-resource countries might not have the human and financial resources to monitor and test imported drugs,” the CDC report stated.