The cause of acute kidney injury that killed at least 70 children in The Gambia recently is still unknown, the west African nation’s pharmacuetical regulator has said. Four cough syrups manufactured by Indian drug maker Maiden Pharmacueticals have been linked to the deaths, which came to light earlier this month.
The Union health ministry has maintained that evidence to prove the allegations against Maiden is not adequate.
In a press briefing on Monday in Kotu village, The Gambia’s Medicine Control Agency (MCA) said that the real cause of the acute kidney injuries that led to the deaths is still unknown.
A report on news portal allAfrica, said that the MCA’s Tijan Jallow, who is a member of the task force investigating the cause of the kidney injuries, said during the briefing that some of the children who died did not consume the drugs manufactured by New Delhi-based Maiden pharmaceuticals.
While the Union health ministry did not formally comment on the matter, an official, on condition of anonymity, said, “The investigation is still on but India had been insisting since the start to provide more data to establish causality.”
In a briefing on October 5, the World Health Organization (WHO) had issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden Pharma.
{{/usCountry}}In a briefing on October 5, the World Health Organization (WHO) had issued a medical product alert over four cough syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup — manufactured and exported by Maiden Pharma.
{{/usCountry}}The WHO said in its alert that two toxic contaminants, diethylene glycol and ethylene glycol, were found in four cough syrups manufactured by Maiden and exported to The Gambia.
After the UN body’s alert, the health ministry had issued a statement that the central drugs regulator was investigating the matter in collaboration with the state regulator.
However, in a letter on October 15, the Drugs Controller General of India (DCGI) also said that WHO’s claims were “inadequate to determine aetiology”. Aetiology is the scientific study of the causes of disease or death.
“The details of illness, sign and symptoms, duration of anuria in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for DEG (diethylene glycol) and EG (ethylene glycol) on clinical samples of the patients, treatment received before and after hospitalisation at the tertiary hospital in (The) Gambia, treatment received before and after AKI was suspected and reasons thereof, the names and brands of the drug formulations used in the treatment before and after hospitalisation, their manufacturers, their expiry and any other relevant information in each of the cases, are necessary,” read DCGI’s letter.