SWITZERLAND —The World Health Organization has stated that it stands by its action in response to an international medical product alert issued on four cough and cold syrups from India and their potential link to more than 60 child deaths in Gambia.
The WHO issued an alert in October advising regulators to halt the sale of the syrups, which were manufactured by an Indian company.
According to an Indian government official, the WHO was “presumptuous” in blaming the syrups.
However, the health organization stated that it was simply carrying out its mandate.
“WHO’s mandate is to issue global alerts about potential risks. WHO stands by the action taken,” an official told the BBC over email.
The Gambia’s medical authorities discovered an increase in cases of acute kidney injury among children under the age of five in late July. The government later stated that 69 children had died as a result of these injuries.
The WHO stated in October that these deaths could be linked to four cough syrups manufactured by Maiden Pharmaceuticals, an Indian company.
The WHO said it had tested samples of the syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – and found that they contained “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”
Diethylene glycol and ethylene glycol are toxic to humans and, if consumed, can be fatal.
India then stated that it was looking into the products and ordered Maiden Pharmaceuticals to halt production at its main plant in the northern state of Haryana.
A December 13 letter from the Drugs Controller General of India to the intergovernmental agency stated that it made a “premature deduction … regarding the cause of death” and that all its further communications were a “reaffirmation of this deduction, without waiting for independent verification.”
Friday’s response from WHO also stated that the organization contracted laboratories in Ghana and Switzerland, which tested the suspected cough syrups from The Gambia and confirmed excess levels of ethylene glycol and diethylene glycol.
The health body added that the “contaminated syrups are dangerous and should not be in any medicine, ever.”
“WHO immediately shared the confirmatory results with authorities in The Gambia, and India, as well as the manufacturer of the suspected products-Maiden Pharmaceuticals,” the response said.
The letter by India’s DCGI’s V G Somani said that the control samples — samples of syrup from the same batch exported to the Gambia maintained by the company for quality control purposes — did not contain ethylene glycol or diethylene glycol.
India produces one-third of the world’s medicines, the majority of which are generic drugs.
The country is known as the “world’s pharmacy” and meets a large portion of the medical needs of African nations. It is home to some of the fastest-growing pharmaceutical companies.