The WHO is investigating whether there is any connection between manufacturers whose contaminated cough syrups have been linked to the deaths of more than 300 children in three countries, a person familiar with the matter said.
Citing “unacceptable levels” of toxins in the products, the WHO is seeking more information about the specific raw materials used by six manufacturers in India and Indonesia to produce medicines linked to the recent deaths, as well as whether the companies obtained them from some of the same suppliers, the person said.
The WHO has not named any suppliers.
Photo: Reuters
The WHO is also considering whether to advise families globally to reassess the use of cough syrups for children in general while questions over the safety of some of these products are unresolved, the person said.
WHO experts are evaluating the evidence for whether, or when, such products are medically necessary for children, the person said.
The deaths of children from acute kidney injury began in July last year in the Gambia, followed by cases in Indonesia and Uzbekistan.
The WHO has said the deaths are linked to over-the-counter cough syrups the children took for common illnesses and which contained a known toxin, either diethylene glycol or ethylene glycol.
To date, the WHO has identified six drugmakers in India and Indonesia that produced the syrups. These manufacturers have either declined to comment on the investigation or denied using contaminated materials that contributed to any deaths.
Reuters has no evidence of wrongdoing by the companies the WHO has named.
“This is of the highest priority for us, to see no more child deaths from something that is so preventable,” WHO spokesperson Margaret Harris said, without commenting further on the details of the organization’s work.
The UN health agency on Monday said that it had widened its investigation into potential diethylene glycol and ethylene glycol contamination in cough syrups to four additional countries where the same products may have been on sale: Cambodia, the Philippines, East Timor and Senegal. It called on other governments and the global pharmaceutical industry to launch urgent checks to root out substandard medicines and improve regulation.
The WHO is expected to comment further on the cough syrup situation during a news conference later yesterday.
It has already issued specific alerts for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October last year and earlier this month. It said their syrups were linked to deaths in the Gambia and Uzbekistan respectively, and the alerts asked people to stop using them.
Maiden and Marion’s manufacturing plants have both been shuttered. Maiden is now seeking to reopen after the Indian government last month said that its testing had found no problems with Maiden’s products.
Maiden has repeatedly told Reuters, including last month, that it did nothing wrong and managing director Naresh Kumar Goyal yesterday said he had no comment on WHO investigating possible connections between the companies under scrutiny.
Marion’s office telephone went unanswered yesterday and the firm did not immediately respond to an e-mail seeking comment.
Earlier this month, it told the government of Uttar Pradesh, where it is located near New Delhi, that it was being blamed for the deaths in Uzbekistan “to malign the image of India and the company.”
The WHO, working with Indonesia’s drugs regulator, also issued an alert in October about cough syrups made by four Indonesian manufacturers and sold domestically. The manufacturers are: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex and PT AFI Farma.
PT Yarindo Farmatama, PT Konimex and PT AFI Farma did not immediately respond to requests yesterday for comments for comment.
PT Universal Pharmaceutical Industries’ lawyer, Hermansyah Hutagalung, said it had pulled from the market all cough syrups deemed dangerous.
“Chase the suppliers, they’re the real criminals,” Hutagalung added. “They’re the ones that forge raw ingredients by falsifying raw ingredient documents all the way to pharmaceutical companies.”
He did not identify specific suppliers or give details to back up the claim.
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