The World Health Organization (WHO) is investigating a link between manufacturers of tainted cough syrups and the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters.
Citing toxins in the products, the WHO is seeking more information about the raw materials used by six Indian and Indonesian manufacturers to make the drugs linked to the recent deaths and whether the companies obtained them from the same supplier.
The WHO is also considering whether to recommend that families worldwide reevaluate the use of cough medicines in children in general, although questions about the safety of some of these products remain unresolved, the person said.
WHO experts are evaluating the evidence to determine whether or not such products are medically necessary for children, the person said. The deaths of 300 children with acute kidney injury first appeared in The Gambia in July 2022, followed by cases in Indonesia and Uzbekistan.
The WHO said the deaths were linked to cough medicines used by children for common illnesses that contained a known poison, either diethylene glycol or ethylene glycol.
Six drug manufacturers were identified.
So far, WHO has identified six drug manufacturers from India and Indonesia that produce syrups. Those manufacturers declined to comment on the study or denied using contaminated materials that caused the deaths. Reuters has no evidence of wrongdoing by the companies named by the WHO.
“It is of the utmost importance to us that there are no more child deaths from something so preventable,” said WHO spokeswoman Margaret Harris, without further commenting on the details of the organization’s work.
The UN health agency announced on Monday that it had expanded its investigation into cough syrups to include possible diethylene glycol and ethylene glycol contamination in four other countries where the same products may have been sold: Cambodia, the Philippines, East Timor, and Senegal. He called on other governments and the global pharmaceutical industry to launch urgent inspections to root out substandard medicines and improve regulation.
WHO will comment on the cough syrup situation in a press conference later on Tuesday. two Indian producers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and at the beginning of this month. It said their syrups had been linked to deaths in Gambia and Uzbekistan and warned people to stop using them.
Maiden and Marion production facilities are both closed. Maiden is now looking to reopen after the Indian government said in December that its tests found no problems with Maiden products.
Maiden has repeatedly told Reuters, including in December, that it did nothing wrong, and CEO Naresh Kumar Goyal said on Tuesday he had no comment on the WHO investigation into possible links between the companies.
A phone call to the Marion office was not answered on Tuesday, and the company did not respond immediately to an email requesting comment.
Earlier this month, it informed the government of Uttar Pradesh, near New Delhi, that it was accused of tarnishing the image of India and the company in Uzbekistan.
Safety issues
The WHO, which works with the Indonesian drug control agency, also issued a warning in October about cough medicines produced by four Indonesian manufacturers and sold domestically. The producers 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 for comment on Tuesday about the WHO investigation into the deaths in the three countries. Hermansyah Hutagalung, a lawyer for PT Universal Pharmaceutical Industries said the company has withdrawn all cough suppressants deemed unsafe from the market. “They are the real criminals when they go after the suppliers,” Hutagalung added. They falsify raw material documents and give them to pharmaceutical companies. He did not identify specific journalists or provide information to support the claim.
