The World Health Organization (WHO) is investigating whether there is any link between manufacturers whose contaminated cough syrups it has linked to the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters.
Citing “unacceptable levels of toxins” in the products, the WHO is seeking more information about the specific raw materials six Indian and Indonesian manufacturers used to make the drugs linked to the recent deaths, as well as whether the companies obtained them from some of the same suppliers, – said the person. WHO has not named any suppliers.
The WHO is also considering whether to advise families around the world to re-evaluate the use of cough syrups in children in general, with safety questions for some of these products unresolved, the person said. WHO experts are evaluating evidence on whether and when such products are medically necessary for children, the person said.
Children’s deaths from acute kidney injury began in 2022. July. Gambia, then Indonesia and Uzbekistan. The WHO said the deaths were linked to over-the-counter cough syrups used by children for common illnesses that contained a known toxin, diethylene glycol or ethylene glycol.
So far, WHO has identified six drug manufacturers in India and Indonesia who produced the syrups. Those manufacturers declined to comment on the investigation or denied using contaminated materials that contributed to any deaths. Reuters has no evidence that WHO has identified wrongdoing by the company.
“It is our highest priority that there are no more preventable child deaths,” said WHO spokeswoman Margaret Harris, without further comment on the details of the organization’s work.
The United Nations health agency said Monday it has expanded its investigation into possible contamination of diethylene glycol and ethylene glycol in cough syrups and four other countries where the same products may have been sold: Cambodia, the Philippines, East Timor and Senegal. It called on other governments and the global pharmaceutical industry to launch urgent inspections to stamp out substandard drugs and improve regulation.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in an emailed statement on Tuesday that its members are “already doing what the WHO calls for”, following national and international guidelines.
Hanan Balkhy, WHO’s acting director of access to medicines, said at a press conference on Tuesday that more children could be affected.
“It’s possible that children have been exposed to these drugs that we don’t even know about,” she told reporters, adding that this calls for transparency across the supply chain to address the issue.
in 2022 In October and earlier this month, the WHO has already issued specific warnings about cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech. It said their syrups had been linked to deaths in The Gambia and Uzbekistan respectively, and warned people to stop using them.
The Maiden and Marion plants were closed. Maiden is now seeking to reopen after the Indian government said in December that its tests had found no problems with Maiden products.
Maiden has repeatedly told Reuters, including in December, that it has done nothing wrong, and CEO Naresh Kumar Goyal said on Tuesday it had no comment on the WHO’s investigation into possible links between the companies under investigation.
A phone call to Marion’s office was not answered Tuesday, and the company did not immediately respond to an email seeking comment. Earlier this month, it told the government of Uttar Pradesh, where it is based near New Delhi, that it was being blamed for the deaths in Uzbekistan “to tarnish the image of India and the company”.
The WHO, in cooperation with Indonesia’s drug regulator, also issued a warning in October about four cough syrups made by Indonesian manufacturers sold in the country. Manufacturers: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex, PT AFI Farma.
PT Yarindo Farmatama, PT Konimex and PT AFI Farma did not immediately respond to requests for comment on Tuesday from the WHO, which is investigating the link between the deaths in the three countries.
Hermansyah Hutagalung, a lawyer for PT Universal Pharmaceutical Industries, said it has withdrawn all cough syrups deemed dangerous from the market. “Go after the suppliers, they are real criminals,” Hutagalung added. “They falsify raw materials by falsifying raw material documents all the way to pharmaceutical companies. He did not identify specific suppliers and did not provide any substantiating details.
The WHO said the syrups were contaminated with diethylene glycol and ethylene glycol, which it called “toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even in small amounts.” Their toxic effects include inability to urinate, kidney damage, and death.
The deaths have exposed potential gaps in global regulation of commonly used drugs, including oversight of factories and supply chains, particularly those producing products for developing countries that lack the resources to monitor drug safety.
WHO sets guidelines for drug manufacturing standards worldwide and supports countries that investigate any violations, but it has no legal or enforcement powers to take direct action against violators.
Additional reporting by Prak Chan Thul in Phnom Penh, Stanley Widianto and Ananda Teresia in Jakarta, Krishna N. Das in New Delhi, Saurabh Sharma in Lucknow, Ed McAllister in Dakar; Edited by Sara Ledwith, Michele Gershberg, Claudia Parsons, William Maclean
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