Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether there is any connection between manufacturers whose contaminated cough syrups it has linked to the deaths of more than 300 children in three countries, a person familiar told Reuters. with the matter.
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 drugs linked to the recent deaths, as well as whether the companies obtained them from any of them. . the same providers, the person said. WHO has not named any vendor.
The WHO is also considering whether to advise families globally to re-evaluate the use of cough syrups for children in general, while questions about the safety of some of these products remain unresolved, the person said. WHO experts are evaluating the evidence on whether or when such products are medically necessary for children, the person said.
Child deaths from acute kidney injury began in July 2022 in The Gambia, followed by cases in Indonesia and Uzbekistan. The WHO has said the deaths are linked to over-the-counter cough syrups that children were taking for common illnesses that contained a known toxin, either diethylene glycol or ethylene glycol.
To date, the WHO has identified six drug manufacturers in India and Indonesia that produced the syrups. These manufacturers either declined to comment on the investigation or denied using contaminated materials that contributed to the deaths. Reuters has no evidence of wrongdoing by the companies named by the WHO.
“This is of the highest priority for us, that there are no more child deaths from seeing something that is so preventable,” WHO spokeswoman Margaret Harris said, without commenting further on the details of the organization’s work.
The United Nations health agency said Monday it had expanded its investigation into possible diethylene glycol and ethylene glycol contamination in cough syrups to four additional countries where the same products may have been for sale: Cambodia, the Philippines, Timor East and Senegal. I call other governments and the global pharmaceutical industry to initiate urgent controls to eradicate 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 asks,” in line with national and international guidelines.
At a press conference on Tuesday, WHO’s acting director of access to medicines, Hanan Balkhy, said more children could be affected.
“There may be children being exposed to these medicines that we are not even aware of,” he told reporters, adding that transparency from everyone in the supply chain was therefore necessary to address the problem.
The WHO has already issued specific alerts for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. It said its syrups were linked to deaths in The Gambia and Uzbekistan respectively, with alerts asking people to stop using them.
The Maiden and Marion manufacturing plants have been closed. Maiden is now looking to reopen after the Indian government said in December that its tests had found no problems with Maiden’s products.
Maiden has repeatedly told Reuters, including in Decemberthat it did nothing wrong and managing director Naresh Kumar Goyal said on Tuesday he had no comment on the WHO investigation into possible connections between the companies under scrutiny.
Marion’s office phone went unanswered Tuesday and the company did not immediately respond to an email seeking comment. Earlier this month, she told the government in Uttar Pradesh, where she is located near New Delhi, that she was being blamed for the deaths in Uzbekistan “to smear the image of India and the company.”
The WHO, in collaboration with Indonesia’s drug regulator, also issued an alert in October on cough syrups made by four Indonesian manufacturers and sold in the country. The manufacturers are: 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 about the WHO’s investigation of the connections between the deaths in the three countries.
PT Universal Pharmaceutical Industries lawyer Hermansyah Hutagalung said it had withdrawn all cough syrups deemed dangerous from the market. “Go after the suppliers, they are the real criminals,” Hutagalung added. “They are the ones who falsify the raw materials by falsifying the documents of the raw materials until they reach the pharmaceutical companies.” He did not identify specific providers or provide details to support the claim.
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.” Its toxic effects include inability to urinate, kidney damage, and death.
The deaths have highlighted potential gaps in the global regulation of commonly used medicines, including oversight of factories and supply chains, particularly those that produce products for developing countries that lack the resources to monitor. the safety of medicines.
The WHO sets guidelines on global drug manufacturing standards and supports countries investigating any failures, but it has no legal mandate or enforcement authority 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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