Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether there is any link between manufacturers of contaminated cough syrups linked to the deaths of more than 300 children in three countries.
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 make drugs linked to the recent deaths, as well as whether the companies bought them from certain companies. the man said the same suppliers. WHO did not name any suppliers.
The World Health Organization is also considering whether to advise families globally to reassess the use of cough syrups for children in general while questions remain about the safety of some of these products. Experts at the World Health Organization are evaluating the evidence on whether or when such products are medically necessary for children, he said.
Deaths from acute kidney injury in children occurred in July 2022 in Gambia, followed by Indonesia and Uzbekistan. The World Health Organization said the deaths were linked to over-the-counter cough syrups that children take for common ailments that contain a toxin known as diethylene glycol or ethylene glycol.
To date, WHO has identified six drug manufacturers in India and Indonesia producing the syrups. These manufacturers either declined to comment on the investigation or denied using contaminated materials that caused any deaths. Reuters has no evidence of wrongdoing by the companies named by the WHO.
“It is our highest priority that there are no more child deaths, rather than something that is preventable,” WHO spokeswoman Margaret Harris said without commenting on the details of the organization’s work.
The United Nations health agency said Monday it has expanded its investigation into potential diethylene glycol and ethylene glycol contamination in cough syrups to four additional countries where the same products may be on sale: Cambodia, the Philippines, East Timor and Senegal. He called to other governments and the global pharmaceutical industry to initiate urgent inspections to root 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 were “already following WHO’s call” in accordance with 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.
“There may be children being exposed to these drugs that we don’t even know about,” he told reporters, adding that there is a need for transparency from everyone in the supply chain to address the problem.
The WHO has already issued special warnings for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. Their syrups have been linked to death in Gambia and Uzbekistan, respectively, and warnings have asked people to stop using them.
Both the Maiden and Marion manufacturing facilities have closed. Maiden is now trying to reopen after Indian government tests in December said it found no problems with Maiden products.
Maiden repeatedly told Reuters, including in Decemberit was nothing wrong and managing director Naresh Kumar Goyal said on Tuesday that he had no comment on the WHO’s investigation into possible links between the companies under investigation.
Mario’s office phone went unanswered Tuesday, and the company did not immediately respond to an email seeking comment. Earlier this month, he told the government of Uttar Pradesh, near New Delhi, that the deaths in Uzbekistan were being blamed “to tarnish the image of India and the company”.
WHO, working with Indonesia’s drug regulator, also issued a warning in October about cough syrups made by four Indonesian manufacturers and sold domestically. 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 that the WHO was investigating links between the deaths in the three countries.
Hermansyah Hutagalung, a lawyer for PT Universal Pharmaceutical Industries, said it has withdrawn all cough syrups deemed unsafe from the market. “Go after the suppliers, they are the real criminals,” Hutagalung said. “They are the ones who falsify the raw ingredients by falsifying the raw ingredient documents all the way to the pharmaceutical companies.” He did not identify specific suppliers or provide details to support the claim.
The World Health Organization 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 if ingested in small amounts.” Their toxic effects include urinary incontinence, kidney damage, and death.
The deaths highlighted potential gaps in global regulation of commonly used drugs, including oversight of factories and supply chains, particularly those that produce products for developing countries that lack the resources to monitor drug safety.
WHO sets guidelines for drug manufacturing standards globally and supports countries investigating any violations, but it has no legal mandate or enforcement authority to take direct action against violators.
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; Editing: Sara Ledwith, Michele Gershberg, Claudia Parsons, William Maclean
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