Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether there is a link between manufacturers whose tainted cough syrups are linked to the deaths of more than 300 children in three countries, said to Reuters a person familiar with the matter.
Citing ‘unacceptable levels’ of toxins in products, the WHO is seeking more information on 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 have them obtained from some of them. the same vendors, the person said. WHO has not named any vendors.
The WHO is also considering advising families around the world to reevaluate the use of cough syrups for children in general as questions about the safety of some of these products remain unresolved, the person said. WHO experts are weighing the evidence on whether, or when, these products are medically necessary for children, the person said.
Child deaths from acute kidney failure began in July 2022 in The Gambia, followed by cases in Indonesia and Uzbekistan. The WHO said the deaths were linked to over-the-counter cough syrups children took for common illnesses that 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 either declined to comment on the investigation or denied using contaminated materials that contributed to fatalities. Reuters has no evidence of wrongdoing by the companies named by the WHO.
“It is of the highest priority for us, to see no more child deaths from something so preventable,” WHO spokeswoman Margaret Harris said, without commenting further on the details of the case. organization work.
The UN health agency said on Monday it had expanded its investigation into possible contamination with diethylene glycol and ethylene glycol in cough syrups to four other countries where the same products may have been on sale : Cambodia, the Philippines, East Timor and Senegal. He called on other governments and the global pharmaceutical industry to launch 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 accordance with national and international guidelines.
At a press conference on Tuesday, the WHO’s acting director for access to medicines, Hanan Balkhy, said more children could be affected.
“There could be children being exposed to these drugs that we are not even aware of,” she told reporters, adding that was why there was a need for transparency from everyone. supply chain actors to solve 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. He 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 closed. Maiden is now looking to reopen after the Indian government said in December its tests found no issues with Maiden’s products.
Maiden repeatedly told Reuters, including in December, that he had done nothing wrong and Chief Executive Naresh Kumar Goyal said on Tuesday he had no comment on the WHO investigation. on possible links between the companies under surveillance.
Marion’s office phone went unanswered on Tuesday, and the company did not immediately respond to an email seeking comment. Earlier this month he told the government of Uttar Pradesh, where he is located near New Delhi, that he was blamed for the deaths in Uzbekistan “to defame the image of India and the country”. ‘business”.
The WHO, in conjunction with Indonesia’s drug regulator, also issued an alert in October regarding cough syrups made by four Indonesian manufacturers and sold domestically. 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 investigation into the links between the deaths in the three countries.
PT Universal Pharmaceutical Industries lawyer Hermansyah Hutagalung said it has removed all cough syrups deemed unsafe from the market. “Chase the suppliers, they are the real criminals,” Hutagalung added. “They are the ones who adulterate raw ingredients by falsifying raw ingredient documents all the way to pharmaceutical companies.” He did not identify specific vendors or give details to back up 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 deadly even taken in small amounts.” Their toxic effects include inability to urinate, kidney damage and death.
The deaths highlighted potential gaps in global regulation of commonly used medicines, including oversight of factories and supply chains, especially those producing products for developing countries that lack the resources to monitor safety medication.
The WHO sets guidelines on global drug manufacturing standards and supports countries in investigating any breaches, 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; Editing by Sara Ledwith, Michele Gershberg, Claudia Parsons, William Maclean
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