(Reuters) – The World Health Organization (WHO) is investigating whether a manufacturer of contaminated cough syrup has been linked to the deaths of more than 300 children in three countries, it said. A person familiar with the matter told Reuters.
Citing “unacceptable levels” of toxins in their products, the WHO said that six manufacturers in India and Indonesia used certain raw materials to produce medicines linked to the recent deaths, and that companies used them to I’m asking for more information on whether I got it from some company. Same supplier, he said. WHO has not nominated a supplier.
WHO also advises families around the world to re-evaluate the use of cough syrups for children in general while questions about the safety of some of these products remain unresolved. WHO experts are evaluating the evidence as to whether or when such products are medically necessary for children, the person said. rice field.
Child deaths from acute kidney injury began in Gambia in July 2022, followed by Indonesia and Uzbekistan. The WHO said the deaths were related to over-the-counter cough syrups taken by children for common ailments, which contained known toxins, either diethylene glycol or ethylene glycol.
To date, WHO has identified six pharmaceutical companies in India and Indonesia that have produced the syrup. Those manufacturers declined to comment on the study or denied using the contaminants that contributed to the deaths. Reuters has no evidence of wrongdoing by the companies WHO has named.
WHO spokeswoman Margaret Harris declined to comment on details of the WHO’s work, saying: “This is a top priority for us and we want to make sure we don’t see more child deaths from preventable causes.” is to
The United Nations health agency on Monday expanded its investigation into diethylene glycol and potential ethylene glycol contamination in cough syrup to four additional countries where the same product may have been sold: Cambodia, the Philippines, Timor-Leste and Senegal. said he did called We call on other governments and the global pharmaceutical industry to initiate urgent checks to eradicate substandard medicines and improve regulation.
The International Federation of Pharmaceutical Manufacturers’ Associations (IFPMA) issued an emailed statement on Tuesday, saying its members were “already doing what the WHO asks” in line with national and international guidelines.
The WHO is expected to comment further on the cough syrup situation at its press conference on Tuesday.
WHO has already issued specific warnings in October 2022 and earlier this month about cough syrups produced by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech. Said to be associated with death, the warning asked people to stop using them.
The Maiden and Marion manufacturing plants have been closed. Maiden is now aiming to reopen after the Indian government announced in December that tests found no issues with Maiden’s products.
Maiden repeatedly told Reuters. in December.
A phone call to Marion’s office went unanswered on Tuesday and the company did not immediately respond to an email seeking comment. and damaged the image of the company,” he said.
The WHO, in collaboration with Indonesia’s drug regulator, also issued warnings in October about cough syrups manufactured by four Indonesian manufacturers and marketed in the country. Manufacturers 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’s investigation into the links between deaths in the three countries.
Hermansyah Hutagalung, an attorney at PT Universal Pharmaceutical Industries, said it has removed from the market all cough syrups deemed unsafe. “Go after the suppliers. They are the real criminals,” he added Hutagalung. “They are the ones who falsify raw materials documents all the way down to pharmaceutical companies.” He did not identify specific suppliers or provide details to support the claims.
The WHO said the syrup was contaminated with diethylene glycol and ethylene glycol, “a toxic chemical used as an industrial solvent and antifreeze agent that can be lethal even in small amounts.” toxic effects include inability to void, renal damage, and death.
Mortality is commonly used, including monitoring of factories and supply chains, especially those producing products for developing countries that lack the resources to monitor drug safety. highlights potential gaps in global regulation of
WHO sets guidelines for good manufacturing practices for medicines globally and helps countries investigate violations, but has no legal obligation or enforcement power to take direct action against violators.
Additional reporting by Prak Chan Thul, Phnom Penh, Stanley Widianto and Ananda Teresia, Jakarta, Krishna N. Das, New Delhi, Saurabh Sharma, Lucknow, and Ed McAllister, Dakar.Editing by Sarah Redwith, Michele Gershberg and Claudia Parsons
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