Jan 24 – The World Health Organization (WHO) is investigating whether there is a link between manufacturers of contaminated cough medicine linked to the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters.
Citing “unacceptable toxins” in the products, the WHO is seeking information on specific raw materials used by six manufacturers in India and Indonesia to make the drug linked to the recent deaths. The person said that it was submitted. WHO did not name any suppliers.
WHO is considering whether to recommend that families worldwide reevaluate cough medicines for children in general, as questions about the safety of some of these products remain unresolved, the person said. WHO experts are not sure whether these products are medically necessary for children. The person said that the evidence is being evaluated.
Child deaths from acute kidney injury began in Gambia in July 2022, with cases in Indonesia and Uzbekistan. The WHO said the deaths were linked to over-the-counter cough syrups taken by children for common ailments and containing a toxin called diethylene glycol or ethylene glycol.
To date, WHO has identified six drug manufacturers in India and Indonesia that produce the syrup. Those manufacturers have declined to comment on the investigation or deny using contaminated materials that caused the deaths. Reuters has no evidence of wrongdoing by the companies named by the WHO.
“This is the highest priority for us, so that there is no more child death from something that cannot be prevented,” WHO spokeswoman Margaret Harris said, without further commenting on the details of the organization’s work.
Diethylene glycol in cough medicines and drugs with the potential to be contaminated with ethylene glycol Cambodia, Philippines East Timor and Senegal are selling to four more countries, the UN health agency announced on Monday. It has called on other governments and the global pharmaceutical industry to conduct urgent inspections to weed 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 is asking, in line with national and international guidelines.
At a press conference on Tuesday, Hanan Balkhy, WHO’s acting director for access to medicines, said children could be more affected.
“There may be children exposed to these drugs that we don’t know about,” he told reporters, adding that solving the problem requires transparency from everyone in the supply chain.
The WHO has already issued special warnings for cough medicines made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. Their lotions have been linked to deaths in Gambia and Uzbekistan, respectively. The warnings asked people not to use them.
Both the Maiden and Marion manufacturing plants were closed. It is now seeking to reopen after the Indian government said in December that its trial found no problems with Maiden’s products.
Maiden has repeatedly told Reuters, including in December, that it has done nothing wrong, and managing director Naresh Kumar Goyal said on Tuesday that he would not comment on the WHO investigation into possible links between the companies, which are under scrutiny.
Marion’s office phone was unanswered Tuesday and the company did not immediately respond to an email seeking comment. Earlier this month, the government of Uttar Pradesh, near New Delhi, was blamed for damaging the company’s image with India over the deaths in Uzbekistan.
The WHO, working with Indonesia’s drug regulatory agency, issued a warning in October about cough medicines produced and sold locally by four Indonesian manufacturers. Producers: 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 as the WHO is investigating links between the deaths.
Hermansyah Hutagalung, a lawyer for PT Universal Pharmaceutical Industries, said that all cough medicines deemed dangerous had been pulled from the market. “Chasing suppliers; They are real criminals,” Hutagalung added. “They are the ones who falsify raw material documents and fake ingredients all the way to pharmaceutical companies.” He did not identify specific suppliers or provide details to back up the claim.
The lotions are contaminated with diethylene glycol and ethylene glycol, which the WHO says are “toxic chemicals used as industrial solvents and freezing agents that can kill even small amounts.” Their toxic effects include urinary incontinence; including kidney damage and death.
The deaths highlight a potential gap in global regulation of commonly used drugs, including oversight of factories and supply chains, where the products are manufactured, particularly for developing countries that lack the resources to monitor drugs for safety.
WHO sets guidelines on pharmaceutical manufacturing standards globally and supports countries investigating violations, but has no formal 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; Sara Ledwith; Michele Gershberg; Claudia Parsons; Edited by William Maclean.
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