Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether manufacturers of tainted cough syrup were linked to the deaths of more than 300 children in three countries, a person familiar with the matter told Reuters.
Citing “unacceptable levels” of toxins in the products, the WHO is seeking more information on the specific raw materials used by six manufacturers in India and Indonesia to produce the drugs linked to the recent deaths, and whether the companies obtained from some obtain these raw materials. The source said the same supplier. The World Health Organization did not name any suppliers.
The WHO is also considering whether to advise families around the world to reassess the use of cough syrup among children in general, and the safety of some of these products has not yet been resolved, the person said. WHO experts are evaluating the evidence on whether or when the products are medically necessary for children, the person said.
Child deaths from acute kidney injury began in Gambia in July 2022, followed by cases in Indonesia and Uzbekistan. The World Health Organization said the deaths were linked to children taking over-the-counter cough syrup for common illnesses that contained a known toxin called diethylene glycol, or ethylene glycol.
WHO has so far identified six manufacturers of the syrup in India and Indonesia. The manufacturers either declined to comment on the investigation or denied using contaminated materials that caused any deaths. Reuters had no evidence of wrongdoing by the companies named by the WHO.
“It is imperative for us that no more children die from something so preventable,” said WHO spokeswoman Margaret Harris, without further comment on the details of the organization’s work.
The U.N. health agency said on Monday it had expanded its investigation into potential diethylene glycol and ethylene glycol contamination in cough syrup to four other countries where the same product may be sold: Cambodia, the Philippines, Timor-Leste and Senegal. It called on other governments and the global pharmaceutical industry to launch urgent inspections to root out substandard medicines and improve regulation.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said in an emailed statement on Tuesday that its members “are already implementing WHO’s request in line with national and international guidance.”
At a news conference on Tuesday, Hanan Balkhy, WHO’s acting director for access to medicines, said more children could be affected.
“There may be children who have been exposed to these drugs that we don’t even know about,” she told reporters, adding that that’s why everyone in the supply chain needs to be transparent to address this.
WHO has issued specific warnings in October 2022 and earlier this month for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech. It said their syrups had been linked to deaths in Gambia and Uzbekistan respectively, and warned people to stop using them.
The manufacturing plants in Maiden and Marion are both closed. Maiden is now seeking to reopen after the Indian government said in December that its tests found no problems with its products.
Maiden has repeatedly told Reuters, including in December, that it did nothing wrong, and managing director Naresh Kumar Goyal said on Tuesday he would not comment on the WHO probe into possible links between companies under review.
Calls to Marion’s office went unanswered on Tuesday, and the company did not immediately respond to an email seeking comment. Earlier this month, it told the government of Uttar Pradesh, near New Delhi, that the deaths in Uzbekistan it blamed had “damaged the image of India and the company”.
The World Health Organization, working with Indonesia’s drug regulator, also issued a warning in October against cough syrup made by four Indonesian manufacturers and sold domestically. The manufacturers are: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex, PT AFI Farma.
On Tuesday, PT Yarindo Farmatama, PT Konimex and PT AFI Farma did not immediately respond to a request for comment on a WHO investigation into links between the deaths in the three countries.
Hermansyah Hutagalung, a lawyer for PT Universal Pharmaceutical Industries, said the company has removed all cough syrups deemed dangerous from the market. “Track down the suppliers, they are the real criminals,” Hutagalung added. “They’re the ones who falsify the ingredient by falsifying the ingredient’s documentation all the way to the drug company.” He didn’t name a specific supplier or provide details to back up the claim.
The World Health Organization said the syrups were contaminated with diethylene glycol and ethylene glycol, which it described as “toxic chemicals used as industrial solvents and antifreeze that can be fatal if taken in small amounts.” Their toxic effects include inability to urinate, Kidney damage and death.
The deaths highlight potential gaps in the global regulation of commonly used drugs, including oversight of factories and supply chains, especially those that manufacture products for developing countries that lack the resources to monitor the safety of drugs.
The WHO sets global guidelines for drug manufacturing standards and supports countries in investigating any lapses, but it has no legal mandate or enforcement agency 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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