Jan 24 (Reuters) – The World Health Organization (WHO) is investigating whether there is a link between manufacturers whose contaminated cough syrup has killed more than 300 children in three countries, it said. A person familiar with the matter told Reuters.
Citing “unacceptable levels” of toxins in the products, the WHO is seeking more information about specific raw materials used by six manufacturers in India and Indonesia to make drugs linked to recent deaths. is, as well as whether companies have obtained them from certain drugs. The same suppliers, the person said. WHO did not name any suppliers.
WHO is also considering whether to advise families globally to reevaluate the use of cough syrups for children in general, the person said, while some of them Questions about product safety remain unresolved. WHO experts are reviewing the evidence to determine whether such 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 WHO said the deaths were linked to cough syrups used by children for common illnesses that contained a known toxin, either diethylene glycol or ethylene glycol.
To date, WHO has identified six drug manufacturers in India and Indonesia who produced these syrups. These manufacturers have either refused to comment on the investigation or have denied using the contaminated materials that caused any of the deaths. Reuters has no evidence of wrongdoing by the companies named by the WHO.
“This is a top priority for us, so that there are no more child deaths from something that is so preventable,” WHO spokeswoman Margaret Harris said, without further commenting on the specifics of the organization’s work.
The United Nations health agency said Monday it has expanded its investigation into possible diethylene glycol and ethylene glycol contamination in cough syrups to four additional countries where the same products may be sold. : Cambodia, Philippines, East Timor and Senegal. It called on other governments and the global pharmaceutical industry to initiate urgent testing 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 are “already doing what the WHO is calling for” in accordance with national and international guidelines. “
At a news conference on Tuesday, WHO acting director for access to medicines Hanan Balkhi said more children could be affected.
“There may be children who are exposed to these drugs that we don’t even know about,” he told reporters, adding that that’s why it’s important to address the problem. Transparency was required from everyone in the supply chain.
The WHO has already issued a specific alert for cough syrups made by two Indian manufacturers, Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier this month. It said their syrups were linked to deaths in Gambia and Uzbekistan, respectively, and the warnings told people to stop using them.
Manufacturing plants in Madden and Marion have both been closed. Madden is now trying to reopen after the Indian government said in December that its tests found no problems with Madden’s products.
Madden has repeatedly told Reuters, including in December, that it has done nothing wrong and managing director Naresh Kumar Goyal said on Tuesday that he had no comment on the investigation into possible links between the companies under WHO scrutiny. do not have.
A phone call to Marion’s office was not answered Tuesday and the company did not immediately respond to an email seeking comment. Earlier this month, it told the government of Uttar Pradesh, where it is located near New Delhi, that the deaths in Uzbekistan were being blamed for “tarnishing the image of India and the company”.
The WHO, working with Indonesia’s drug regulator, also issued an alert in October about cough syrups made by four Indonesian manufacturers and sold locally. Manufacturers are: PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex, PT AFI Farma.
PT Yarindo Farmatama, PT Konimex and PT AFI Pharma did not immediately respond to requests for comment on Tuesday about the WHO investigating the link between the deaths in the three countries.
Hermansia Hotagaling, lawyer for PT Universal Pharmaceutical Industries, said it has withdrawn all cough syrups from the market that are considered dangerous. “Go after the suppliers, they are the real criminals,” Hutagalung added. “They are the ones who manufacture raw ingredients to pharmaceutical companies by falsifying raw ingredient documents.” He did not identify specific suppliers or provide 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 fatal in small amounts.” Can be.” Their toxic effects include urinary incontinence, kidney injury, and death.
The deaths have highlighted potential gaps in global regulation of commonly used drugs, including oversight of factories and supply chains, particularly those producing products for developing countries that lack pharmacovigilance for safety. There is a lack of resources.
WHO sets guidelines on global drug manufacturing standards and supports countries investigating any lapses, but has no legal mandate to take direct action against violators or There is no enforcement authority.
Additional reporting by Prak Chinthal in Phnom Penh, Stanley Vidyanto and Ananda Tricia in Jakarta, Krishna N. Das in New Delhi, Saurabh Sharma in Lucknow, Ed McAllister in Dakar. Edited by Sarah Leiduth, Michelle Gershberg, Claudia Parsons, William McLean
Our Standards: Thomson Reuters Trust Principles.