The World Health Organisation (WHO) is seeking more information about the raw materials used by six manufacturers that produced contaminated cough syrups linked to the deaths of more than 300 children in three countries.
Citing “unacceptable levels” of toxins in the products, the WHO is investigating the materials used by the manufacturers in India and Indonesia of the medicines linked to the recent deaths, as well as whether the companies obtained them from some of the same suppliers.
The WHO has not named any suppliers, reports Reuters, but is considering whether to advise families globally to reassess the use of cough syrups for children in general while questions over the safety of some of these products are unresolved. WHO experts are also evaluating the evidence for whether, or when, such products are medically necessary for children.
The deaths of children from acute kidney injury began in July 2022 in The Gambia, followed by cases in Indonesia and Uzbekistan. The deaths have all been linked to over-the-counter cough syrups taken by the children took for common illnesses and which contained a known toxin, either diethylene glycol or ethylene glycol.
To date, the WHO has identified six drugmakers in India and Indonesia who produced the medicines. These manufacturers have either declined to comment on the investigation or denied using contaminated materials that contributed to any deaths.
The UN health agency has widened its investigation into potential diethylene glycol and ethylene glycol contamination in cough medicines to four additional countries where the same products may have been on sale: Cambodia, the Philippines, East Timor and Senegal. It has called on other governments and the global pharmaceutical industry to launch urgent checks to root out substandard medicines and improve regulation.
The agency has already issued specific alerts for syrups made by Indian manufacturers Maiden Pharmaceuticals and Marion Biotech, in October 2022 and earlier in January. It said their syrups were linked to deaths in The Gambia and Uzbekistan respectively, and the alerts asked people to stop using them.
Maiden’s and Marion’s manufacturing plants have both been closed down, but Maiden wants to reopen after the Indian Government said in December that its testing had found no problems with the company’s products.
Maiden has repeatedly told Reuters, including in December, that it did nothing wrong and MD Naresh Kumar Goyal said this week that he had no comment on the WHO investigating possible connections between the companies under scrutiny.
Marion did not respond to an email seeking comment, but earlier in January, it told the Government of Uttar Pradesh, where it is located near New Delhi, that it was being blamed for the deaths in Uzbekistan “to malign the image of India and the company”.
The WHO, working with Indonesia’s drugs regulator, also issued an alert in October about cough syrups made by four Indonesian manufacturers and sold domestically. The 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 respond to requests for comment, but PT Universal Pharmaceutical Industries’ lawyer, Hermansyah Hutagalung, said it had pulled from the market all cough syrups deemed dangerous. “Chase the suppliers, they’re the real criminals,” Hutagalung said.
“They’re the ones who forge raw ingredients by falsifying raw ingredient documents all the way to pharmaceutical companies.” He did not identify specific suppliers or give details to back up the claim.
The WHO said diethylene glycol and ethylene glycol were “toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts”. Their toxic effects include an inability to pass urine, kidney injury and death.
The deaths have highlighted potential gaps in global regulation of commonly used medications, including oversight of factories and supply chains, particularly those producing products for developing countries that lack the resources to monitor medicines for safety.
The WHO sets guidelines on medicine manufacturing standards globally and supports countries investigating any lapses, but it has no legal mandate or enforcement authority to take direct action against violators.
See more from MedicalBrief archives:
Indonesia families launch lawsuit over contaminated cough syrup
Probe into Indian cough syrup link to Gambian children’s deaths
Indonesia revokes firms’ licences after 150 deaths from toxic meds
Children's deaths in The Gambia linked to either paracetamol or E.coli