According to a source familiar with the situation who spoke to Reuters, the World Health Organization (WHO) is looking into if there is any connection between the manufacturers whose tainted cough syrups it has connected to the deaths of more than 300 children in three countries.
The WHO is looking for more information about the specific raw materials used by six manufacturers in India and Indonesia to produce the medicines linked to the recent deaths, as well as whether the businesses obtained them from some of the same suppliers, the person said, citing "unacceptable levels" of toxins in the products. The WHO has not identified any vendors.
The WHO is also debating whether to encourage families internationally to reevaluate the use of children's cough syrups in general amid concerns about their safety.
Beginning in Gambia in July 2022, instances of paediatric acute renal damage spread to Indonesia and Uzbekistan. According to the WHO, the deaths were caused by youngsters using over-the-counter cough syrups for common diseases that included either diethylene glycol or ethylene glycol, two recognised toxins.
The WHO has so far identified six medicine manufacturers who made the syrups in Indonesia and India. These producers either chose not to comment on the inquiry or denied utilising hazardous products that were a factor in any fatalities. The corporations the WHO has identified are not guilty of any misconduct, according to Reuters.
WHO spokesperson Margaret Harris stated, "Seeing no more child fatalities from something so avoidable is of the utmost concern for us."
The United Nations health organisation announced on Monday that it had expanded its investigation into possible diethylene glycol and ethylene glycol contamination in cough syrups to four additional countries, including Cambodia, the Philippines, East Timor, and Senegal, where the same products may have been sold. It urged other countries and the international pharmaceutical sector to conduct immediate audits in order to weed out inferior medications and strengthen control.
A press conference later on Tuesday is when the WHO is anticipated to make more comments about the cough syrup issue. In October 2022 and earlier this month, the WHO issued specific cautions regarding cough syrups produced by two Indian producers, Maiden Pharmaceuticals and Marion Biotech. According to the notifications, the use of these syrups had been related to deaths in the Gambia and Uzbekistan, respectively.
The manufacturing facilities in Marion and Maiden have both been shut down. After the Indian government said in December that its testing had discovered no issues with Maiden's goods, Maiden is now attempting to reopen.
Maiden has frequently assured Reuters that it done nothing improper, most recently in December. On Tuesday, managing director Naresh Kumar Goyal said he had no comment about WHO's investigation into any ties between the firms under consideration.
On Tuesday, Marion's office phone was unanswered, and an email requesting response from the business was not promptly responded. It informed the Uttar Pradesh government earlier this month that the fatalities in Uzbekistan were being linked to it "to damage the image of India and the firm," given it is situated close to New Delhi.
In October, the WHO and Indonesia's drug enforcement agency jointly issued a warning on cough syrups produced by four Indonesian companies and distributed locally. PT Yarindo Farmatama, PT Universal Pharmaceutical, PT Konimex, and PT AFI Farma are the manufacturers.
When contacted for comment regarding the WHO's investigation into possible links between the fatalities in the three nations on Tuesday, PT Yarindo Farmatama, PT Konimex, and PT AFI Farma did not immediately react.
Hermansyah Hutagalung, PT Universal Pharmaceutical Industries' attorney, said that the company has removed all cough syrups from the market that were deemed hazardous. Hutagalung said, "Go after the suppliers; they're the actual culprits." They are the ones that falsify raw ingredient documentation all the way up to pharmaceutical businesses in order to fake raw materials. He made the allegation without naming any individual suppliers or providing evidence to support it.
Diethylene glycol and ethylene glycol, which the WHO described as "toxic compounds used as industrial solvents and antifreeze agents that may be lethal even in little concentrations," were found to be present in the syrups, according to the WHO. Their poisonous consequences include death, renal damage, and the inability to pass urine.
The fatalities have drawn attention to possible weaknesses in the worldwide regulation of routinely used drugs, including control of manufacturing facilities and supply chains, particularly those producing goods for impoverished nations that lack the means to monitor the safety of pharmaceuticals.
The WHO establishes worldwide standards for the manufacture of medicines and aids nations in their investigations of any flaws, but it lacks the mission or enforcement power to prosecute offenders directly.
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