According to a person familiar with the situation, the World Health Organization (WHO) is looking into if there is any connection between the manufacturers whose tainted cough syrups it has linked to the deaths of more than 300 children in three countries.
The WHO is looking for further 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.
In light of ongoing concerns about the safety of some of these medicines, the WHO is also debating whether to encourage families worldwide to reevaluate the use of cough syrups for kids in general. The person claimed that WHO experts are assessing the evidence to determine whether or when such items are medically necessary for youngsters.
Beginning in Gambia in July 2022, cases 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 illnesses that included either diethylene glycol or ethylene glycol, two known 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 contaminated products that were a factor in any fatalities. The corporations the WHO has named are not guilty of any misconduct, according to Reuters.
Without going into additional information about the specifics of the organization’s efforts, WHO spokesperson Margaret Harris stated, This is of the highest concern for us, to see no more child fatalities from something that is so preventable.
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 news conference later on Tuesday is when the WHO is anticipated to make additional comments regarding the cough syrup issue.
In October 2022 and earlier this month, the WHO issued specific alerts 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 announced in December that its testing had discovered no issues with Maiden’s products, Maiden is now attempting to reopen.
Maiden has frequently assured Reporters that it done nothing improper, most recently in December. On Tuesday, managing director Naresh Kumar Goyal said he had no comment regarding WHO’s investigation into any connections between the companies under consideration.
On Tuesday, Marion’s office phone went unanswered, and an email requesting response from the business was not promptly responded. It informed the Uttar Pradesh government earlier this month that the deaths in Uzbekistan were being linked to it to damage the image of India and the company, 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 about the WHO’s investigation into possible links between the deaths 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 added, Go after the suppliers; they’re the actual criminals. They are the ones who 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 can be lethal even in little concentrations, were found to be present in the syrups, according to the WHO. Their poisonous effects include death, renal damage, and the inability to pass urine.
The fatalities have drawn attention to possible weaknesses in the global regulation of routinely used drugs, including control of manufacturing facilities and supply chains, particularly those producing goods for developing 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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