The WHO issued the alert over contaminated syrup by an Indian manufacturer, warning that it is unsafe for use, especially in children, and may result in serious injury or death.
New Delhi: Another cough syrup manufactured in India lands in trouble following a ‘Medical Product Alert’ alert issued by the World Health Organisation (WHO). The alert by the organisation was issued for a batch of “substandard (contaminated)” Guaifenesin Syrup TG Syrup. The WHO issued the alert warning that it is unsafe for use, especially in children, and may result in serious injury or death.
“The substandard product was identified in the Marshall Islands and Micronesia and reported to WHO on 6 April 2023,” a WHO statement said.
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“The substandard product referenced in this Alert is unsafe and its use, especially in children, may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” the alert by WHO said.
It may be noted here that Guaifenesin is an expectorant that is used to treat chest congestion and other cough symptoms.
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The stated manufacturer of the affected product is QP Pharmachem Ltd (Punjab, India). The stated marketer of the product is Trillium Pharma (Haryana, India). To date, neither the stated manufacturer nor the marketer have provided guarantees to WHO on the safety and quality of these products.
Samples of the Guaifenesin syrup TG syrup from the Marshall Islands were analysed by quality control laboratories of the Therapeutic Goods Administration (TGA) of Australia. The analysis found that the product contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
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The product referenced in this alert may have marketing authorisations in other countries in the Western Pacific region. It may have also been distributed, through informal markets, to other countries or regions, the alert by the global health agency said.
The alert said that Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal. WHO advised that if people have the affected product, they should not use it.
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WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products. Increased surveillance of the informal/unregulated market is also advised. National regulatory authorities/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country.
Manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, sorbitol, and/or glycerin/glycerol, are urged to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
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Healthcare professionals should report any suspicious cases of adverse events linked to the use of these contaminated medicines to the National Regulatory Authorities/ National Pharmacovigilance Centre, it said.
Company Dismisses Claim
Reacting to the alert issued by WHO on the syrup, the MD of its manufacturer, QP Pharma Chem Limited said that they doubt their product was ‘duplicated’
“Food And Drug Administration of Punjab doubts that someone has duplicated the product (cough syrup) sent to Cambodia and then sold it in the Marshall Islands and Micronesia to defame the Government of India. The FDA department has taken samples of cough syrup sent to Cambodia for testing. A total of 18,336 bottles of cough syrup were sent,” MD Sudhir Pathak told ANI.
QP Pharmachem also said WHO tested expired samples of the cough syrup and was dismissive of the results.
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“Our company had dispatched a total of 18,336 bottles of the cough syrup in November 2020 and the shipment was only meant to be exported in Cambodia as per the order. We have no idea why WHO sent the samples to Australia for testing without any prior communication and now we are being framed in this allegation for contamination,” Sudhir Pathak, MD, QP Pharmachem exclusively told CNBC-TV18.
Similar cases
Recently, questions have been raised over the quality of drugs manufactured by India-based companies. In February, the Tamil Nadu-based Global Pharma Healthcare recalled its entire lot of eye drop allegedly linked to vision loss in the US.
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A few months prior, a cough syrup produced by a company named Maiden Pharma was alleged to have caused a significant number of children deaths in the African nation of Gambia.
Around the same time, Uzbekistan claimed that 18 children in the country died after allegedly being administerd a cough syrup made by Marion Biotech, a Noida pharma manufacturer.
