GENEVA, 25 April 2023: The World Health Organisation (WHO) has in a Medical Product Report Alert refers to a cough syrup produced by a Punjab-based Indian company and marketed by a Haryana-based marketing company Trillium Pharma as being ‘unsafe’ and if used by children can lead to ‘serious injury or death’.
The WHO alert summery says:
“This WHO Medical Product Alert refers to a batch of substandard (contaminated) GUAIFENESIN SYRUP TG SYRUP identified in the Marshall Islands and Micronesia (Federated States of) and reported to WHO on 6 April 2023.
Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough.
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.
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.
The product referenced in this Alert may have marketing authorizations in other countries in the Western Pacific region. It may have also been distributed, through informal markets, to other countries or regions.”
Risks
“Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
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.”
Substandard and falsified medical products
According to WHO, ” Up to two billion people around the world lack access to necessary medicines, vaccines, medical devices including in vitro diagnostics, and other health products, which creates a vacuum that is too often filled by substandard and falsified products. This problem is growing as global supply chains become more complex, meaning products manufactured in one country may be packaged in a second country and distributed across borders to be marketed or sold to consumers in a third. The growth of e-commerce also contributes to this trend by making it easier to purchase medicines online, often from unauthorized sources.”
Source- , Medical product alert, Geneva
