New Delhi, April 25
The World Health Organisation on Tuesday issued a global medical alert product in respect of a allegedly contaminated cough syrup manufactured by Punjab based QP Pharmachem and marketed by Haryana-based Trillium Pharma.
The world body said it had identified the product in its Western Pacific Region but did not say whether the product led to any children falling sick.
This is the third recent red flag involving India made drugs. In October last, a WHO medical alert allegedly linked the death of over 66 Gambian children to cold and cough formulations made by Sonepat based Maidan Pharma; in December last, Uzbekistan health ministry reported 18 child deaths allegedly from consuming a cough syrup made by Noida based Marion Biotech; most recently in April 2023, the USFDA linked Chennai based Global Pharma made eye drops to three deaths and blindness in the US.
The latest WHO Medical Product Alert refers to a batch of substandard (contaminated) GUAIFENESIN SYRUP TG SYRUP identified in the Marshall Islands and Micronesia and reported to WHO on April 6, 2023.
Guaifenesin is an expectorant used to relieve chest congestion and the symptoms of cough.
The WHO said 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 and were found to contain contaminants diethylene glycol and ethylene glycol.
“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 (Punjab, India). The stated marketer of the product is Trillium Pharma (Haryana, India),” the world body said.
It said 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,” the WHO said.
For nations the global health body had the following advice — “If you have the affected product, WHO recommends that you do not use it. If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a healthcare professional.”
WHO asked member states for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products.
The union health ministry when contacted said it would respond when it gets information related to the product alert through WHO channels.
Risks
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
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