WHO issues product alert over contaminated syrup by Indian manufacturer
United Nations, Apr 25: The World Health Organisation on Tuesday issued a product 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.
The 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 April 6, 2023.
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 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 said.
There was no immediate comment from the manufacturer on the WHO alert.
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 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.
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.
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.
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.
Before that, India-made cough syrups were allegedly linked to children deaths in the Gambia and Uzbekistan last year.
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FIR registered against nurse, doc, pvt hospital mgt after finger of infant partially severed
Bengaluru (PTI): A case was registered against the nurse, doctor and management of a private hospital here for alleged negligence after the finger of a six-month-old baby boy was partially severed during the discharge process, police said on Wednesday.
According to police, in his complaint, Vijay Kumar said that on February 19, he took his six-month-old child to a private hospital in Indiranagar here for consultation after he developed fever and cold. As per the doctor's advise, he was admitted for further treatment at about 10.57 am.
He was to be discharged at 3 pm on February 24 and accordingly, the hospital bill was paid while the discharge process was going on in the ward.
At the time of discharge, the nurse on duty removed the drip. While removing the dressing, she allegedly cut the tip of the little finger on the child's left hand. Due to this, the child suffered severe pain and injury, he alleged, as per the FIR.
"Immediately thereafter, the child was taken to the emergency ward, where dressing was done and a plaster was applied. Initially, the concerned staff informed us that it was not a major injury and that since the child is small, it would heal on its own. However, due to their negligence, my 6-month-old child sustained a serious injury to the little finger of his left hand, causing immense pain and damage," the FIR read.
Based on the complaint, a case was registered under section 125 (b) (act endangering life or personal safety of others) of the Bharatiya Nyaya Sanhita against the nurse, doctor and the management of the hospital and the matter is being investigated.
