WHO Issues Alert for Substandard Cough Syrup Manufactured in India
New Delhi
New Delhi: The World Health Organisation (WHO) on Monday issued a substandard medicine alert from Iraq for a cough syrup manufactured by an Indian firm, making it fifth such warning for India-made drugs in the past 10 months.
“A sample of the ‘Cold Out’ Syrup was obtained from one location in Iraq and submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants,” WHO said in a statement. “The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%.”
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The affected batch of the syrup, branded Cold Out, was manufactured by Tamil Nadu-based Fourrts (India) Laboratories Pvt Ltd for Maharashtra-based Dabilife Pharma Pvt Ltd.
“This WHO medical product alert refers to one batch of substandard (contaminated) Cold Out syrup (Paracetamol and Chlorpheniramine Maleate) identified in Iraq and reported to the World Health Organization on 10 July 2023 by a third party,” the United Nations body’s statement read.
Paracetamol and chlorpheniramine combination syrups are used to treat common cold and allergy symptoms.
At least five of the India-manufactured drugs have come under WHO scrutiny in close to a year.
India-made cough syrups were allegedly linked to the deaths of 66 and 18 children in The Gambia and Uzbekistan, respectively, last year. Another alleged episode of cough-syrup related contamination was recently reported from Cameroon. In the US, children suffered severe eye infection allegedly after using India-made eye drops.
The substandard batch of the product found in Iraq is unsafe, WHO said, 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 Union health ministry did not respond to the development till the time of going to press.
The UN health body issued a detailed advisory to regulatory authorities and the public as a precautionary measure.
“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-effects after use, you are advised to seek immediate medical advice from a healthcare professional,” the UN body said in its advisory. “While this medical product alert relates to only one batch of the product…, out of an abundance of caution, WHO recommends increased vigilance and testing in respect of the product in general.”
WHO requested increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these products, and also advised increased surveillance of informal and unregulated markets.
National regulatory authorities and health authorities have been 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, polyethylene 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,” WHO said.
Healthcare professionals have been advised to report any suspicious cases of adverse events linked to the use of contaminated medicines to the National Regulatory Authorities or National Pharmacovigilance Centre.
