WHO bans contaminated India-made cough syrup
Published: 10:08 AM,Aug 08,2023 | EDITED : 02:08 PM,Aug 08,2023
Muscat: The World Health Organisation (WHO) has banned Cold Out syrup (Paracetamol and Chlorpheniramine Maleate) citing reasons of contamination in their Medical Product Alert under the head ‘Substandard (contaminated) syrup medicines’ issued on Tuesday.
The Indian-made cough syrup considered to be substandard (contaminated) was identified in the Republic of Iraq and reported to the World Health Organization (WHO) last month by a third party in WHO Region of the Eastern Mediterranean.
Diethylene glycol and ethylene glycol found in Cold Out are toxic to humans when consumed and can prove fatal. The substandard batch of the product referenced in WHO Alert is unsafe and its use, especially in children, as it 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 that may lead to death.
“This WHO Medical Product Alert refers to one batch of substandard (contaminated) COLD OUT syrup (Paracetamol and Chlorpheniramine Maleate). Paracetamol and chlorpheniramine combination syrups are used to treat and relieve symptoms of the common cold and allergy symptoms,” said a WHO representative.
A sample of the COLD OUT Syrup was obtained from one location in Iraq after getting the tip off and was submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25per cent) and ethylene glycol (2.1per cent) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10per cent, the WHO spokesperson added.
“If you have the affected product, WHO recommends that you do not use it. If you, or someone you know, has, 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 stated manufacturer of the affected batch of the product is Fourrts (India) Laboratories Private Limited and the product is stated to be manufactured for Dabilife Pharma Private Limited. To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.
WHO further said that, however, the product referenced in the alert may have marketing authorisations in other countries or regions and it may also have been distributed, through informal markets, to other countries.
In the Sultanate of Oman, it was earlier banned and no pharmacies sell the same since then.
“We don’t take or sell or deal in Cold Out in our pharmacies nor do the private pharmacies in the country,” a pharmacist from the Ministry of Health (MoH) told the Observer.
A random survey through most of the pharmacies, Badr Samaa, Muscat Pharmacy, Scientific Pharmacy, Hala Pharmacy, Salama Pharmacy, Al Hashar Pharmacy revealed that the said syrup is not being sold here.
WHO has previously published four Alerts on other contaminated liquid dosage medicines and medical products that fail to meet quality standards or specifications and the current alert relates to only one batch of the product and out of an abundance of caution, WHO recommends increased vigilance and testing in respect of the product in general.
The alert further urges manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
In addition, all healthcare professionals have been requested to report any suspicious cases of adverse events linked to the use of contaminated medicines to the concerned authorities.
The Indian-made cough syrup considered to be substandard (contaminated) was identified in the Republic of Iraq and reported to the World Health Organization (WHO) last month by a third party in WHO Region of the Eastern Mediterranean.
Diethylene glycol and ethylene glycol found in Cold Out are toxic to humans when consumed and can prove fatal. The substandard batch of the product referenced in WHO Alert is unsafe and its use, especially in children, as it 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 that may lead to death.
“This WHO Medical Product Alert refers to one batch of substandard (contaminated) COLD OUT syrup (Paracetamol and Chlorpheniramine Maleate). Paracetamol and chlorpheniramine combination syrups are used to treat and relieve symptoms of the common cold and allergy symptoms,” said a WHO representative.
A sample of the COLD OUT Syrup was obtained from one location in Iraq after getting the tip off and was submitted for laboratory analysis. The sample was found to contain unacceptable amounts of diethylene glycol (0.25per cent) and ethylene glycol (2.1per cent) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10per cent, the WHO spokesperson added.
“If you have the affected product, WHO recommends that you do not use it. If you, or someone you know, has, 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 stated manufacturer of the affected batch of the product is Fourrts (India) Laboratories Private Limited and the product is stated to be manufactured for Dabilife Pharma Private Limited. To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product.
WHO further said that, however, the product referenced in the alert may have marketing authorisations in other countries or regions and it may also have been distributed, through informal markets, to other countries.
In the Sultanate of Oman, it was earlier banned and no pharmacies sell the same since then.
“We don’t take or sell or deal in Cold Out in our pharmacies nor do the private pharmacies in the country,” a pharmacist from the Ministry of Health (MoH) told the Observer.
A random survey through most of the pharmacies, Badr Samaa, Muscat Pharmacy, Scientific Pharmacy, Hala Pharmacy, Salama Pharmacy, Al Hashar Pharmacy revealed that the said syrup is not being sold here.
WHO has previously published four Alerts on other contaminated liquid dosage medicines and medical products that fail to meet quality standards or specifications and the current alert relates to only one batch of the product and out of an abundance of caution, WHO recommends increased vigilance and testing in respect of the product in general.
The alert further urges manufacturers of liquid dosage forms, especially syrups that contain excipients including propylene glycol, polyethylene glycol, sorbitol, and/or glycerin/glycerol, to test for the presence of contaminants such as ethylene glycol and diethylene glycol before use in medicines.
In addition, all healthcare professionals have been requested to report any suspicious cases of adverse events linked to the use of contaminated medicines to the concerned authorities.