The World Health Organization on Monday urged governments to take immediate action to remove substandard medical products from circulation.
The global health body said that in the past four months, several incidents have been reported of over-the-counter cough syrups for children with confirmed or suspected contamination with diethylene glycol and ethylene glycol.
Syrups are ideally not supposed to contain even traces of ethylene glycol, which is found in industrial grade glycerine not permitted for medicinal uses. Ethylene glycol and diethylene glycol can cause vomiting, convulsions, affect the circulatory system and cause acute renal failure.
Since October, the WHO has issued three global medical alerts over substandard medicines and cough syrups for children.
In October, the health body had issued a global alert for four cough syrups manufactured by Haryana-based Maiden pharmaceuticals after it was linked with deaths of children in The Gambia.
Earlier this month, the World Health Organization had recommended not using two cough syrups made by an Indian pharmaceutical firm after the company’s product was linked with deaths in Uzbekistan.
On Monday, the health body urged governments to detect and remove any substandard medical products that have been identified in the WHO medical alerts as potential causes of deaths and disease.
“Ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized/licensed suppliers,” the WHO said in its call to action.
It also recommended steps like market surveillance, assigning appropriate resources to improve and increase risk-based inspections of manufacturing sites, and introducing relevant legal measures to help combat substandard medicines.
WHO’s global alerts about India-made medicines
The global health body’s chief Tedros Adhanom Ghebreyesus had said in October that four cough syrups manufactured by Haryana-based Maiden Pharmaceuticals Limited had potentially linked with cases of “acute kidney injuries” in 66 children in The Gambia.
The four cough syrups were identified as – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
Laboratory analysis of the syrups “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the health body had said.
However, on December 13, Drugs Controller General of India VG Somani had claimed that the global health body drew a premature link between the deaths of children in The Gambia and the cough syrups.
On December 27, Uzbekistan’s health ministry had said that 18 children died after consuming Dok 1 Max syrup manufactured by Noida-based company Marion Biotech Limited.
The World Health Organization, in its medical product alert, had said that Ambronol and Dok 1 Max manufactured by Marion Biotech Limited “contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants” as per laboratory analysis carried out by authorities in Uzbekistan.
On December 29, Marion Biotech had said that it has stopped manufacturing the Dok 1 Max cough syrup. The company’s legal department head Hasan Harris claimed that there were no problems on the company’s part in testing the cough syrup.
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