In the wake of deaths in children linked to cough syrups and medicines made by manufacturers based in India and Indonesia, the WHO has called on countries to “urgently respond” to incidents of counterfeit medical products and to protect children from contamination. Call to Action” has been issued. Medicine.
The World Health Organization (WHO) said that over the past four months, countries reported several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). has been informed.
The cases are from at least seven countries, with three of these countries reporting more than 300 deaths, most of them children under the age of five.
The WHO said pollutants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even in small amounts and should never be found in medicines.
“WHO is issuing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and counterfeit medical products,” the global health agency said.
Since October last year, WHO has issued three global medical alerts on substandard pediatric medicines and syrups.
In October 2022, it issued an alert on Promethazine Oral Solution, Cofexmalin Baby Cough Syrup, Macoff Baby Cough Syrup and Magrip N Cold Syrup manufactured by Maiden Pharmaceuticals Ltd., Haryana, India.
Also read: Deaths linked to cough syrup in Uzbekistan: Drugs Standard Control Organization launches investigation
Four “substandard products” were identified in The Gambia and reported to the WHO in September 2022.
In November, an alert was issued by the WHO on eight products, including Unibaby Cough Syrup, Unibaby Demm Paracetamol Drops and Unibaby Demm Paracetamol Syrup, which were identified in Indonesia and manufactured by PT Afi Pharma.
Earlier this month, the WHO issued an advisory to warn against the use of two “substandard” cough syrups manufactured by Marion Biotech, India, which have been linked to the deaths of 18 children in Uzbekistan.
Ambronol Syrup and DOK-1 Max Syrup were manufactured by Marion Biotech based in Noida, Uttar Pradesh.
The global health organization issued an alert saying that the syrups fail to meet quality standards and contain contaminants that can prove fatal.
WHO medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO member states.
These medical product warnings requested the detection and removal of contaminated drugs from circulation in markets; increased surveillance and diligence within the supply chains of affected countries and territories; Immediate notification to WHO if these substandard products are detected in the country; and otherwise inform the public about the dangers and toxic effects of controversial drugs.
It noted that since these are not isolated incidents, WHO called on regulators and governments to detect and remove from circulation any substandard medical products in their respective markets that have been identified in the alert as potential causes of death and illness. have been identified as; Ensure that all medical products are approved for sale by the competent authorities in their respective markets and can be procured from authorized/licensed suppliers.
It urged the authorities to allocate appropriate resources to improve and enhance risk-based inspections of construction sites within their jurisdiction in accordance with international norms and standards and to help deal with construction, distribution and/or use of laws and other Also urged to implement and implement relevant legal measures. substandard and counterfeit drugs
WHO calls on drug manufacturers to purchase pharmaceutical grade excipients only from qualified and genuine suppliers; Perform extensive testing upon receipt of supplies and prior to use in the manufacture of finished products and provide assurance of product quality through certificates of analysis based on appropriate test results.
It also urged suppliers and distributors of medical products to always check for signs of falsification and physical condition of drugs and other health products that they distribute and/or sell and only from sources authorized and authorized by the competent authorities. Distribute and/or sell drugs. among other measures.
In December, India’s drug regulator told the WHO that the global health body found a premature link between child deaths in Gambia and four India-made cough syrups that have raised concerns about the country’s pharmaceutical products worldwide. adversely affected the image. ,
In a letter to Dr Rogerio Gaspar, DCGI’s director (regulation and pre-qualification), DCGI’s Dr VG Somany said a statement issued by the global health body in October in the wake of the deaths was “unfortunately publicized by the global media, which Due to the narrative being created internationally targeting the quality of Indian pharmaceutical products”.
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