The World Health Organization (WHO) has asked regulators in all member states to remove contaminated syrups from circulation, increase market surveillance, and prevent the use of substandard and counterfeit medicines after at least 300 deaths in three countries were linked to contaminated over-the-counter syrups for children.
In a statement released on Monday, the WHO also requested that manufacturers source and test only pharmaceutical-grade components.
It was stated that seven countries had recorded such incidents, with the majority of victims being youngsters under the age of five.
“Since these are not isolated cases, WHO urges key players in the medical supply chain to take quick and coordinated action,” the organisation said in a statement.
The intergovernmental organisation had previously notified Deccan Era that “no direct ties have been discovered between these three incidents/alerts.” Nonetheless, inquiries continue. Therefore, we do not intend to speculate on the causes.”
The first of three medical alerts was issued by the WHO in October for four syrups manufactured by India-based Maiden Pharmaceuticals and related to deaths in the Gambia. In November, a second warning was issued for eight syrups manufactured by four companies and linked to deaths in Indonesia. In January, a third notice was issued for two syrups manufactured by the Indian company Marion Biotech and linked to deaths in Uzbekistan.
All of the syrups were either suspected of containing ethylene glycol and di-ethylene glycol, which are harmful to humans and can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, and changed mental state. Moreover, it can result in acute renal injury, which can be fatal in youngsters.
The WHO has requested that regulators and governments detect and remove the products for which medical alerts have been issued, ensure that all medical products are approved for sale by competent authority and obtained from licenced suppliers, increase risk-based inspections of manufacturing sites, increase market surveillance, and prevent the sale or use of substandard or counterfeit medicines.
After the occurrences came to light, India’s top pharma regulator conducted inspections of both Maiden Pharma and Marion Biotech’s manufacturing facilities and shut them down due to violations of good manufacturing procedures. Since then, India’s medicines regulator has begun risk-based inspections of additional production facilities.
The intergovernmental organisation requested that manufacturers purchase only “pharmaceutical-grade” ingredients from qualified suppliers, test them prior to use, guarantee product quality with certificates of analysis based on appropriate testing results, and “keep accurate, complete, and proper records.”
Due to the use of non-pharmaceutical grade solvents, such as propylene glycol or glycerin, to dissolve active components in syrups, experts believe that the two pollutants can enter syrups.
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