WHO alert on another ‘contaminated’ cough syrup made in India

THE World Health Organisation has issued another alert for an India-manufactured, contaminated cough syrup sold in the Marshall Islands and Micronesia.

This is the third such alert within seven months for contaminated cough syrups produced in India, with the previous cases having been identified in the Gambia and Uzbekistan.

The alert says that the syrup Guaifenesin—used to relieve chest congestion and cough—was found to contain “unacceptable amounts of diethylene glycol and ethylene glycol” by the quality control labs of the Therapeutic Goods Administration of Australia.

These are the same contaminants that were found in syrups allegedly linked to the deaths of 70 children in the Gambia and 18 children in Uzbekistan due to acute kidney injury.

The alert asks people to not use the syrup and regulators to increase surveillance of supply chains. It also asks manufacturers to test raw materials used in such syrups such as propylene glycol, sorbitol and glycerine/glycerol before using them in a medical formulation.

The most likely source of the two contaminants is thought to be contaminated solvents that are used for the manufacturing of the syrups. While the solvents used are not harmful, both the contaminants are known to be toxic to humans. They can lead to abdominal pain, vomiting, diarrhoea, headache, altered mental status, inability to pass urine and acute kidney injury. The contaminants can also be fatal.

The contaminants were reported from one batch of the medicine with an expiry date in October 2023. The contamination was reported to the WHO on April 6, according to the alert issued on Tuesday night.

The syrup sold in the two Pacific Ocean countries was stated to have been manufactured by Punjab-based QP Pharmachem Ltd and marketed by Haryana-based Trillium Pharma.

“To date, neither the stated manufacturer nor the marketers have provided guarantees to WHO on the safety and quality of these products,” the WHO said.

In the previous two cases, teams of central and state drug inspectors were rushed to the manufacturing facilities and manufacturing was halted for violations of good manufacturing practices.

While contamination was not detected in the control samples or raw materials collected from Maiden Pharma, linked to the cases in the Gambia, it was detected in raw material collected from Marion Biotech, linked to the Uzbek cases. A case was registered against the company.