WHO Issued Substandard Medicine Alert Over Indian Manufacturer's Contaminated Syrup

The World Health Organisation has issued a "Medical Product Alert" today about a cough syrup produced in India.

According to a statement from the World Health Organization (WHO), on 6 April 2023, a notification was released regarding a batch of Guaifenesin Syrup TG Syrup that was found to be substandard or contaminated. The identified substandard product was reported in both the Marshall Islands and Micronesia, prompting the issuance of an alert.

Guaifenesin is an expectorant commonly employed for treating chest congestion and cough-related symptoms. However, an investigation conducted by WHO revealed that the product in question contained unsatisfactory levels of diethylene glycol and ethylene glycol, deemed as contaminants according to laboratory analysis.

The manufacturer of this product is QP Pharmachem Ltd, located in Punjab. Trillium Pharma from Haryana was identified by WHO as the marketer of the said product.

The statement noted that "neither the stated manufacturer nor the marketer have provided guarantees to WHO on the safety and quality of these products."

According to WHO, the usage of the medicine in question is unsafe, and its use, particularly in children, could lead to severe harm or even mortality.

"Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death," it added.

Indian pharmaceutical companies have recently faced a string of similar incidents. One such occurrence involved Maiden Pharma, whose cough syrup was suspected of causing numerous child fatalities in Gambia. Likewise, Marion Biotech, another Indian drug manufacturer based in Noida, was alleged of administering a cough syrup that resulted in the deaths of 18 children in Uzbekistan, during the same time period. This marks the third incident in quick succession involving Indian drug manufacturers.