India-Manufactured Cough Syrups Under WHO Scanner

Several India-manufactured cough syrups were detected with contaminants recently. Of these, four were marketed in Gambia, two in Uzbekistan, and one in the Marshall Islands and Micronesia. The World Health Organization (WHO) has issued alerts against the use of these formulations.

Overall, seven Indian cough syrups have been rejected over the past seven months India; major contaminants identified were – diethylene glycol and ethylene glycol, known toxic compounds that can be fatal. The syrups were classified substandard as they failed to meet quality standards and safety specifications. 

On April 25th, the WHO issued an alert against a batch of Guaifenesin Syrup TG Syrup, exported to the Marshall Islands and Micronesia, which was categorized contaminated and substandard due to the presence of diethylene glycol and ethylene glycol. Other WHO-issued alerts have been directed against the cough syrups – Ambronol syrup, DOK-1 Max syrup, Kofexmalin Baby Cough Syrup, Magrip N Cold Syrup, Makoff Baby Cough Syrup, and Promethazine Oral Solution.

The manufacturer – QP Pharmachem Ltd, Punjab, India, and the marketer – Trillium Pharma, Haryana, India, are to blame for the sale of these contaminated cough syrups. However, neither had guaranteed the safety and quality of their products. The WHO reported that contaminated Guaifenesin syrup could have gained marketing authorization in certain Western-Pacific countries and were likely distributed to other regions through informal markets.

Last year, the WHO had alerted against substandard cough syrups identified in Gambia – by Maiden Pharmaceuticals Limited, Haryana, India. Early this year, two contaminated cough syrups by Marion Biotech Limited, Uttar Pradesh, India were found contaminated in Uzbekistan.