Abstract

BANNED EXCIPIENT COMBINATIONS IN COUGH SYRUPS: A REVIEW ON GLOBAL SAFETY AND REGULATORY CONCERNS

*Mr. Arun G. Krishnan, Hana Shajahan, Irfana S, Shafna N., Shehana, Thansi

Abstract

The safety of pharmaceutical excipients used in cough syrup formulations has emerged as a critical global issue due to several incidents of contamination and toxicity. Although excipients are considered pharmacologically inactive, recent evidence indicates that they can significantly affect product safety, especially in paediatric formulations. Contaminants such as Di-Ethylene Glycol (DEG) and Ethylene Glycol (EG) have led to fatal poisonings, prompting worldwide recalls and regulatory interventions. Between 2022 and 2025, the World Health Organization (WHO) and National Drug Authorities including the U.S. Food and Drug Administration (FDA) and India’s Central Drugs Standard Control Organization (CDSCO) issued multiple alerts on substandard cough syrups. The 2021 study by Zupanets et al. provided critical insights into the cumulative risks of excipients in paediatric Phyto mucolytic syrups, reinforcing the need for regulatory vigilance and comprehensive safety evaluation of excipients. This review highlights the significance of recent global bans, mechanisms of toxicity, and the urgent call for harmonized excipient testing standards.

Keywords: Banned excipients, cough syrup, Di-Ethylene Glycol, Ethylene Glycol, WHO alert, Excipient toxicity, Paediatric safety, Pharmaceutical regulation.