The latest episode of cough syrup-associated pediatric deaths in India linked to the reported diethylene glycol (DEG) contamination reverberates a long-standing catastrophic history from the Elixir Sulfanilamide disaster in the USA to the similar incidents in Haiti, Panama, and Gambia. Such recurring preventable tragedies highlight continuing concerns on global pharmaceutical regulation enforcement, toxicological implications on public health, and drug safety, particularly in low- and middle-income countries. In spite of clearly established pharmacopeial limits of diethylene glycol and other excipients used in pharmaceutical industry, probable gaps in excipient verification, insufficient quality control measures, and patchy regulatory monitoring have continued to be discussed in relation to contaminated drug formulations reaching global markets. Existing conventional strategies to combat reoccurrences, such as mandatory analytical testing of excipients and final drug products, vendor qualification, and strict pharmacovigilance programs, are necessary but not sufficient. This article describes the toxicological aspects of diethylene glycol poisoning, provides a brief overview of the historical events, and critically examines the reasons behind recurrence of DEG-related poisonings. Further, it provides specific recommendations to eradicate such catastrophes by employing futuristic strategies using block chain technology and artificial intelligence-based solutions.
Suhas et al. (Sat,) studied this question.