Critical evaluation of endotoxin contamination in intravenous solutions: A call for enhanced regulatory oversight and quality control

Abstract

The recent identification of bacterial endotoxins in Ringer’s Lactate (RL) from a manufacturing batch by M/s. Vision Parenteral Pvt. Ltd. has raised significant concerns regarding the safety of intravenous solutions. These endotoxins, originating from Gram-negative bacteria, can trigger severe systemic inflammatory responses, worsening conditions like haemorrhagic shock and leading to organ dysfunction and increased mortality. The interaction between RL and endotoxins is particularly problematic, as it can exacerbate inflammation, disrupt fluid balance, and complicate metabolic and immune responses. This situation underscores significant gaps in pharmaceutical manufacturing practices and highlights the urgent need for stricter regulatory oversight and quality control. The healthcare community must reassess the use of RL in clinical settings, particularly in cases where endotoxin contamination could pose a significant risk, to protect patient health and safety.

Keywords

• Intravenous Solutions
• Ringer’s Lactate
• Bacterial Endotoxins
• Quality Control