Comparative Analysis of Over The Counter (OTC) Pain Reliever Recalls Due to Quality Issues: A Case Study of Ireland V/S India

Abstract

This study examined the differences in recall practices for over- the counter (OTC) pain relievers in Ireland and India, focusing on quality related issues, regulatory enforcement and recall outcomes. With increasing reliance on OTC medications such as paracetamol and ibuprofen for self-medication, ensuring drug quality and safety is paramount. The study explores the differences between Ireland’s centralised, EU-aligned regulatory model governed by the Health Products Regulatory Authority (HPRA) and India’s decentralised recall system under the Central Drugs Standard Control Organisation (CDSCO). Using a mixed-methods approach, recall data from the past 2 years were analysed alongside expert interviews to categorise recall causes and evaluate the effectiveness of recall systems. It was shown that Ireland’s centralised, Eu aligned recall framework enables quicker and more transparent recall execution compared to India’s decentralised and inconsistently enforced system. Contamination and mislabelling were identified as the leading causes of recalls, with India exhibiting a higher frequency of such events due to weaker post-marketing surveillance and inadequate regulatory infrastructure. The findings revealed significant gaps in recall tracking and consumer notification in India, while Ireland faced challenges related to Eu coordination delays. The analysis highlighted that despite regulatory progress in both countries, key gaps persist in recall traceability, communication and stakeholder compliance. India’s fragmented recall structure hampers timely action while Ireland reliance on EU coordination can create inter-agency delays. The conclusions drawn from these findings suggest that regulatory efficiency, digital traceability and public communication are critical in safeguarding patient safety. This dissertation concludes that effective recall management requires strategic reforms tailored to each country’s regulatory landscape. enforcement consistency and public communication. Strategic recommendations were proposed, including the implementation of centralised recall database in India, adoption of digital traceability systems, greater consumer education efforts and greater alignment with global best practices. These measures are essential for reducing the occurrence and impact of substandard OTC pain relievers and tom restore public trust in pharmaceutical quality control. The study underscores the need for harmonised international best practices to improve drug safety and protect public health.