Research at Innopharma Education

“Comparative Analysis of Over the Counter (OTC) Pain Reliever Recalls Due to Quality Issues: A Case Study of Ireland V/S India” by Aleena Manoj 

This study compared recall practices for over-the-counter (OTC) pain relievers in Ireland and India, focusing on quality issues, regulatory enforcement, and recall outcomes. It contrasted Ireland’s centralized, EU-aligned system under the Health Products Regulatory Authority (HPRA) with India’s decentralized recall system managed by the Central Drugs Standard Control Organisation (CDSCO). Using mixed methods, including two years of recall data and expert interviews, the study found Ireland’s system enables faster, more transparent recalls, while India’s system suffers from inconsistent enforcement and weaker post-marketing surveillance. Contamination and mislabelling were the main recall causes, with India experiencing more frequent incidents due to regulatory gaps. India showed significant deficiencies in recall tracking and consumer notification, whereas Ireland faced delays linked to EU coordination. Despite progress, both countries have persistent issues in traceability, communication, and compliance. The study recommends strategic reforms such as implementing a centralized recall database in India, adopting digital traceability, enhancing consumer education, and aligning with global best practices to improve patient safety and restore trust in pharmaceutical quality control. It emphasizes the need for harmonized international standards to safeguard public health.

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