ABSTRACTPurpose:Over-the-counter (OTC) sale of antibiotics have contributed to the growing threat of antibiotic resistance. The Government of India has instituted regulatory measures, such as Schedule H1 and public campaigns such as Red Line Campaign, to limit such sales. This study was conducted to assess the perceptions of stakeholders regarding their effectiveness.Methods:To assess Schedule H1, pharmacists who own retail pharmacies in the state of Kerala, India, were interviewed using a pre-prepared question guide. In the next phase, healthcare professionals and patients in a hospital were shown the Red Line on an antibiotic blister pack and asked about its significance. Finally, 100 patients were shown a blister pack of Amoxicillin, and asked to identify the medicine or its use.Results:It was observed that there is poor awareness about antibiotic regulations and a perception of laxity in enforcement. Regarding the Red Line, only 7% of healthcare professionals could describe its significance and none among patients. Among the 100 patients who were shown Amoxicillin, only 42 could identify it as an antibiotic or describe its use.Conclusions:There is a general perception that regulations are poorly enforced and all are not aware of the Red Line campaign including healthcare professionals. Greater awareness at all levels about appropriate antibiotic use through prescriptions followed by greater efforts towards regulatory implementation and compliance should form parts of a multi-modal strategy to contain OTC sales of antibiotics. This will greatly help to aid physicians in improving overall healthcare through safe and effective prescribing.