The impact assessment of Scheduel H1 on the sales of over-the-counter antibiotics in India: Evidence from quasi-experimental research design

Abstract

Purpose: The Schedule H1 of Drugs and Cosmetics Act of Government of India sought to regulate over the counter antibiotic sales in the private market. The objective of this research is to conduct impact evaluation of this policy intervention. Methods & Materials: The intervention is a policy for redcuing over-the-counter sales of antibiotics named Schedule H1 of Drugs and Cosmetics Act of Government of India implemented through/on retail pharmacies on selected antibiotic notified under the new Schedule H1. Monthly data on the antibiotics sold in the private retail market were studied. An ITS model controlling for seasonality and autocorrelation was used to examine the dataset for significant level and trend shifts. Results: Our preliminary analysis suggest a post intervention decrease in the average monthly market share of antibiotics under Schedule H1 by 1.56 percent which was significant (p < 0.05) and a decrease in the trend by 0.041 percent which was not significant (p > 0.05). The ITS model adjusted for seasonality and autocorrelation suggets slight reduction effect size i.e. −1.53% from −1.56% in level change but no change in the trend estimate. Conclusion: The segmented regression analysis of pharmaceutical sales is a robust method for measuring the impact of interventions directed towards medicines utilization. The Schedule H1 intervention was associated with significant decrease in over-the-counter sales of the notified antibiotics intially but the reduction in sales or the impact of the intervention could not be sustained over long term.