The Impact of the Production of Active Pharmaceutical Ingredients in Iran on Price, Quality, and access of Medicines

Abstract

2020] Objective (s ) : Active Pharmaceutical Ingredients (APIs) are a significant contributing factor to the price, quality, and access of pharmaceutical products. Thus countries often would develop their policy of supplying APIs based on these three factors. This study examined the impact of the supply policies of APIs on the price, quality, and access of medicines in Iran. Methods: This study consisted of qualitative and quantitative phases . In the qualitative phase, semi-structured interviews were carried out with leading experts in the field, and thematic analysis method was used for data analysis. In the quantitative phase, the price of domestic APIs was compared to that from China and India in the case of 50 medicine products, and the ratio of the API price to the final product was determined. In addition, opinion of manufacturers of final products was asked about the quality of domestic and imported APIs. Results: In 45 products, the price of domestic APIs was higher than that of their counterparts imported from China and India. Judging by the opinion of quality control experts in drug manufacturing companies, the quality of domestic APIs was also inferior to that of the imported ones. Conclusion: Economic reasoning and quality of APIs in supply constitute the main business principles of final product manufacturers. To promote market of domestic active pharmaceutical ingredients, their price and quality should be