(80) Self-Sufficiency and Pharmaceutical Local Production of Chronic Diseases Medicines in Saudi Arabia: The Case of Type Two Diabetes Medications

Publication Number: 411

Background: The dependence on imported drugs and/or raw materials used to produce locally manufactured medications is one of the public health threats to every health system worldwide. Therefore, strengthening drug security and achieving self-sufficiency in pharmaceutical manufacturing has become a priority in the health policy planning process in Saudi Arabia, particularly for chronic disease medications.

Objectives: To determine the extent of self-sufficiency in pharmaceutical supply of oral antidiabetic drugs in Saudi Arabia. 2. to describe the growth rate of the registration and utilization of locally produced and imported oral antidiabetic drugs from 2016 to 2020. 3. To assess the correlation between local production of oral antidiabetic drugs and access to these medications.

Methods: The Saudi Food & Drug Authority (SFDA) registered drugs list was examined to assess self-sufficiency status in oral antidiabetic drug production in Saudi Arabia in 2021. In addition, we used a retrospective time-series analysis design to investigate trends in the registration and utilization of oral antidiabetic drugs in Saudi Arabia from 2016 to 2020. The compound annual growth rate (CAGR) was calculated to demonstrate the average yearly change. A Person Correlation coefficient was used to assess the correlation between local production of oral antidiabetic drugs and access to these medicines in Saudi Arabia

Results: The current self-sufficiency status of oral antidiabetic drugs production is 52% in Saudi Arabia. Around 14% were classified as primary manufacturing, while the rest was either secondary (53%) or tertiary manufactured (33%). Of the oral antidiabetics on the national essential medicines list, 72% were locally produced. The CAGR of the registered local drugs was comparable to imported drugs during the whole period (12.3% vs 12%). However, in 2016, the number of local drugs was markedly higher than imported drugs by 67%. The market volume of local drugs was considerably higher than imported drugs from 2016 to 2020, and both peaked in 2019. Conversely, the market volume of local drugs fell substantially in 2020, while the market volume of imported drugs remained stable. The study found a strong positive correlation between local production and access to oral antidiabetic drugs in Saudi Arabia, r (3) = .770, p=.13.

Conclusions: Saudi Arabia has made enormous efforts to enhance the self-sufficiency and drug security in the country; however, more efforts are still needed to invest in the local production of pharmaceuticals, particularly for chronic diseases. Policies on enhancing local production and reducing reliance on imported Active Pharmaceutical Ingredients (APIs), intermediates, and finished pharmaceuticals are warranted to strengthen drug security in Saudi Arabia.