Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

Abstract

Active Pharmaceutical Ingredients (API)
 of good quality is core to the manufacturing of effective
 and safe essential drugs. The price of APIs is the main cost
 driver for manufacturing. Only a limited number of large
 manufacturers of finished pharmaceutical products have their
 own API manufacturing capabilities, and none of them can
 make all required APIs in-house. The majority of
 manufacturers, including all those located in Sub-Saharan
 Africa (with the exception of one company in South Africa)
 have to buy all APIs in the open market. The paper tries to
 make the structures of the API market more transparent,
 trying to determine how difficult it is for small
 manufacturers in developing countries to navigate the global
 API market and ensure that they get a quality product at a
 fair price. It also looks into the competitiveness of the
 market, trying to assess the risk that manufacturers or
 traders monopolize parts of the API market for essential
 medicines with low commercial attractiveness. The author
 confirms the initial assumption that the API market provides
 a challenge in particular to small manufacturers, who have
 limited means to verify the quality of the APIs they are
 buying. One potential way to address this problem would be
 to broaden the World Health Organization (WHO)
 prequalification system to include APIs for drugs that are
 on the WHO model list for essential medicines.