Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

Exploratory Study on Active Pharmaceutical Ingredient Manufacturing for Essential Medicines

Active Pharmaceutical Ingredients (API) of good quality are 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 WHO

Prequalification system to include APIs for drugs that are on the WHO Model List for

Essential Medicines.

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