WHO Prequalification: The Key to Donor-Funded Tender Procurement
For ARVs, antimalarials, anti-TB medicines and vaccines, WHO Prequalification status is close to a prerequisite for reaching the largest institutional buyers.
WHO Prequalification (WHO PQ) is a rigorous World Health Organization assessment confirming that a specific product from a specific manufacturing site meets international quality, safety and efficacy standards. It is manufacturer- and product-specific — a company can hold WHO PQ for one product line and not another.
Why it matters commercially
Global Fund, PEPFAR, UNICEF and Gavi — the dominant buyers of ARVs, antimalarials, anti-TB medicines and vaccines for low- and middle-income countries — effectively require WHO PQ status to participate in their procurement. For categories like antiretrovirals, where India supplies the majority of medicines used in these countries, PQ status plus a competitive per-patient-year price is close to the entire basis of competition.
What buyers should ask
- Which specific product and manufacturing site holds current WHO PQ status
- Whether that status covers the exact strength and presentation being quoted
- Expected reorder cadence and tender cycle for the relevant procurement programme