ArticlePLOS global public health2026
Tiered manufacturing of pharmaceuticals as a commercial determinant of health: Implications for medicine quality and equity.
Article in PLOS global public health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Regulatory Convergence in Cell and Gene Therapy: Harmonizing Quality, CMC, and Approval Pathways Across the FDA, EMA, PMDA, and Emerging Markets.Biotech (Basel (Switzerland)) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Tiered manufacturing, the practice of adapting different levels of pharmaceutical production standards to low- and middle-income countries (LMICs) versus high-income countries, has not been investigated as a commercial determinant of health (CDoH), defined by the World Health Organization as a private sector activity affecting public health. This paper examines this practice and its implications for medicine quality, universal health coverage, and global health equity. Guided by the CDoH framework, we conducted semi-structured interviews with 31 mostly India-based experts in pharmaceutical development, manufacturing, procurement, and regulation between May and July 2025. Purposive sampling ensured variation in geography, organizational type, and role. Transcripts were coded deductively using CDoH domains and inductively for emergent themes. Respondents consistently described "tiered manufacturing" - using different production standards by market. Medicines for countries regulated by Stringent Regulatory Authorities (SRA) (now called WHO Listed Authorities (WLA)) adhere to international good manufacturing practices (GMP) through rigorous documentation, stability testing, impurity profiling, and advanced infrastructure. In contrast, products supplied to LMICs are often produced with uncertain GMP compliance, cheaper raw materials, weaker documentation, and less stringent oversight, leading to variable quality and shortened shelf life. Commercial drivers were key determinants. Proposed solutions include improved mechanisms to verify versions of products being received, reliance on WHO prequalification or WLA approvals, procurement conditionality and strengthened local regulatory and manufacturing capacity. Tiered manufacturing was widely perceived as a common practice among respondents. Recognition of this practice as a CDoH is essential to strengthen regulatory reliance and enforcement, procurement leverage, and sustainable capacity-building, ensuring quality medicines for all globally.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.