Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture
Bibliographic record
Abstract
Background: Some medicines for sale in developing countries are approved by a stringent regulatory authority (SRA) or the World Health Organization (WHO) prequalification program; many of these are global brands. This study ascertains whether medicines approved by SRAs or the WHO perform better in simple quality tests than those that have not been approved by either. Methods: Over the past 4 years, 2652 essential drugs (products to treat malaria, tuberculosis, and bacterial infections) were procured by covert shoppers from eleven African cities and eight cities in a variety of mid-income nations. All samples were assessed using the Global Pharma Health Fund eV Minilab ® protocol to identify whether they were substandard, degraded, or counterfeit. Results: The failure rate among SRA-approved products was 1.01%, among WHO-approved products was 6.80%, and 13.01% among products that were not approved by either. African cities had a greater proportion of SRA- or WHO-approved products (31.50%) than Indian cities (26.57%), but they also experienced a higher failure rate (14.21%) than Indian cities (7.83%). The remainder of cities tested had both the highest proportion of approved products at 34.46% and the lowest failure rate at 2.70%. Products made in Africa had the highest failure rate at 25.77%, followed by Chinese products at 15.74%, Indian products at 3.70%, and European/US products, which failed least often, at 1.70%. Most worrying is that 17.65% of Chinese products approved by the WHO failed. Conclusion: The results strongly indicate that approval by either an SRA or the WHO is correlated with higher medicine quality at a statistically significant level. The comparatively high failure rates among WHO-approved products suggest there may be some weakness in post-marketing surveillance of these products, especially of Chinese-made WHO-approved products. The discrepancy between the failure rate of WHO-approved products from India (2.39%) and China (17.65%) is cause for concern. It is possible that more of the failures originating in China are counterfeit products, but this cannot be ascertained without greater help from the manufacturers themselves. Keywords: stringent regulatory authority, World Health Organization prequalification program, product approval, counterfeit, India, China
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".