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Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal

Overview of attention for article published in Globalization and Health, June 2015
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Title
Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal
Published in
Globalization and Health, June 2015
DOI 10.1186/s12992-015-0110-3
Pubmed ID
Authors

Petra Brhlikova, Ian Harper, Madhusudan Subedi, Samita Bhattarai, Nabin Rawal, Allyson M. Pollock

Abstract

Local pharmaceutical production has been endorsed by the WHO as a means of addressing health priorities of developing countries. However, local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. These standards determine production rights for on-patent and off-patent medicines, and guide international procurement of medicines. We reviewed the literature on the impact of Good Manufacturing Practice (GMP) on local production; a gap analysis from the literature review indicated a need for further research. Over sixty interviews were conducted with people involved in the Nepali pharmaceutical production and distribution chain from 2006 to 2009 on the GMP areas of relevance: regulatory capacity, staffing, funding and training, resourcing of GMP, inspectors' interpretation of the rules and compliance. Although Nepal producers have increased their overall share of the domestic market, only the public manufacturer, Royal Drugs, focuses on medicines for public health programmes; private producers engage mainly in brand competition for private markets, not essential medicines. Nepali regulators and producers state that implementation of GMP standards is hindered by low regulatory capacity, insufficient training of staff in the industry, financial constraints and lack of investment for upgrading capital. The transition period to mandatory compliance with WHO GMP rules is lengthy. Less than half of private producers had WHO GMP in 2013. Producers are not directly affected by international harmonisation of standards as they do not export medicines and the Nepali regulator does not enforce the WHO standards strictly. Without an international GMP certificate they cannot tender for donor dependent health programmes. In Nepal, local private manufacturers focus mainly on brand competition for private consumption not essential medicines, the government preferentially procures essential medicines from the only public producer while donor funded programmes rely on international manufacturers compliant with international GMP standards. We also found evidence of private hospitals bypassing national medicines approvals process. Policies in support of local pharmaceutical production in developing countries as a source of essential medicines need to examine carefully how GMP regulations impact on regulators, local industry and production of essential medicines in practice.

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Mendeley readers

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The data shown below were compiled from readership statistics for 80 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 80 100%

Demographic breakdown

Readers by professional status Count As %
Student > Master 17 21%
Researcher 10 13%
Student > Ph. D. Student 9 11%
Student > Bachelor 8 10%
Other 6 8%
Other 13 16%
Unknown 17 21%
Readers by discipline Count As %
Medicine and Dentistry 16 20%
Pharmacology, Toxicology and Pharmaceutical Science 12 15%
Social Sciences 11 14%
Nursing and Health Professions 6 8%
Business, Management and Accounting 4 5%
Other 12 15%
Unknown 19 24%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 23 June 2015.
All research outputs
#18,806,562
of 23,306,612 outputs
Outputs from Globalization and Health
#1,043
of 1,120 outputs
Outputs of similar age
#191,635
of 265,543 outputs
Outputs of similar age from Globalization and Health
#16
of 16 outputs
Altmetric has tracked 23,306,612 research outputs across all sources so far. This one is in the 11th percentile – i.e., 11% of other outputs scored the same or lower than it.
So far Altmetric has tracked 1,120 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 22.1. This one is in the 1st percentile – i.e., 1% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 265,543 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 16th percentile – i.e., 16% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 16 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.