© 2015 Brhlikova et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://
creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.This work was supported by the Economic and Social Research Council and
the Department for International Development [RES-167-25-0110] through
the collaborative research project
Tracing Pharmaceuticals in South Asia
(2006
–
2009). In addition to the authors of this paper, the project team
included: Soumita Basu, Gitanjali Priti Bhatia, Erin Court, Abhijit Das, Stefan
Ecks, Patricia Jeffery, Roger Jeffery, Rachel Manners, and Liz Richardson.
Martin Chautari (Kathmandu) and the Centre for Health and Social Justice
(New Delhi) provided resources drawn upon in writing this paper but are
not responsible for the views expressed, nor are ESRC or DFID.
Ethical review was provided by the School of Social and Political Science at
the University of Edinburgh, and ethical approval in Nepal for the study
granted by the Nepal Health Research Council (NHRC)

A Abdo-Rabbo

AH Meshkini

Allyson M. Pollock

B Shakya

B Shrestha

DA Grimes

E Toledo

ES Pinheiro

H Dixit

HSSP

I Harper

Ian Harper

J Abraham

J-M Guimier

K Losse

K Morimoto

K Timmermans

M Santhosh

Madhusudan Subedi

Nabin Rawal

P Brhlikova

P Trouiller

PEPFAR

Petra Brhlikova

PG Mujinja

S Budhathoki

S Chaudhuri

S Hill

S Palaian

Samita Bhattarai

SAWTEE

Thapa

UNCTAD

UNIDO

W Kaplan

WA Kaplan

WHO WHO

Globalization and Health

English

PubMed

Background: 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. Results: 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. Conclusions: 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.</p

Brhlikova, Petra

Harper, Ian

Subedi, Madhusudan

Bhattarai, Samita

Rawal, Nabin

Pollock, Allyson M.

Edinburgh Research Explorer

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

Brhlikova, P

Harper, I

Subedi, M

Bhattarai, S

Rawal, N

Pollock, AM

Queen Mary Research Online

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

Crossref

BACKGROUND: 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. RESULTS: 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. CONCLUSIONS: 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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Aid conditionalities, international Good Manufacturing Practice standards and local production rights: A case study of local production in Nepal

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

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