title: Aid conditionalities, international Good Manufacturing Practice standards and local production rights: a case study of local production in Nepal.
abstract: 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.
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. pbrhlikova@gmail.com.
authors.forename: Petra
authors.initials: P
authors.lastname: Brhlikova
authors.affiliation: School of Social and Political Science, University of Edinburgh, 15a George Square, Edinburgh, EH8 9LD, UK. ian.harper@ed.ac.uk.
authors.forename: Ian
authors.initials: I
authors.lastname: Harper
authors.affiliation: Patan Academy of Health Sciences, Nepal and Central Department of Sociology and Anthropology, Tribhuvan University, Kathmandu, Nepal. madhusudansubedi@gmail.com.
authors.forename: Madhusudan
authors.initials: M
authors.lastname: Subedi
authors.affiliation: Northeastern University, Boston, MA, USA. samitabhattarai@gmail.com.
authors.forename: Samita
authors.initials: S
authors.lastname: Bhattarai
authors.affiliation: Central Department of Sociology/Anthropology, Tribhuvan University, Kathmandu, Nepal. nabinrawal@gmail.com.
authors.forename: Nabin
authors.initials: N
authors.lastname: Rawal
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK. a.pollock@qmul.ac.uk.
authors.forename: Allyson M
authors.initials: AM
authors.lastname: Pollock
mesh_terms: D003132:Commerce; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D007407:Interviews as Topic; D009390:Nepal; D019982:Organizational Case Studies; D055553:Prescription Drugs / Q000600:supply & distribution; D036301:Qualitative Research
chemical_list: D055553:Prescription Drugs