Abstract
BackgroundLocal 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.ResultsAlthough 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.ConclusionsIn 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.
Highlights
The Global strategy and plan for action on public health, innovation and intellectual property adopted by the 61st WHA in 2008 identified local pharmaceutical production as one of the key building blocks required for needs-based essential health research and development addressing health priorities of developing countries [1]
Background to Good Manufacturing Practice (GMP) standards and their international harmonisation According to the WHO, GMP “is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization” [15]
Issues with GMP implementation in Nepal in itself depends on the role of the enforcers and the staff who are employed
Summary
The Global strategy and plan for action on public health, innovation and intellectual property adopted by the 61st WHA in 2008 identified local pharmaceutical production as one of the key building blocks required for needs-based essential health research and development addressing health priorities of developing countries [1]. Local producers of essential medicines must comply with international pharmaceutical standards in order to be eligible to compete in donor tenders. GMP standards and their international harmonisation According to the WHO, GMP “is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorization” [15]. They apply to producers and other parties involved in labelling and packaging pharmaceutical products. The WHO has made clear that the implementation and enforcement of GMP is a matter for individual states and their respective drug regulatory bodies which can specify different sets of requirements
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