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Standards and Their Role in Pharmaceutical Upgrading in Low- and Middle-Income Countries

Mugwagwa, J   Kale, D   Banda, G  

March 2015

The supply of medicines and other medical products into health delivery systems is intensively regulated and governed by strict product, process, marketing and institutional standards. The regulations and standards cover the lab to bench value chain; research and development, proof of concept, proof of efficacy, followed by authorisation and registration for production, marketing to the public and post production/marketing surveillance, monitoring and recall. It has been argued that the history of standards in pharmaceutical products is traceable to adverse events in patient safety. Notable failures of patient safety were amply demonstrated by the 1950/60s thalidomide disaster, where a morning sickness pill containing thalidomide taken by pregnant mothers resulted in new-borns with severe birth defects. This disaster catalysed stringent drug approval and monitoring processes. This necessitated the passing of the Kefauver-Harris Drug Amendments Act in 1962 which called for proof of safety and efficacy in the approval process that now uses animal testing and clinical trials and can take up to 12 years. This process is followed for new drugs that need to be launched onto the market. The situation is slightly less complex for generic medicines modelled on expired branded drugs, as proof of safety and efficacy would have already been demonstrated. The generic drug producer needs at the minimum to demonstrate the equivalence of the drug for approval, and as such, does not go through rigorous clinical trials taking up to 12 years. The bulk of medicines produced in developing countries to cater to health requirements are mostly generics, which do not have high margins like the branded drugs produced through the blockbuster model.

Government departments, regulatory agencies and industry associations play a key role in the issue of standards. They have instituted procedures and laws that assure quality in Chemistry, Manufacturing and Controls (CMC) for pharmaceuticals, addressing conditions that may be harmful to patient health. There are numerous contentions, however, about the impact of standards on pharmaceutical sector development in particular, and health delivery in general in developing countries. These contentions range from who sets the standards and in whose interests to whether or not enough is being done to purse alternative, easier-to-sustainbutequallyeffective standards for developing countries given their manufacturing capabilities and health system requirements.


This policy brief draws on a pilot study carried out in 2014 in India, Kenya and South Africa by Innogen Institute researchers with funding from the Open University’s Innovation, Knowledge and Development (IKD) Research Centre, to engage with some of the issues above, with the objective of contributing to clearer understandings on ‘what standards are, which standards are mutable and which ones are immutable and whether standards are hindering or promoting innovation, technological capability upgrading and the making of medicines in low and middle income countries’. The pilot study encompassed extensive literature reviews and interviews with up to 30 respondents representing pharmaceutical and biotech industry experts, academia, science policy think tanks and innovation consultants, industry associations, regulators and related others in the study countries.

Our main finding and the key message of this policy brief is that while standards for the pharmaceutical industry are sometimes seen as independent drivers of technological capability upgrading, the reality is far more complex. Standards in pharmaceuticals change over time and are shaped by a complex mix of firms’ innovations, lobbying, procurement politics and market protection. Consequently, standards may both help to ensure safe and efficacious medicines, and also act as an undesirable market entry barrier.

This policy brief and the broader work underpinning it seek not only to draw attention to standards and their effects on health innovation and technological capability upgrading for sustainable pharmaceutical manufacturing in developing countries, but will hopefully contribute to better health delivery and access to medicines options in developing countries.

Standards and Their Role in Pharmaceutical Upgrading in Low- and Middle-Income Countries PDF, 577KB