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.

This policy brief considers the role and potential of biopharmaceutical industry associations in building capacities for health innovation in India. Empirical evidence from the project indicates that biopharmaceutical associations and related umbrella organisations play a critical role in informing government on regulation and standards, having forged an uneven yet productive relationship with government that has contributed to a robust and dynamic Indian biopharmaceutical industry. However, further developing India’s biopharmaceutical industry in a way that both builds its globally competitive innovation capacities while effectively addressing its local healthcare needs will require greater trust and transparency and more complimentary relations between industry and government and civil society.

 

The increased importance of biopharmaceutical industry associations in influencing innovative economic performance in developing countries requires new thinking and policy regarding the institutions which diffuse and govern knowledge in emerging contexts of economic and political pluralism. Based on a Leverhulme Trust funded research project, this policy brief considers the role of biopharmaceutical industry associations in building capacities for health innovation in South Africa. Empirical evidence from the project shows that biopharmaceutical industry associations in South Africa play an important role in shaping regulatory environments for medical technologies and therefore have the potential to contribute towards developing governance capacities for health innovation.

Ungovernable? Biotech and its xerophytic challenges

Julius Mugwagwa, reflects on status of pharmaceutical industry in Africa based on his recent visit to South Africa and Zimbabwe. 

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