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In-vitro diagnostics (IVDs) innovations for resource-poor settings: The Indian experience

This article illustrates how the present institutional arrangements and the policy regime under perusal have not been able to support the development of an ecosystem for innovation-making for in-vitro diagnostics (IVDs) for resource-poor settings. Policies favouring trade liberalization and foreign direct investment, market deregulation, strong intellectual property rights, absence of stringent regulations of accreditation and quality control and limiting public R&D support to basic research and development of scientific and technical manpower have defined the dynamics of innovation-making for the IVDs in India since the year 2000. Investment in the IVDs for the management of priority diseases for resource-poor settings continues to be only a small fraction of the R&D investment, translational research and market formation in India. Seventy-five per cent of diagnostics needs are still met through imported and maladapted diagnostic innovations. Although with the help of public-funded policy initiatives undertaken by the government there are now some young start-ups that have emerged and are beginning to focus on some of the diagnostic needs and challenges facing resource-poor settings, but they have not been able to enter the market with fully developed products in any kind of significant way. Low levels of interest in innovation, making for resource-poor settings, is reflected in the system-building activities of public sector R&D institutions, industry and the healthcare system. Lack of collaboration between national R&D institutions and large domestic firms continues to be the defining feature of the national innovation system in the case of IVDs. Innovation-making for resource-poor settings is yet to become a priority for the challenge-based innovation system-building approach. Analysis confirms the impact of convergence of neo-liberal deregulation, trade liberalization and investment liberalization on the processes of fragmentation and underdevelopment of capabilities, preference for market calculations over social calculations and undervaluation of the needs of resource-poor settings. Since the relevant actors have been bidding a good-bye to the values of universality, equality and comprehensiveness, the neglect of non-market based social calculations is reflected in the innovation-making practice of R&D institutions and industry. The article suggests that the challenge of innovation-making for resource-poor settings cannot be tackled without shifting away from the path of deregulation, liberalization of trade and investment, and moving into the implementation of a challenge-based innovation system-building approach by the state, in the case of IVDs.