G20 presidency: fostering global collaboration to accelerate regional manufacturing for diagnostics

It is crucial to build a resilient architecture for both, R&D and manufacturing of diagnostics

The COVID-19 pandemic has highlighted the vulnerability of our world to infectious diseases, and it is inevitable that we will face future outbreaks. As Dr. Tedros, Director-General of the World Health Organisation (WHO), said at the 76th World Health Assembly, “Although COVID-19 may no longer be a global public health emergency, countries must still strengthen the response to the disease and prepare for future pandemics and other threats”. The pandemic also demonstrated the fragility of global supply chains which severely limited the availability of diagnostics in low- and middle-income countries (LMICs). So, as we reflect on the lessons learned from COVID-19, it is crucial to invest in building capacities for the development and manufacturing of diagnostics in LMICs as a key component of our response to the next pandemic.

A critical priority of the G20 agenda under India’s presidency is to create a global mechanism for equitable access to vaccines, drugs, diagnostics, and other essential medical tools. With the Indian presidency of the G20, we have an important opportunity to build on the momentum created by the pandemic towards a future where diagnostics are developed and rolled out where they are needed the most.

Currently, only a handful of companies dominate the manufacturing of diagnostics, including those widely used for COVID-19. These companies are predominantly based in the high-income countries of Asia, North America, or Europe. We know by now that the limited investment in research and development (R&D) and highly centralised production capacity for diagnostic tests present significant challenges, contributing to the scarcity of tests tailored to country-relevant diseases or environmental conditions. For example, of the 20 neglected tropical diseases that primarily affect LMICs, only two have adequate diagnostic tools. Among the 21 rapid diagnostic tests (RDTs) prequalified by the WHO for HIV, only one is stable at high temperatures, a common challenge in many LMICs.

It is crucial to build a resilient architecture for both, R&D and manufacturing of diagnostics. Fostering better geographical distribution of R&D and manufacturing facilities for these products will be essential to mitigate shortages during outbreaks and pandemics. This can only be achieved by building new and strengthening existing national and regional manufacturing facilities which would enable LMICs to independently produce locally relevant diagnostic tools, accelerating their journeys towards universal health coverage. India is already moving ahead in this direction by investing in five existing med-tech parks and 50 new medical clusters as proposed under the National Medical Device Policy 2022. Further, the Government of India has already initiated product-linked incentives to enhance India’s manufacturing capabilities and contribute to product diversification towards high-value goods in the pharmaceutical and medical devices sectors. It is, however, pivotal to remember that investments in strengthening manufacturing need to be accompanied by concomitant R&D efforts to sufficiently meet the demand that arises from health crises.

When the COVID-19 pandemic emerged, it led to a breakdown of the global supply chain, leaving many countries without the necessary testing capabilities. India, however, rose to the occasion by fostering domestic production and a network of laboratories to conduct evaluations and accelerate market access, via initiatives like the Centre for Cellular and Molecular Platforms (C-CAMP). National Diagnostics led Catapult (InDx 1.0) which contributed in a big way towards increasing access and affordability of these otherwise expensive tests. Today, National Diagnostics Catapult (InDx 2.0) – a program supported by FIND and other partners — is serving as a model for capacity building in diagnostics as well as R&D in LMIC settings.

The success of such endeavors depends on the cooperation and support of countries, manufacturers, and research institutions worldwide. There is a need to collaboratively nurture an ecosystem of R&D and manufacturing of diagnostics, which will identify, include and strengthen existing regional capacities and facilitate new networks wherever the need exists.

Alongside the second G20 health working group meeting in Goa, 25 diagnostics manufacturers from 13 countries were convened by FIND and Unitaid. Subsequently, a high-level meeting organised by FIND in collaboration with the Department of Pharmaceuticals, Government of India, and Unitaid, further advanced discussions on the creation of a geographically diverse R&D as well as manufacturing network, designed to enhance testing accessibility in LMICs and improve outbreak preparedness.

During these meetings, diagnostics manufacturers explored potential strategies to advocate for stronger regional manufacturing capabilities. Key topics included complementing private investment through G20 funding models, which could be used to build new infrastructure and facilitate the transfer of technology to regional manufacturers. Reducing trade and tariff barriers to streamline the flow of raw materials to produce rapid diagnostic tests were also explored. During the meeting, harmonised pathways across countries with a rapid turnaround to expedite market access were recommended.

To ensure the sustainability of regional manufacturing networks, there must be demand for the tests they produce. Procurement policies implemented by governments and other buyers will need to ensure that home-grown solutions are appropriately prioritised. Further, prioritisation of budgetary allocations from member states to purchase regionally produced goods is critical.

As we move forward into the last leg of India’s G20 presidency, it will be important for countries to consider measures for greater investment in diagnostics via collaborative R&D and manufacturing networks that complement existing efforts and strengthen local capacities to address policy, infrastructure, and human resource-related challenges. India is committed to strengthening local and regional manufacturing capacities as well as sustainable global and regional R&D networks to facilitate better access to diagnostics and underscore the importance of public-private partnership, technology transfer, and knowledge sharing on voluntary and mutually agreed terms, as feasible.

This article is authored by Dr. Sanjay Sarin, Vice President of Access at FIND.

This op-ed was published in ET Edge Insigths, 17.08.2023