By Mark Kessel & Dr CN Paramasivan
Diagnostics are key to identifying illnesses and providing patients with the most appropriate treatment option. But the right diagnostic test is often unavailable or remains unaffordable, is overlooked, or simply does not exist. As well as directly impacting patients, this has dire public health consequences as diagnostics are vital for early disease detection and monitoring, in preventing the spread of disease, curbing antimicrobial resistance, and also enabling enhanced surveillance. Having the right diagnostics in place generates huge savings across healthcare systems, while providing improved healthcare.
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Universal Health Coverage in India
Universal health coverage (UHC) has re-emerged as a top priority for the WHO and is an essential element of the Sustainable Development Goals (SDGs) adopted in 2015. However, despite progress at the country level, no major report or statement explicitly acknowledges the need for including essential diagnostics within the UHC framework. This is problematic, as when diagnostics are not acknowledged as an essential component of the healthcare system, they get little attention, budget, and support for implementation. Diagnostic innovation also suffers.
India leads world production of generic medicines and vaccines. Private enterprise and governmental stewardship have helped build the colossus that the country’s pharmaceutical sector is today. A top five contributor to Indian exports, the sector grew 11% to 19.2 billion USD in the last year alone. Generic medicines accounted for 75% of revenues, with India serving as a source of affordable drugs for low- and middle-income countries (LMICs). Indian production of generic hepatitis C (HCV) treatment is a good example, as it provides affordable drugs to LMICs, while also critically reducing healthcare costs to manage the domestic HCV epidemic.
In vaccines, due to early investment in the National Immunization Programme, India not only achieved self-sufficiency but is estimated to manufacture ~50% of vaccines globally and has become a leading exporter.
These efforts have positioned India firmly at the centre of global health. Despite this, the country has not followed the same upward curve when it comes to innovation in diagnostics research and development. Today – even though India was the first country to adopt a national Essential Diagnostics List (EDL) – the vast majority of medical devices and diagnostics are imported. As of 2015, more than 75% of medical devices and diagnostics in the Indian market were imported, with local manufacturing largely covering “low cost, low innovation” products.
This is all the more surprising given the tremendous opportunity diagnostics represents, with a growth rate of 27.5% – faster than other parts of the health sector – and a domestic market expected to reach 13 billion USD by 2021. Further, diagnostic development time is about one third of that required for drug and vaccine development.
Biomedical Innovation in India: Prospects and Challenges
Biomedical innovation requires scientists, engineers, and managers with the right mix of skills; publicly supported research with strong links to industry; financing for product development; access to technology; rigorous but supportive regulation; functioning infrastructure; and, of course, markets for products. The Government of India has set up the Biotechnology Industry Research Assistance Council (BIRAC) to specifically strengthen India’s value chain in healthcare products and spur local research and development, and these elements are in place in India to varying degrees. But important gaps to meeting the Indian economy’s needs remain. Devising, carrying out and managing biomedical R&D in India is the next frontier– and there is scope to design and develop diagnostic solutions in India to meet demand in India and beyond.
Smart, forward-looking public policy has helped to create a strong, multi-billion dollar Indian pharmaceutical industry. We cannot afford to drop the torch. The time is ripe for India to transform from a low-cost contract research and reverse engineering centre to a global centre of high-value, locally generated innovation and manufacturing.
Diagnostics innovation is key to affordable healthcare and central to the UHC agenda that India is trying to achieve through its Ayushman Bharat programme. With the right framework conditions and support through initiatives such as “Make in India” alongside the introduction of the Indian EDL, Indian diagnostic R&D is poised to be the next success story, one that builds on past achievements and strengthens the country’s position as a leading provider of healthcare solutions, to the benefit of our fellow citizens and the global community.
[The columnists are Chairman of the Board, Foundation for Innovative New Diagnostics (FIND) and Director, FIND India respectively. Views expressed are their own.]