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TB diagnostics in India: from importation and imitation to innovation
Organisers of a recent conference on the topic deliberate
on the key takeaways and challenges ahead
The scale up of DOTS in India by the Revised National TB Control Programme
(RNTCP) is a great public health accomplishment, and yet undiagnosed and poorly
managed tuberculosis (TB) continues to fuel the epidemic. Recognising these
challenges, the Government of India has set an ambitious goal of providing universal
access to quality diagnosis and treatment for all TB patients. Innovative tools
and delivery systems in both the public and private sectors are critical for
reaching this goal. In particular, novel and improved diagnostic tests for TB
are urgently needed to control the epidemic that continues to affect more than
nine million people every year. Existing tests are slow, insensitive or expensive
and require highly specialised facilities which are difficult to provide in
resource-poor countries such as India, where TB is rampant.
The current in-vitro diagnostics market, particularly molecular tests, in India
is dominated by imported, expensive products. But India has the potential to
solve its TB problem with "home-grown" solutions. Just as Indian pharma
and biotech companies revolutionised access to high-quality, affordable AIDS
drugs and hepatitis vaccines through generic production, Indian diagnostic companies
could also become the world's hub for high-quality generic diagnostics.
India also has the potential to lead the world in developing new TB products.
The Indian industry has done well with generic products but the transition to
innovation is not an easy one. In fact, easy success with generics has actually
made it harder for Indian industry to innovate. Development of new technologies
will require changes such as progressive policies by the government to increase
funding and partnership opportunities between government, donors, researchers
and the private industry.
A recent conference at St. John´s Research Institute (SJRI) in Bangalore
brought together for the first time over 220 representatives from industry,
government, donors, academia, hospitals, civil society and the media to discuss
what it takes to innovate in TB diagnostics in India and to move from importation
and imitation to innovation. The goal of this conference was to engage these
stakeholders to stimulate interest and investments in TB innovations (conference
proceedings are available at http://www.tbevidence.org/rescentre/presentations/bangalore.htm).
Why organise this conference in India?
There is a lot of buzz about the potential of BRICS countries in the development
of affordable health-care technologies. This is especially exciting for diseases
of poverty, such as TB, that may not be of great interest to rich countries
or to industry, which do not see a market to justify investments. While BRICS
countries have a large TB burden, they also have the technical and economic
resources to invest in solutions and are capable of addressing the funding gap
by infusing more resources into research and development (R&D) for diseases
such as TB.
There is also potential for philanthropic initiatives from high-net-worth individuals
and companies in these growing economies. With over two million new TB cases
every year, India has the highest burden of TB in the world. Despite this large
burden, Indian industry and academics have not developed any new tools (diagnostics,
drugs or vaccines) for TB.
Why has India failed to innovate in TB R&D?
The conference featured several panel discussions comprised of a mix of different
stakeholders that highlighted the challenge of R&D in TB diagnostics from
its different angles and facets. The general challenges that industry representatives
voiced can be summarised as: lack of clear definition of minimum and optimum
target product profiles from either the Revised National TB Control Programme,
users or donors; unclear definition of the size and nature of the TB diagnostics
market in India; lack of clarity on what price points to aim for; limited access
to sample repositories (for test development and validation) and R&D facilities
for TB; poor regulatory mechanisms to evaluate new tests and assure quality;
unclear prequalification process for TB tests by the World Health Organisation;
general difficulties in accessing knowledge, infrastructure and qualified human
resources required for innovation; lack of awareness about funding opportunities;
weak or non-existent collaboration between RNTCP and industry, between industry
and clinicians, industry and academia and general disconnect with the patient
or end user; and a generally non-conducive culture for innovation that reduces
creative confidence within companies.
The government on the other hand, needs to embrace new technologies with increased
budgets for innovative tools, and develop mechanisms to deal with questions
such how and when to phase out older tests and how to incorporate new technologies
into its program. To begin with, the RNTCP should clearly articulate its diagnostic
needs, and publish clearly defined target product profiles that test developers
and industry partners and funders can aim for.
In particular, industry colleagues were keen to learn more about what type of
TB tests need to be developed for various indications (active TB, latent TB,
multidrug-resistant TB (MDR-TB), extrapulmonary disease, point-of-care testing,
etc.) and what the performance benchmarks ought to be for each.
The nature and size of TB diagnostics market was debated at length. A preliminary
analysis by McKinsey and Company suggests that the TB diagnostics market in
India might be in the ballpark of about $100 million, although there is considerable
uncertainty surrounding the estimates from the private sector.
The RNTCP screens over 7.5 million people with suspected active TB every year,
and a similar number is likely to seek care in the private sector. Thus, at
least 15 million persons with suspected TB will need to be tested, and that
should translate into a fairly sizeable market. In addition, diagnostics will
be needed to diagnose extrapulmonary TB, MDR-TB, childhood TB, and latent TB
infection. Repeated testing will also be required for monitoring success of
TB therapy. If a good, point-of-care test were to be developed, it might open
the option of intensive and active case finding at the community level, increasing
the overall number of patients identified. Furthermore, if a new test were to
be developed on a versatile platform that can be used for other diseases, then
this opens new markets beyond TB.
Lastly, since India accounts for a fifth of the global TB burden, there is a
large potential market outside of India. Clearly, a more refined TB market analysis
will be enormously helpful to engage both industry and funders.
Companies, especially those not working in TB, seem to want “mentorship”
or technical advice on TB, and it is not clear who they can approach for such
issues.
When and how should companies engage with the RNTCP for
advice, possible endorsement or evaluation?
As more TB products get developed, it is not clear which agency or organisation
can conduct head-to-head validation studies to identify the best products for
scale-up. More importantly, which agency or organisation should take on a convening
role to pull together key stakeholders that make up the complete value chain
for TB innovations in India? Who can serve as the “honest broker”
to bring stakeholders together (and facilitate “match-making”)? To
address such issues, it was suggested that an Indian TB Diagnostics Task Force
must be formed, comprised of a small group of relevant stakeholders, with clear
objectives and timelines. Such a Task Force would be able to support, fund and
guide diagnostics test developers, academics and industry, liaise with governmental
agencies such as RNTCP and Drug Controller General of India [DCGI], and to test
and validate any new promising technologies, through the network of already
existing research institutions.
The Bangalore conference was clearly a first step to begin a dialogue among
the stakeholders and to support networking among potential partners. A lot more
needs to be done. A major challenge will likely be in continuing the engagement
of various stakeholders.
There is a general lack of collaboration and coordination,
and lack of clarity on what various stakeholders want: Who is the consumer and
what does she/he need? What does industry want and need to innovate in TB? What
are the diagnostic needs of the RNTCP (target product profiles)? How can governmental
agencies (e.g. Department of Biotechnology [DBT], Indian Council of Medical
Research [ICMR], Translational Health Science and Technology Institute [THSTI]
and Council of Scientific and Industrial Research [CSIR]) work together in supporting
TB innovations?
Given the overall lack of industry engagement in TB, even
if a handful of companies and stakeholders make a serious effort at developing
innovative products for TB, that would be a big success.
The conference showed that there is an urgent need to improve and strengthen
all sorts of structures supporting innovation in diagnostics. It also showed
that while technology offers solutions, we cannot focus too narrowly on the
development of new tools while neglecting the need to innovate delivery systems,
partnerships, funding, regulatory and communication mechanisms among all stakeholders.
 Dr
Nora Engel, assistant professor, Global Health, Department of Health, Ethics
and Society, Maastricht University, Netherlands. n.engel@maastrichtuniversity.nl
 Dr John Kenneth,
professor and head, division of infectious diseases, St. Johns Research
Institute, Bangalore. johnkennet@gmail.com
 Dr Madhukar
Pai, professor and TB researcher, McGill University, Montreal, Canada; co-chair
of the Stop TB Partnership's New Diagnostics Working Group (NDWG), and consultant
to the Bill & Melinda Gates Foundation (BMGF). The views expressed in
this article are the author's own and do not necessarily reflect those of
NDWG or BMGF. madhukar.pai@mcgill.ca |
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