Skip to main content
SpringerLink
Log in

New diagnostics for multi-drug resistant tuberculosis in India: Innovating control and controlling innovation

  • Original Article
  • Published:
BioSocieties Aims and scope Submit manuscript

Abstract

Among the challenges for tuberculosis control is the emergence of multi-drug resistance, which has led to the search for new diagnostic solutions worldwide. The focus of this article is the interplay between innovation of diagnostics for multi-drug resistant tuberculosis in India and control through standardization of operational and technical processes. Innovation in diagnostics is closely related to processes of standardization. As a form of social ordering, standardization not only controls patients, bacteria, artefacts, health-care staff and medical providers, but also the diagnostic process as such. On the basis of qualitative fieldwork, I analyse the innovative efforts of a demonstration project for a new test by an international NGO and the development of tests by smaller players. The main argument is that a balance is needed between the extremes of controlling the diagnostic process through standardization in such a way that it becomes exclusive for particular local settings or expertise, and innovating a diagnostic test without standardizing operational processes, which is not programmatically feasible. These negotiations between innovation and control can be found in situated assessments, yet require flexibility in standardization.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  1. TB is an infectious disease that in its most common form affects mainly the lungs (pulmonary TB). The disease is in principle curable with a 6–8 month treatment, partly with antibiotics, provided by public sector programmes free of charge.

  2. MDR-TB is defined as resistance to at least rifampicin and isoniazid, two of the most important standard anti-TB drugs. XDR-TB is MDR-TB that is resistant to three or more of the six classes of second-line drugs (WHO, 2008). Multi-drug resistance develops due to infection with a resistant strain or because of poor treatment with inadequate drugs or irregular drug intake (CTD, 2007a).

  3. The DOTS strategy (directly observed treatment, short course) consists of five elements: government commitment, case detection by sputum microscopy, standardized treatment regimens of 6–8 months with direct observation (DOT) for at least the initial 2 months, regular supply of anti-TB drugs and a standardized recording and reporting system (WHO, 2010). Patients are directly observed while swallowing their drugs to ensure adherence.

  4. Technology in TB control, broadly conceived, includes all artefacts, knowledge and practices related to the health-care process of coping with TB (Bijker, 2009). Technology for TB control can include transportation, communication, power, guidelines and the TB programme itself.

  5. While TB is a social as much as a biomedical problem, the main focus of the Indian TB programme is on the drugs and adherence to the treatment. Critics argue that despite the fact that direct observation was promoted to overcome treatment default or non-adherence, it ignores the obstacles that mainly the poor face when accessing health services (such as life circumstances and social class barriers) (Narayan, 1998).

  6. Depending on the biosafety and training requirements of future tests, these could be used at the point of treatment. Currently, MDR-TB testing is planned to take place in regional reference laboratories, as tests still require high levels of skills and biosafety (WHO, 2010).

  7. Interviews are numbered if more than one person with the same function was interviewed at the same location.

  8. At the point of my fieldwork, in 2008/2009, four laboratories had been officially accredited for MDR-TB testing. By 2011, 27 laboratories are operational, among them eight private/NGO laboratories, and efforts are underway to increase the number to 43 (Bhargava et al, 2011).

  9. The Global Fund to Fight AIDS, Tuberculosis and Malaria is a global health partnership created in 2001 to dramatically increase resources to fight three of the world's most devastating diseases. It funds public–private partnerships with a strong emphasis on civil society participation. This push is tied to substantial funding, which is mostly related to performance and specific evaluation indicators (GFATM, 2009).

  10. Different actors involved in diagnostic R&D are uncoordinated and there is hardly any coordinated translation of research into applicable products (interview: microbiologist medical college, Delhi, 21 January 2009). This situation is often related to a lack of assigned funds to TB (interview: director research centre, Mumbai, 19 December 2008). In conversations with officials at the Central TB Division and throughout state and district TB offices, I also got the impression that research into new technologies is regarded as an issue that is dealt with at the international level. My questions about the role of research for TB control were almost always shrugged off by programme officers as being something separate, beyond their reach, concern or interest and uncoupled from the efforts of the TB programme.

  11. FIND is a non-profit foundation that was founded in 2003 with funds from the Bill & Melinda Gates Foundation, the European Union and the Government of the Netherlands. The aim of FIND is to foster the development of new diagnostics for selected poverty related diseases (TB and MDR-TB among others) in contractual partnerships with industry and academics, national governments and the WHO (Perkins, 2000).

  12. The WHO RNTCP consultant is part of a network of young, well-educated, committed Indians that the WHO India established in the early years of the RNTCP to support the functioning of the programme in the field across the country (interview: physician RNTCP – 2, Ahmedabad, 2 December 2008) and also to provide feedback to the Central TB Division.

  13. UNITAID is an international facility for the purchase of drugs against HIV/AIDS, Malaria and TB through innovative development financing mechanisms by leveraging price reductions for quality diagnostics and medicines and accelerating the pace at which these are made available.

  14. The microscopic observation drug susceptibility (MODS) test offers a simplified and cheap way of a liquid-based culture test to diagnose TB and MDR-TB (Moore et al, 2006). PATH India, the India office of an international non-profit organization, established in 1978 with a grant from the Ford Foundation to design health technologies for low-resource settings, benefits from several advantages in comparison to local NGOs or medical colleges: an international status, connections to the highest decision-makers and the fact that the test already exists in a similar form in other low-resource countries.

  15. Similar is the consideration of indigenous and local knowledge without which technology transfer is likely to fail. The role of local factors is increasingly being recognized in the literature on technological innovation (Lall, 1992; Romijn, 1997; INNOGRIPS, 2007; Soete, 2008). The emphasis on local, rather lengthy learning processes and the need to localize technology is important. Yet, the recognition to solve problems of acceptance of new technologies is insufficient.

  16. The exclusion of patients from innovation processes is not unique to the RNTCP or to India (Garcia-Goni, 2008).

References

  • Agarwal, S.P., Sehgal, S. and Lal, S.S. (2005) Public-private mix in the Revised National TB Control Programme. In: S.P. Agarwal and L.S. Chauhan (eds.) Tuberculosis Control in India. New Delhi, India: Directorate General of Health Services, Ministry of Health and Family Welfare; Elsevier, pp. 135–144.

    Google Scholar 

  • Benatar, S.R. (2003) Global poverty and tuberculosis: Implications for ethics and human rights. In: M. Gandy and A. Zumla (eds.) The Return of the White Plague: Global Poverty and the ‘New’ Tuberculosis. London, New York: Verso, pp. 222–235.

    Google Scholar 

  • Bhargava, A., Pinto, L. and Pai, M. (2011) Mismanagement of tuberculosis in India: Causes, consequences, and the way forward. Hypothesis 9 (1): 1–13.

    Article  Google Scholar 

  • Bijker, W.E. (1995) Of Bicycles, Bakelites, and Bulbs: Toward a Theory of Sociotechnical Change. London, Cambridge, MA: MIT Press.

    Google Scholar 

  • Bijker, W.E. (2009) How is technology made? That is the question! Cambridge Journal of Economics 34 (1): 63–76.

    Article  Google Scholar 

  • Bijker, W.E., Bal, R. and Hendriks, R. (2009) The Paradox of Scientific Authority: The Role of Scientific Advice in Democracies. London, Cambridge, MA: MIT Press.

    Book  Google Scholar 

  • Bowker, G. and Star, S.L. (1999) Sorting Things Out. Classification and Its Consequences. Cambridge, MA: MIT Press.

    Google Scholar 

  • Busch, L. (2011) Standards: Recipes for Reality (Infrastructures). Cambridge, MA: MIT Press.

    Google Scholar 

  • Buse, K. and Harmer, A.M. (2007) Seven habits of highly effective global public–private health partnerships: Practice and potential. Social Science & Medicine 6 (2): 259–271.

    Article  Google Scholar 

  • Buse, K. and Walt, G. (2000) Global public-private partnerships: Part I – A new development in health? Bulletin of the World Health Organization 78 (4): 549–561, http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0042-96862000000400019&nrm=iso, accessed 15 June 2007.

    Google Scholar 

  • Caws, M. and Drobniewski, F.A. (2001) Molecular techniques in the diagnosis of mycobacterium tuberculosis and the detection of drug resistance. Annals of the New York Academy of Science 953b (1): 138–145.

    Article  Google Scholar 

  • Chaturvedi, K., Chataway, J. and Wield, D. (2007) Policy, markets and knowledge: Strategic synergies in Indian pharmaceutical firms. Technology Analysis & Strategic Management 19 (5): 565–588.

    Article  Google Scholar 

  • Consoli, D., McMeekin, A., Ramlogan, R., Mina, A., Tampubolon, G. and Metcalfe, J.S. (2005) Progress in medicine: The structure and evolution of know-how for the treatment of glaucomea. CRIC Discussion Paper, 72, http://www.esrc.ac.uk/my-esrc/grants/L218252056/outputs/WorkingPaper/read/a24b6f13-e266-4705-8d8f-ee21483b8162, accessed 17 April 2007.

  • Costa, A.D., Johansson, E. and Diwan, V.K. (2008) Barriers of mistrust: Public and private health sectors’ perceptions of each other in Madhya Pradesh, India. Qualitative Health Research 18 (6): 756–766.

    Article  Google Scholar 

  • Crane, J.T. (2011) Viral cartographies: Mapping the molecular politics of global HIV. BioSocieties 6 (2): 142–166.

    Article  Google Scholar 

  • CTD. (2007a) Multi-drug resistant and extensively drug resistant TB in India. Consensus statement on the problem, prevention, management and control. From the consultative meeting of national experts organized by the TB Research Centre, ICMR, Government of India, on 14–15 September 2007. Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, India, http://tbcindia.org, accessed 20 August 2009.

  • CTD. (2007b) TB in India: RNTCP Status Report. Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, India, http://tbcindia.org, accessed 27 March 2008.

  • CTD. (2009a) Manual of Standard Operating Procedures (SOPs). Culture of Mycobacterium tuberculosis and drug susceptibility testing on solid medium. Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, India, http://www.tbcindia.org, accessed 9 February 2010.

  • CTD. (2009b) TB India: RNTCP Status Report. Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, India, http://tbcindia.org, accessed 4 May 2010.

  • CTD. (2010) RNTCP DOTS Plus guidelines. Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, India, http://tbcindia.org, accessed 10 August 2010.

  • Cunningham, P. (2005) Innovation in the Public Health Sector: A Case-study Analysis. Oslo, Norway: NIFU STEP.

    Google Scholar 

  • den Hertog, F., Groen, M. and Weehuizen, R. (2005) Mapping healthcare innovations: Tracing walls and ceilings. MERIT Research Memorandum Series, 007, http://arno.unimaas.nl/show.cgi?fid=3132, accessed 17 April 2007.

  • Enarson, D. and Billo, N. (2007) Critical evaluation of the global DOTS expansion plan. Bulletin of the World Health Organization 85 (5): 395–398.

    Article  Google Scholar 

  • Farmer, P. (1997) Social scientists and the new tuberculosis. Social Science & Medicine 44 (3): 347–358.

    Article  Google Scholar 

  • Farmer, P. (2001) DOTS and DOTS-plus: Not the only answer. Annals of the New York Academy of Science 953b (1): 165–184.

    Article  Google Scholar 

  • Farmer, P. (2003) Pathologies of Power: Health, Human Rights and the New War on the Poor. London, Berkeley, CA: University of California Press.

    Google Scholar 

  • Farmer, P. and Kim, J.Y. (1998) Community based approaches to the control of multidrug resistant tuberculosis: Introducing ‘DOTSplus’. British Medical Journal 317 (5): 671–674.

    Article  Google Scholar 

  • FIND. (2007) Collaboration between FIND and India's central TB division, http://www.finddiagnostics.org/media/news/071001_2.html, accessed 4 February 2009.

  • Gandhi, N.R. et al (2006) Extensively drug-resistant tuberculosis as a cause of death in patients co-infected with tuberculosis and HIV in a rural area of South Africa. The Lancet 368 (9547): 1575–1580.

    Article  Google Scholar 

  • Gandy, M. and Zumla, A. (eds.) (2003) The Return of the White Plague: Global Poverty and the ‘New’ Tuberculosis. London, New York: Verso.

    Google Scholar 

  • Garcia-Goni, M. (2008) The adoption and diffusion of technological and organizational innovations in a Spanish hospital. Innovation in Public Sector Services: Entrepreneurship, Creativity and Management. Cheltenham, UK; Northampton, MA: Edward Elgar, pp. 89–117.

    Google Scholar 

  • GFATM. (2009) Proposal Form – Round 9 (Single Country Applicants). Geneva: GFATM, The Global Fund to Fight AIDS, Tuberculosis and Malaria.

  • Guillerm, M., Usdin, M. and Arkinstall, J. (2006) Tuberculosis Diagnosis and Drug Sensitivity Testing. An Overview of the Current Diagnostic Pipeline. Geneva: Medicins Sans Frontieres, MSF.

    Google Scholar 

  • Hanseth, O., Monteiro, E. and Hatling, M. (1996) Developing information infrastructure: The tension between standardization and flexibility. Science, Technology & Human Values 21 (4): 407–426.

    Article  Google Scholar 

  • Hanseth, O., Thoresen, K. and Winner, L. (1994) The politics of networking technology in health care. Computer Supported Cooperative Work (CSCW) 2 (1): 109–130.

    Google Scholar 

  • IAVI. (2007) Accelerating AIDS Vaccine R&D in India: An Assessment of Obstacles and Possible Solutions. Policy Research Working Paper IAVI Public Policy Department and IAVI-India, 11, http://www.iavi.org/Accelerating_India_Research, accessed 28 April 2008.

  • ICMR. (2004) Health research policy. ICMR Bulletin 34 (9–10): 51–59.

  • INNOGRIPS. (2007) Innovation and the Fight against Poverty, Hunger and Disease, Innovation Policy Workshop #1. Rabat, Morocco: INNO-GRIPS.

  • Joshi, A. and Moore, M. (2004) Institutionalized co-production: Unorthodox public service delivery in challenging environments. Journal of Development Studies 40 (4): 31–49.

    Article  Google Scholar 

  • Kale, D. and Little, S. (2007) From imitation to innovation: The evolution of R&D capabilities and learning processes in the Indian pharmaceutical industry. Technology Analysis & Strategic Management 19 (5): 589–609.

    Article  Google Scholar 

  • Kim, J.Y., Mukherjee, J.S., Rich, M.L., Mate, K., Bayona, J. and Becerra, M.C. (2003) From multidrug-resistant tuberculosis to DOTS expansion and beyond: Making the most of a paradigm shift. Tuberculosis 83 (1–3): 59–65.

    Article  Google Scholar 

  • Lall, S. (1992) Technological capabilities and industrialization. World Development 20 (2): 165–186.

    Article  Google Scholar 

  • Lampland, M. and Star, S.L. (eds.) (2009) Standards and Their Stories: How Quantifying, Classifying, and Formalizing Practices Shape Everyday Life. Ithaca, NY: Cornell University Press.

    Google Scholar 

  • Latour, B. (1983) Give me a laboratory and I will raise the world. In: K.D. Knorr-Cetina and M. Mulkay (eds.) Science Observed. London: Sage Publications, pp. 141–170.

    Google Scholar 

  • Latour, B. (1987) Science in Action: How to Follow Scientists and Engineers through Society. Cambridge, MA: Harvard University Press.

    Google Scholar 

  • Migliori, G.B., Matteelli, A., Cirillo, D. and Pai, M. (2008) Diagnosis of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis: Current standards and challenges. Canadian Journal of Infectious Diseases & Medical Microbiology 19 (2): 169–172.

    Article  Google Scholar 

  • Moore, D.A.J. et al. (2006) Microscopic-observation drug-susceptibility assay for the diagnosis of TB. New England Journal of Medicine 355 (15): 1539–1550.

    Article  Google Scholar 

  • Moore-Gillon, J. (2001) Multidrug-resistant tuberculosis: This is the cost. Annals of the New York Academy of Science 953b (1): 233–240.

    Article  Google Scholar 

  • Narayan, T. (1998) A study of policy process and implementation of the national tuberculosis control programme in India. Doctoral dissertation, London University, London.

  • Narayan, T. (1999) A violation of citizens’ rights: The health sector and tuberculosis. One's understanding of the problem of tuberculosis affects the choice of intervention strategies. Indian Journal of Medical Ethics 7 (3).

  • Narayanan, P.R., Garg, R., Santha, T. and Kumaran, P. (2003) Shifting the focus of tuberculosis research in India. Tuberculosis 83 (1–3): 135–142.

    Article  Google Scholar 

  • Ogden, J. (1999) Compliance versus adherence: Just a matter of language? The politics and poetics of public health. In: J.M. Grange and J. Porter (eds.) Tuberculosis: An Interdisciplinary Perspective. London: Imperial College Press, pp. 213–234.

    Chapter  Google Scholar 

  • Pai, M. (2011) Tuberculosis control in India: Time to get dangerously ambitious? The National Medical Journal of India 24 (2): 65–68.

    Google Scholar 

  • Paramasivan, C.N. and Venkataraman, P. (2004) Drug resistance in tuberculosis in India. Indian Journal of Medical Research 120 (4): 377–386.

    Google Scholar 

  • Pasveer, B. (1989) Knowledge of shadows: The introduction of X-ray images in medicine. Sociology of Health & Illness 11 (4): 360–381.

    Article  Google Scholar 

  • Paxson, H. (2008) Post-Pasteurian cultures: The microbiopolitics of raw-milk cheese in the United States. Cultural Anthropology 23 (1): 15–47.

    Article  Google Scholar 

  • Perkins, M.D. (2000) New diagnostic tools for tuberculosis. International Journal of Tuberculosis and Lung Diseases 4 (2): 182–188.

    Google Scholar 

  • Perkins, M.D., Roscigno, G. and Zumla, A. (2006) Progress towards improved tuberculosis diagnostics for developing countries. The Lancet 367 (9514): 942–943.

    Article  Google Scholar 

  • Porter, J.D.H. and Ogden, J. (1999) Public health, ethics and tuberculosis: Is DOTS a breakthrough or inappropriate strategy in the Indian context? Issues Medical Ethics 7 (3): 79–84.

    Google Scholar 

  • Pronyk, P. and Porter, J. (1999) Public health and human rights: The ethics of international public health interventions for tuberculosis. In: J.M. Grange and J. Porter (eds.) Tuberculosis: An Interdisciplinary Perspective. London: Imperial College Press, pp. 99–120.

    Chapter  Google Scholar 

  • Ravishankar, N. et al (2009) Financing of global health: Tracking development assistance for health from 1990 to 2007. The Lancet 373 (9681): 2113–2124.

    Article  Google Scholar 

  • Romijn, H. (1997) Acquisition of technological capability in development: A quantitative case study of Pakistan's capital goods sector. World Development 25 (3): 359–311.

    Article  Google Scholar 

  • Sharma, S.K. and Mohan, A. (2004) Multidrug-resistant tuberculosis. Indian Journal of Medical Research [NLM – MEDLINE] 120 (4): 354–376.

    Google Scholar 

  • Soete, L. (2008) Science, Technology and Development: Emerging Concepts and Visions. UNU-Merit Working Paper Series 2008-001.

  • Specter, M. (2010) A deadly misdiagnosis: Is it possible to save the millions of people who die from TB? The New Yorker Magazine 15 November.

  • Star, S.L. and Bowker, G.J. (1996) Of lungs and lungers: The classified story of tuberculosis, http://epl.scu.edu/~gbowker/tb.html, accessed 27 August 2009.

  • Stop TB Department. (2005) Stop TB Working Group on DOTSplus for MDR-TB: Strategic Plan for 2006–2015. Geneva: Stop TB Department.

  • Stop TB Department. (2006) The Stop TB Strategy: Building on and Enhancing DOTS to Meet the TB-related Millennium Development Goals. Geneva: Stop TB Department.

  • Timmermans, S. and Berg, M. (2003) The Gold Standard. The Challenge of Evidence-based Medicine and Standardization in Health Care. Philadelphia, PA: Temple University Press.

    Google Scholar 

  • Udwadia, Z.F. (2008) XDR-TB in India: When will we heed the alarm? Journal of the Association of Physicians of India 56 (6): 409–410.

    Google Scholar 

  • Udwadia, Z.F., Pinto, L.M. and Uplekar, M.W. (2010) Tuberculosis management by private practitioners in Mumbai, India: Has anything changed in two decades? PLoS ONE 5 (8): e12023.

    Article  Google Scholar 

  • Uplekar, M., Pathania, V. and Raviglione, M.C. (2001) Private practitioners and public health: Weak links in tuberculosis control. The Lancet 358 (9285): 912–916.

    Article  Google Scholar 

  • Uplekar, M. and Shepard, D.S. (1991) Treatment of tuberculosis by private general practitioners in India. Tubercle 72 (4): 284–290.

    Article  Google Scholar 

  • WHO. (2008) Anti-Tuberculosis Drug Resistance in the World. Geneva: WHO. Report No. 4.

  • WHO. (2010) WHO endorses new rapid tuberculosis test. 8 December 2010, http://www.who.int/tb/features_archive/new_rapid_test/en/index.html, accessed 10 January 2011.

  • Windrum, P. and Koch, P. (eds.) (2008) Innovation in Public Sector Services: Entrepreneurship, Creativity and Management. Cheltenham, UK; Northampton, MA: Edward Elgar.

    Book  Google Scholar 

  • Wyatt, S. (2007) Technological determinism is dead: Long live technological determinism. In: E.J. Hackett, O. Amsterdamska, M. Lynch and J. Wajcman (eds.) The Handbook of Science and Technology Studies, 3rd edn. Cambridge, MA: MIT Press, pp. 165–179.

    Google Scholar 

  • Zuiderent-Jerak, T. (2007) Preventing implementation: Exploring interventions with standardization in healthcare. Science as Culture 16 (3): 311–329.

    Article  Google Scholar 

  • Zuiderent-Jerak, T. (2009) Embodied interventions – Interventions on bodies: Experiments in practices of science and technology studies and hemophilia care. 0162243909337119, http://sth.sagepub.com/cgi/content/abstract/0162243909337119v1 doi:10.1177/0162243909337119, accessed 26 June 2009.

Download references

Acknowledgements

This article benefitted from feedback by three anonymous reviewers, as well as feedback on an earlier and extended version by the participants of a workshop of the Netherlands Graduate School of Science, Technology and Modern Culture (WTMC), namely Jessica Messman, Sally Wyatt and Sonja Jerak-Zuiderent. I also thank all my informants who offered their time and provided me with insights into their thoughts and daily practices. I also thank UNU-Merit for funding the fieldwork and appreciate the administrative support of the Link Secretariat at CRISP in Hyderabad, India.

Author information

Authors and Affiliations

  1. Department of Health, Ethics and Society, Faculty of Health, Medicine and Life Sciences, Maastricht University, PO Box 616, NL – 6200 MD, Maastricht, The Netherlands

    Nora Engel

Authors
  1. Nora Engel
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Engel, N. New diagnostics for multi-drug resistant tuberculosis in India: Innovating control and controlling innovation. BioSocieties 7, 50–71 (2012). https://doi.org/10.1057/biosoc.2011.23

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1057/biosoc.2011.23

Keywords

Search

Navigation