What Can We Learn About the Processes of Regulation of Tuberculosis Medicines From the Experiences of Health Policy and System Actors in India, Tanzania, and Zambia?

Document Type : Original Article


1 Public Health Foundation of India, Gurgaon, India

2 Global TB Programme, World Health Organization, Geneva, Switzerland


The unregulated availability and irrational use of tuberculosis (TB) medicines is a major issue of public health concern globally. Governments of many low- and middle-income countries (LMICs) have committed to regulating the quality and availability of TB medicines, but with variable success. Regulation of TB medicines remains an intractable challenge in many settings, but the reasons for this are poorly understood. The objective of this paper is to elaborate processes of regulation of quality and availability of TB medicines in three LMICs – India, Tanzania, and Zambia – and to understand the factors that constrain and enable these processes.
We adopted the action-centred approach of policy implementation analysis that draws on the experiences of relevant policy and health system actors in order to understand regulatory processes. We drew on data from three case studies commissioned by the World Health Organization (WHO), on the regulation of TB medicines in India, Tanzania, and Zambia. Qualitative research methods were used, including in-depth interviews with 89 policy and health system actors and document review. Data were organized thematically into accounts of regulators’ authority and capacity; extent of policy implementation; and efficiency, transparency, and accountability.
In India, findings included the absence of a comprehensive policy framework for regulation of TB medicines, constraints of authority and capacity of regulators, and poor implementation of prescribing and dispensing norms in the majority private sector. Tanzania had a policy that restricted import, prescribing and dispensing of TB medicines to government operators. Zambia procured and dispensed TB medicines mainly through government services, albeit in the absence of a single policy for restriction of medicines. Three cross-cutting factors emerged as crucially influencing regulatory processes - political and stakeholder support for regulation, technical and human resource capacity of regulatory bodies, and the manner of private actors’ influence on regulatory policy and implementation.
Strengthening regulation to ensure the quality and availability of TB medicines in LMIC with emerging private markets may necessitate financial and technical inputs to upgrade regulatory bodies, as well as broader political and ethical actions to reorient and transform their current roles.


Main Subjects

  1. Ratanawijitrasin S, Wondemagegnehu E. Effective Drug Regulation: A Multicountry Study. Geneva: World Health Organization; 2002.
  2. Management Sciences for Health (MSH). Improving Drug Management to Control Tuberculosis. Manager. 2001;10(4):1-22.
  3. Maalaoui N. Strengthening TB Drug Management in the Sudanese National TB Control Program: In-Depth Review of TB Drug Management. Khartoum; 2009.
  4. Vermund SH, Altaf A, Samo RN, et al. Tuberculosis in Pakistan: A decade of progress, a future of challenge. J Pak Med Assoc. 2009;59(4):1-8.
  5. Lönnroth K, Castro KG, Chakaya JM, et al. Tuberculosis control and elimination 2010-50: cure, care, and social development. Lancet. 2010;375(9728):1814-1829. doi:10.1016/s0140-6736(10)60483-7
  6. Lönnroth K, Uplekar M, Arora VK, et al. Public-private mix for DOTS implementation: what makes it work? Bull World Health Organ. 2004;82(8):580-586.
  7. Uplekar M. Involving private health care providers in delivery of TB care: global strategy. Tuberculosis (Edinb). 2003;83(1-3):156-164.
  8. Wondemagegnehu E. Counterfeit and Substandard Drugs in Myanmar and Viet Nam. Geneva: World Health Organization; 1999. http://apps.who.int/medicinedocs/pdf/s2276e/s2276e.pdf. Accessed December 17, 2014.
  9. Barrett S, Fudge C. Policy and Action : Essays on the Implementation of Public Policy. London: Methuen; 1981.
  10. Hjern B, Hull C. Implementation Research as Empirical Constitutionalism. Eur J Polit Res. 1982;10(2):105-115. doi:10.1111/j.1475-6765.1982.tb00011.x
  11. Gilson L, Hanson K, Sheikh K, Agyepong IA, Ssengooba F, Bennett S. Building the field of health policy and systems research: social science matters. PLoS Med. 2011;8(8):e1001079. doi:10.1371/journal.pmed.1001079.
  12. Sheikh K. Experiences of Regulating and Restricting the Availability of TB Medicines in Tanzania and Zambia. Geneva:World Health Organization; 2009.
  13. Sheikh K, Singh A, Chokshi M, George SM. Regulating the Availability of TB Medicines in India – a Policy Process Appraisal. Public Health Foundation of India; 2011.
  14. Patton MQ. Qualitative Research and Evaluation Methods. London: SAGE; 2002.
  15. Silverman D. Qualitative Research: Theory, Method and Practice. Sage Publications Inc; 2004.
  16. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Burgess RG, Bryman A, eds. Analyzing Qualitative Data. London: Routledge; 1994:173-194.
  17. Catalani E. Review of the Indian market of anti-tuberculosis drugs: focus on the utilisation of rifampicin-based products. Int J Tuberc Lung Dis.1999;3(11s3):S289-S291.
  18. Langer E, Kelkar A. Pharmaceutical Distribution in India. Biopharm International website.http://www.biopharminternational.com/. Accessed December 17, 2014. Published 2008.
  19. Uplekar M, Shepard D. Treatment of tuberculosis by private general practitioners in India. Tubercle. 1991;72(4):284-290. doi:10.1016/0041-3879(91)90055-w
  20. Singla N, Sharma P, Singla R, Jain R. Survey of knowledge, attitudes and practices for tuberculosis among general practitioners in Delhi, India. Int J Tuberc Lung Dis. 1998;2(5):384-389.
  21. Uplekar M, Juvekar S, Morankar S, Rangan S, & Nunn P. Tuberculosis patients and practitioners in private clinics in India. Int J Tuberc Lung Dis, 1998;2(4), p324-9.
  22. Udwadia ZF, Pinto LM, & Uplekar MW. Tuberculosis management by private practitioners in Mumbai, India: has anything changed in two decades? PloS One, 2010;5(8).
  23. Prasad R, Nautiyal RG, Mukherji PK, Jain A, Singh K, Ahuja RC. Treatment of new pulmonary tuberculosis patients: what do allopathic doctors do in India? Int J Tuberc Lung Dis. 2002;6(10):895-902.
  24. Janovsky K, Travis P, Non-state Providers of Health Care in Tanzania: Governance, stewardship and international support, Report for WHO; 2006.