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Accessibility of novel treatments for multi-drug resistant tuberculosis in India: the role of big pharma

Adapted from


Despite India’s tremendous efforts to tackle tuberculosis (TB) and eliminate it by 2025, there is no shortage of challenges that need to be addressed before this goal can become a reality. With only three years left until the target year is reached, India still faces the highest global burden of TB disease and has the highest number of multi-drug resistant TB (MDR-TB) in the world (WHO, 2021). Aside from key determinants of health including socioeconomic status, health status, and undernutrition, the largest barrier to MDR-TB elimination is access to effective and affordable treatment regimens (Central TB Division, 2021).

A recent article published in the Guardian by Catherine Davison (2022) titled “Patients are falling through the cracks: drug costs hinder India’s response to TB” uses the story of Meera Yadav, a TB advocate, to outline some key accessibility barriers many TB patients in India face, including the affordability of novel and effective treatment regimens for MDR-TB. Yadav lost her lung after developing drug resistance following an ineffective TB treatment course in 2013. Luckily, she recovered once she accessed appropriate MDR-TB antibiotics for free at a local Médecins sans Frontiers clinic many years later (Davison, 2022).

Yadav was not the only patient to have struggled accessing appropriate treatment for MDR-TB. Another TB patient filed a lawsuit and won against the Indian government to obtain proper treatment. Prior to the lawsuit, there were tight regulations over the distribution of bedaquiline, a highly effective drug against MDR-TB, to residents of five Indian states. As a non-resident, the patient was denied prescription for bedaquiline. Her landmark victory in court not only allowed her to have access to lifesaving treatment but also removed barriers for other MDR-TB patients to have access to the drug (Kirby, 2017).

While increased drug accessibility is one step in overcoming the challenges of providing effective treatment, these novel treatment regimens almost always come with a cost. The current cost of bedaquiline, which is patented by Johnson & Johnson, is estimated to be $350 per patient. Delamanid, another MDR-TB drug available on the market patented by Otsuka Pharmaceutical, is estimated to be $1200 per patient (Davison, 2022). The costs of these drugs are extremely high for many low-middle-income countries (LMICs) like India to absorb, which limits their distribution to a select few among the populations in need, further perpetuating health inequalities (Pai and Furin, 2017).

Yadav is currently suing the Indian government demanding that they petition to override the patents of bedaquiline and delamanid. Such a motion can be granted under a World Trade Organization (WTO) agreement, which would allow the local production of generic versions of patented pharmaceuticals at a cheaper cost during public health crises (Davison, 2022). A recent analysis of the cost effectiveness of producing generic drugs for MDR-TB demonstrated that there would be a 5-10 times increase in MDR-TB drug supply using the current budget allocated towards those treatments (Gotham et al., 2017). Having increased supply of these drugs would undoubtedly allow for more patients to have access to more affordable treatment regimens.

The issue when dealing with big pharma is that they tend to prioritize profit margins over patient care, ultimately selling their therapies at extremely high costs to reflect the costs of research and development (Vincent Rajkumar, 2020). During a lecture given by Dr. Madhukar Pai, a world-renowned TB scientist, at McGill University, he described a discussion between himself and a pharmaceutical company over lowering costs of a specific TB technology. The pharma representative was willing to bring down the price of the technology such that the profit margin was zero; however, this value was still too inflated for most LMICs health budgets (Pai, 2019). What is most unfortunate is that this gap between accessibility and profitability disproportionately affects those who need these lifesaving treatments in LMICs where TB is huge public health problem.

In recent years, TB diagnosis and treatment was disrupted as the focus shifted on the COVID-19 pandemic (Central TB Division, 2021). Despite this, the COVID-19 pandemic demonstrated that when there is a collective will to achieve something, we have the capacity and the resources to accomplish it. As the focus slowly shifts back to TB, there are many lessons to be learnt from the pandemic, predominantly a need for a comprehensive approach to include social determinants of health at the forefront of future TB interventions (Zimmer et al., 2022).

As of June 2022, the WTO waived the patents on COVID-19 vaccine technology to allow for more equitable vaccine production and access in LMICs (WTO, 2022). With such a decision being made for COVID-19, hope remains for an equally positive outcome for Yadav’s lawsuit against the Indian government to apply for a patent waiver for MDR-TB drugs. Having such an approval by the WTO would without a doubt be helpful in reducing the burden of MDR-TB through better supply and distribution of the drugs, and in turn, reduce the overall global burden of MDR-TB disease in India.



Central TB Division, Ministry of Health and Family Welfare, Government of India. 2021. India TB Report 2021.

Davison, C. 2022. ‘Patients are falling through the cracks’: drug costs hinder India’s response to TB [Online]. Mumbai: The Guardian. Available: through-the-cracks-drug-costs-hinder-indias-response-to-tb [Accessed November 11 2022].

Gotham, D., Fortunak, J., Pozniak, A., Khoo, S., Cooke, G., Nytko, F. E., III & Hill, A. 2017. Estimated generic prices for novel treatments for drug-resistant tuberculosis. Journal of  Antimicrobial Chemotherapy, 72, 1243-1252.

Kirby, T. 2017. Landmark legal ruling sees Indian girl prescribed bedaquiline for XDR-TB. The Lancet Respiratory Medicine, 5, 249.

Pai, M. 2019. Tuberculosis: Road to Elimination. Lecture notes. PPHS 511 Fundamentals of Global Health. McGill University [Delivered February 29, 2019]

Pai, M. & Furin, J. 2017. Tuberculosis innovations mean little if they cannot save lives. Elife, 6.

Vincent Rajkumar, S. 2020. The high cost of prescription drugs: causes and solutions. Blood Cancer Journal, 10, 71.

WHO 2021. Global Tuberculosis Report 2021.

WTO. 2022. TRIPS Council welcomes MC12 TRIPS waiver decision, discusses possible extension [Online]. WTO. Available: [Accessed November 11 2022].

Zimmer, A. J., Klinton, J. S., Oga-Omenka, C., Heitkamp, P., Nawina Nyrienda, C., Furin, J. & Pai, M. 2022. Tuberculosis in times of COVID-19. J Epidemiol Community Health, 76, 310-316.

3 replies to “Accessibility of novel treatments for multi-drug resistant tuberculosis in India: the role of big pharma”

  1. s2215530 says:

    Testing comments

  2. says:

    Thanks for the blog.

  3. Kristy says:

    Hi Emina,

    I thought this blog was well written and provided an excellent overview of the complexities surrounding Big Pharma and its focus on profit over people. I found the section on Yadav suing the government particularly interesting as I didn’t know such motions could be graded under a World Trade Agreement. While I’m sure this process is lengthy, expensive, and laden with challenges, I wonder why more companies/people don’t pursue this avenue as a potential to lower other cost-prohibitive drugs. Again, thanks for the thought-provoking and well-written piece.

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