“We are now faced with the fact that tomorrow is today. We are confronted with the fierce urgency of now. In this unfolding conundrum of life and history, there “is” such a thing as being too late. This is no time for apathy or complacency. This is a time for vigorous and positive action.”
― Martin Luther King Jr.
2023 saw unprecedented political commitment towards tuberculosis (TB) in India — from the rejection of Johnson & Johnson’s attempt to evergreen the bedaquiline patent, to investing in and incentivizing TB vaccine research, to reiterating the promise of a “TB-free society” by 2025 during the One World TB Summit in March 2023 in Varanasi. However, while these laudatory decisions are critical steps towards achieving TB control in India, frequent concerns about TB drug shortages and stockouts in India have continually undermined the country’s efforts in past years. According to several news reports, the country faced shortages and stockouts of key TB drugs, including first-line drugs like rifampicin, isoniazid, and companion drugs (such as clofazimine, cycloserine, and linezolid). The situation underscores the challenges faced in fulfilling the promise of cheaper generics — exacerbated by sub-optimal procurement and supply chain management (PSM) — ultimately impeding India’s battle against TB.
TB Drug Shortages and Stockouts
The World Health Organization (WHO) defines stockouts as “the complete absence of the medicine, health product or vaccine at the point of service delivery to the patient” and shortages as “the supply of medicines, health products, and vaccines identified as essential by the health system is considered to be insufficient to meet public health and patient needs.” Shortages and stockouts of multiple TB drugs in India are incredibly concerning due to three key reasons.
First, treating both drug-susceptible TB (DS-TB) and drug-resistant (DR-TB) requires a multi-drug regimen, wherein a combination of drugs are used to ensure that the Mycobacterium tuberculosis bacterial cells are effectively targeted and eliminated to reduce the chances of disease relapse and the emergence of drug resistance in M. tuberculosis, which can render TB drug treatments ineffective. Second, under-performing supply chain management and frequent stockouts of TB medicines lead to treatment interruption and non-adherence to anti-tuberculosis treatment, which subsequently results in the increased risk for infections or the emergence of drug-resistant M. tuberculosis strains that are harder to treat — resulting in increased risk of illness and death. Considering the public health relevance and disease burden of TB in India, with many anti-tuberculosis drugs listed in India’s National List of Essential Medicines, it is critical to ensure that populations can access these essential TB medicines without supply chain disruptions. Third, India has the highest number of people living with TB and DR-TB — accounting for approximately 25% of the global TB burden. The global fight against TB cannot be won if India fails to provide its population with essential drugs. Without greater political commitment, increased policy agility, and universal access to TB regimens, people will face increases in mortality, morbidity, and the catastrophic costs associated with the disease.
Shortcomings of the Indian Government’s Response
As stories of individuals affected by drug stockouts began to circulate in 2023, concerned stakeholders wrote a letter to India’s prime minister and union health minister, urging them to ensure the availability of anti-tuberculosis drugs. Subsequently, the Ministry of Health and Family Welfare released two notifications on the Press Information Bureau (PIB) in September and October 2023, stating that these reports were “false, misleading, motivated” and “vague and ill-informed, without any specific information on the availability of anti-TB medicines in stock.” Furthermore, these notifications specifically: 1) provided an update on the available stocks and the procurement status of TB drugs and 2) directed states to procure TB drugs locally in situations where they are not available. However, this response fails to take into account the complexity and nuance associated with TB and the TB drug supply chain for four key reasons.
First, TB is a disease of poverty and neglect, which fuels further stigmatization, discrimination, and marginalization. The mere availability of drugs does not guarantee access to optimal medical interventions for the most vulnerable. Rather, efforts should be directed toward developing and providing people-centered care packages and replacing colonial models with equitable ones. The government must also ensure that health services are hospitable, especially to key populations, and facilitate treatment completion and success. Additionally, while the PIB notifications provide estimates on the stocks of TB drugs, they fail to specify how long these stocks will last.
Second, procurement supply management is more than just having adequate stocks of drugs. It includes access to optimal drugs in optimal quantities at the right place and at affordable prices such that users can easily access drugs in a timely and reliable way. Therefore, not only is it essential that drugs are available, but greater clarity is also required on “where” TB drugs are most needed to close the gap between accessibility and need. Moreover, based on the PIB notifications, the government relied heavily on “Ni-kshay Aushadhi,” a web-based PSM portal for TB. However, the portal continues to face several shortcomings, including the lack of reliable internet connectivity, overburdened healthcare workers, and inadequate training to run the platform. Furthermore, comprehensive and robust data on drug stockouts are lacking globally, with stakeholders mostly relying on anecdotal evidence regarding stockouts.
For example, other countries’ research studies have identified several key determinants leading to stockouts of first-line TB drugs. These factors include the delayed supply of anti-TB drugs and the delivery of reduced quantity of TB drugs from the country’s pharmaceutical supply agency to health facilities. Errors in the use of stock management software and information systems, inadequate supply planning capacity, and poor inventory management practices also contribute to the problem. In addition, issues relating to communication and coordination between stakeholders, the educational levels of stock managers, transportation and road infrastructure challenges, and budget constraints further exacerbate the situation. Furthermore, unforeseen fluctuations in demand, changes in regulatory environments, and the supply of drugs with short expiry dates play a major role.
In 2014, the State Government of Odisha, India assessed the extent and reasons for stockouts of essential medicines within the state. They found that the reasons for chronic stockouts of essential medicines ranged from improper forecasting of annual drug requirements (resulting in incorrect quantities of drug supply) to inadequate drug storage and transportation facilities. They also identified factors, including understaffed and untrained pharmacists in health facilities, incorrect administration of stock management software, and the lack of basic information technology skills among staff in health facilities. While Odisha’s assessment did not specifically focus on TB drug stockouts, its results can potentially shed light on possible reasons behind TB drug stockouts across India. Dismissing reports of stockouts in India without adequate investigation into the reasons does not bode well for the country’s TB control targets. Regular monitoring will be necessary to understand the root causes behind TB drug stockouts and shortages, which can result in more effective targeted state- and national-level policies to improve supply chain systems. In fact, the government should have taken this moment to review the supply chain challenges faced by people affected by TB and adopted approaches to include the voices of the community and people affected by TB — doing so would have strengthened the country’s health systems to respond to such health threats.
Third, the PIB notification directs states on how to procure their own drugs should the need arise. Procuring TB drugs is complicated by the division of the TB drug market into first-line and second-line drugs and three separately financed supply chains at the global, national, and state levels. This raises the questions about bargaining disparities: states with more fiscal space and experience to tender and negotiate would be at a greater advantage in procuring drugs. Further, the Ministry of Health and Family Welfare’s PIB notification leaves it unclear if states can contract directly with global procurement agencies, like Global Drug Facility, to meet the demand. During the COVID-19 pandemic, a similar situation of decentralized procurement played out when the central government issued the “Liberalized Vaccine Policy,” which directed states and private players, apart from the central government, to procure vaccines directly from manufacturers. The Supreme Court of India took Suo Moto cognizance of the matter and asserted that “procurement would be centralized, distribution of the vaccines across India within the States/UTs would be decentralized.” The court held that such a mechanism leads to unfair and unnecessary competition between states — creating fragmented markets and giving pharmaceutical companies more negotiating power and the ability to sell these lifesaving interventions to the “highest bidder.”
Fourth, as supply challenges continue, questions about accountability, answerability, and the preemptive steps remain unresolved. Indeed, TB PSM is a challenging task, especially in a diverse country like India. Managing the TB supply chain is not a singular task, as it involves managing the preventative, DS-TB, and DR-TB supply chains — all of which have distinct features and complexities. Additionally, there are very few suppliers of TB drugs, which translates into greater fragility. Ensuring transparency and accountability among all stakeholders involved in TB PSM, from the national to primary healthcare levels, is crucial. This oversight could aid in the early detection and resolution of supply challenges.
Fifth, in a world recovering from the shocks of COVID-19, such shortages are bound to occur and have occurred not only in LMICs but also in countries like the United States. Nevertheless, research on this aspect remains limited, with scant data and assessments available to understand why TB stockouts and shortages persistently afflict India. Currently, there have been limited efforts to ensure that lapses and successes in TB drug procurement are documented in a structured manner. The situation is even more alarming in a world where most goods are available almost instantly at the push of a button — highlighting the neglect of TB PSM in India, both in terms of investment and innovation.
Looking Ahead
As India continues implementing its National Strategic Plan to eliminate TB by 2025, optimizing supply chain management is vital to achieve this target. This year’s TB Day slogan, “Yes! We can end TB,” cannot be achieved if people living with TB return empty-handed from the health centers. India must take the lead to revisit, rethink, and innovate the national TB PSM strategy to make it credible, accountable, transparent, and responsive to the needs of people living with TB.
