Anti-tuberculosis (TB) Drug Stockouts in India: Implementation Gaps, Implications for Patients and Public Health

As per the Global TB Report 2023, India carries the highest global burden of TB and multidrug-resistant tuberculosis (MDR-TB), accounting for 26.8% of cases.[1] In India, TB takes a toll of about 4,80,000 deaths each year. India has announced an ambitious plan for TB Elimination by 2025- a target to eliminate TB five years ahead of the target set by the UN’s sustainable development goals. The Indian Government launched several initiatives such as mandatory notification of all TB cases, expansion of diagnostics services, programmatic management of drug-resistant TB (PMDT) service expansion, etc. as listed in the National Strategic Plan (NSP 2017-25).[2] In March 2024, a week before World TB Day, a letter dated 18 March 2024 was issued by the Deputy Director General (DDG) TB regarding the drug procurement for drug-sensitive (DS) TB.[3] It stated that “the procurement process of most anti-TB drugs and diagnostics has been completed at the national level. Central Government procurement of DSTB-IP (A) and DSTB-CP (A) is at an advanced stage. However, the supplies may get delayed due to unforeseen and extraneous circumstances”. Further, it stated that the approval of the competent authority was being conveyed for local procurement of these drugs for the period of three months so that individual patient care would not be affected. There was flexibility offered regarding pack sizes and if the dose combinations and dosages per pill per day were as per the National TB Elimination Program (NTEP) recommendations. Clear instructions were provided that the drugs could be procured at the State/District level by utilizing the budget under the National Health Mission (NHM) already approved by the relevant head. Also, on a case-by-case basis, the provision for reimbursement of costs towards the drugs was stated in case the district health facilities were unable to provide free drugs. Despite the above clear instructions from the DDG office, anti-TB drug supplies were disrupted in many states for nearly four to five months (March-July 2024) and some rural areas continue to have a drug shortage.[4] As a result, many patients did not receive their free medications and were forced to purchase their medicines from private (retail) pharmacies. Several anecdotes from patients with TB revealed that they faced financial problems as they had to purchase medicines by spending money out of their pocket. Patients were not informed about the provision of reimbursement of costs that they paid. Some patients missed their medications. Such a situation has several important consequences not only for patients but also for the public health at large. First, besides the deterioration of health, patients faced financial problems (due to loss of daily wages and out-of-pocket expenditure toward buying medicines) and psychological stress as they had to shop around for medicines. Second, due to missed doses, some patients might have undergone inadequate treatment and or have received non standard drug combinations. Both are often seen as major factors leading to the emergence of anti-TB drug resistance.[5] Third, such inadequately/partially treated patients can act as major reservoirs of TB infection in the community and cause transmission of TB strains (both drug-susceptible and resistant) within their families and the communities, and thereby pose a threat to public health.[6] A previous study on the effects and determinants of drug stockouts in South Africa showed a positive correlation between TB death rates and TB drug stockouts, suggesting that districts with more TB drug stockouts were likely to experience worse TB treatment outcomes.[7] The operational issues in the drug procurement process thus have several serious implications, which need to be carefully thought out before undertaking such large-scale operations in a high-burden country like India. A massive nationwide stockout of anti-TB drugs was previously also reported in India.[8] Such instances indicate challenges in the operational implementation of the NTEP and the communication gap between the Centre and State/district level functioning, which needs to be bridged; otherwise, TB elimination will remain a distant reality as it happened so far. On the other side, it is important to understand the exact reasons behind the drug stockouts. These include lack/inadequate supply of major pharmaceutical ingredients, damage, expiry, and theft due to poor storage, corruption, lack of stock management, late or no timely payment to pharmaceutical companies, lack of skilled staff, etc.[7] Understanding the role of determinants of political is and actions is also crucial.[9] Going forward, I would like to suggest a few strategies for the NTEP: 1. Identify the exact reasons for the drug stockouts (which may be local, regional, state, or national level) 2. Make efforts for effective communication and subsequent actions between the Centre and State agencies; 3. Organize trainings for the state/district officials on how to initiate and complete local drug procurement processes in advance while ensuring the adequate drug stocks; 4. Undertake a survey with patients to know the real magnitude of the problem of missed doses and ensure uninterrupted anti-TB drug supply in future; 5. Inform the patients on restoration of drug supply as it occurs and initiate the reimbursement process for the costs that they already spent out of their pockets for purchasing medicines from the retail pharmacies; 6. Conduct regional surveillance to monitor the levels of drug resistance, especially for rifampicin-resistant(RR)/MDR-TB and fluoroquinolone resistance. Data availability statement This is a perspective article based on the literature and actual field experiences. Author contribution Conceptualization and complete writing. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.