The Indian government is planning to restrict the sale of new and off-patent tuberculosis (TB) drugs to government channels, effectively barring their private sale. This move aims to curb drug resistance and bolster the country's efforts to eliminate TB.

Rationale Behind the Restriction

The primary reason for this decision is to prevent the misuse and irrational use of these drugs, which can lead to the development of multi-drug-resistant TB (MDR-TB). The Central TB Division has raised concerns about the open market availability of these medications, prompting intervention from the Drug Controller General of India (DCGI). By limiting the distribution of TB drugs to government-approved channels, the authorities can ensure that they are used according to the Standards of TB Care in India (STCI) guidelines and within the National TB Elimination Programme (NTEP). This regulated distribution will enable proper usage and monitoring, which are critical to preventing drug resistance.

Implementation and Monitoring

To implement this policy, states and Union Territories will need to amend their licensing agreements to include a clause restricting the use of these TB drugs to the NTEP. The drugs will be exclusively supplied through NTEP-approved hospitals and TB treatment centers, allowing for better monitoring of their distribution and patient administration. Drug packaging will also be required to carry a warning stating "For use in NTEP only." This will ensure complete oversight of the manufacturing and patient administration.

National TB Elimination Programme (NTEP)

The NTEP, formerly known as the Revised National Tuberculosis Control Programme (RNTCP), was renamed in 2020 with the goal of eliminating TB in India by 2025. This target is five years ahead of the global Sustainable Development Goals. The program focuses on early diagnosis, free treatment, providing nutritional support through the Nikshay Poshan Yojana, and tracking patients through the Nikshay portal. The NTEP is supported by universal drug susceptibility testing and public-private partnerships. It aligns with the World Health Organization's (WHO) End TB Strategy, which aims for zero TB deaths and suffering. Despite these efforts, the program faces challenges such as underreporting, drug resistance, and gaps in last-mile delivery.

Broader Implications and Earlier Initiatives

This is not the first time the Indian government has considered restricting the sale of TB drugs in the open market. In 2013, similar proposals were discussed to ensure calibrated and monitored administration of these medicines. The current move is a renewed effort to address the issue of drug resistance, which has been a long-standing concern. The government aims to administer drugs on a daily basis instead of intermittently, which was identified as a factor contributing to growing resistance to anti-TB drugs.

Benefits of the Restriction

Consolidating the procurement, distribution, and provision of new TB drugs in the public sector will allow the government to set up a system for tracking and monitoring patient outcomes and other relevant variables. This will promote the rational use of new TB drugs and ensure that patients are rapidly put on correct and effective treatment regimens, in combination with existing medicines. Access to timely and accurate diagnosis will be key to achieving these goals.

The introduction of shorter, more effective treatment regimens

In September 2024, the Union Health Ministry approved the introduction of a new, shorter, and more effective treatment regimen for drug-resistant TB in India. The BPaLM regimen, consisting of bedaquiline, pretomanid, linezolid, and moxifloxacin, has been proven to be safer and quicker than previous MDR-TB treatments. This move is expected to significantly boost the country's progress toward eliminating TB.

By restricting the sale of TB drugs to government channels, India aims to enhance treatment success, reduce mortality among TB patients, and combat the growing threat of drug resistance.