India is taking a decisive step to combat the growing threat of drug-resistant tuberculosis (TB) by restricting the sale of new and off-patent TB medicines to government channels only. This move, as revealed in recent documents, aims to ensure that these critical drugs are used judiciously and monitored effectively, aligning with the Standards of TB Care in India (STCI) guidelines. The decision, communicated by the apex drug regulator to all states and Union Territories, underscores the importance of regulated distribution through the National TB Elimination Programme (NTEP).

The rationale behind this policy shift is rooted in the urgent need to control the spread of drug-resistant TB, a significant public health challenge in India. According to the WHO's Global TB Report 2023, India bears the highest burden of drug-resistant TB globally, with an estimated 110,000 new cases emerging annually. A critical aspect highlighted in the India TB Report 2023 is that only 76% of the patients tested for TB were also tested for rifampicin resistance, which is a key indicator of drug resistance. By channeling the distribution of TB drugs through government programs, the country aims to improve monitoring and ensure appropriate prescription of drugs.

The National TB Elimination Programme (NTEP), formerly known as the Revised National Tuberculosis Control Programme (RNTCP), is at the forefront of India's fight against TB. Renamed in 2020, NTEP aims to eliminate TB in India by 2025, ahead of the global target of 2030. The program operates under four strategic pillars: "Detect – Treat – Prevent – Build," and includes initiatives to improve TB detection, treatment, and prevention. A key component of the NTEP is Universal Drug Susceptibility Testing (UDST), which ensures that every diagnosed TB patient is tested for drug resistance at the time of treatment initiation.

In line with these efforts, India has introduced a novel treatment for Multi-Drug-Resistant Tuberculosis (MDR-TB), known as the BPaLM regimen. This shorter, more effective treatment option includes the new anti-TB drug Pretomanid, in combination with Bedaquiline and Linezolid (with or without Moxifloxacin). The BPaLM regimen has been shown to cure drug-resistant TB in just six months, compared to the traditional treatments that can last up to 20 months and have severe side effects. With approximately 75,000 drug-resistant TB patients in India, this new regimen offers significant relief and cost savings.

India has also made considerable strides in improving TB care through innovative diagnostics and treatments. These include AI-powered chest X-ray analysis (DeepCXR) for faster TB detection, a cost-effective skin test for latent TB (CyTb), and molecular tests for simultaneous detection of TB and drug resistance (PathoDetectTM NAAT test). Furthermore, the government provides nutritional support to TB patients through the Ni-kshay Poshan Yojana, offering financial assistance of Rs 500 per month during treatment. The TB Mukt Bharat Abhiyaan, launched in 2022, encourages community participation and support for TB patients.

Despite these advancements, challenges remain. A significant concern is the timely processing of drug tenders to avoid stockouts. Reports have indicated interruptions in the supply of laboratory reagents and essential medicines for drug-resistant TB. The country also needs to scale up testing for drug resistance, with current rates below optimal levels. According to a recent report, in 2023 and 2024, India reported 25.5 lakh and 26.07 lakh tuberculosis (TB) cases, marking the highest number of notified cases ever.

To achieve its ambitious goal of eliminating TB by 2025, India needs to continue strengthening its TB control program, increase budget allocation, and ensure effective implementation of strategies. Engaging the private sector, which manages a significant proportion of TB cases, is also crucial. By addressing these challenges and leveraging innovative approaches, India can make significant progress in its fight against tuberculosis and protect its population from this deadly disease.