Tuberculosis (TB) could be drug sensitive (DS TB), which can be treated by a few first-line oral drugs, or drug resistant (DR TB), wherein there is resistance to one or more drugs, making it difficult to treat, potentially leading to more complications and even death. Drugs for any form of TB are provided free of cost through the Indian government’s National Tuberculosis Elimination Programme (NTEP). Newer anti-tubercular (anti-TB) drugs like Bedaquiline, Delamanid and Pretomanid are key drugs that have revolutionised the treatment of DR TB, since they are orally administered and require shorter treatment durations compared to the older regimen of daily injections, which were to be taken for many months. Another key drug is Rifapentine, which is mainly used to prevent TB in people who have come in contact with TB-infected individuals or in people with HIV disease.

The Drugs Controller General of India (DCGI), following a letter from the Central TB Division of the Ministry of Health & Family Welfare, mooted an important proposition regarding the regulation of newer anti-TB drugs in the private market, in the 66^th Drugs Consultative Committee (DCC) meeting held on June 17, 2025. The DCGI is planning to restrict access to the newer anti-TB drugs Bedaquiline, Delamanid, and Pretomanid and Rifapentine by making them conditionally accessible only through NTEP, in adherence to the Standards of TB Care in India. The reasons and implications of this move need to be closely examined.

The mechanism of supplying drugs under NTEP

NTEP has its own exclusive procurement and supply chain management system for anti-TB drugs, laboratory consumables and TB preventive drugs. India, like many countries in the world, procures most of its anti-TB drugs from the Global Drug Facility (GDF), a not-for-profit establishment funded by the Global Fund, along with procurement via domestic funding through the Central Medical Services Society . GDF does not aim to make a profit and therefore provides drugs and consumables at very low prices to countries through bulk procurement. The Central TB Division places an order to GDF at least one year prior by forecasting the need, based on the disease burden in the country. The drugs are then routed through Government Medical Store Depots to State Drug Stores of NTEP, from where they go to District Drug Stores and then down to DOTS centres at Tuberculosis Units and Peripheral Health Institutions. This entire process is managed real-time through a portal called Ni-Kshay Aushadhi, which is accessible only to NTEP personnel. The Central procurement of drugs is based on drug requests received from peripheral health institutions at the grassroots level. Timely online drug requests through the Ni-Kshay Aushadhi portal are imperative for uninterrupted procurement and supply of drugs in NTEP. However, studies have shown the sub-optimal use of the portal in the field owing to various reasons like lack of digital literacy and training of peripheral level staff, portal interface not being user-friendly and stock planning and forecasting not being perceived as a ‘felt need’ by staff.

Why restrict access to newer anti-TB drugs

A new drug that is developed can be patented by the company that developed it (originators) for a minimum of 20 years. No other company can undertake commercial production of the drug during this period. However, when a drug goes off-patent (expiry of patent period), it can be manufactured by any other pharmaceutical company and can be marketed for use. Patenting was done in the case of Bedaquiline (Johnson & Johnson), Delamanid (Otsuka), Pretomanid (TB Alliance) and Rifapentine (Sanofi) by their originators. These drugs are procured by the government and available only through NTEP to registered beneficiaries.

Over the past 5 or 6 years, patents for all these drugs have expired, except for Pretomanid, and several generic pharmaceutical companies like Lupin, Macleods, Natco, etc. have taken up the production of these drugs, leading to lower costs and more availability in the market. Since they are off-patent, these companies could produce them for the open market as well. The easy availability and low prices of antibiotics in the open market drive private prescriptions, often leading to their injudicious use. This, in turn, promotes the emergence of drug-resistant bacterial strains, ultimately rendering these antibiotics ineffective.

With the advent of drug-resistant and extensively drug-resistant strains of bacteria, TB treatment is already facing a crisis which warrants the discovery of newer drugs. Hence, the move of DCGI assumes importance in the journey to combat antimicrobial resistance. Making them conditionally accessible through NTEP would ensure rational use of these drugs.

Possible implications of the restriction

However, there are certain risks to this decision if implemented in the current context. In the event of a break in the supply chain of NTEP, these drugs would become unavailable for the persons with TB (PwTB) who are supposed to take them regularly, most often daily, without missing the doses.

A terrible drug stock-out of anti-TB drugs during 2023-24 is an example of this threat. The stock-out affected almost every State in India and occurred both for DS-TB and DR-TB drugs. PwTB and their families had to run from pillar to post to obtain drugs needed daily for even the most common DS-TB regimen. Since the NTEP centres ran out of stock, a few PwTB who could afford it, sourced drugs from the open market. For persons affected by DR-TB, since drugs were available only through NTEP, they had to take incomplete regimens or miss their doses altogether. Lack of an alternative source to obtain drugs can be detrimental for PwTB if similar situations arise in future. Missed or incomplete doses can lead to delays in cure or no cure, increased risk of development of drug resistance and increased out of pocket expenditure for patients. This also leads to loss of trust in government systems built over several years, and in the larger picture, is a deterrent to our goal of TB elimination.

What can be done?

The proposition to make newer anti-TB drugs accessible only through NTEP is a welcome move, provided the government ensures a reliable and uninterrupted supply of drugs through the programme. Similar to how the Ni-Kshay dashboard on real-time disease burden in the country is visible to the public, the Ni-Kshay Aushadhi dashboard depicting available stock of drugs should also be made accessible. This would ensure accountability and help public health advocates to forecast and flag any potential drug stock-outs. A high level of vigilance from civil society is required to ensure that stock-outs at the regional level are predicted, prevented or mitigated. The existing TB Mukt Panchayat initiative could be leveraged for the involvement of local self-governments (gram panchayats) in doing the same. Accountability of the programme to provide drugs to all beneficiaries can be attained if people in power are also devoted to the cause.

The idea to restrict the availability of newer anti-TB drugs therefore, must be implemented after careful planning and adequate groundwork, in order to prevent any interruption of access to eligible individuals.

(Swathi Krishna Njarekkattuvalappil is a public health physician and researcher based in Pune, working in tuberculosis, health policy and systems research. [email protected]; Parth Sharma is a community physician and a public health researcher based in Delhi. [email protected])