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The Hindu
14-07-2025
- Health
- The Hindu
The paradox of market restriction for anti-TB drugs
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 66th 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 Aushadh i , 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. Also Read: Gross mismanagement: On TB drug shortages and India's national TB programme 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. swathikdk@ Parth Sharma is a community physician and a public health researcher based in Delhi.
Time of India
26-06-2025
- Health
- Time of India
Plans to restrict open market access to tuberculosis medicines
With cases of drug-resistant tuberculosis on the rise in India, authorities are set to tighten open market access to newer anti-TB drugs Bedaquiline and Delamanid , which went off patent last year. The Central TB division-which is under the health ministry-had written to the Central Drugs Standard Control Organisation (CDSCO) citing "access risks" that are leading to indiscriminate use, potentially increasing cases of treatment failure and resistance to these drugs. The patents for Bedaquiline and Delamanid expired last year, paving the way for pharmaceutical companies to manufacture the molecule. The drugs eventually became available in the market. The newer anti-TB drugs, including Bedaquiline, Delamanid, Pretomanid and Rifapentine, are available in the market. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Chuck Norris Begs Seniors: Avoid These 3 Foods Like The Plague Roundhouse Provisions Learn More Undo This week, the matter was taken up by the Drugs Consultative Committee (DCC), an expert committee under the CDSCO, which suggested that licences be issued on the condition that the use of Bedaquiline, Delamanid, Pretomanid and Rifapentine will be as per Standards of TB Care in India (STCI), and that there should be conditional access through the National TB Elimination programme (NTEP). The experts also said that if such a condition is not mentioned in the existing licences, it should be modified accordingly. It also said the label on the container of the drug, as well as the packaging, should bear the warning-"For use in NTEP", which shall be in a box with a red background. Live Events "The DCC, after detailed deliberation, agreed with the proposal to issue suitable guidance to all state licensing authorities to address the issue uniformly. The DCC also recommended that in case some SLAs had already issued the manufacturing licence for such a product, they can issue separate letters for communicating the above conditions," the minutes of the meeting suggested. ET has seen a copy of the minutes.
News18
25-06-2025
- Health
- News18
Centre Plans To Restrict New TB Drugs To Govt Channels, Bar Private Sale
Experts fear that unregulated access could lead to indiscriminate use, risking treatment failures and accelerating the development of drug resistance The central government is considering a proposal to tighten the regulation of critical anti- tuberculosis (TB) drugs—Bedaquiline, Delamanid, Pretomanid, and Rifapentine—in India's private healthcare market following growing concerns of misuse and drug resistance, News18 has learnt. The panel of experts, the Drug Consultative Committee (DCC), has recommended that the manufacture and sale of anti-TB drugs should be allowed conditionally. Overall, the idea is to bar manufacturers from selling the drugs in the private market, including pharmacies, hospitals, and clinics, unless they procure them via the government under the National TB Elimination Programme (NTEP). The move comes after the Central Drugs Standard Control Organisation (CDSCO) received a letter from the Central TB Division, Ministry of Health and Family Welfare, warning that the expiry of patents on Bedaquiline and Delamanid in 2023 has triggered a surge in their production by multiple pharmaceutical companies, making them freely available in the private sector. Experts fear that this unregulated access could lead to indiscriminate use, risking treatment failures and accelerating the development of drug resistance. Why is this move important? According to WHO's Global TB Report, India has made significant progress in fighting tuberculosis. Under the NTEP, the incidence rate of TB cases has dropped by nearly 17.7%, from 237 cases per 1 lakh people in 2015 to 195 in 2023. TB-related deaths have also reduced, falling from 28 to 22 per 1 lakh people during the same period. 'We have been making significant progress in eliminating TB. If anti-TB drugs are made available via the private market, there is a high chance of people consuming these drugs without medical supervision. We cannot afford to create drug resistance against the available options," said a senior official working on NTEP. The step To curb this fear, the Union Ministry of Health and Family Welfare has recommended that the manufacturing and sale of these drugs be conditional. Specifically, they should be permitted only in accordance with the Standards of TB Care in India (STCI) and made available through conditional access via the National TB Elimination Programme (NTEP). If existing licenses do not reflect this condition, the proposal calls for their immediate modification. 'To mitigate this risk, it has been requested to issue the licenses with a condition for use of Bedaquiline, Delamanid, Pretomanid and Rifapentine as per Standards of TB Care in India (STCI) and conditional access through National TB Elimination programme (NTEP)…," read the minutes of the meeting held on June 17, seen by News18. Although the drugs have been on the market for over four years—thus no longer qualifying as 'new drugs" which come for approval before the apex Drug Controller General of India (DCGI)—regulators have requested that State Licensing Authorities (SLAs) include these restrictions in all future and past licenses. Further, the panel agreed that 'the label on the immediate container of the drug as well as the packing in which the container is enclosed should bear the following warning – 'For the use in National TB Elimination Programme (NTEP)' which shall be in a box with a red background." Also, the panel has agreed to issue uniform guidance to all SLAs. It further advised that SLAs which had already granted licenses for these drugs should send separate letters to manufacturers, informing them of the updated usage conditions. The document has been sent to all relevant health officials by the Drug Controller General of India (DCGI), Dr Rajeev Singh Raghuvanshi, on June 24 for 'taking necessary actions" as per the recommendations decided by the panel. According to experts, the move is in the right direction. 'It's a good proposal. Globally, we have already seen signs of antibiotic resistance to certain TB drugs, so it's crucial that we take steps in India to prevent it," said Jyotsna Singh, co-convenor, Working Group on Access to Medicines and Treatments, India. However, Singh added that while this proposal is thoughtful, the government should also look at the continuous stock-outs of TB drugs. 'It's a recurring problem that requires better forecasting and enough money." First Published: June 26, 2025, 00:53 IST News india Centre Plans To Restrict New TB Drugs To Govt Channels, Bar Private Sale
Mint
24-06-2025
- Health
- Mint
India restricts sale of off-patent TB medicines to government channels to combat drug resistance
New Delhi: India will make new and off-patent tuberculosis drugs available only through government channels to curb resistance to the drugs and boost efforts to fight the disease, documents reviewed by Mint showed. 'The drug should be used as per Standards of TB Care in India (STCI) guidelines with the conditional access through the National TB Elimination Programme only," the apex drug regulator said in a letter to all states and Union Territories. The Drugs Controller General of India (DCGI) emphasised that the labels of all such TB drugs and their packaging should carry a warning in a box with a red background, stating: "For the use in National TB Elimination Programme only." It said these medicines are critical drugs that are reserved for the treatment of Multi-Drug-Resistant TB infection. Availability of such drugs in the open market through retail outlets may lead to indiscriminate use and development of resistance, causing treatment failure. Also Read | Govt disburses ₹3,649 crore to 12 million tuberculosis patients for nutrition The regulator asked the states and UTs to amend the conditions of all licences already granted to manufacture such drugs and incorporate the clause on their restricted usage. It also sought action-taken reports from them. The DGCI directive pertains to drugs such as Bedaquiline (100 mg and 20 mg), Delamanid (50 mg and 25 mg), Pretomanid (100 mg), and Rifapentine (150 mg and 300 mg), said an official with knowledge of the matter. Patents for Bedaquiline and Delamanid expired last year, leading to their widespread manufacture by several pharmaceutical companies and their subsequent open availability in private drug stores. The Central TB Division had raised concerns about the easy availability of these TB drugs in October last year and sought the DCGI's intervention to regulate their sale. Latent TB infection The drugs are vital components of the combination therapy for latent TB infection, when an infected person has no symptoms and cannot spread the disease to others, and Multi-Drug-Resistant Tuberculosis (MDR-TB). Rifapentine and a fixed dose combination of Rifapentine and Isoniazid have been approved for the treatment of latent TB infection. Last year, India rolled out a six-month MDR-TB regimen called BPaL (Bedaquiline, Pretomanid and Linezolid), which has a very high success rate and treatment outcome. These medicines are provided free to patients in both government and private healthcare set-ups. TB medicines are approved for import/manufacturing by the Central Drugs Standard Control Organisation in consultation with the Subject Expert Committee and experts from the Central TB Division at the ministry of health and family welfare. Also Read | New AI model could guide personalised treatments for tuberculosis: Study 'The matter was discussed last week during the Drugs Consultative Committee meeting chaired by the DCGI," the person said. 'These drugs will primarily be distributed through government channels under the National TB Elimination Programme to hospitals and TB treatment centres, allowing for detailed tracking of manufacturers and patients." Elimination campaign Last month, Prime Minister Narendra Modi chaired a high-level meeting on the National TB Elimination Programme and called for strategies to be scaled up to meet India's commitment to eliminate TB. At a recent 100-Day TB elimination campaign, over almost 720,000 TB cases were detected across the country, including 285,000 asymptomatic cases, highlighting the challenge and the importance of controlled drug access. Also Read | Lupin recalls over 16,000 bottles of generic tuberculosis drug in the US citing manufacturing issue TB is a contagious disease caused by a bacterium called Mycobacterium tuberculosis. It mainly affects the lungs. It can also affect other parts of the body such as the brain, the kidneys, or the spine. India reported 2.6 million TB cases last year. Despite the challenges, India has made significant strides in its fight against TB. The WHO Global TB Report 2024 indicates an 18% reduction in TB incidence and a 21% decline in TB mortality from 2015 to 2023, double the global pace. With an 85% treatment coverage, India is steadily nearing its TB elimination target. Queries sent to the health ministry spokesperson and the DCGI's office were unanswered.
