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Time of India
15 hours ago
- 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
2 days ago
- 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
