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Experts fear that unregulated access could lead to indiscriminate use, risking treatment failures and accelerating the development of drug resistance
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. Representational image
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.”
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective.
She is particularly pass…Read More
Himani Chandna, Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective.
She is particularly pass… Read More
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