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The Central government may soon restrict the distribution of new anti-tuberculosis (TB) drugs bedaquiline, delamanid, pretomanid and rifapentine in the open market, allowing conditional access through the National TB Elimination Programme (NTEP).
The move is to avoid risks including indiscriminate use, potentially increasing cases of treatment failure and resistance to the anti-TB drugs, which would result in a larger problem of multiple drug resistance in TB patients.
The Drugs Consultative Committee (DCC) meeting held recently under the Chairmanship of the Drugs Controller General (India) Dr Rajeev Singh Raghuvanshi, has agreed to the proposal.
The proposal as following a letter from the Central TB Division under the ministry of health and family welfare to the Central Drugs Standard Control Organisation (CDSCO) that the patent for bedaquiline and delamanid expired last year leading to its production by multiple pharma companies have started manufacturing the molecule and the drug has been made freely available in the private market. This open market access will have several risks, it added.
To mitigate this risk, it was requested to issue the licenses with conditions for use of bedaquiline, delamanid, pretomanid and rifapentine as per Standards of TB Care in India (STCI) & Conditional access through NTEP. The division also stated that if such a condition is not mentioned in the existing licenses issued to all the current license holders of the drug, it should be modified accordingly.
DCC was also apprised that as these drugs have already crossed more than 4 years and now do not bear the status of a new drug, the SLAs are requested to issue the licenses with condition for use as per Standards of TB Care in India (STCI) & Conditional access through National TB Elimination Programme.
Further, 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 red background.
"DCC after detailed deliberation agreed with the proposal to issue suitable guidance to all the SLAs to uniformly address the issue," said the minutes of the meeting.
DCC also recommended that in case some of the SLAs had already issued the manufacturing licence for such a product, they can issue a separate letter for communicating the above conditions to such manufacturers.
The Union ministry of health and family welfare (MoHFW) has in September, 2024, approved introduction of the much anticipated BPaLM regimen consisting of four-drug combination – bedaquiline, pretomanid, linezolid and moxifloxacin - for multi-drug-resistant tuberculosis (MDR-TB) under the National TB Elimination Programme as a highly effective and shorter treatment option.
The drug regimen includes a new anti-TB drug namely pretomanid in combination with bedaquiline & linezolid (with/without moxifloxacin). Pretomanid has earlier been approved and licensed for use in India by Central Drugs Standard Control Organization. The BPaLM regimen has been proven to be safe, more effective and a quicker treatment option than the previous MDR-TB treatment procedure.
A country-wide time-bound roll out plan of the BPaLM regimen was announced by the Central TB Division of ministry of health & family welfare in consultation with states/UTs, which includes rigorous capacity building of health professionals for safe administration of the new regimen.
While traditional MDR-TB treatments can last up to 20 months with severe side effects, BPaLM regimen can cure the drug-resistant TB in just six months with high treatment success rate. India’s 75,000 drug-resistant TB patients will now be able to avail benefit of this shorter regimen and there will be an overall saving in cost, said the Ministry during the approval.
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