The recommendations were made during the 66th DCC meeting, held on June 17, 2025, at CDSCO headquarters, New Delhi, under the chairmanship of Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India).
The committee was apprised that the Central TB Division, Ministry of Health and Family Welfare, had informed CDSCO that the patents for Bedaquiline and Delamanid expired last year, after which “multiple pharma companies have started manufacturing the molecule and the drug has been made freely available in the private market.”
This open market access, the Division cautioned, “risks indiscriminate use, potentially increasing cases of treatment failure and resistance to these drugs.”
Conditional Licensing and Mandatory Label Warning Proposed
To mitigate this public health risk, the DCC noted, “It has been requested to issue the licenses with condition for use of Bedaquiline, Delamanid, Pretomanid and Rifapentine as per Standards of TB Care in India (STCI) & Conditional access through National TB Elimination Programme (NTEP).”
Further, the DCC recommended that if existing licenses do not mention these usage restrictions, “it then be modified accordingly.”
The committee also proposed specific labelling standards to limit off-label or unregulated use, “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 box with red background.”
Uniform Guidance to State Licensing Authorities (SLAs)
Since these drugs have now crossed four years of market presence and are no longer considered “new drugs”, the DCC noted that State Licensing Authorities (SLAs) are empowered to issue manufacturing licenses, but must do so with the proposed restrictions.
The committee formally recorded, “DCC after detailed deliberation agreed with the proposal to issue suitable guidance to all the SLAs to uniformly address the issue.”
Moreover, in states where such licenses have already been issued without the proposed condition, the DCC advised that, “They can issue separate letter for communicating the above conditions to such manufacturers.”
The DCC's recommendation comes at a critical juncture for India’s TB elimination mission. While patent expiry and increased production of advanced anti-TB drugs may lower costs and improve availability, unregulated private sector access threatens to erode treatment efficacy.
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