India Pharma Outlook Team | Friday, 27 June 2025
The Indian government is set to limit open market access to key anti-tuberculosis medicines in order to contain misuse of critical medications that could lead to the emergence of drug resistance.
This measure comes in light of the expiry of patents on key anti-tuberculosis medicines—Bedaquiline, Delamanid, Pretomanid, and Rifapentine—following the introduction of generic versions of these drugs.
Meanwhile, the Central TB Division raised alarm bells about the unregulated use of these medicines outside the National TB Elimination Programme (NTEP) on the premise that misuse or oversights of these lifesaving medicines could lead to treatment failures, and thus lead to drug resistance. More than one expert explained that bringing these drugs into uncontrolled use could be one of the worst outcomes of the TB programme. In response, the Drugs Consultative Committee (DCC) recommended regulatory action that limited the unregulated distribution of these medicines.
Under this framework, manufacturers will be required to comply with the Standards for TB Care in India (STCI) in order to receive a manufacture license for these medicines. These particular medicines will be restricted to the NTEP program to limit the distribution of product.
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Additionally, to further restrict and control the unregulated use of these medicines, manufacturers will be required to label their packaging with the prominent language "For use in NTEP," in red font. The DCC also recommended to the Central Drugs Standard Control Organisation (CDSCO) to issue uniform guidance, so that all State Licensing Authorities make these conditions mandatory for all new license by new manufacturers or current license by any existing manufacturer of these drugs.
Ultimately, this initiative will be to protect these key TB medicines from misuse, due to their critical importance to preserve patient health or quality of life.
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