India Pharma Outlook Team | Monday, 10 November 2025
The Indian Pharmacopoeia Commission (IPC) intends to work on monographs and quality standards of three important TB drugs, such as delamanid, pretomanid and a fixed-dose combination (FDC) of rifapentine and isoniazid.
This action follows a co-stakeholder meeting with NITI Aayog and the Central TB Division (CTD) to facilitate the increased efforts in the control of TB in India.
The meeting was organized by IPC and its main two purposes were to enhance the quality of the anti-TB medicines and promote their rational use to save lives.
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Professionals analyzed existing monographs to suggest any amendments in accordance with the changing medical needs. The rifapentine-isoniazid FDC is very crucial in the treatment and prevention of TB, especially during the 12 weeks, once a week, giving of the drug in the case of latent TB infection (LTBI). On the contrary, the nitroimidazole drugs delamanid and pretomanid are involved in the treatment of TB strains that are resistant.
Delamanid is licensed to treat multidrug-resistant (MDR) TB whereas pretomanid is taken to treat extensively drug-resistant (XDR) TB or patients who fail to respond to standard MDR-TB treatment. Such updates have been made in line with the intention of providing data on adverse drug reactions (ADRs) on anti-TB drugs to IPC via the Pharmacovigilance Programme of India (PvPI), which is interconnected with the Nikshay platform.
IPC operates 1,120 ADR Monitoring Centres (AMCs) across India today. Through collaboration with the National Tuberculosis Elimination Programme (NTEP), and the international community, including the WHO, IPC continues to be at the forefront of providing quality and safety in TB treatment in the country.
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