Programmatic Addition of Clofazimine to Multidrug Therapy for Paucibacillary Leprosy in India: A One-Size-Fits-All Approach in Absence of Sound Clinical Evidence.

Abstract

In 2024, the Indian National Leprosy Eradication Program released Revised Treatment Guidelines for management of paucibacillary (PB) leprosy, introducing clofazimine into the existing PB multidrug therapy (PB-MDT). This treatment simplification has a dubious scientific basis and serious long-term implications. Notably, this policy shift is derived from WHO guidelines (2018), which issued only a conditional recommendation for uniform-MDT, relying on very low-quality evidence to support the change. We reviewed the studies cited in support and found multiple methodological shortcomings, including insufficient samples, lack of blinding, and unvalidated outcome measures. This significantly undermines the justification for incorporating clofazimine into PB-MDT. Leaving these limitations unaddressed could lead to unintended consequences, including increased drug resistance, higher treatment costs, and adverse drug effects, further complicating disease management. Such a fundamental policy revision should be preceded by rigorous, field-level research, preferably a multicentric, triple-blind superiority trial, alongside establishing surveillance for clofazimine resistance.