Leprosy Multidrug Therapy
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Direct answer
Since 1 April 2025, India's National Leprosy Eradication Programme treats every newly diagnosed leprosy patient with a uniform three-drug regimen of rifampicin, dapsone and clofazimine — paucibacillary cases for six months and multibacillary cases for twelve — replacing the older scheme in which paucibacillary patients received only rifampicin plus dapsone. Rifampicin 600 mg once monthly under supervision is the keystone bactericidal dose, dapsone 100 mg daily is the cheap workhorse with haematological and hypersensitivity risks, and clofazimine, long restricted to multibacillary disease, now reaches everyone, with its familiar red-brown pigmentation and ichthyosis. The change, aligned with WHO recommendation and India's target of interrupting transmission by 2027, simplifies logistics and reduces the risk of dapsone resistance.
What you must remember
- The classical regimens that textbooks and older MCQs still quote: paucibacillary disease (up to five skin lesions, smear negative) — rifampicin 600 mg monthly plus dapsone 100 mg daily for 6 months; multibacillary — rifampicin 600 mg monthly, clofazimine 300 mg monthly plus 50 mg daily, and dapsone 100 mg daily for 12 months.
- The 2025 Indian change: both groups receive all three drugs — an MB-style regimen for everyone — with durations of 6 months (PB) and 12 months (MB); know both schemes because exams lag programme reality.
- Rifampicin is the most powerful bactericidal agent, rendering a patient essentially non-infectious after the first supervised monthly dose — the fact that underpins "no isolation needed for leprosy".
- Clofazimine: red-black skin discolouration and conjunctival pigmentation, dry ichthyotic skin, and gastrointestinal complaints; it is anti-inflammatory and somewhat protects against type 2 reactions.
- Dapsone: dose-dependent haemolysis and methaemoglobinaemia (worse in G6PD deficiency), and the idiosyncratic dapsone hypersensitivity syndrome — fever, rash progressing to exfoliation, hepatitis, lymphadenopathy and eosinophilia — which demands immediate withdrawal and steroid support.
- Single-lesion paucibacillary disease was historically treated with a single dose of ROM (rifampicin 600 mg, ofloxacin 400 mg, minocycline 100 mg) — an older, now largely superseded option still asked in exams.
- Patients are declared "released from treatment" when the course ends, not "cured" on the day; residual skin lesions may fade slowly, and fixed-duration therapy needs no smear monitoring to stop.
- Relapse (new lesions appearing after years, with bacillary return on smears) must be distinguished from lepra reactions — inflammatory flares in existing lesions, type 1 reversal or type 2 erythema nodosum leprosum — which are treated with corticosteroids and thalidomide respectively, and never by changing MDT.
How to work through treatment decisions
A 30-year-old man has three hypopigmented anaesthetic plaques on the back and thigh, with a thickened ulnar nerve and slit-skin smears negative for bacilli — paucibacillary disease under any classification. Under the regimen in force since April 2025, he still receives the three-drug kit: daily self-administered dapsone 100 mg and clofazimine 50 mg, with monthly supervised rifampicin 600 mg plus clofazimine 300 mg, for six months. Contrast a woman with a dozen infiltrated plaques, glove-and-stocking numbness and a positive smear — multibacillary, twelve months of the same three drugs. Her household contacts, in addition, are offered post-exposure prophylaxis under the programme — historically a single dose of rifampicin, with the ROM combination used in some settings — a contact-management point worth half a mark. Before starting therapy in any patient, ask three safety questions: G6PD status or prior haemolysis (dapsone), pregnancy and skin colour concerns (clofazimine pigmentation is reversible but slow), and jaundice or rifampicin interactions (it induces liver enzymes and renders oral contraceptives unreliable). During therapy, counsel on the three expected events: red discolouration of urine after rifampicin, gradual skin darkening from clofazimine, and the possibility of a reaction in the first months — a reaction means adding anti-inflammatory treatment, never stopping MDT, because stopping chemotherapy invites resistance while the reaction is immunological, not failure of the drugs. At completion, document nerve function and review annually, since reactions and quiet neuropathy can occur after release from treatment.
Where students slip
The trap set for 2026 candidates is precisely the transition: an exam question asking the regimen for a paucibacillary case has two defensible answers, and the candidate who writes "rifampicin and dapsone for six months" without noting the April 2025 uniform three-drug change looks out of date, while one who writes only "three drugs for all" without durations is incomplete — the safe viva answer names both the current programme regimen and the classical one it replaced. The second slip is the reaction-versus-relapse confusion: new tender red plaques with fever during treatment are erythema nodosum leprosum, treated with thalidomide or steroids, whereas quietly appearing new anaesthetic lesions after treatment completion suggest relapse or re-infection. Third, students stop MDT to treat reactions — exactly wrong — and forget that rifampicin's monthly supervised dose is what makes the public-health claim of immediate infectiousness reduction true.
Frequently asked questions
What is India's current leprosy treatment regimen?
Since 1 April 2025, a uniform three-drug MDT of rifampicin, dapsone and clofazimine for all patients — six months for paucibacillary and twelve months for multibacillary disease — replacing the two-drug paucibacillary course of older guidelines.
What are the classical monthly and daily MDT doses in multibacillary disease?
Rifampicin 600 mg once monthly supervised with clofazimine 300 mg monthly, plus daily self-administered dapsone 100 mg and clofazimine 50 mg, continued for twelve months.
Which drug toxicities must be monitored during MDT?
Dapsone haemolysis and methaemoglobinaemia with the dapsone hypersensitivity syndrome; clofazimine skin and conjunctival pigmentation with ichthyosis; and rifampicin-related hepatitis, enzyme induction and drug interactions including oral contraceptive failure.
Why is a leprosy patient considered non-infectious soon after starting treatment?
The single supervised monthly rifampicin dose is profoundly bactericidal, killing the overwhelming majority of viable Mycobacterium leprae rapidly, so segregation is unnecessary and family contact can continue.
What is single-dose ROM and when was it used?
Rifampicin 600 mg, ofloxacin 400 mg and minocycline 100 mg given once for single-lesion paucibacillary leprosy under older guidance — historically convenient, now superseded by the uniform three-drug approach.