Concern of Shortage of Clofazimine Key Leprosy Drug


    In News 

    • Clofazimine, a key drug for the treatment of leprosy, which had been in short supply in the Indian market for several months, is now “not available.


    • It is a fat soluble, brick red dye that is used in combination with other agents in the therapy of leprosy. 
    • Clofazimine is one of the three essential drugs in the MultiDrug Treatment of Multibacillary Leprosy (MBMDT) cases, along with Rifampicin and Dapsone.
    • Clofazimine has shown activity against MultiDrug Resistance Tuberculosis and has been recommended by the WHO to treat drug resistance.

    About Leprosy (Hansen’s Disease) 

    • It is a chronic infectious disease caused by Mycobacterium leprae, an acid-fast, rod-shaped bacillus.
      • M leprae multiplies slowly and the incubation period of the disease, on average, is 5 years. 
      • Symptoms may occur within 1 year but can also take as long as 20 years or even more.
    • It is an age-old disease, described in the literature of ancient civilizations.
    •  The disease mainly affects the skin, the peripheral nerves, mucosa of the upper respiratory tract, and the eyes. 
    • Transmission 
      • It is likely transmitted via droplets, from the nose and mouth, during close and frequent contact with untreated cases. 

    Leprosy in India 

    • India reports more than 1,25,000 new patients of leprosy every year
      • These official numbers apart, another 50,000 to one lakh patients of leprosy are seen at the private clinics of dermatologists all over India. 
    • Leprosy is endemic in several States and Union Territories of India, with the annual case detection rate of 4.56 per 10,000 population. 
    • The prevalence rate of leprosy is 0.4 per 10,000 population in the country. 
      • Of the new cases detected during 2020-2021, 58.1% were multibacillary, 39% were women, 5.8% were children less than 14 years of age, and 2.41% had visible deformities. The rate of visible deformities was 1.1 per million population
    • Treatment 
      • Leprosy is curable and treatment in the early stages can prevent disability.
      • Clofazimine is one of the three essential drugs in the Multi Drug Treatment of Multibacillary Leprosy (MB-MDT) cases, along with Rifampicin and Dapsone. 
        • The currently recommended MDT regimen consists of medicines: dapsone, rifampicin and clofazimine. 
    • WHO response
      • In 2018, WHO reviewed available evidence on key issues related to elimination of leprosy and developed ‘WHO guidelines for the diagnosis, treatment and prevention of leprosy 2018’, recommending  three-drug regimen (rifampicin, dapsone and clofazimine)  to both pauci-bacillary and multibacillary types of leprosy. 
      • The guidelines also introduced prevention of leprosy through single dose of rifampicin for eligible familial and social contacts
    • Governments efforts 
    • The National Leprosy Eradication Programme is a centrally sponsored Health Scheme under the National Health Mission of the Ministry of Health and Family Welfare, Govt. of India.
      • Under the NLEP (National Leprosy Eradication Programme), the government has been ensuring the steady supply of monthly blister packs for 12 months to all the Multibacillary Leprosy cases containing these 3 (rifampicin, dapsone and clofazimine)drugs.