Clofazimine, a key drug for treatment of leprosy, which had been in short supply in the Indian market for several months, is now “not available”, with the situation turning into a crisis over the past three months. Fearing the worst for their patients, doctors have written to the Health Ministry for urgent intervention and immediate restoration of medicine’s supply in the private sector.
“The medicine is readily available in the government sector [government hospitals and Primary Health Centres]. It is in the private sector that the shortage is being felt and we request the government to help overcome this problem,’’ Rashmi Sarkar, president, Indian Association of Dermatologists, Venereologists and Leprologists, said.
The Association’s secretary general, Dinesh Kumar Devaraj, added that India reports more then 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. Alternative three-drug regimens without Clofazimine are very costly and often not feasible. Leprosy is still a dreaded disease with potential risk of transmission,’’ Dr. Devaraj said.
According to World Health Organization (WHO), 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
The Association has written to the Ministry stating that Clofazimine is needed not just for the therapy/cure of leprosy, but also for controlling acute exacerbations of this disease, which occur frequently.
The Association noted: “Clofazimine is one of the three essential drugs in the Multi Drug Treatment of Multibacillary Leprosy (MB-MDT) cases, along with Rifampicin and Dapsone. 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 drugs. But, the present market crisis of Clofazimine is seriously affecting the Indian Leprosy Treatment scenario.’’
In the absence of Clofazimine in the market, dermatologists and leprologists are also facing a serious challenge in treating leprosy patients who want private treatment.
“In this decade, when India is fighting to eliminate the disease, easy availability of essential drugs like Clofazimine is crucial not only in government set ups but also with distributors and in pharmacies from the public health point of view,” the Association said.
Also, Clofazimine has shown activity against Multi Drug Resistance Tuberculosis and has been recommended by the WHO to treat drug resistance, the Association explained in its letter.
It added that many leprosy patients require extended treatment beyond the government’s supply of 12-18 months. Blister packs may also be lost, misplaced or damaged. In such cases too, medicines might need to be procured privately.
Doctors have said that though the other two drugs are very easily available, non-availability of Clofazimine is a dangerous situation as all three drugs have to be given together to prevent drug resistant leprosy.
“A very crucial area where Clofazimine is important, and the provision of which is not laid down in NLEP, is in the management of Type II Lepra reactions: extremely painful, disabling and long recurring conditions in many leprosy patients. Though steroids are the mainstay of management, considering the health hazards of long-term steroids, Clofazimine is being used by dermatologists and leprologists across India to bring down steroids or sometimes added if standard doses of steroids are not able to control the reactions. Clofazimine unavailability seriously jeopardizes the health of these patients,’’ the Association said.
