Acute shortage of clofazimine, a key drug for the treatment of leprosy, in the private sector has left doctors worried.
Fearing the worst for their patients, doctors have written to the Union Health Ministry seeking its urgent intervention and immediate restoration of the supply of the medicine.
“The medicine is readily available in the government sector (government hospitals and primary health care 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 Venereologist & Leprologists, said.
Dinesh Kumar, secretary-general of the association, added that India reported more then 1,25,000 new patients of leprosy every year.
“These official numbers apart, another 50,000 to 1 lakh patients of leprosy are seen at 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 added.
According to World Health Organization, 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, in its letter to the Ministry, said that clofazimine is needed not just for therapy or cure of leprosy, but also to control acute exacerbations of this disease, which occur frequently.
“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 NLEP [National Leprosy Eradication Programme], 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,’’ it added.
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 noted.
It said clofazimine had shown activity against multidrug-resistant tuberculosis (MDR TB) and had been recommended for its treatment by the WHO.
It added that many leprosy cases require extended treatment beyond the government supply of 12-18 months. Blister packs may also be lost/ misplaced/ damaged. In such cases, medicines might need to be procured privately.
The doctors said that though the other two drugs were easily available, the non-availability of clofazimine had created a dangerous situation as all the three drugs have to be given together to prevent drug-resistant (DR) 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 jeopardises the health of these patients,’’ the Association said.
