Kala azar drug to be released

Published: Wednesday 30 April 2003

There is some good news for the thousands of people who get affected by kala azar (visceral leishmaniasis) in India. A new drug is being soon introduced in the market by German Remedies, a subsidiary of Ahmedabad-based Zydus Cadila. Miltefosine -- the drug -- is better than the existing cures because it can be taken orally. Currently used treatments based on antimonial compounds or amphotericin B have to be administered through injections.

Kala azar is transmitted by the sand fly. India accounts for 50 per cent of the worldwide cases of the disease. It is most prevalent in Bihar, Jharkhand, Uttaranchal, Uttar Pradesh and West Bengal. Eradication methods have successfully brought down the disease incidence by 80 per cent -- from 77,000 cases in 1992 to 14,000 cases in 2002.

In 1995, Zydus Cadila signed an agreement with the World Health Organization (who) for the clinical development of miltefosine. The safety of the drug has been shown through phase IV trial carried out at public and private clinics of Bihar. The trial was conducted on 1,200 patients, with a six-month follow-up to test efficacy and safety, and a 1.5-year follow-up to assess effects on the male reproductive system.

Miltefosine may soon be included in the kala azar eradication programme of the New Delhi-based National Anti Malaria Programme. The drug has also been given concessions in custom duty by the Union government.

Initially, the drug was developed as an anti-cancer drug by Germany-based asta Medica in collaboration with Max-Planck-Institut. The drug inhibits the process of signal transmission between cancer cells, thus preventing the spread of the disease. But high doses of the drug are required, that too for a long time period. This leads to many side-effects.

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