New drug for kala azar

Miltefosine - an oral drug, likely to hit the Indian market soon, is the result of joint efforts by ICMR and some foreign institutions.

A new oral drug for kala azar, one of the neglected diseases that inflict the poorest in countries like India, is likely to hit the Indian market soon, a top World Health Organisation official has said.

The drug, miltefosine, is the result of joint efforts by Indian Council of Medical Research, UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR), and a German company, Zentaris, Dr Rob Ridley, coordinator, product research and development (PRD) told PTI.

Studies on the drug, which is an anti-cancer one, to treat kala azar (leishmaniasis) had been taking place since 1992-93, Ridley said adding, it was being made available on case-by-case basis in India.

'The drug is likely to hit the market in India very soon,' he said. The drug has high efficacy - over 95 per cent - and very little adverse effects, in comparison with the currently available drugs to which the parasite is developing resistance, Ridley added.

'ICMR has been involved in clinical trials, toxicological evaluation, adverse drug monitoring and interatcing with the regulatory boides and the government,' Dr NK Ganguly, ICMR chief, said.

Ganguly said that the use of this drug in treating kala azar through a different mode of action was discovered by TDR. The oragansiation then tied up with ICMR and the German company.

Several trials have taken place for the drug in Bihar and it is currently undergoing phase IV trials, Ganguly said.

It would have a special price for public use in India.

Most of the drugs for kala azar are given as intra-veinous infusion, are costly, require long treatment regimes and are becoming more and more ineffective, Ridley said. This has necessitated the use of more toxic drugs.

The phase III clinical trials on another new drug for kala azar, 'Paromomycin', were also likely to start soon under a new initiative called Drugs For Neglected Diseases Initiative (DNDi), which has ICMR as a partner besides four other eminent public research institutes and a Noble-prize winning body working in the area of health across the world.

Preliminary results are 'promising', Ridley said adding, phase III trials would take about an year while phase I and II studies have already been done. The work was taking place in India, South America and Africa, he said.

The drug is injectible and the aim was to get an efficacy of over 90 per cent, Ridley said.

Currently there are about 84,000 cases of kala azar in Bihar. The disease also affects people in West Bengal and eastern UP.

The symptoms of leishmaniasis include fever, weight loss, and swelling of spleen, liver and lymph nodes in the visceral form.