Nicholas Piramal to launch drug for malaria

Mumbai-based Nicholas Piramal India Ltd. will introduce a new anti-malarial drug bulaquine in April 2000. It''s called bulaquine.

Bulaquine is the original research molecule developed by the Lucknow-based Central Drug Research Institute, or CDRI. It is understood to be a derivative of primaquine, a drug known to be effective in the treatment of plasmodium falciparum malaria.

Nicholas Piramal has bagged the marketing rights for the drug and has agreed to pay one-time know-how fees for technology transfer and a percentage of sales as royalty to CDRI, say company sources. The drug will be manufactured at Nicholas Piramal’s formulation facility at Pithampur in Madhya Pradesh.

The marketing pact is a culmination of an agreement that Nicholas Piramal had signed with CDRI way back in 1994 for funding anti-malarial research projects, according to an industry expert.

Bulaquine has been found to be particularly useful against P falciparum parasite, says a company source. However, its efficacy compared to primaquine is not known.

Plasmodium falciparum malaria is the most fatal among all types of malaria. It is responsible for all cases of mortality and most of the morbidity in the world. Around 2 million cases of P falciparum malaria are reported every year around the world.

Clinical trials of bulaquine are currently on at four different centres in India. Nicholas Piramal officials feel that bulaquine has the potential to replace chloroquine since increasing cases of drug resistance have been reported with chloroquine.

A study carried out by the Clinical Pharmacology and Research Services Unit of King Edward Medical College, Mumbai, confirmed the existence of chloroquine resistance in P falciparum cases in Mumbai with five per cent incidence to the full dose of chloroquine. Medical experts feel resistance to chloroquine may be much higher since most such cases are not reported.

Moreover, chloroquine is mostly effective against malarial parasites present in the blood stream and does not tackle parasites present in the liver. This often leads to relapse, say medical experts.

Bulaquine, on the other hand, is effective in eliminating parasites present in the liver as well as in the blood stream, says a Nicholas Piramal marketing official.

Bulaquine is the second anti-malarial product from CDRI. The first was a plant-based compound, arteether, derived from Artemisia annua. The drug is marketed under the brand name E Mal.

India''s battle against malaria has seen major ups and down. The disease was nearly eradicated in the early 1960s but has re-emerged as a major public health problem.

If a shortage of DDT was the major problem with malaria eradication in the 1960s, the disease''s resurgence in the 1970s was the result of technical, financial and operational problems, notes V P Sharma in the Indian Journal of Medical Research.

As many as 6.45 million cases of malaria were recorded in 1976 by the National Malaria Eradication Programme, the highest since its resurgence. Following the implementation of the Urban Malaria Scheme in 1971-72 and the Modified Plan of Operation in 1977, malaria cases were reduced to 2 million. However, these two programmes had their impact mainly on vivax malaria. Since the 1970s P falciparum cases showed a steady upward trend.

In 1977, the Plasmodium falciparum Containment Programme was launched to contain the spread of falciparum malaria in areas where the containment programme was operated. But its general spread has not yet been contained.