Nov. 05--India may soon ban the use of artemisinin as a stand-alone drug to treat malaria, but will allow it to be used in combination with other medicines.
The move by the drug controller general of India comes four years after the World Health Organization (WHO) cautioned against the use of artemisinin as monotherapy--when a single drug is used in any treatment--because patients develop resistance to it very quickly.
"The unregulated use of artesunate monotherapy will allow artemisinin-resistant strains of falciparum malaria (a deadly strain) to emerge and spread. That would weaken the last effective anti-malarial (drug) we have," said Leena Menghaney, campaign co-ordinator, Medecins Sans Frontieres' Access Campaign India. "So, it is crucial that the WHO recommendation be implemented strictly with private healthcare providers."
The drug regulator had previously directed state governments to stop distributing artemisinin. But states are not required to follow such orders, and it had little impact.
"There are so many states that it is difficult to track which ones are following the order and which are not. So, we have decided to make the ban official and get it notified," said an official at the Central Drugs Standard Control Organisation.
The official, who did not want to be identified, said the decision was taken on the basis of WHO's recommendation. If resistance to the drug becomes widespread, there will be no medicine left to treat malaria effectively, the official added.
The decision on the conditional ban awaits the health ministry's approval and could take up to six months to come into effect.
In November 2006, India had recorded 1.04 million cases of malaria and 890 deaths, according to the National Vector Borne Disease Control Programme.
A recent study published in the Lancet medical journal pegged the annual number of malarial deaths in India at 200,000 every year compared with WHO's estimate of 15,000.
According to WHO, the shift from failing drugs to the highly effective artemisinin-based combination therapies (ACTs) has been a breakthrough. Appropriate treatment with ACTs succeeds in more than 90% cases.
But drug resistance threatens these gains. In 2009, the WHO said monotherapy fosters resistance because it is easier for the parasite to adapt and eventually overcome obstacles presented by a single drug than by a combination of drugs.
"The use of combination therapy to reduce the risk of resistance has been demonstrated in several disease areas, including tuberculosis and HIV/AIDS," said a member of a health organization who works with malaria patients, asking not to be named. "The beauty of artemisinin is that, when given in combination with other drugs, it can cure malaria in three days flat."
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