The drug controller general of India (DCGI) has asked the state drug controllers to take steps to phase out the anti-malarial drug artemisinin and its derivatives from the market by the end of this month, in line with the recommendations of the World Health Organisation (WHO) and the DCC.
He has asked the licensing authorities not to issue any new license for the oral single drug formulation of artemisinin and withdraw the licences granted earlier. The deadline for phasing out the drug has been put as July 31, according to the letter from DCGI along with the approved minutes of the DCC which recommended the same.
The formulations of artemisinin derivatives, artesunate and artemether have been permitted for manufacture in the country as anti-malarial formulations both as injectable and capsule/tablet form.
"In order to ensure that malaria parasite does not become resistant to the drug, WHO recommended for the withdrawal of oral artemisinin based mon therapies from the market. It however, recommended the use of artemisinin in combination with other effective anti-malarials as artemisinin based combination therapies for the treatment of uncomplicated faciparum malaria," the letter said, adding that DCC meeting in December last approved the phasing out of the drug from Indian market.
A high-level meeting at WHO regional office for South East Asia region in October 2008 on anti-malarial treatment has recommended that the SLAs should withdraw the manufacturing and export licenses for oral atemisinin monotherapies in a period of six months, that is, by July 2009. Following this, the matter came up at the DCC meeting.
"The members after deliberations agreed that oral single drug formulations of artemisinin derivatives like artesunate and artemether should be withdrawn from the market in a phased manner. No new license should be granted for the formulation. Manufacturing licenses granted earlier should be withdrawn by March 2009. The formulations should be phased out from the market by July 2009. DCGI office should issue directive to all state controllers in the matter for uniform compliance in the country," according to the DCC meeting minutes.