The Drugs Controller General of India (DCGI) has asked the state drug controllers to immediately cancel the manufacturing licenses of oral single drug formulations of Artemisinin and its derivatives, and also to ensure that no consignment of oral single drugs fonnulations of Artemisinin and its derivatives is exported from India with immediate effect.

The DCGI's order comes in the wake of WHO reports that continued use of Artemisinin derivatives as monotherapy for the deadly disease malaria is one of the main factors which contributes to the development and spread of drug resistance.

The WHO had some time back written to the DCGI stating that there is increasing evidence that the continued use of the Artemisinin derivatives as monotherapy is one of the main factors which contributes to the development and spread of resistance. Resistance to Artestinate was first reported in 2009 in limited geographical area at the Thai-Cambodian border, where Artemisinin have been used alone as monotherapies for many years, especially in the private sector.

Artemisinin based combination therapy is-the first line of treatment for all P. Falciparum malaria cases around the world. Monotherapy with the Artemisinin has been withdrawn in India also.

Earlier, the question of phasing out of oral single drug formulations of Artemisinin and its derivatives from the market was considered in the 39th meeting of the Drugs Consultative Committee held on December 10, 2008 at the DCGI office.  The committee 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agreed that oral single drug formulations of Artemisinin derivatives like Artesunate and Artemether should be withdrawn from the market in a phased manner by July 2009.

However, it has been brought to the notice of the DCGI office that some of the manufacturers are exporting the monotherapies of Artemisinin to other countries, which prompted him to act tough in this regard.

Monotherapy with Artemisinin poses a great threat to global malaria control as resistance in any part of the world can be detrimental to the use of Artemisinin-based Combination Therapy in other parts of the world, the DCGI in its order said.

Alarmed over the emerging situation in this regard, the WHO had recently warned that 'the world risks losing its most potent treatment for malaria unless steps are quickly taken to prevent the development and spread of drug resistant parasites'.

The global plan for artemisinin resistance containment outlines the necessary actions to contain and prevent resistance to artemisinins, which are the critical component of Artemisinin-based Combination Therapies (ACTs), the most potent weapon in treating falciparum malaria, the deadliest form of the disease. Resistance to artemisinins has already emerged in areas on the Cambodia-Thailand border. Although ACTs are currently more than 90% efficacious around the world, quick action is essential. If these treatments fail, many countries will have nothing to fall back on, the WHO warns.