DCGI: Cancel licences of those exporting banned malaria drug

New Delhi, 27 Apr: The oral single drug formulation of Artemisinin, having potential to become resistant to malaria, has been withdrawn from India. However, some manufacturers continue to produce and export it as a mono therapy. On Tuesday, the Drug Controller General of India (DCGI) asked the state drug controllers to cancel the licence of such manufacturers with immediate effect. The issue of phasing out Artemisinin and its derivatives was raised in 2008. In November 2010, the World Health Organisation (WHO) alerted the government regarding the continued use of the drug as a mono therapy around Thai-Cambodia border. The DCGI then found out about the export of the drug. In a letter to all state drug controllers, the DCGI has asked them to cancel the licences granted to manufactures with immediate effect and stop the export of Artemisinin as a mono therapy. "In this regard you are directed to ensure that no consignment of oral single drug formulations of Artemisinin and derivatives are exported from India," said the DCGI letter. The WHO in 2006 warned all malaria-affected countries to stop oral treatment regimen using Artemisinin alone due to potential risk of drug resistance.

Indian Express