Indian Authorities Asked To Stop Licensing Artemisinin-Only Malaria Drugs

The Drugs Controller General of India (DCGI) asked state drug licensing authorities to avoid authorizing new licenses for single drug formulations of artemisinin and withdraw existing licences for these types of drugs by the end of this month, reports. To prevent drug resistance, the WHO has advised against the use of drugs that only contain artemisinin to treat malaria and recommends using artemsinin in combination with other drugs. “India’s drug advisory body, the drug consultative committee, had in December approved the phasing out of the [artemisinin only] drug[s] from the market,” writes.

H.G. Koshia, the commissioner of the food and drug control administration for the state of Gujarat, said, “The state department has received the last directive in this regard a couple of weeks ago, and we have already informed all existing licence holders to stop manufacturing. The brand recalls from the market is also in progress, though there aren’t many at present.”

According to “Ipca Laboratories Ltd., Themis Medicare Ltd., Plethico Pharmaceuticals Ltd., GVS Laboratories Ltd., Cipla and Lupin Ltd. are some of the top firms in the domestic anti-malaria market. These are also key suppliers to overseas markets through [the] WHO or direct channels, and most have already stopped making the product following [the] WHO’s warning on single oral therapy using artemisinin and its derivatives.”

R.B. Smartha, the managing director of Mumbai-based Interlink Marketing Consultancy Pvt. Ltd., said, “The impact of the DCGI order would not be big for the industry as the market for oral single formulation of artemisinin derivatives has already shrunk” (Pandeya/Unnikrishnan, 7/22).

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