Mumbai: India’s drugs regulator has written to all state drug commissioners to stick to the 31 July deadline to cancel licences issued by them to drug companies for making and selling oral malaria drug artemisinin. The regulator had earlier alerted the states to phase out this formulation— tablets of artemisinin derivatives such as artesunate and artemether—from the market after the World Health Organization (WHO), in 2006, warned all malaria-affected countries to stop oral treatment regimen using this drug alone due to potential risk of drug resistance.
Dangerous bite: An Anopheles Gambiae mosquito, the most common species in Africa and the primary malaria-causing vector in humans. Eurek Alert / Bloomberg
In the new communication, the Drugs Controller General of India (DCGI) asked the licensing authorities in the states not to issue any new licence for the oral single drug formulation of artemisinin and withdraw the licences granted earlier by the end of this month.
In order to ensure that the malaria parasite does not become resistant to the drug, WHO had recommended withdrawal of oral artemisinin- based therapies. However, it recommends the use of artemisinin in combination with other effective anti-malarials. India’s drug advisory body, the drug consultative committee, had in December approved the phasing out of the drug from the market.
Confirming the latest DCGI note on the drug recall, H.G. Koshia, commissioner, food and drug control administration 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.”
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 WHO or direct channels, and most have already stopped making the product following WHO’s warning on single oral therapy using artemisinin and its derivatives. However, some firms have valid manufacturing licences for these drugs and a few of them—especially the smaller ones—continue to do so though they don’t advertise it.
Ipca Laboratories executive director A.K. Jain said the company had discontinued the oral single formulations of artemisinin three years ago. Themis Medicare, though holding a licence to make the drug, hasn’t been selling it for some time now, said Sumit Mitra, deputy general manager, who heads its global sales.
Artemisinin, an effective anti-malarial medicine extracted from a Chinese herb, is seen as among the most effective drugs to fight malaria which kills at least a million people a year around the world, mostly in Africa.
“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,” says R.B. Smartha, managing director, Interlink Marketing Consultancy Pvt. Ltd, a pharmaceutical marketing adviser in Mumbai.