DCGI flags illegal sales of single-drug malaria pills, seeks urgent action

Subscribe to enjoy similar stories. New Delhi: India’s drug regulator has raised an urgent red flag over a threat to the country’s most effective malaria medicines, directing all state drug controllers to immediately trace and stop the manufacturing and sale of oral single-drug artemisinin formulations, the active ingredient used in the country's most potent malaria drugs, two officials said, citing an 8 December order seen by Mint.

The Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi noted that despite a nationwide ban since 2009, some producers are still suspected of selling these formulations in violation of global protocols and advisories of the World Health Organization (WHO). The issue is pertinent because using artemisinin alone accelerates resistance and risks undermining the "gold-standard" therapies that India relies on to treat the deadly plasmodium falciparum strain of the mosquito-borne disease.

The latest directive serves as a stringent reminder of a decision originally taken nearly two decades ago to protect the efficacy of life-saving medicines. The WHO has long warned against using this drug by itself in pill form, in a treatment known as ‘monotherapy’.

Following the 2009 domestic ban, the DCGI had issued an order in 2011, cancelling manufacturing licenses for exports to curb global resistance. The latest directive reinforces the earlier orders to close any remaining regulatory gaps.

In his letter to state and Union territory drug controllers, the DCGI said that in order to ensure the malaria parasite does not become resistant to the drug, the WHO had recommended the withdrawal of oral single-drug formulations of artemisinin and its derivatives. An official explained that the oral