In a pioneering move in the global fight against drug resistance, the Central Drugs Control Organisation has started phasing out an anti-malarial drug formation, artemisinin, known to cause drug resistance.
In a pioneering move in the global fight against drug resistance, the Central Drugs Control Organisation (CDCO) has started phasing out an anti-malarial drug formation, artemisinin, known to cause drug resistance.
On April 25, India’s drug controller general Dr Surinder Singh wrote to all state drug controllers asking them to take action against manufacturers/exporters who export derivatives of the drug like artesunate and artemether and cancel their licences with immediate effect.
The oral single drug formation, artemisinin, has been made unavailable in India but is being exported to other countries by Indian pharmaceutical companies. It is however, available in injectible form. Artemisinin-based combination therapy is the first-line treatment for falciparum malaria cases all over the world.
“Monotherapy with arteminisin poses a great threat to global malaria control, as resistance in any part of the world can be detrimental to the use of arterminisin-based combination therapy in other part of the world,” Dr Singh’s letter states.
Joint commissioner of the Food and Drug Administration PR Uttarwar said: “We have stopped the export of the oral drug formation with immediate effect.”
Experts say that artemisinin resistance is seen in patients in India too. “Many general practitioners start the treatment with monotherapy, sometimes before diagnosis of malaria in cases of fever,” said Dr Ira Shah, a paediatric infectious diseases expert practising at Wadia Children’s Hospital and Nanavati hospital.
Dr Om Shrivastav, an infectious diseases expert, said, “Artemisinin is available in combination with lumifantrine. The injectibles are only available in hospitals. Resistance has multiple factors such as partial, incomplete or sub-optimal treatment. If measures are being taken to conserve these drugs, it will be good.”
Dr Hemant Thakker, a consulting physician at Jaslok hospital, said: “Any patient who is treated inadequately, intermittently and incompletely, stands a chance of developing resistance.”
Resistance to the drug was first reported in a limited geographical area on the Thai-Cambodian border, where artemisinin has been used as monotherapy for years, especially by the private sector.
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