Pharmexcil Asks IPC To Delete Artemisinin From Indian Pharmacopoeia.

The Pharmaceuticals Export Promotion Council (Pharmexcil) has asked the Indian Pharmacopoeia Commission (IPC) to delete Artemisinin from Indian pharmacopoeia as none of the Indian companies which are marketing Artemisinin derivative drugs are formulating Artemisinin as a drug.

Pharmexcil executive director Dr P V Appaji, in a letter to the IPC secretary-cum-scientific director Dr G N Singh, said that Artemisinin is being used as an intermediate to manufacture the drugs like Artesunate, Artemether and Arteether (the artemisinin-derived drugs) and none of the Indian companies which are marketing Artemisinin derivative drugs are formulating Artemisinin as a drug.

Besides, none of the Indian brands like Larither, Paluther and Malther have Artemisinin as such as an ingredient, but only carry derivatives of Artemisinin, it said.

Driving home its point to delete Artemisinin from Indian Pharmacopoeia (IP), Pharmexcil said that Artemisia annua (sweet wormwood), the plant from which artemisinin comes, has to be grown and extracted. Artemisinin is a sesquiterpene endoperoxide lactone form of Artemisia annua. Artemisinin lacks bioavailability and is poorly soluble in water and oil. It has short elimination half life. Because of its poor oral availability, artemisinin is not used directly anymore but modified into derivatives like dihydroartemisinin, artemether and artesunate and arteether.

Thus, the drugs that are used are Artesunate, Artemether and Arteether. All these three drugs are also listed in Indian Pharmacopoeia (IP). It is to be noted that Artemisinin is still listed in Indian pharmacopoeia 2010.

“Based on the facts and all above information, it is logical to delete Artemisinin from the Indian Pharmacopoeia,” Dr Appaji in his letter said.

He further said that the World Health Organization (WHO) has already urged regulators to stop marketing of oral artemisinin-based monotherapies and to promote access to Artemisinin-based Combination Therapies (ACTs).

In fact, in the middle of the year 2009, Drugs Controller General of India (DCGI) had ordered all state drug regulators to phase out all oral single drug formulations of artemisinin and its derivatives.

“In view of the above, it is necessary to exclude artemisinin as a drug from Indian Pharmacopoeia,” Dr Appaji in his letter said.

Earlier in April this year, the DCGI had asked the state drug controllers to immediately cancel the manufacturing licenses of oral single drug formulations of Artemisinin and its derivatives, and also to ensure that no consignment of oral single drugs fonnulations of Artemisinin and its derivatives is exported from India with immediate effect.

The DCGI's order came in the wake of WHO reports that continued use of Artemisinin derivatives as monotherapy for the deadly disease malaria is one of the main factors which contributes to the development and spread of drug resistance.

Source : pharmabiz.com