The office of the Drugs Controller of India (DCI) has received 30 applications for new drug molecule approvals during the current year. While DCI has approved three molecules, the rest are under various stages of investigation, it is learnt. The approved drugs are Tritropium (April 2003), Torsamide and Gadovarsitamide (both in June).
The name of the other drugs and its clearance status are as below:
Indocynain Green (CDL testing), Tadalafil (clinical trial report awaited), Modafinil (referred to experts), Cladribine (referred to experts), Zonisamide (referred to experts), Rosuvastatin (clinical trial report received), Levosiminden (information asked), Duloxetin HCL (referred to experts), Alfuzosin (clinical trial asked), Teriparatide (referred to experts), Ezetimibe (clinical trial CDL), Diflucortlan Cream (referred to experts), Miglitol (clinical trial asked), Oxycodon (information asked), Aceclofenac (clinical trial granted), Rebamipide (information asked), Acitretin (clinical trial granted), Etoricoxib (clinical trial granted), Nuvaring Ring (referred to experts ICMR), Lacitol Monohydrat (information asked), Nitazoxanide (information asked), Residronate Sod (referred to experts), Geftinib (under process), Seratrodost (under process), Eplerenone (under process), Orlistat (under process) and Edaravone (under process).
The list comprises of the new drug applications received from January to July 2003.