The Central Drugs Standard Control Organisation (CDSCO) has approved 23 new drug molecules which are introduced in the country for the first time during the current year. The total number of approvals, if all categories of new drugs are considered, exceeded 600 it is learnt.
The first time approvals given during the current year (2004) are Dutasteride (Dr Reddy's Lab), Gefitinib (AstraZeneca), Imidapril (Elder Pharma), Adefovir (Cipla), Etoricoxib (Cadila Healthcare, Glenmark, Hetero), Diacerein (Elder Pharma), Nitazoxanide (Ind-Swift Ltd), Trolamine (FDC Ltd), Neotame (Nutra Sweet Co. India), Alfuzosin (Ranbaxy Labs Ltd), Tiagabine HCL (Sun Pharma), Ibandronic Acid (Roche Scientific Co India Pvt Ltd), Memantine HCL (Sun Pharma), Pimecrolimus (Novartis India Ltd), Rebamipide (Macleods Ltd), Miglitol (Glenmark), Citicholine (Sun Pharma & Elder Pharma), Everolidmus (Novartis India Ltd), Voriconazole (Pharmacia), Orlistat (Intas Pharma), Deflazacort (Macleods), Duloxetine (Torrent Pharma) and Atomozetine (Torrent Pharma).
According to CDSCO, there are still about 900 new drug applications at various stages of evaluation.
The evaluation of new drug applications is a complex process as per Schedule Y under Drugs & Cosmetics Rules and varies according to the nature of molecule or drug, published data and information furnished by the applicants. Depending upon the nature of the application, it may take on an average 3 to 5 years for an applicant to complete all phase of trials required for approval of investigational new drug. In the case of first time approval of the drug already approved elsewhere but requiring confirmatory clinical trial the time taken could be about 1-3 years. For subsequent applications for already approved drugs, the approval would come within three months.