The Office of the Drugs Controller General of India (DCGI) has given 14 new drug approvals during the current year upto July 2003. The new drugs approved are Cefprozil (Antibiotic), Cilostazol caudication (intermittent), Escitalopram oxalate (Anti depressant), Anastrazole (Anti cancer), Rizapriptan (Anti migrain), Gadobenate (MRI Contrast Medium), Tacrolimus ointment (Immuno-modulator), Metolazone (Diuretic), Tiotropium Bromide (Anti asthematic), Gadoversetamide injection (MRI Contrast Medium), Torsamide (Diuretic), Cyproterone Tablet (Prostatic Cancer), Aripiprazole (Anti schizophrenia) and Bendrofluazide (Diuretic).
The authority had given approvals for 51 new drug molecules in year 2002. The number of SNDAs came to 800 during the year. DCI has informed that any comparison on the number of approvals between the two years is not possible as drug approval involves complex procedures are testing.
The requirements for granting New Drug approval are specified in Rules, 122-A to 122-E and Schedule-Y of Drugs & Cosmetics Rules. The evaluation of new Drugs is a complex process and varies according to the nature of the molecule/drug. Approval process of New Drugs includes examination of chemical and pharmaceutical information, data on pre-clinical/clinical trials for safety and efficacy of the drug generated abroad as well as in Indian population, bio-equivalence study, stability and dissolution study reports, Central Drugs Laboratories Test reports for validation of test protocol and specification of the drug, consultation with experts etc.