The Drugs Controller General of India has approved 24 new drugs during the current year. While Sun Pharma got four of their applications cleared, it was three each for Cipla and Glenmark. Microlabs, Ranbaxy and Hetero received two new drug approvals each during the period until October 2003.
The clearances given to Sun Pharma were for Aripiprazole (anti-schizophrenia), Escitalopram Oxalate (anti-depressant), Metadoxine (chronic intoxication of alchohol) and Rosuastatin Calcium (hypercholesterolaemia). Glenmark got approvals for marketing Cilostazol (for intermittent claudication), Tacrolimus Oinment (immuno-modulator) and Tazarotene (plague psoriasis and acne vulgaris). In the case of Cipla the approvals were for Cyproterone Tablet (for prostatic cancer), Rizapriptan (anti-migraine) and Tiotripium Bromide (anti asthematic).
Ranbaxy and Hetero have been allowed to market Cefprozil (antibiotic) and Imepenem + Cilastatin, and Dorzolamide (glaucoma/ocular hypertension) and Terenderapil respectively. Microlabs received approvals for azelaic acid and Torsamide (diuretic).
The other companies and their products are Intas (aceciofenac - analgesic anti-inflammatory), Astra Zeneca (anastrazole - anticancer), Unichem (bendrofluazide - diuretic), Orchid (cefprozil), Torrent (escitalopram oxalate - antidepressant), Cadila (metolazone - diuretic), Emcure (S-atenoiol) and Eli Lilly (tadalafil - erectile dysfunction).
On import registrations front, the DCGI has approved 61 bulk drugs and 28 formulations during the last one-month (Sep 15 to Oct 15). While 22 of the bulk drugs cleared are to be imported from France, 15 are from China. Bulk drugs from Korea and Switzerland have also been cleared during the period.