The office of the Drugs Controller General of India (DCGI) has given marketing approvals for 40 fixed dose combinations since January 2002. While Torrent Pharma received seven approvals, Glenmark got six, followed by Cipla and Emcure (four each). The DCGI has also cleared 88 new drug applications during the period.
The products and the corresponding companies who received the approvals during the period January 2002 and November 2003 are Mometasone furoate + Terbinafin (Ranbaxy), Rosiglitazone + Metformin (Torrent, Glenmark), Mosapride + MPS (Intas, Ontop), Formeterol + Budesonide (Cipla Ltd), Butenafine + Betamethasone (Glenmark), Amlodipine + Benazapril (Cipla), Sucralfete + Metronidazole (Starssenburg Pharma), Glycapyrrolate + Neostigmine (Neon Lab), Betamethasone + Salicylic acid (Ontop), Mefenamic acid + Tizanidine (Blue Cross), Latanoprost + Timolol (Pharmacia India), Tobramycin + Fluromethalone (M J Pharma), Betamethasone + Gentamicin (Ontop Pharma), S Amlodipine + Atenolol (Emcure), S Amlodipine + Losartan (Emcure), Pioglitazone + Glimeperide (Ranbaxy), Glimeperide + Metformin (Torrent), Rosiglitazone + Glimeperide (Torrent), Tramadol + Paracetamol (Cadilla), Ramipril + s(-) Amlodipine (Torrent), Olanzapine + Fluoxetine (Sun), Ciprofloxocin + Ornidazole (Panacea), Quinapril + HCTZ (Cipla), Aspirin + Dipyridamole (Intas), Cyproterone + Ethinyl Estradiol (Cadila), Pioglitazone + Glimeperide (Glenmark), S Amlodipine + Lisinopril (Emcure), Valsartan + HCTZ (Novartis India), Montelukast + Bambuterol (Okasa), Adapeline + Clindamycin (Glenmark), Ramipril + Candisartan (Okasa), Telmisartan + HCTZ (Glenmark), Rofecoxib + Tizanidine (Torrent), Losartan + Ramipril (Unichem), Rofecoxib + Paracetamol (Torrent), Lamivudine + Zidovudine + Abacavir (Cipla, Hetero), Nadiflloxacin + Clobetasol (Wockhardt), Lercanidipine + Atenolol (Glenmark), S Amlodipine + Valsartan (Torrent) and S Atenolol + S-Amlodipine (Emcure).
Of the 88 new drug approvals, the recent ones are the clearances given to Roche for marketing Valgancyclovir (CMV drug), approval to Galderma for Amoroifine (anti-fungal) and the ones given to Novartis India for Isopropyl Unoprostone (Opthalmic) and Fluvastatin Sodium (Lipid lowering agent).