The office of the Drugs Controller General of India has given marketing approvals for 44 fixed dose combinations (FDCs) during June 2005-06. This includes anti-AIDS FDCs like Lamivudine + Abacavir and Lamivudine + Stavudine + Efavirenz. Majority of the FDCs (27) are in tablet form. The increasing number of FDC approvals given by the DCGI is an indication of the increased compliance level among state drug authorities when it comes to non-approval of FDCs, it is felt.
According to official statistics, the approvals have been given to Gatiflozacin + Ornidazole (200+500mg - Tablets), Lamivudine+Abacavir (300mg +600mg - Tablets), Lamivudine + Stavudine + Efavirenz (150mg + 40mg + 600 mg - Combikit), Lamivudine + Zidovudine + Efavirenz (150mg + 300mg +600mg - Combikit), Aceclofenac + Linseed Oil + Methyl Salicylate + Menthol + Capsaicin ( 1.5% +3% + 10% +5% + 0.025% - Gel), Losartan + Atenolol ( 50mg + 50mg - FC Tablets), Nitrazoxanide + Ofloxacin (500mg + 200mg - Tablets), Papain + Urea ( >521700 Units + 100mg - Ointment), Amlodipine + Bisoprolol (5mg + 2.5/5mg - FC Tablets), Ceftriaxone + Tazobactam (0.5/1g + 62.5/125mg - Inj.), Levodopa + Carbidopa +Entacapone (50/100/150mg + 12.5/25/37.5mg + 200mg - FC Tablets), Atorvaststin + Nicotinic Acid (10mg + 375/500mg (ER) - Tablets), Ambroxol + Levocetrizine (75mg SR + 5mg - Capsules), Methylcobalamin + Gabapentin ( 500mcg + 300mg - FC Tablets), Stavudine + Lamivudine (6/12mg + 30/60 mg - Dispersible Tablets), Glimepiride + Pioglitazone + Metformin (1/2mg + 15mg + 500 mg ER - FC Tablets), Calcipotriol + Betamethasone (50mcg + 0.5mg - Ointment), Methylcobalamin + Pyridoxine + Folic Acid (1500mcg (ER) + 20mg (IR) + 5mg (IR) - Tablets), Nimesul;ide + Methyl Salicylate (1% + 5% - Aerosol), Feracrylum + Metronidazole (1% + 1% - Gel), Enalapril + HCTZ ( 2.5/5mg + 12.5mg - Tablets), Tazarotene + Memetasone (0.05%0.1% +0.1% - Lotion), Ambroxol + Desloratadine (75mg SR pellets + 5mg - Capsules), S(-) Metoprolol + HCTZ (25/50mg (ER) + 12.5mg (IR) - Tablets), Stavudine + Lamivudine + Nevirapine (10mg + 40mg +70mg - Dispersible Tablets), Domperidone + Activated Dimethicone (10mg + 125mg - Chewable Tablets), Moxifloxacin + Dexamethsaone (0.5mg W/v + 0.1% w/v - Eye Drops), Brimonidine + Timolol ( 0.5/0.2% + 0.5% - Eye Drops), Olmesartan + HCTZ (20/40mg + 12.5mg - Tablets), Ketorolac Tromethamine + Ofloxacin (Each ml contains: 5mg + 3mg - Ophthalmic Solution), Hyoscine-N-Butyl Bromide + Paracetamol (10mg + 500mg - FC Tablets), Losartan + Amlodipine (50+5mg - FC Tablets), Ceftriaxohe + Sulbactam ( 0.5/1g + 250/500mg - Injection), Tamsulosin + Dutasteride (0.4mg MR pellets + 0.5.mg - Combipack Capsules), Nebivolol + Valsartan (5mg Tab+ 80mg Tab - Tablet), Alendronic acid + Cholecalciferol (70mg + 2800 IU - FC Tablets), Asprin + Clopidogrel (150mg + 300mg - Tablets), S(-) Amlodepine + HCTZ ( 2.5mg + 12.5mg - Tablets), Tenofovir Disoproxil Fumarate + Emtricitabine (300 + 200mg - FC Tablets), Diclofenac Sodium + Misoprostol (50/75mg (EC tab) + 200mcg - Tablets), Pantoprazole + Itopride (40mg EC granules + 150mg SR Pellets - Capsules), Amlodepine + Metoprolol (5mg + 50mg Capsules), Nebivolol + Amlodipine (5mg + 10mg - FC Tablets) and Gatifloxacin + Prednisolone (Each ml contains: 3mg + 10mg - Eye Drops).