The Central Drugs Standard Control Organisation (CDSCO) has approved 91 new drugs during the current year. Among the approvals are anti-HIV drugs like Tenofovir combinations and various fixed dose formulations of Lopinavir, Lamivudine and Stavudine, Atazanavir and Saquinavir formulations. The latest HIV drug approval came on August 1, for Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet.

The other HIV drugs that got marketing approval during the year are Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet, Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength), Lamivudine 40mg + Stavudine 10mg dispersible tablet, Atazanavir (100/150/200mg), and Saquinavir (500mg) tablet (addl. Strength).

The department has also approved eight hypertension drugs during the last eight months. The drugs are Nebivolol (as HCl) 5mg + Valsartan 80mg, Atenolol 50mg + HCTZ 25mg (addl. Strength), Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg, Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet, Olmesartan (as Medoxomil) 10mg (addl. Strength), Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg, Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. and Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength).

The antibiotic formulations that got CDSCO marketing approval are Cefixime 200mg + Pot. Clavulanate (125mg) tablet, Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength), Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet, Cefditeron (as pivoxil) 200mg tablet, Cefetamet Pivoxil Hcl oral suspension 250mg/ml and Cefprozil Powder for oral suspension (125mg/5ml).


The other drugs and their therapeutic usages that got approval in 2006 are Oxandrolone Tablet (2.5/10mg) (To promote weight gain), Lumiracoxib Tablet (100/200/400mg) (For OA, RA acute pain & primary dysmenorrhoea), Quetiapine S.R tablet 200/300mg.(For psychotic disorder), Amisulpiride Tablet (50/100/200mg) (For schizophrenic disorder), Baclofen E.R capsule (30mg) (spasticity), Forskolin Eye drop (1%) (For open angle glaucoma), Sodium Hyaluronate Injection (1%) (For OA), Clobestasol Propionate ( 0.05%) + Calcipotriol Ointment (0.005%) Ointment (For plaque psoriasis), Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup (For productive cough), Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet (For vitamin C deficiency), Deferasirox dispersible tablet 125/250/500mg (For chronic iron overload due to blood transfusion), Zolpidem Tartrate E.R tablet (6.25mg/12.5mg) (For insomnia), Solifenacin Succinate Tablet (5mg/10mg) (For overactive bladder with urge urinary incontinence urgency & urinary frequency), Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet (Irritable bowel syndrome), Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops ( For reduction of IOP), Buclizine HCl tablet (25mg) & Syrup 6mg/5ml (As appetite stimulant), Levofloxacin 0.5% Ear drops (For otitis media), Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) (As loading dose for prevention of in-stent restenosis in PCI), Methyl Prednisolone Aceponate Cream (0.1%) (For atopic dermatitis), Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg (For iron deficiency anemia), Olopatadine Ophthalmic solution( 0.1%) (for allergic conjunctivitis), Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg) (Anti-epileptic), Icodextrin 7.5% peritoneal dialysis solution (For peritoneal dialysis), Bemiparin Sodium Solution for injection (5000/7500/10,000 I.U) (For deep vein thrombosis), Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream (For dermatoses), Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops (For Ophthalmic use), Cyclosporin Eye drops (0.1%) (addl. Strength) (For Ophthalmic use), Perflutren liquid microsphere injectable suspension (For diagnostic use), Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet (For production cough),Itopride 150mg capsule ( S.R) (For GERD), Ciclesonide rotacaps (200/400mcg) (For Asthma), Oxcarbazepine S.R 450mg/900mg (addl. Strength) (Anti-epileptic), Midazolam (as maleate) 7.5mg/15mg tablet (For insomnia), Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler (For Asthma & COPD), Nadifloxacin Gel 1% (Acne vulgaris), Nicorandil E.R Tablet (10mg/20mg) (Angina Pectoris), Oseltamivir formulation (additional indication) (For Prophylaxis of influenzae in adult and children >14 years of age), Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R (For GERD), D-trans Fentantyl Transdermal patches (For pain), Resperidone Tablet & Syrup (addl. Ind ) (Acute mania & mixed episode in bipolar-I disorder), Doxofylline Syrup (20mg/ml) (For bronchial asthma & COPD), Cholestyramine Powder for oral suspension (4gm/sachet) (For hypercholesterolaemia), Lactulose Enema (20%) (For constipation & hepatic encepthalopathy), Tobramycin Inhalation solution (300mg/5ml) (For chronic pulmonary infection cystic fibrosis), Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial (Chronic congestive heart failure), Eflornithine HCl Cream (139mg/gm) (For reduction of unwanted facial hair in women), Sodium Hyaluronate Cream 0.2% (For leg ulcer, diabetic ulcer etc), Fluorescein Sodium Solution for Injection (100mg/ml) (Ophthalmological diagnostic agent), Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg.(For OA & RA), Atomoxetine 60mg capsule (Addl. Strength) (For ADHD), Levetiracetam Oral Solution (100mg/ml) (Anti-epileptic), Aceclofenac 200mg ( S.R) tablet (NSAID), Desflurane liquid for inhalation (240mg/bottle) (For induction & maintenance of anaesthesia), Voriconazole Powder for oral soluion (40mg/ml) (Anti-fungal), Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) (For replacement therapy in males with Testosterone deficiency), Zanamavir inhalation powder 5mg/blister (For influenzae), Doxofylline Tablet (400mg) (For bronchial asthma & COPD), Ciclesonide Inhaler 80/160mcg per actuation (For persistent Asthma), Pegaptinib Sodium Injection ( 0.3mg) (For neovascular (wet) age related macular degeneration), Dexibuprofen Tablet (200mg/300mg/400mg) (For OA, RA & ankylosing spondylitis), Moxifloxacin Eye Ointment (5mg/gm) (For ophthalmic use), Erdosteine Powder for oral suspension 35mg/ml (For chronic obstructive bronchitis), Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet (For BPH), Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U Vit.D) Tablet (For osteoporosis) and Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 0.5mg (10no.) (For BPH).