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List of new drugs cleared by the Drugs Controller General India, New Delhi. In view of provisions under part X-A of the Drugs and Cosmetics Rules, 1945 a new drug for clinical trials or marketing can be imported of manufactured only in accordance with the permission granted by the Drugs Controller General India who is the Licensing Authority under Rule 21 of the Drugs and Cosmetics Rules, 1945. New drugs is defined under Rule 122E of the Drugs and Cosmetics Rules, 1945 by virtue of explanation to the Rule 122E, all vaccines are considered as new drugs. However, the Licensing Authority under Rule 21 has the power to certify that a particular vaccine shall not be considered as new drug. A new drug cleared by the DCGI shall continue to be a new drug for a period of 4 years from the date of approval or its inclusion in Indian Pharmacopoeia whichever is earlier.
| Sr. No. | Name of Drug | Pharmacological Classification / Indication | Date of Approval | | | | 1969-1974 | | | | | | | Methylsulphadiazine Sulpha Drug 2. Amantadine HCl For Parkinsonism 3. Aprotinin Acute Pancreatitis 4. Azathioprine Cytotoxic agent 5. Beclomethasone Dipropionate Topical Corticosteroid 6. Betamethasone Benzoate Topical anti-inflammatory steroid 7. Biperlden HCl For Parkinsonism 8. Bitoscanate Anthelmintic 9. Bleomycin Anti-cancer 10. Bronopol (2-Bromo- 2-nitroproman-1, 3-diol) Preservative 11. Bupivacaine HCl Local analgesic 12. Carbenicillin Sodium Antibiotic 13. Carbenoxolene Sodium Gastric Ulcer 14. Cephalexin Broad Spectrum antibiotic 15. Clorazimine Anti-leprosy drug 16. Cyclandelate Vasodilator 17. Daunorubicin Anti-cancer 18. Desamino-Oxytocin Indicated in the treatment of induction of labour for various reasons and for adequate uterine 19. Dimethothrazine Anti-histaminic 20. Dimethylpolysiloxane Skin protective cream 21. Diphenoxylate HCl Anti-diarrhoeal agent 22. Doxepin HCl Psychotic drug 23. D-Penicillamine Metallic Poisoning 24. Epicillin Antibiotic 25. Ethacridine Lactate Anti-diamhoeal agent 26. Ethacranic acid Non-thiazide seluretic diuretic 27. Fenfluramine HCl Glycoliptic agent 28. Fluphenozine Decanoate Anti-psychotic 29. Glibenclamide Oral anti-diabetic 30. Clomiphene Citrate Fertility drug 31. Hydroxyurea Antineoplastic agent 32. Ibuprofen Non-steroidal anti-rheumatic compound 33. Ketamine Non-barbiturate anaesthetic 34. L-Asparginase Anti-cancer 35. L-Dihydroxyphenylalanlne Anti-parkinsonism drug 36. Lidoflazin Coronary Vasodilator 37. Lithini Carbonate Esychstric Drug 38. Lorazepam Psychiatric drug 39. Mebendazole Broad spectrum anthelmintic 40. Mebeverine HCl Misculocropic spasmolytic 41. Meglumine locarmate X-ray contrast media 42. Mesterolone Oral androgen 43. Miconazole Topical anti-fungal antibacterial agent 44. Nalidixic Acid Chemotherapeutic Agent 45. Nicofuranose Vasodilator 46. Nitrazepam Hypnotic 47. Oxolinic Acid Urinary anti-fungal antibacterial agent 48. Oxprenolol HCl Beta-blocker 49. Oxyfedrine Coronary Vasodilator 50. Pancuronium Bromide Non-polarising neuromuscular blocking agent 51. Parbendazole Vet. Drug 52. Pimozide Neuroleptic and anti-psychotic agent 53. Pindolol Beta-blocker 54. Polyglycolic Acid Sutures 55. Prednisolone Corticosteroid Stearoglycolate 56. Prooanidid Short acting IV non-barbiturate anaesthetic 57. Prothionamide Anti-Tuberculosis 58. Pyrantel Pamoate Anthelmentic 59. Quinestrol Oestrogenic –steroid 60. Retinoin Topical acne therapy 61. Rifampicin Anti-tubercular drug 62. Salbutamol Sulphate Bronchodilator 63. Sarocolysin Anti-cancer 64. Sodium Cromoglycate Anti-asthmatic 65. Sodium Fusidate Antibiotic 66. Sodium Meglumin Iothalamate X-ray contrast medium 67. Solution of solic benzoic & For the treatment of burns, salicy acid in acqueous varicose, ulcers propylene alcohol, malic acid 68. Testolactone Anti-cancer drug 69. Tetramisole HCl Broad spectrum anthelmintic 70. Thiophanate Vet. Anthelmintic 71. THV (Turkey Herpex Mercks Disease Vaccine Virus) Inn. 72. Tinidazole Trichomona agent 73. Trifluperidol HCl Neuroleptic Agent 74. Trimethoprim & Chemotherapeutic agent Sulphadoxine 75. Trimethoprim & Bactericidal Chemotherapeutic Sulphamethoxazole agent 76. Yeast – tannic acid Anti-diarrhoeal agent compound | Sr. No. | Name of Drug | Pharmacological Classification / Indication | Date of Approval | 77 A mixture of sodium salt & Methyloglucamine salt X-ray contrast medium 78 Aminosidine Sulphate Antibiotic 79 Autolysate of B-subtilis & B-megatherium Anti-allergic 80 Betahistine Dihydrochloride Indicated in the treatment of Menier’s Syndreme, characterised by unilateral or bilateral tinnitus , vertigo, sensonneural hearing loss 81 Carbadox Vet, Antibiotic 82 Cephradine Antibotic 83 Clonidine HCl Anti-hypertensive agent 84 Clotrimazole Anti-fungal & local anti- trichomonial agent 85 Desoximetasone Topical corticosteroid 86 Dimetridazole Vet. Drug 87 Doxorubicin HCl Anti-cancer drug 88 Extract of Centella Asiatica Indiacated for the treatment (Medecassol) of uicers, burns, skin grafts, kelcids, bed sores,etc. 89 Glipizidex Oral hypoglycaemc agent 90 Halcinonide Topical cream 91 Loperamide Anti-diarrhoeat agent 92 Mefanamic acid Analgesic with anti- inflammatory agent 93 Metoclopramide Anti-emetic 94 Niflumic acid Anti-inflammatory agent 95 Obtained from streptomyces Vet. Antibiotic virginies (Virginiamycin) 96 Oxibendazole Vet. anthelmintic 97 Pentoxiflyline Vasodilator 98 Sodium Hydroxy oxopyrido Phynoxazine Carboxylate Anti-cataract preparation 99 Trimethoprim & Sulfamoxole Chemotherapeatic agent 100 Trofosfamide Anti-cancer drug Sr. No Name of Drug Pharmacological Date of Classification/Indication Approval 1977-78 101 Amoxycillin Antibiotic Dec. 1978 102 Benorylate Analgestic Anti-pyietic Dec. 1978 103 Beta-methyldigoxin Cardiac giycoside Dec. 1977 104 Diazoxide Antihypertensive Aug. 1978 105 Dicloxacillin Antibiotic Jul-78 106 Disopyramide Anti-arrhythmic agent Jan-77 107 Dothiapine HCl Anti-depressant May-77 108 Doxapram HCl Respiratory stimulant Sep. 1977 109 Flavanoides extracted from Rutacea, containing standard amount of Diosmin Haemarrhcides Jun-78 110 Flupenthixol Neuroleptic agent Jan-77 111 Fluprednydine – 21- acetate Topical cormosteroide Dec. 1977 112 Fusagurgin Fungal antibiotic Jan-77 113 Futraful5fluorociracil Anti-cancer Jun-77 114 Garason Eye drops/ Oint. Ophthalmic drug Nov. 1977 115 Gatanthamine HCl Tab./ Inj. Neurotropic/ Psychotropic drug Dec. 1978 116 Glucagon Inj. Hypoglycaomic agent Oct. 1978 117 Ifosfamide Anti-cancer Sept. 1978 118 Indapamide hemihydrate Anti-hypertensive duiretic Oct. 1978 119 Ioxitolmic acid Contrast medium Apr-77 120 Isometamedium Chloride Anti-arrhythmic agent Jan-77 121 Merckenzyme Enzyme May-77 122 Methyl prenisolone Corticosteriod Mar-78 123 Nimorazole Anti-trichomoniasis Sep. 1977 124 Pergonal Inj. (FSH) Fertility Drug Oct. 1978 125 Piracetam Memory enhancer Dec. 1977 126 Salcalcitonin Polypeptide hormone Jul-78 127 Salfametopyrazine Antimalarial Jun-78 128 Sotalol Beta-blocker Aug. 1978 129 Suramin Inj. Veterinary drug Sep. 1977 130 Trichloromethiazide Diuretic Dec. 1978 131 Urovison Inj. Contrast Media Dec. 1978 Sr. No Name of Drug Pharmacological Date of Classification/Indication Approval March 1979 to July 1981 132 Albendazole Vet. Anthelmintic 133 Amiloride HCl Diuretic anti-hypertensive 134 Azatadine Maleate Anti-allergic 135 Betamethasone Dipropionate Topical corticosteroid 136 Bromhexine HCl Mucolytic agent 137 Bumetanide Diuretic 138 Carboprost Tromethamine Prostaglandin alxotificient 139 Cimetidine Anti-ulcer 140 Clemastine (as Hydrogen Fumarate) Anti-histaminic 141 Clopamide Diuretic 142 Dilazep HCl Sympathomimetic agent 143 Dopamine HCl &nb | 
