:: ADDITIONS ::
= Chemicals: 1. 2-Deoxy-D-Glucose 2. 2-Deoxy-D-Glucose Sachet 3. Amifostine 4. Amifostine for Injection 5. Amlodipine and Valsartan Tablets 6. Apremilast 7. Apremilast Tablets 8. Aprotinin Injection 9. Azithromycin Eye Drops 10. Bosutinib 11. Bosutinib Tablets 12. Brivaracetam 13. Brivaracetam Tablets 14. Ceftriaxone and Sulbactam for Injection 15. Desogestrel 16. Desogestrel and Ethinyl Estradiol Tablets 17. Dextran 1 18. Dextran 40 19. Dextran 70 20. Dextropropoxyphene Hydrochloride and Paracetamol Tablets 21. Diclofenac Potassium 22. Diclofenac Potassium Tablets 23. Epalrestat 24. Epalrestat Tablets 25. Estradiol Hemihydrate 26. Ethyl Acetate 27. Ethynodiol Diacetate 28. Ethynodiol Diacetate and Ethinyl Estradiol Tablets 29. Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Prolonged-release Tablets 30. Glipizide and Metformin Tablets 31. Itraconazole 32. Lenvatinib Mesylate 33. Lenvatinib Capsules 34. Mesna Tablets 35. Oxetacaine 36. Polymyxin B Sulphate 37. Polymyxin B for Injection 38. Prasugrel and Aspirin Gastro-resistant Capsules 39. Repaglinide and Voglibose Tablets 40. Ribavirin Capsules 41. Risperidone Syrup 42. Rocuronium Bromide 43. Rocuronium Injection 44. Sodium Starch Glycolate (Type B) 45. Sofosbuvir 46. Sofosbuvir and Daclatasvir Tablets 47. Sofosbuvir Tablets 48. Sugar Spheres 49. Tofacitinib Citrate 50. Tofacitinib Tablets 51. Trazodone Hydrochloride 52. Trazodone Tablets 53. Teneligliptin and Metformin Hydrochloride Prolonged-release Tablets 54. Triamterene and Hydrochlorothiazide Tablets 55. Valacyclovir Hydrochloride 56. Valacyclovir Tablets 57. Valganciclovir Hydrochloride 58. Valganciclovir Tablets 59. Vildagliptin and Metformin Tablets 60. Zanamivir.
= Vitamins, Minerals, Amino Acids, Fatty Acids etc - 1. Oil-Soluble Vitamins Capsules 2. Oil-Soluble Vitamins Oral Solution 3. Oil-Soluble Vitamins Tablets 4. Water-Soluble Vitamins Capsules 5. Water-Soluble Vitamins Tablets 6. Alpha Lipoic Acid 7. Biotin 8. Calcium Citrate Malate 9. Chromium Picolinate 10. Copper Gluconate 11. Glutamic Acid 12. Inositol 13. Lutein 14. Lysine Hydrochloride 15. Phenylalanine 16. Selenomethionine 17. Selenious Acid 18. Threonine 19. Tryptophan 20. Valine 21. Zinc Citrate
= Herbs and Herbal Products - 1. Chitrak 2. Siris
= Vaccines and Immunosera for Human Use - 1. Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine Adsorbed 2. Meningococcal Group A, C, W135 and Y Conjugate Vaccine 3. Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine Adsorbed 4. Bivalent Poliomyelitis Vaccine Type 1 & 3, Live (Oral)
= Blood and Blood Related Products - 1. Anti-D Blend (IgM + IgG) Monoclonal Reagents 2. Anti-D (IgG) Monoclonal Reagents
= Biotechnology Derived Therapeutic Products - 1. Rituximab 2. Rituximab Injection 3. Teriparatide Concentrated Solution
= New General Chapters - 2.2.29 Microbiological Examination of Burkholderia cepacia Complex in Non-Sterile Products 2.2.30 Approach to Alternative Micro-biological Methods 2.2.31 Design and Development of Biological Assay and its Validation 2.2.32 Subvisible Particulate Matter in Therapeutic Protein Injections 2.3.56 Assay of Calcium Pantothenate 2.4.47 Raman Spectrometry 2.5.4. (i) Uniformity of Dosage Units 2.7.14 Test for absence of Mycobacteria 2.7.15 Protocol for determination of the PRP content of Haemophilus Type b Conjugate Vaccine by HPAECPAD 2.7.16 Adjuvants for vaccines 5.10 Elemental Impurities 5.11 Nitrosamine Impurities
= New General Monographs Active Pharmaceutical Ingredients New General Requirements 1. Therapeutic Monoclonal Antibodies for Human Use 2. General Requirements on Phytopharmaceuticals
:: UP-GRADATIONS ::
= General Notices - 1. Rounding rules for Calculation of Results
= General Chapters - 2.2.9 Microbial Contamination in Non-sterile Products 2.2.10 Microbiological Assay of Antibiotics 2.3.1 General Identification Reactions of Ions and Functional Groups 2.3.33 Assay of Oxygen 2.3.34 Oxygen-Flask Method 2.3.46 Assay of Insulins 2.4.7 Ultraviolet and Visible Absorption Spectrophotometry 2.4.13 Gas Chromatography 2.4.14 Liquid Chromatography 2.4.15 Paper Chromatography 2.4.17 Thin-layer Chromatography 2.4.22 Optical Rotation and Specific Optical Rotation 2.4.26 Solubility 2.4.42 Inductively Coupled Plasma Spectrometry 2.5.2 Dissolution 2.5.5 Friability of Uncoated Tablets 2.5.6 Content of Packaged Dosage Units 2.7.1 Composition of Polysaccharide Vaccines 2.7.2 Cell Substrates for the Production of Vaccines for Human Use 2.7.3 Extraneous Agents in Viral Vaccines 2.8.2 Assay of Human Anti-D Immunoglobulin 3.1 Infra-red Reference Spectra 3.2 Thin Layer Chromatograms of Phytopharmaceuticals, Herbs and Herbal Products 3.2.1 Thin Layer Chromatograms of Phytopharmaceuticals 3.2.2 Thin Layer Chromatograms of Herbs and Herbal Products 3.3 Liquid/HPTLC/Gas Chromatograms of Phytopharmaceuticals, Herbs and Herbal Products 3.3.1 Liquid/HPTLC/Gas Chromatograms of Phytopharmaceuticals 3.3.2 Liquid/HPTLC/Gas Chromatograms of Herbs and Herbal Products 4.1 Buffer Solutions 4.2 General Reagents 5.5 Impurities 5.9 Reference Substances
= General Monographs - 1. Capsules 2. Inhalation Preparations 3. Parenteral Preparations
= Chemical Monographs - 1. Amantadine Capsules 2. Amiloride and Hydrochlorothiazide Tablets 3. Aminocaproic Acid Tablets 4. Amitriptyline Tablets 5. Amlodipine Tablets 6. Ammonium Chloride 7. Amoxycillin and Potassium Clavulanate Oral Suspension 8. Amphotericin B 9. Amphotericin B Injection 10. Anastrozole Tablets 11. Anticoagulant Citrate Dextrose Solution 12. Anticoagulant Citrate Phosphate Dextrose Solution 13. Artemether and Lumefantrine Tablets 14. Aspartame 15. Aspirin Gastro-resistant and Atorvastatin Capsules 16. Aspirin Gastro-resistant and Rosuvastatin Capsules 17. Aspirin Tablets 18. Soluble Aspirin Tablets 19. Atenolol and Chlorthalidone Tablets 20. Atenolol Tablets 21. Atomoxetine Hydrochloride 22. Atosiban Acetate 23. Atracurium Besylate Injection 24. Azelnidipine 25. Azelnidipine Tablets 26. Bacitracin 27. Bacitracin Zinc 28. Benzoic Acid 29. Betamethasone Injection 30. Betamethasone Sodium Phosphate Tablets 31. Bicalutamide 32. Bicalutamide Tablets 33. Bisacodyl 34. Bromhexine Hydrochloride 35. Bromhexine Tablets 36. Bromocriptine Capsules 37. Bromocriptine Tablets 38. Bumetanide Tablets 39. Buprenorphine and Naloxone Sublingual Tablets 40. Buprenorphine Hydrochloride 41. Buprenorphine Sublingual Tablets 42. Calamine 43. Capreomycin Sulphate 44. Capreomycin Injection 45. Captopril 46. Captopril Tablets 47. Carbimazole Tablets 48. Carvedilol 49. Cefpodoxime Oral Suspension 50. Ceftazidime for Injection 51. Celecoxib 52. Activated Charcoal 53. Chlorpheniramine Tablets 54. Chlorthalidone 55. Chlorthalidone Tablets 56. Clemastine Tablets 57. Clindamycin Capsules 58. Clomipramine Capsules 59. Clonidine Tablets 60. Codeine Syrup 61. Codeine Tablets 62. Colchicine 63. Colchicine Tablets 64. Croscarmellose Sodium 65. Cyclizine Tablets 66. Cyclophosphamide 67. Cyclophosphamide Tablets 68. Cyclosporine Eye Drops 69. Cyproheptadine Tablets 70. Dalteparin Sodium 71. Dapsone 72. Deferasirox 73. Dexchlorpheniramine Maleate 74. Dextran 40 Infusion 75. Dextran 70 Infusion 76. Dicyclomine Tablets 77. Didanosine Gastro-resistant Capsules 78. Didanosine Tablets 79. Diethylcarbamazine Tablets 80. Diphenhydramine Capsules 81. Disulfiram 82. Disulfiram Tablets 83. Dobutamine Hydrochloride 84. Docetaxel Trihydrate 85. Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets 86. Donepezil Hydrochloride 87. Dothiepin Hydrochloride 88. Doxepin Capsules 89. Doxorubicin Hydrochloride 90. Doxorubicin Injection 91. Doxycycline Capsules 92. Dydrogesterone 93. Dydrogesterone Tablets 94. Econazole Cream 95. Efavirenz Tablets 96. Enoxaparin Sodium 97. Ergotamine Tablets 98. Esmolol Hydrochloride 99. Esomeprazole Gastro-resistant Tablets 100. Ethacrynic Acid Tablets 101. Ethanol 102. Ethanol (95 Per Cent) 103. Ethinyloestradiol Tablets 104. Ethosuximide 105. Fingolimod Hydrochloride 106. Flavoxate Tablets 107. Fludarabine Phosphate 108. Fludarabine Phosphate Injection 109. Fludrocortisone Tablets 110. Fluphenazine Tablets 111. Flurbiprofen Tablets 112. Framycetin Sulphate 113. Glipizide Tablets 114. Griseofulvin 115. Griseofulvin Tablets 116. Haloperidol Tablets 117. Heparin sodium 118. Hyoscine Butylbromide Tablets 119. Imatinib Mesylate 120. Imipenem and Cilastatin Injection 121. Indinavir Sulphate 122. Indinavir Capsules 123. Irinotecan Hydrochloride Trihydrate 124. Iron Dextran Injection 125. Isopropyl Alcohol 126. Isopropyl Rubbing Alcohol 127. Labetalol Hydrochloride 128. Labetalol Injection 129. Labetalol Tablets 130. Lamivudine and Tenofovir Tablets 131. Lamivudine and Zidovudine Tablets 132. Lamivudine Tablets 133. Lapatinib Ditosylate 134. Lapatinib Tablets 135. Levamisole Injection 136. Levetiracetam 137. Levofloxacin Hemihydrate 138. Levofloxacin Infusion 139. Levonorgestrel 140. Levonorgestrel and Ethinyloestradiol Tablets 141. Lincomycin Hydrochloride 142. Lincomycin Capsules 143. Lorazepam 144. Lorazepam Injection 145. Lorazepam Tablets 146. Luliconazole 147. Luliconazole Lotion 148. Magnesium Hydroxide 149. Maltodextrin 150. Marbofloxacin Injection 151. Mebendazole 152. Mebendazole Tablets 153. Meclizine Tablets 154. Megestrol Tablets 155. Menotropin 156. Menotropin for Injection 157. Methadone Tablets 158. Methyldopa Tablets 159. Methylparaben 160. Metoclopramide Tablets 161. Miconazole Cream 162. Mitomycin Injection 163. Montelukast Granules 164. Nabumetone Tablets 165. Nalidixic Acid Tablets 166. Natamycin 167. Nitrofurantoin 168. Nitrofurantoin Tablets 169. Norgestrel and Ethinyloestradiol Tablets 170. Oestradiol Injection 171. Olanzapine Tablets 172. Omeprazole and Domperidone Capsules 173. Omeprazole Gastro-resistant Capsules 174. Ondansetron Oral Solution 175. Ondansetron Tablets 176. Oxazepam Tablets 177. Oxprenolol Tablets 178. Oxygen 179. Oxygen 93 Per Cent 180. Oxytetracycline Capsules 181. Oxytetracycline Dihydrate 182. Oxytetracycline Hydrochloride 183. Oxytetracycline Hydrochloride Injection 184. Oxytetracycline Injection 185. Pantoprazole Gastro-resistant and Domperidone Prolonged-release Capsules 186. Pantoprazole Gastro-resistant Tablets 187. Paracetamol Oral Suspension 188. Paracetamol Paediatric Oral Suspension 189. Paracetamol Tablets 190. Penicillamine Tablets 191. Perphenazine Tablets 192. Phenindione Tablets 193. Phenobarbitone Tablets 194. Phenoxyethanol 195. Phenytoin sodium 196. Pindolol Tablets 197. Polyethylene Glycol 4000 198. Pravastatin Tablets 199. Pregabalin 200. Procainamide Tablets 201. Prochlorperazine Tablets 202. Procyclidine Tablets 203. Propylparaben 204. Propylthiouracil Tablets 205. Protriptyline Tablets 206. Pseudoephedrine Tablets 207. Pyridostigmine Tablets 208. Pyrimethamine Tablets 209. Quiniodochlor 210. Rabeprazole Gastro-resistant and Itopride Prolonged-release Capsules 211. Rabeprazole Gastro-resistant Tablets 212. Ranitidine Hydrochloride 213. Ranitidine Injection 214. Ranitidine Oral Solution 215. Ranitidine Tablets 216. Remdesivir Injection 217. Selegiline Tablets 218. Silver Sulphadiazine 219. Compound Sodium Lactate Injection 220. Sodium Phosphate 221. Sodium Starch Glycolate (Type A) 222. Sodium Valproate Gastro-resistant Tablets 223. Sodium Valproate Injection 224. Streptokinase Injection 225. Sterile Water for Injections 226. Talc 227. Tamoxifen Citrate 228. Tamoxifen Tablets 229. Tenofovir Alafenamide Fumarate 230. Tenofovir Disoproxil Fumarate 231. Testosterone Propionate 232. Theophylline 233. Theophylline Injection 234. Theophylline Prolonged-release Tablets 235. Thiocolchicoside 236. Thiomersal 237. Thiotepa 238. Thiotepa Injection 239. Thyroxine Sodium 240. Ticagrelor 241. Ticagrelor Tablets 242. Tigecycline 243. Tigecycline Injection 244. Timolol Tablets 245. Tiotropium Bromide Monohydrate 246. Tolazamide Tablets 247. Topiramate 248. Torsemide 249. Torsemide Tablets 250. Tranexamic Acid 251. Tranexamic Acid Injection 252. Tranexamic Acid Tablets 253. Triamcinolone Tablets 254. Triamterene Capsules 255. Trifluoperazine Tablets 256. Triflupromazine Tablets 257. Trimethoprim and Sulphamethoxazole Tablets 258. Trimethoprim Tablets 259. Triprolidine Tablets 260. Urokinase 261. Ursodeoxycholic Acid Tablets 262. Vancomycin Hydrochloride 263. Voriconazole Injection 264. Warfarin Tablets 265. Zolmitriptan
= Vitamins, Minerals, Amino Acids, Fatty Acids etc. - 1. Ascorbic Acid 2. Ascorbic Acid Injection 3. Ascorbic Acid Tablets 4. Calcium Folinate Injection 5. Calcium Lactate 6. Calcium Lactate Tablets 7. Calcium Pantothenate 8. Ferrous Ascorbate 9. Folic Acid Tablets 10. Glycerin 11. Phytomenadione Injection 12. Pyridoxine Tablets 13. Riboflavin 14. Riboflavin Sodium Phosphate 15. Riboflavin Tablets 16. Thiamine Mononitrate 17. Thiamine Tablets
= Phytopharmaceuticals - 1. Aegle marmelos PPI 2. Andrographis paniculata PPI 3. Curcuma longa PPI 4. Gymnema sylvestre PPI 5. Lawsonia inermis PPI 6. Phyllanthus amarus PPI 7. Silybum marianum Dry Extract PPI
= Herbs and Herbal Products - 1. Acacia 2. Ajwain 3. Amalaki 4. Amaltas 5. Amarbel 6. Amla Juice Powder 7. Amra 8. Anantmula 9. Anise Oil 10. Arachis Oil 11. Arjuna 12. Arjuna Dry Extract 13. Artemisia 14. Ashwagandha 15. Ashwagandha Dry Extract 16. Asoka 17. Bakuci 18. Bala 19. Basil Oil (Methyl Chavicol Type) 20. Bassant 21. Bassant Dry Extract 22. Belladonna Leaf 23. Belladonna Dry Extract 24. Belladonna Dry Extract Tablets 25. Belladonna Soft Extract 26. Belladonna Tincture 27. Bhibhitaki Aqueous Extract 28. Bhringraj 29. Bhuiamla Dry Extract 30. Birmi 31. Black Pepper Oil 32. Brahmi 33. Brahmi Extract 34. Caraway Oil 35. Castor Oil (Refined) 36. Castor Oil (Virgin) 37. Citronella Oil (Java Type) 38. Clove Bud Oil 39. Coconut Oil 40. Dill Oil 41. Green Coffee Bean Extract 42. Nutmeg Oil 43. Shellac
= Vaccines and Immunosera for Human Use :
- General Requirements: 1. Vaccines 2. Antisera
- Monographs: 1. Adsorbed Diphtheria, Tetanus and Hepatitis B (rDNA) Vaccine 2. Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Haemophilus influenzae Type b Conjugate Vaccine 3. Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B (rDNA) Vaccine 4. Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component), Inactivated poliomyelitis Vaccine and Haemophilus influenzae Type b Conjugate Vaccine 5. Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated poliomyelitis Vaccine 6. Adsorbed Pertussis (Acellular Component) Vaccine 7. Adsorbed Pertussis (Acellular; Co-purified) Vaccine 8. Diphtheria and Tetanus vaccine (Adsorbed) 9. Diphtheria and Tetanus vaccine (Adsorbed) for adults and adolescents 10. Diphtheria, Tetanus and Pertussis vaccine (Adsorbed) 11. Diphtheria, Tetanus, Pertussis (Whole Cell), Hepatitis B (rDNA) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) 12. Diphtheria, Tetanus, Pertussis (Whole Cell) and Hepatitis B (rDNA) Vaccine (Adsorbed) 13. Diphtheria, Tetanus, Pertussis (Whole Cell) and Haemophilus influenzae Type b Conjugate Vaccine (Adsorbed) 14. Diphtheria Vaccine (Adsorbed). 15. Diphtheria vaccine (Adsorbed) for adults and adolescents 16. Haemophilus influenza Type b Conjugate Vaccine 17. Hepatitis B Vaccine (rDNA). 18. Hepatitis A (Inactivated) Vaccine (Adsorbed) 19. Inactivated Hepatitis B Vaccine 20. Inactivated Influenza Vaccine (Split Virion) 21. Inactivated Influenza Vaccine (Surface Antigen) 22. Inactivated Influenza Vaccine (Whole Virion) 23. Influenza Vaccine (Human, Live Attenuated) 24. Japanese Encephalitis Vaccine (Human) 25. Japanese Encephalitis Live Vaccine (Human) 26. Japanese Encephalitis vaccine Inactivated (Adsorbed, Human) 27. Measles and Rubella Vaccine (Live) 28. Measles vaccine (Live) 29. Measles, Mumps and Rubella Vaccine (Live) 30. Group A Meningococcal Conjugate Vaccine 31. Meningococcal Poly saccharide Vaccine 32. Mumps Vaccine (Live) 33. Plague Vaccine 34. Pneumococcal Polysaccharide conjugate Vaccine (Adsorbed) 35. Poliomyelitis Vaccine, Live (Oral) 36. Rabies Vaccine, Human. 37. Rotavirus vaccine (Live attenuated, Oral) 38. Rubella vaccine (Live) 39. Scorpion Venom Antiserum 40. Tetanus Vaccine (Adsorbed) 41. Tick-borne Encephalitis Vaccine (Inactivated) 42. Typhoid Polysaccharide Vaccine 43. Typhoid Paratyphoid A Vaccine 44. Typhoid Vi Conjugate Vaccine 45. Typhus Vaccine 46. Varicella Vaccine, Live 47. Yellow fever Vaccine
= Blood and Blood Related Products - 1. Anti-A Blood Grouping Serum 2. Anti-B Blood Grouping Serum 3. Anti-AB Blood Grouping Serum 4. Anti-D (IgM) Monoclonal Blood Grouping Reagent 5. Anti Human Globulin (AHG) serum 6. Anti-D (Rho) Immunoglobulin 7. Anti-D Immunoglobulin for Intravenous Use 8. Blood Grouping Lectins Anti-A 1 9. Blood Grouping Lectins Anti-H 10. Dried Human Anti-haemophilic Fraction 11. Fibrin Sealant Kit 12. Human Albumin 13. Human Normal Immunoglobulin for Intravenous use 14. Human Prothrombin Complex
= Biotechnology Derived Therapeutic Products 1. Filgrastim Concentrated Solution 2. Follicle Stimulating Hormone 3. Follicle stimulating Hormone Concentrated Solution 4. Follicle Stimulating Hormone Injection 5. Pegfilgrastim 6. Recombinant Streptokinase Bulk Solution
= Allergen Products - - Allergen Products
= Veterinary Monographs - 1. Amprolium Hydrochloride and Ethopabate Premix 2. Amprolium, Ethopabate and Sulphaquinoxaline Premix 3. Decoquinate Premix 4. Dimetridazole Premix 5. Furazolidone Premix 6. Levamisole Injection 7. Lincomycin Premix 8. Oxyclozanide Primix 9. Oxytetracycline Hydrochloride Injection 10. Oxytetracycline Dihydrate Injection 11. Pentobarbitone Injection 12. Thiabendazole Premix 13. Infectious Bursal Disease Vaccine, Live 14. Peste Des Petits Ruminants Vaccine, Live |