DNA Explainer: Why is Ranitidine no more an essential medicine? Check updated list of 384 drugs here

2022-10-08 18:08:18 By : Mr. Peter Zhou

Reported By:| Edited By: DNA Web Team |Source: DNA Web Desk |Updated: Sep 13, 2022, 07:50 PM IST

As many as 34 new drugs have been added and 26 dropped in the much-hyped revision of the National List of Essential Medicines (NLEM). The Union Health Ministry announced the revised list of 384 essential drugs across 27 categories. 

Popular antacid salt Ranitidine has been removed from the list over cancer-causing concerns. Ranitidine is sold under brand names like Aciloc, Rantac and Zinetac among others, and is commonly prescribed for acid-related cough, indigestion, stomach pain and heartburn.

The salt has been under investigation since 2019 when the US-based Food and Drug Administration found probable cancer-causing impurity in the drug. Drug-regulators found cancer-causing impurity N-nitrosodimethylamine (NDMA) at “unacceptable levels” in samples of drugs containing ranitidine.

Zantac was one of the world's first drugs to top USD 1 billion in annual sales way back in 1988.

Meanwhile, several anti-cancer drugs, antibiotics and vaccines will now become more affordable as they are among 34 new additions to the NLEM, with the government saying this will reduce "patients' out-of-pocket expenditure".

Anti-infectives like Ivermectin, Mupirocin and Meropenem have also been added to the list, taking the total drugs under it to 384. Four major anti-cancer drugs -- Bendamustine Hydrochloride, Irinotecan HCI Trihydrate, Lenalidomide and Leuprolide acetate which are effective in various types of cancers -- and psychotherapeutic medicines -- Nicotine Replacement Therapy and Buprenorphine -- have been added to the list.

The 26 drugs which have been excluded from the list of essential medicines include: 

1. Alteplase 2. Atenolol 3. Bleaching Powder 4. Capreomycin 5. Cetrimide 6. Chlorpheniramine 7. Diloxanide furoate 8. Dimercaprol 9. Erythromycin 10. Ethinylestradiol 11. Ethinylestradiol(A) Norethisterone (B) 12. Ganciclovir 13. Kanamycin 14. Lamivudine (A) + Nevirapine (B) + Stavudine (C) 15. Leflunomide 16. Methyldopa 17. Nicotinamide 18. Pegylated interferon alfa 2a, Pegylated interferon alfa 2b 19. Pentamidine 20. Prilocaine (A) + Lignocaine (B) 21. Procarbazine 22. Ranitidine 23. Rifabutin 24. Stavudine (A) + Lamivudine (B) 25. Sucralfate 26. White Petrolatum

Here is the revised list of 384 drugs in the essential medicines' list:

1. 5-aminosalicylic acid (Mesalazine/Mesalaine) 2. 5-Fluorouracil 3. 6-Mercaptopurine 4. Abacavir 5. Abacavir (A) + Lamivudine (B) 6. Acetazolamide 7. Acetylsalicylic acid 8. Actinomycin D 9. Activated Charcoal 10. Acyclovir 11. Adenosine 12. Adrenaline 13. Albendazole 14. Allopurinol 15. All-trans retinoic acid 16. Alprostadil 17. Amikacin 18. Amiodarone 19. Amitriptyline 20. Amlodipine 21. Amoxicillin 22. Amoxicillin (A) + Clavulanic acid (B) 23. Amphotericin B a) Amphotericin B (conventional) b) Lipid Amphotericin B c) Liposomal Amphotericin B 24. Ampicillin 25. Anti-D immunoglobulin 26. Anti-rabies immunoglobulin 27. Anti-tetanus immunoglobulin 28. Arsenic trioxide 29. Artemether (A) + Lumefantrine (B) 30. Artesunate 31. Artesunate (A) + Sulphadoxine Pyrimethamine (B) 32. Ascorbic acid (Vitamin C) 33. Atazanavir (A) + Ritonavir (B) 34. Atorvastatin 35. Atracurium 36. Atropine 37. Azathioprine 38. Azithromycin 39. Baclofen 40. Barium sulphate 41. BCG vaccine 42. Bedaquiline 43. Bendamustine Hydrochloride 44. Benzathine benzylpenicillin 45. Benzoyl peroxide 46. Benzylpenicillin 47. Betamethasone 48. Betamethasone (valerate) 49. Bicalutamide 50. Bisacodyl 51. Bleomycin 52. Bortezomib 53. Budesonide 54. Budesonide (A) +Formoterol (B) 55. Bupivacaine 56. Buprenorphine 57. Buprenorphine (A) + Naloxone (B) 58. Caffeine 59. Calamine 60. Calcium carbonate 61. Calcium folinate 62. Calcium gluconate 63. Capecitabine 64. Carbamazepine 65. Carbimazole 66. Carboplatin 67. Carboxymethyl cellulose 68. Cefadroxil 69. Cefazolin 70. Cefixime 71. Cefotaxime 72. Ceftazidime 73. Ceftriaxone 74. Cefuroxime 75. Cetirizine 76. Chlorambucil 77. Chlorhexidine 78. Chloroquine 79. Cholecalciferol 80. Ciprofloxacin 81. Cisplatin 82. Clarithromycin 83. Clindamycin 84. Clobazam 85. Clofazimine 86. Clomiphene citrate 87. Clomipramine 88. Clonazepam 89. Clopidogrel 90. Clotrimazole 91. Cloxacillin 92. Clozapine 93. Coagulation factor IX 94. Coagulation factor VIII 95. Coal tar (A) + Salicylic Acid (B) 96. Colchicine 97. Condom 98. Co-trimoxazole [Sulphamethoxazole (A) + Trimethoprim (B)] 99. Cryoprecipitate 100. Cyclophosphamide 101. Cycloserine 102. Cyclosporine 103. Cytosine arabinoside 104. D- Penicillamine 105. Dabigatran 106. Dacarbazine 107. Daclatasvir 108. Dapsone 109. Darunavir 110. Darunavir (A) + Ritonavir (B) 111. Daunorubicin 112. Delamanid 113. Desferrioxamine 114. Dexamethasone 115. Dextran-40 116. Diazepam 117. Diclofenac 118. Dicyclomine 119. Diethylcarbamazine 120. Digoxin 121. Diltiazem 122. Dinoprostone 123. Diphtheria antitoxin 124. Dobutamine 125. Docetaxel 126. Dolutegravir 127. Domperidone 128. Donepezil 129. Dopamine 130. Doxorubicin 131. Doxycycline 132. DPT vaccine 133. DPT+ Hib+ Hep B vaccine 134. Efavirenz 135. Enalapril 136. Enoxaparin 137. Entecavir 138. Erythropoietin 139. Escitalopram 140. Esmolol 141. Ethambutol 142. Ethinylestradiol (A) + Levonorgestrel (B) 143. Ethionamide 144. Ethyl alcohol (Denatured) 145. Etoposide 146. Fentanyl 147. Ferrous Salts (A) + Folic Acid (B) 148. Ferrous salts 149. Filgrastim 150. Fluconazole 151. Fludrocortisone 152. Flunarizine 153. Fluorescein 154. Fluoxetine 155. Fluphenazine 156. Folic Acid 157. Framycetin 158. Fresh frozen plasma 159. Furosemide 160. Fusidic acid 161. Gadobenate dimeglumine 162. Gefitinib 163. Gemcitabine 164. Gentamicin 165. Glimepiride 166. Glucose 167. Glucose(A) + Sodium chloride (B) 168. Glutaraldehyde 169. Glycerin 170. Glyceryl trinitrate 171. Glycopyrrolate 172. Griseofulvin 173. Haemodialysis fluid 174. Haloperidol 175. Halothane 176. Heparin 177. Hepatitis B immunoglobulin 178. Hepatitis B vaccine 179. Homatropine 180. Hormone releasing IUD 181. Human chorionic gonadotropin 182. Human normal immunoglobulin 183. Hydrochlorothiazide 184. Hydrocortisone 185. Hydrogen Peroxide 186. Hydroxocobalamine 187. Hydroxychloroquine 188. Hydroxypropyl methylcellulose 189. Hydroxyurea 190. Hyoscine butylbromide 191. Ibuprofen 192. Ifosfamide 193. Imatinib 194. Insulin (Soluble) 195. Insulin Glargine 196. Insulin Intermediate Acting (NPH) 197. Insulin Premix Injection 30:70 (Regular : NPH) 198. Iohexol 199. Ipratropium 200. Irinotecan HCI Trihydrate 201. Iron sucrose 202. Isoflurane 203. Isoniazid 204. Isosorbide dinitrate 205. Ispaghula 206. Itraconazole 207. IUD containing Copper 208. Ivermectin 209. Japanese Encephalitis Vaccine 210. Ketamine 211. Labetalol 212. Lactulose 213. Lamivudine 214. L-Asparaginase 215. Latanoprost 216. Lenalidomide 217. Letrozole 218. Leuprolide acetate 219. Levetiracetam 220. Levodopa (A) + Carbidopa (B) 221. Levofloxacin 222. Levonorgestrel 223. Levothyroxine 224. Lignocaine 225. Lignocaine (A) + Adrenaline (B) 226. Linezolid 227. Lithium 228. Loperamide 229. Lopinavir (A) + Ritonavir (B) 230. Lorazepam 231. Magnesium sulphate 232. Mannitol 233. Measles vaccine 234. Mebendazole 235. Medroxyprogesterone acetate 236. Mefenamic acid 237. Mefloquine 238. Meglumine diatrizoate 239. Melphalan 240. Meropenem 241. Mesna 242. Metformin 243. Methotrexate 244. Methylergometrine 245. Methylprednisolone 246. Methylrosanilinium chloride (Gentian Violet) 247. Methylthioninium chloride (Methylene blue) 248. Metoclopramide 249. Metoprolol 250. Metronidazole 251. Midazolam 252. Mifepristone 253. Miltefosine 254. Misoprostol 255. Montelukast 256. Morphine 257. Moxifloxacin 258. Mupirocin 259. Mycophenolate mofetil 260. N-acetylcysteine 261. Naloxone 262. Natamycin 263. Neostigmine 264. Nevirapine 265. Nicotine replacement therapy (NRT) 266. Nifedipine 267. Nitrofurantoin 268. Nitrous oxide 269. Noradrenaline 270. Norethisterone 271. Nystatin 272. Omeprazole 273. Ondansetron 274. Oral poliomyelitis vaccine 275. Oral rehydration salts 276. Ormeloxifene (Centchroman) 277. Oxaliplatin 278. Oxygen 279. Oxytocin 280. Paclitaxel 281. Pantoprazole 282. Para- aminosalicylic acid 283. Paracetamol 284. Paromomycin 285. Peritoneal dialysis solution 286. Permethrin 287. Pheniramine 288. Phenobarbitone 289. Phenoxymethyl penicillin 290. Phenylephrine 291. Phenytoin 292. Phytomenadione(Vitamin K1) 293. Pilocarpine 294. Piperacillin (A) + Tazobactam (B)* 295. Platelet rich plasma/ Platelet concentrates 296. Podophyllin resin 297. Potassium chloride 298. Potassium permanganate 299. Povidone iodine 300. Pralidoxime chloride (2-PAM) 301. Praziquantel 302. Prednisolone 303. Primaquine 304. Procaine Benzylpenicillin 305. Proparacaine 306. Propofol 307. Propranolol 308. Protamine Sulphate 309. Pyrazinamide 310. Pyridoxine 311. Quinine 312. Rabies vaccine 313. Raltegravir 314. Ramipril 315. Red blood cells/ Packed RBCs 316. Ribavirin 317. Riboflavin 318. Rifampicin 319. Ringer lactate 320. Risperidone 321. Ritonavir 322. Rituximab 323. Rotavirus vaccine 324. Salbutamol 325. Salicylic acid 326. Sevoflurane 327. Silver sulphadiazine 328. Snake Venom Antiserum a. Soluble/ liquid polyvalent b. Lyophilized polyvalent 329. Sodium bicarbonate 330. Sodium chloride 331. Sodium nitrite 332. Sodium nitroprusside 333. Sodium thiosulphate 334. Sodium Valproate 335. Sofosbuvir 336. Somatostatin 337. Spironolactone 338. Streptokinase 339. Streptomycin 340. Succinylcholine 341. Sulfasalazine 342. Sumatriptan 343. Surfactant 344. Tacrolimus 345. Tamoxifen 346. Telmisartan 347. Temozolomide 348. Tenecteplase 349. Teneligliptin 350. Tenofovir (A) + Lamivudine (B) 351. Tenofovir (A) + Lamivudine (B) + Dolutegravir (C) 352. Tenofovir (A) + Lamivudine (B) + Efavirenz (C) 353. Tenofovir Alafenamide Fumarate (TAF) 354. Tenofovir Disproxil Fumarate (TDF) 355. Terbinafine 356. Tetanus toxoid 357. Thalidomide 358. Thiamine 359. Thiopentone 360. Timolol 361. Tiotropium 362. Tramadol 363. Tranexamic acid 364. Trastuzumab 365. Trihexyphenidyl 366. Tropicamide 367. Tuberculin, Purified Protein derivative 368. Valganciclovir 369. Vancomycin 370. Vecuronium 371. Verapamil 372. Vinblastine 373. Vincristine 374. Vitamin A 375. Warfarin 376. Water for Injection 377. Whole blood 378. Xylometazoline 379. Zidovudine 380. Zidovudine (A) + Lamivudine (B) 381. Zidovudine (A) + Lamivudine (B) + Nevirapine (C) 382. Zinc Sulphate 383. Zoledronic acid 384. Zolpidem 

The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects -- cost, safety and efficacy, Union Health Minister Mansukh Mandaviya said.

He said the NLEM is a dynamic document and is revised on a regular basis considering the changing public health priorities as well as advancement in pharmaceutical knowledge. The NLEM was formulated in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.

Revision of NLEM 2022 has been done after constant consultation with stakeholders spanning from academia, industrialists and public policy experts etc., and crucial documents like WHO EML 2021.

In the revised list, endocrine medicines and contraceptives Fludrocortisone, Ormeloxifene, Insulin Glargine and Teneliglitin have been added. Montelukast, which acts on the respiratory track, and ophthalmological drug Latanoprost also figure in the list.

Besides, cardiovascular medicines Dabigatran and Tenecteplase too find place in the list besides medicines used in palliative care.

"Antinfectives such as Ivermectine, Meropenem, Cefuroxime, Amikacin, Bedaquiline, Delamanid, Itraconazole ABC Dolutegravir have been added to the NLM," Dr Y K Gupta, Vice Chairman of the Standing National Committee on Medicines, said.

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