Drugs Banned in India

Drugs Banned in India

Drugs undergo rigorous testing before they are introduced into the market. They are first tested in animals and then in human beings during clinical trials for their efficacy as well as safety. Despite all precautions, some adverse effects of drugs appear only when the drug is used in the general population after its approval. These adverse effects are detected though a process of regular monitoring after the drug is released into the market called pharmacovigilance(1^✔).

If the adverse effects are severe or the risks of using the drug outweigh the benefits, or if the drug is ineffective, the country may ban the drug or the drug company may itself voluntarily withdraw the drug. Some drugs may cause adverse effects only when combined with particular drugs. In such cases, only the fixed dose combination is banned and not the individual drugs(2^✔).

A number of single drugs as well as fixed dose combinations have been banned for manufacturing, marketing and distribution in India. Some individual drugs banned in India are mentioned below:

Drugs Used for Obesity and Weight Loss - Fenfluramine, dexfenfluramine, rimonabant , sibutramine, phenylpropanolamine

The introduction of weight loss drugs in the Indian market provided hope to numerous people suffering from overweight and obesity. These drugs could not only help people with a better body image, but they also promised reduction of health consequences of obesity. Unfortunately, these drugs were associated with serious side effects and had to be withdrawn for the following reasons(3^✔):

• Fenfluramine and dexfenfluramine affected the cardiovascular system and were associated with diseases of the heart valves, the formation of fibrous tissue in the heart, and pulmonary hypertension (high blood pressure in the lung circulation).
• Rimonabant was withdrawn due to its association with serious brain-related side effects like depression, suicidal tendencies and seizures.
• Sibutramine has been banned since it caused cardiovascular side effects like heart attack and stroke(3^✔).

Non-steroidal Painkillers - Rofecoxib, Valdecoxib

Rofecoxib and valdecoxib were second generation non-steroidal painkillers. They claimed to provide pain relief without causing stomach ulcers unlike conventional painkillers like aspirin, ibuprofen and indomethacin. However, their use was eclipsed with a higher incidence of heart attack and stroke in patients taking the drugs and therefore, they were banned.

Patients taking valdecoxib were also at a higher risk for serious skin reactions. These adverse effects did not support the use of these drugs for pain relief when safer drugs are available(4^✔).

Anti-allergy Drugs - Astemizole, Terfenadine

Astemizole and terfenadine belong to a class of edications called antihistamines and were used to prevent and treat allergies. They have been withdrawn because they were linked to a problem with the heart rhythm called torsades de pointes, especially when used along with certain other drugs like erythromycin and ketoconazole(5^✔).

Antidiabetes Drugs - Phenformin, Rosiglitazone

Phenformin, an anti-diabetes drug related to metformin, was banned because it caused lactic acidosis, where it increased the pH of the blood. In more recent times, rosiglitazone has been withdrawn because of its associated risk of heart attack(6^✔).

Pioglitazone was suspended for manufacture and sale by the Indian drug regulator in June 2013 due to its association with urinary bladder carcinoma, which was revoked within a short period (July 2013)(7^✔).

Gastrointestinal Drugs - Cisapride, Tegaserod

• Cisapride was a drug used in the treatment of acidity and constipation. It had the possibility of causing abnormal heart rhythms when used in high doses or when used along with other drugs like erythromycin and ketoconazole.
• Tegaserod was another drug acting on the digestive system that was used to treat patients with a condition called irritable bowel syndrome with predominantly constipation. Its association with cardiovascular events like heart attack and stroke have prompted its exit(8^✔).

Antibiotic - Gatifloxacin

Gatifloxacin, an antibiotic belonging to the class fluoroquinolone, has been banned due to its ability to cause high blood sugar levels when taken either orally or through injection. However, eye drops containing gatifloxacin are still available(9^✔).

Banned Fixed Dose Drug Combinations in India as of March 2016

The Central Drugs Standard Control Organization (CDSCO) in India has banned the manufacture and sale of more than 300 fixed dose drug combinations to prevent the misuse of drugs and to prevent drug resistance(10^✔).

A gazette notification by Ministry of Health and Family Welfare was issued on 10^th March 2016 to ban these fixed drug combinations. The list includes common cough syrup solutions, analgesics and antibiotic combinations. Some of these drugs are sold over the counter. In 2014 a committee was set up to review over 6000 drug combinations that had entered the market based only on state regulators approval.

This ban is likely to affect many leading pharmaceutical drug manufacturers such as Pfizer, Abbott, Macleods Pharma and Glenmark Pharmaceuticals. Some of these companies have already appealed to the court and received interim injunctions.

Final Verdict as on 12^th September 2018

The latest notification banned the manufacture along with the sale, and the distribution of more than 300 fixed-dose combinations (FDCs) under the section 26A of the Drugs and Cosmetics Act, 1940 as advised by the Drug Technical Advisory Board or DTAB(10^✔).

The reason for this ban is to stop the use of FDCs without a valid reason. Notably, there was no therapeutic justification found when these ingredients were used in combinations. Moreover, these fixed-dose combinations are not logical and may cause a risk to humans.

The complete list of banned drugs(11^✔) -

1. Aceclofenac (SR) + Paracetamol
2. Aceclofenac + Paracetamol + Famotidine
3. Aceclofenac + Paracetamol + Rabeprazole
4. Aceclofenac + Zinc Carnosine
5. Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine
6. Acetaminophen + Loratadine + Ambroxol + Phenylephrine
7. Acriflavine + Thymol + Cetrimide
8. Acrivastine + Paracetamol + Caffeine + Phenylephrine
9. Albuterol + Bromhexine + Theophylline
10. Albuterol + Etofylline + Bromhexine + Menthol
11. Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium Hydroxide
12. Allantoin + Dimethieone + Urea + Propylene + Glycerin + Liquid Paraffin
13. Ambroxol + Levocetirizine + Phenylephrine + Guaiphenesin + Menthol
14. Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
15. Ambroxol + Salbutamol + Choline Theophyllinate + Menthol
16. Ambroxol + Salbutamol + Theophylline
17. Ambroxol + Terbutaline + Dextromethorphan
18. Ambroxol+ Guaiphenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + Menthol
19. Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol
20. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
21. Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate
22. Amoxicillin + Cefixime + Potassium Clavulanic Acid
23. Amoxicillin + Dicloxacillin
24. Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5
25. Amoxycillin + Dicloxacillin + Serratiopeptidase
26. Amoxycillin + Tinidazole
27. Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium Phosphate + Adrenochrome monosemicarbazone
28. Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine
29. Azithromycin + Acebrophylline
30. Azithromycin + Ambroxol
31. Azithromycin + Cefixime
32. Azithromycin + Cefpodoxime
33. Azithromycin + Levofloxacin
34. Azithromycin + Ofloxacin
35. Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drops
36. Beclomethasone + Clotimazole + Neomycin + lodochlorohydroxyquinone
37. Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline
38. Beclomethasone Diproprionate + Neomycin + Tolnaftate + lodochlorhydroxyquinoline +Chlorocresol
39. Benfotiamine + Metformin
40. Benzoxonium Chloride + Lidocaine
41. Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam
42. Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate + lodochlorhydroxyquinoline (ICHQ)
43. Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline
44. Betamethasone + Gentamycin + Zinc Sulphate + Clotrimoazole + Chlorocresol
45. Betamethasone + Neomycin + Tolnaftate + lodochlorohydroxyquinoline + Cholorocresol
46. Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy Benzoate
47. Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol
48. Bromhexine + Cetrizine + Phenylephrine IP+Guaifenesin + Menthol
49. Bromhexine + Dextromethorphan
50. Bromhexine + Dextromethorphan + Phenylephrine + Menthol
51. Bromhexine + Phenylephrine + Chlorepheniramine Maleate
52. Caffeine + Paracetamol + Chlorpheniramine
53. Caffeine + Paracetamol + Phenylephrine + Cetirizine
54. Calcium Gluconate + Chlorpheniramine + Vitamin C
55. Calcium Gluconate + Levocetirizine
56. Cefixime + Levofloxacin
57. Cefixime + Linezolid
58. Cefpodoxime Proxetil + Levofloxacin
59. Cefuroxime + Linezolid
60. Cephalexin + Neomycin + Prednisolone
61. Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide
62. Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc Gluconate
63. Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Menthol
64. Cetirizine + Dextromethorphan + Ambroxol
65. Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin
66. Cetirizine + Dextromethorphan + Phenylephrine + Tulsi
67. Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + Menthol
68. Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol
69. Cetirizine + Diethyl Carbamazine
70. Cetirizine + Phenylephrine + Dextromethorphan + Menthol
71. Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine
72. Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate
73. Cetririzine + Nimesulide + Phenylephrine
74. Chlopheniramine Maleate + Dextromethorphan + Guaiphensin + Phenylephrine
75. Chloramphenicol + Beclomethasone + Clomitrimazole + Lignocaine
76. Chloramphennicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + Antipyrine
77. Chlorphaniramine + Ammonium Chloride + Sodium Chloride
78. Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol
79. Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate
80. Chlorpheniramine + Codeine + Sodium Citrate + Menthol Syrup
81. Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol
82. Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine
83. Chlorpheniramine + Phenylephrine + Caffeine
84. Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol
85. Chlorpheniramine + Phenylephrine + Paracetamol + Zink Gluconate
86. Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride + SodiumCitrate + Menthol
87. Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate + Menthol
88. Chlorpheniramine + Vitamin C
89. Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate
90. Chlorpheniramine+Ammonium Chloride + Menthol
91. Chlorpromazine + Trihexyphenidyl
92. Chromium Polynicotinate + Metformin
93. Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate
94. Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol
95. Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin
96. Ciprofloxacin + Phenazopyridine
97. Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone
98. Clindamycin + Clotrimazole + Lactic Acid Bacillus
99. Clindamycin + Telmisartan
100. Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole
101. Clobetasol + Neomycin + Miconazole + Clotrimazole
102. Clobetasol + Neomycin + Miconazole + Zinc Sulphate
103. Clobetasol + Ofloxacin + Ketoconazol + Zinc Sulphate
104. Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate
105. Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine
106. Clobetasole + Gentamicin + Miconazole + Zinc Sulphate
107. Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene+ Selenium + Levocarnitine Tartrate + L-Arginine
108. Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Aicd + Sodium Methyl Paraben +Propyl Paraben
109. Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine
110. Clotrimazole + Ofloxaxin + Lignocaine + Glycerine and Propylene Glycol
111. Codeine + Chlorpheniramine + Alcohol Syrup
112. Codeine + Levocetirizine + Menthol
113. Combikit of 3 tablets of Serratiopeptidase (enteric coated 20000 units) + Diclofenac Potassium & 2 tablets of Doxycycline
114. Combikit of Azithromycin, Secnidazole and Fluconazole
115. Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets
116. Cyproheptadine + Thiamine
117. Dextrometharphan + Chlopheniramine + Ammonium Chloride+ Menthol
118. Dextrometharphan + Chlopheniramine + Ammonium + Sodium Citrate + Menthol
119. Dextrometharphan + Phenylephrine + Guaiphenesin
120. Dextromethophan + Chlopheniramine + Bromhexine
121. Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + Menthol
122. Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
123. Dextromethorphan + Bromhexine + Guaiphenesin
124. Dextromethorphan + Bromhexine + Guaiphenesin + Menthol
125. Dextromethorphan + Cetirizine
126. Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride
127. Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate
128. Dextromethorphan + Chlorpheniramine + Guaiphenesin
129. Dextromethorphan + Levocetirizine + Phenylephrine + Zinc
130. Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine
131. Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol
132. Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + Chlorpheniramine
133. Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine
134. Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol
135. Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen
136. Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine
137. Dextromethorphan + Phenylephrine + Tripolidine + Menthol
138. Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol
139. Dextromethorphan + Tripolidine + Phenylephirine
140. Dextromethorphan + Triprolidine + Phenylephrine
141. Dextromethorphen + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin
142. Dextromethorphen + Promethazine
143. Diclofenac + paracetamol + chlorpheniramine maleate + mgnesium Trisillicate
144. Diclofenac + Paracetamol + Chlorzoxazone + Famotidine
145. Diclofenac + paracetamol + magnesium Trisilicate
146. Diclofenac + Paracetamol injection
147. Diclofenac + Tramadol + Chlorzoxazone
148. Diclofenac + Tramadol + Paracetamol
149. Diclofenac + Zinc Carnosine
150. Dicyclomine + Paracetamol + Domperidone
151. Diethyl Carbamazine + Chlorpheniramine + Guaifenesin
152. Diethylcabamazine Citrate + Cetirizine + Guaiphenesin
153. Diethylcarbamazine + Cetirizine + Ambroxol
154. Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol
155. Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine
156. Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + Menthol
157. Diphenoxylate + Atropine + Furazolidonee
158. Disodium Hydrogen Citrate + Paracetamol
159. Doxycycline + Serratiopeptidase
160. Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol
161. Dried Alumnium Hydroxie Gel + Prophantheline + Diazepam
162. Drotaverine + Clidinium + Chlordiazepoxide
163. Enrofloxacin + Bromhexin
164. Ergotamine Tartrate + Belladona Dry Extarct+Caffeine + Paracetamol
165. Ethylmorphine + Noscapine + Chlorpheniramine
166. Famotidine + Oxytacaine + Magaldrate
167. Flunarizine + Paracetamole + Domperidone
168. Flupentixol + Escitalopram
169. Furazolidone + Metronidazole + Loperamide
170. Gabapentin + Mecobalamin + Pyridoxine + Thiamine
171. Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine
172. Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin
173. Glibenclamide + Metformin (SR)+ Pioglitazone
174. Gliclazide 40mg + Metformin 400mg
175. Gliclazide 80 mg + Metformin 325 mg
176. Glimepiride + Pioglitazone + Metformin
177. Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/1000mg/1000mg
178. Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg
179. Glipizide 2.5mg + Metformin 400 mg
180. Glucosamine + Methyl Sullfonyl Methane + Vitamin D3 + Manganese + Boron + Copper + Zinc
181. Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol
182. Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase(as enteric coated granules) 10000 SP Units
183. Guaifenesin + Dextromethorphan
184. Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine
185. Heparin + Diclofenac
186. Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl
187. Ketoconazole + Tea Tree oil + Allantion + Zinc Oxide + Aloe Vera + Jojoba oil +Lavander oil + Soa noodels
188. Ketotifen + Cetirizine
189. Ketotifen + Levocetrizine
190. Ketotifen + Theophylline
191. L-5-Methyltetrahydrofolate Calcium + Escitalopram
192. L-Arginine + Sildenafil
193. Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin
194. Levocetirizine + Ambroxol + Phenylephrine + Paracetamol
195. Levocetirizine + Dextromethorphan + Zinc
196. Levocetirizine + Montelukast + Acebrophylline
197. Levocetirizine + Paracetamol + Phenylephirine + Caffeine
198. Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol
199. Levocetirizine + Ranitidine
200. Levofloxacin + Bromhexine
201. Levofloxacin + Ornidazole + Alpha Tocopherol Acetate
202. Levothyroxine + Phyridoxine + Nicotinamide
203. Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone
204. Lornoxicam + Paracetamol + serratiopeptidase
205. Lornoxicam + paracetamol + Tramadol
206. Lornoxicam + paracetamol + trypsin
207. Magaldrate + Famotidine + Simethicone
208. Magaldrate + Papain + Fungul Diastase + Simethicone
209. Magaldrate + Ranitidine + Pancreatin + Domperidone
210. Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium butyricum + Bacillusmesentricus + Lactic Acid Bacillus)
211. Menthol + Anesthetic Ether
212. Metformin (SR) 500mg + Pioglitazone 5mg
213. Metformin (Sustainded Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg
214. Metformin + Atorvastatin
215. Metformin + Bromocriptine
216. Metformin + Gliclazide + Chromium Polynicotinate
217. Metformin + Gliclazide + Piogllitazone + Chromium Polynicotinate
218. Metformin + Glimepiride + Methylcobalamin
219. Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mg
220. Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg
221. Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg
222. Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg
223. Metformin ER + Gliclazide MR + Voglibose
224. Metronidazole + Norfloxacin
225. Metronidazole + Tetracycline
226. N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocertirizine
227. Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine
228. Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorobutol
229. Naproxen + Paracetamol
230. Neomycin + Doxycycline
231. Nimesulide + Certirizine + Phenylephrine
232. Nimesulide + Cetrizine + Caffeine
233. Nimesulide + Diclofenac
234. Nimesulide + Dicyclomine
235. Nimesulide + Loratadine + Phenylephrine + Ambroxol
236. Nimesulide + Paracetamol + Cetirizine + Phenylephrine
237. Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine
238. Nimesulide + paracetamol Injection
239. Nimesulide + Paracetamol Suspension
240. Nimesulide + Phenylephrine + Caffeine + Levocetirizine
241. Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol
242. Nimesulide + Serratiopeptidase
243. Nimesulide + Tizanidine
244. Nimorazole + Ofloxacin
245. Norfloxacin+ Metronidazole + Zinc Acetate
246. Oflaxacin + Ornidazole Suspension
247. Ofloxacin + Clotrimazole + Betamethasone + Lignocaine
248. Ofloxacin + Metronidazole + Zinc Acetate
249. Ofloxacin + Nitazoxanide
250. Ofloxacin + Ornidazole + Zinc Bisglycinate
251. Olmesartan + Hydrochlorothiazide + Chlorthalidone
252. Omepraozle + Paracetmaol+ Diclofenac
253. Oxetacaine + Magaldrate + Famotidine
254. Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets)
255. Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine
256. Paracetamol + Caffeine + Codeine
257. Paracetamol + Caffine + Phenylephrine + Chlorpheniramine
258. Paracetamol + Cetrizine + Caffeine
259. Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine
260. Paracetamol + Codeine + Chlorpheniramine
261. Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine
262. Paracetamol + Dextromethorphan + Chlorpheniramine
263. Paracetamol + Diclofenac + famotidine
264. Paracetamol + Disodium Hydrogen Citrate + Caffeine
265. Paracetamol + DL Methionine
266. Paracetamol + domperidone + Caffeine
267. Paracetamol + Levocetirizine + Phenylephirine + Zink Gluconate
268. Paracetamol + Levocetirizine + Pseudoephedrine
269. Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine
270. Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine
271. Paracetamol + mefenamic Acid + ranitidine + Dicyclomine
272. Paracetamol + Pheniramine
273. Paracetamol + Phenylephrine + Chlorpheneramine + Dextromethorphan + caffeine
274. Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate
275. Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol
276. Paracetamol + Phenylephrine + Levocetirizine + Caffeine
277. Paracetamol + Phenylephrine + Triprolidine
278. Paracetamol + Phenylephrine + Triprolidine + Caffeine
279. Paracetamol + Prochloperazine
280. Paracetamol + Prochlorperazine Maleate
281. Paracetamol + Promethazine
282. Paracetamol + Propyphenazone + Caffeine
283. Paracetamol + Pseudoephedrine + Cetrizine
284. Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine
285. Paracetamol + Tapentadol
286. Paracetamol+Phenylephrine+Levocetirizine+Sodium Citrate
287. Paracetamol+Pseudoephedrine+Certirizine+Caffeine
288. Permethrin + Cetrimide + Menthol
289. phenylbutazone + sodium salicylate
290. Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine
291. Pholcodine + Phenylephrine + Promethazine
292. Pioglitazone 15mg + Metformin 850 mg
293. Pioglitazone 30 mg + Metformin 500 mg
294. Pioglitazone 7.5/7.5mg + Metformin 500/1000mg
295. Pseudoephedrine + Bromhexine
296. Pseudoephedrine + Cetirizine
297. Pseudoephedrine + Dextromethorphan + Cetirizine
298. Rabeprazole + Diclofenac + Paracetamol
299. Rabeprazole + Zinc + Domperidone
300. Rabeprazole + Zinc Carnosine
301. Ranitidine + Domperidone + Simethicone
302. Ranitidine + Magaldrate
303. Ranitidine + Magaldrate + Simethicone
304. Roxithromycin + Serratiopeptidase
305. Salbutamol + Aminophylline + Guaiphensin
306. Salbutamol + Bromhexine + Guaiphenesin + Menthol
307. Salbutamol + Certirizine + Ambroxol
308. Salbutamol + Choline Theophylinate + Ambroxol
309. Salbutamol + Choline Theophylinate + Carbocisteine
310. Salbutamol + Theophylline + Bromhexine
311. Salbutamol+Hydroxyethyltheophylline (Etofylline) + Bromhexine
312. Sildenafil + Estradiol Valerate
313. Tamsulosin + Diclofenac
314. Telmisartan + Metformin
315. Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol
316. Terbutaline + Bromhexine + Etofylline
317. Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan
318. Terbutaline + Etofylline + Ambroxol
319. Terbutaline + N-Acetyl L-Cysteine + Guaifenesin
320. Terpinhydrate + Dextromethorphan + Menthol
321. Thyroid + Thiamine + Riboflavin + Phyridoxine + Calcium Pantothenate + Tocopheryl Acetate +Nicotinamide
322. Thyroxine + Pyridoxine + Folic Acid
323. Tranexamic Acid + Proanthocyanidin
324. Ursodeoxycholic Acid + Silymarin
325. Voglibose + Pioglitazone + Metformin
326. Voglibose+ Metformin + Chromium Picolinate
327. Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + Simethicone
328. Zinc Carnosine + Oxetacaine
329. Zinc Carnosine + Sucralfate

List of Drugs Banned in 2019(11^✔)

• Activated charcoal + Fungal diastase + Lactic acid
• 5-bromosalicyl-4-chloranilide + Salicylic acid
• Allobarbitone + Phospho-dimethyl-isopropyl-pyrazolone
• Artesunate + Arteether + Artemether
• Atorvastatin + Acetyl Salicylic acid + Caffeine
• Chlormezanone + Paracetamol+ Diclofenac sodium
• Chlormezanone +Paracetamol + Ibuprofen
• Chlorzoxazone + Ibuprofen + Paracetamol + Diclofenac + Oxyphenbutazone + Magnesium hydroxide
• Chlorzoxazone + Paracetamol + Ibuprofen + Diclofenac sodium
• Ciprofloxacin + Tinidazole + Dicyclomine
• Dicyclomine + Dextromethorphan + Paracetamol
• Dicyclomine + Paracetamol + Chlordiazepoxide
• Dicyclomine +Paracetamol +Phenylisopropyl Pyrazolone
• Dicyclomine + Serratiopeptidase
• Ibuprofen + Colchicine
• Ibuprofen + Dextropropoxyphene + Paracetamol
• Ibuprofen + Paracetamol + Colchicine
• Ibuprofen + Paracetamol+ Magnesium trisilicate
• Mebeverine + Alprazolam
• Mecobalamin + Methenamine mandelate
• Norfloxacin +Tinidazole +Dicyclomine
• Norfloxacin+Tinidazole+Loperamide
• Ondansetron +Paracetamol
• Paracetamol + Alprazolam
• Paracetamol + Diclofenac Sodium + Amoxicillin + Cloxacillin + Pantoprazole + Lactic Acid Bacillus + Serratiopeptidase
• Paracetamol + Diclofenac sodium + Magnesium Trisilicate + Chlorpheniramine Maleate
• Paracetamol + Ketoprofen + Dextropropoxyphene
• Ranitidine + Dicyclomine + Clidinium bromide
• Ranitidine + Omeprazole
• Acriflavine + Gentian violet + Brilliant green
• Allantoin + Triclosan + Vitamin E + Zinc Oxide
• Allantoin + Vitamin E + Camellia Sinensis
• Atorvastatin + Omega 3 Fatty Acid 250mg
• Atorvastatin + Ubidecarenone
• Cefixime + Lactobacillus + Clavulanic Acid
• Cefixime + Ornidazole
• Ceftriaxone + Vancomycin
• Cefuroxime + Ornidazole
• Diclofenac + Pitofenone Hydrochloride + Fenpiverinium Bromide + Paracetamol
• Dicyclomine + Paracetamol + Dextropropoxyphene + Chlordiazepoxide
• Dicyclomine + Paracetamol + Dimethylpolysiloxane
• Dicyclomine + Paracetamol+ Simethicone
• Doxycycline + Tinidazole
• Drotaverine + Omeprazole
• Fenpiverinium Bromide + Diclofenac sodium + Pitofenone hydrochloride
• Glucosamine + Ascorbic Acid
• Glucosamine + Boswellia Serrata
• Glucosamine + Calcium Carbonate
• Glucosamine + Cetyl Myristate Oleate
• Glucosamine + Chondroitin sulphate +Methyl sulfonyl methane
• Glucosamine + Chondroitin sulphate + Vitamin C+ manganese
• Glucosamine + Chondroitin + Vitamin C + Vitamin E + Manganese
• Glucosamine + Chondroitin + Vitamin C
• Glucosamine + Chondroitin + Vitamin C + Vitamin E + Manganese sulphate + Sodium borate + Selenium dioxide
• Glucosamine + Cholecalciferol + Manganese + Ascorbic acid
• Glucosamine + Manganese
• Glucosamine +Mecobalamin + Dimethyl Sulfone
• Glucosamine + Mecobalamin
• Glucosamine + Mecobalamin + Milk calcium
• Glucosamine + Methyl sulfonyl methane
• Glucosamine + Methyl sulfonyl methane + Cetyl Myristate
• Glucosamine + Vitamin C + Calcium + Methyl Sulfonyl Methane + Chondroitin + Manganese
• Glucosamine + Vitamin C+ Vitamin E + Chondroitin sulphate + Methyl sulfonyl methane + Manganese sulphate
• Glucosamine sulphate + Chondroitin sulphate + Vitamin E + Manganese
• Glucosamine + Calcium + Vitamin D3
• Ornidazole + Doxycycline
• Ornidazole + Fluconazole + Azithromycin
• Propranolol + Hydralazine
• Propranolol + Hydrochlorothiazide + Dihydralazine
• Ranitidine + Dicyclomine + Nimesulide
• Ranitidine + Dicycloverine + Simethicone
• Ranitidine + Drotaverine
• Telmisartan + Ramipril + Hydrochlorothiazide
• Ibuprofen + Paracetamol+ Phenylephrine + Chlorpheniramine maleate
• Nimesulide + Phenylephrine + Chlorpheniramine maleate + Caffeine
• Nimesulide + Pitofenone + Fenpiverinium Bromide
• Nimesulide+ Pseudoephedrine + Cetirizine
• Ofloxacin + Diclofenac + Lignocaine
• Ondansetron + Omeprazole
• Hydrochlorothiazide + Ramipril +Losartan Potassium

Fixed dose compositions of corticosteroids with any other drug [excluding Tamsulosin HCl 0.4mg (as film coated modified release tablet) + Deflazacort 30mg in hard gelatin capsule] for internal use, except formulations for meter dose inhalers and dry powder inhalers.

List of Cough Syrups Banned in India

• Promethazine Oral Solution
• Kofexmalin Baby Cough Syrup
• Makoff Baby Cough Syrup
• Magrip N Cold Syrup

This WHO Medical Product Alert concerns four subpar goods discovered in The Gambia and submitted to WHO in September 2022. Substandard medical items are products that fail to satisfy either their quality standards or specifications and are, therefore "out of specification".The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). The claimed producer has not yet given WHO any assurances regarding the reliability and safety of these products.

Laboratory examination of samples from each of the four items reveals impurities such as diethylene glycol and ethylene glycol at prohibited concentrations. These four products have so far only been found in The Gambia, but they may have travelled to other nations or areas via unofficial markets. When ingested by humans, diethylene glycol and ethylene glycol are poisonous and can be fatal. Toxic consequences can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, changed mental state, and acute kidney injury, which can result in death(12^✔).

Drugs Banned in other Countries but Available in India

Several drugs that are prohibited or withdrawn from other countries like the United States are still widely available in India. Some of these include the following:

Painkillers - Oxyphenbutazone, Nimesulide, Propoxyphene

• Oxyphenbutazone is a non-opioid painkiller that has been banned in many countries since it causes bone marrow depression thereby reducing the number of blood cells in the body, and other side effects. Its combination with any other drug is banned in India though it is available as a single drug(13^✔).
• Nimesulide is a non-opioid painkiller that was found to cause liver failure and was never introduced in the US. Children with viral infection were particularly susceptible to this adverse effect of nimesulide. In India, its use in children below 12 years of age is banned though it can be used in adults(14^✔).
• Propoxyphene is an opioid painkiller that may alter the electrical activity of the heart, causing problems in heart rhythm. It is not banned in India(15^✔).

Antibacterials - Furazolidone, Nitrofurazone

• Furazolidone is used in the treatment of diarrhea caused by bacteria or protozoa, alone or in combination with another drug, metronidazole. Studies indicate that its use has a possibility of causing cancer, and it is therefore not used in several countries. In India, only its combination with loperamide, an anti-motility drug used in the treatment of diarrhea, is banned(16^✔).
• Nitrofurazone is a topically used antibacterial similar to furazolidone and therefore, could also possibly cause cancer. It is banned in some countries, but not yet in India(17^✔).

Anabolic Steroid - Nandrolone decanoate

Nandrolone decanoate is a drug that is used in the treatment of anemia due to kidney disease and osteoporosis. The drug is commonly abused by athletes to build muscle mass. It has been discontinued in the United States but is still used in India(18^✔).

Drugs Acting on the Brain - Thioridazine, Pergolide, Pemoline

• Thioridazine is an antipsychotic drug used in the treatment of conditions like schizophrenia. Its side effects include abnormal heart rhythms or arrhythmia, eye damage, and a condition called neuroleptic malignant syndrome where the patient suffers from high temperature and muscle rigidity. It continues to be available in India(19^✔).
• Pergolide is a drug used for the treatment of Parkinson's disease, a condition that affects the nervous system resulting in stiffness and tremors. For a long time, levodopa and carbidopa were the only drugs effective in this condition. The availability of new drugs provided hope for the patients. Pergolide was among these newer drugs, however it had to be withdrawn because it caused damage to heart valves(20^✔).
• Pemoline, a drug used in the treatment of attention deficit hyperactivity disorder, has been withdrawn in the United States due to its liver toxicity risk. However, it is not discontinued in India(21^✔).

Cholesterol Lowering Drug - Cerivastatin

Cerivastatin is a cholesterol-lowering drug that caused several cases of rhabdomyolysis (destruction of skeletal muscles). With this side effect, patients suffered from damage to muscles followed by kidney failure. Unfortunately, it is still available in India(22^✔).

Constipation - Phenolphthalein

Phenolphthalein belongs to a group of drugs called stimulant purgative, which are useful in the treatment of constipation. Studies in mice have indicated that its use may be associated with cancer or genetic damage, due to which it is not available in several countries. Though available in India, it is not frequently used(23^✔).

Human Placental Extract

The human placental extract is derived from the placenta obtained during delivery of a baby and finds use in the cosmetic industry. As other tissues of human origin, it may transmit infections like hepatitis B and HIV if adequate precautions are not taken, and is therefore not used in several countries. It is only allowed for two conditions in India - to be used locally for wound healing, and to be injected for pelvic inflammatory disease(24^✔).

References:

1. Adverse drug reactions - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6297296/)
2. A study on drug safety monitoring program in India - (https://www.ijpsonline.com/articles/a-study-on-drug-safety-monitoring-program-in-india.html)
3. Rise and fall of anti-obesity drugs - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3083904/)
4. Withdrawal of COX-2 selective inhibitors rofecoxib and valdecoxib: impact on NSAID and gastroprotective drug prescribing and utilization - (https://pubmed.ncbi.nlm.nih.gov/17605893/)
5. Consensus Statement for the Diagnosis and Treatment of Urticaria: A 2017 Update - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838750/)
6. Ban on Manufacture for sale and Distribution of Rosiglitazone and their formulations for human use - (https://www.dfda.goa.gov.in/media-1/158-ban-on-manufacture-for-sale-and-distribution-of-rosiglitazone-and-their-formulations-for-human-use)
7. Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819028/)
8. Cardiovascular safety of prokinetic agents: A focus on drug-induced arrhythmias - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6364982/)
9. Gatifloxacin Ophthalmic Solution for Treatment of Bacterial Conjunctivitis: Safety, Efficacy and Patient Perspective - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619660/)
10. Prohibition of 328 Fixed Dose Combinations by the Central Government vide Gazette notification nos. S.O. 4379 (E) to S.O. 4706(E) - (https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTk1Mg==)
11. List of Drugs Prohibited for Manufacture and Sale Through Gazette Notifications Under Section 26a of Drugs & Cosmetics Act 1940 by the Ministry of Health and Family Welfare With Their Present Status As On 22.11.2021. - (https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODE5Mg==)
12. Substandard (contaminated) paediatric medicines - (https://www.who.int/news/item/05-10-2022-medical-product-alert-n-6-2022-substandard-(contaminated)-paediatric-medicines)
13. Oxyphenbutazone - (https://pubchem.ncbi.nlm.nih.gov/compound/Oxyphenbutazone)
14. Use of nimesulide in Indian children must be stopped - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1125612/)
15. Propoxyphene and the Risk of Out-of-Hospital Death - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3694329/)
16. Furazolidone therapy for Helicobacter pylori: Is it effective and safe? - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2670425/)
17. Detection, accumulation and distribution of nitrofuran residues in egg yolk, albumen and shell - (https://pubmed.ncbi.nlm.nih.gov/17164214/)
18. Anabolic Steroids - (https://www.ncbi.nlm.nih.gov/books/NBK482418/)
19. Discontinuation of thioridazine - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124456/)
20. Pergolide - (https://pubchem.ncbi.nlm.nih.gov/compound/Pergolide)
21. Pemoline - (https://pubchem.ncbi.nlm.nih.gov/compound/Pemoline)
22. Withdrawal of cerivastatin from the world market - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59524/)
23. Case series on a diversity of illicit weight-reducing agents: from the well known to the unexpected - (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3040546/)
24. Final report on the safety assessment of human placental protein, hydrolyzed human placental protein, human placental enzymes, human placental lipids, human umbilical extract, placental protein, hydrolyzed placental protein, placental enzymes, placental lipids, and umbilical extract - (https://pubmed.ncbi.nlm.nih.gov/12042062/)

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