MEMBERS' REFERENCE SERVICE LARRDIS LOK SABHA SECRETARIAT, NEW DELHI REFERENCE NOTE. No.14/RN/Ref./March/2017

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1 MEMBERS' REFERENCE SERVICE LARRDIS LOK SABHA SECRETARIAT, NEW DELHI REFERENCE NOTE No.14/RN/Ref./March/2017 For the use of Members of Parliament NOT FOR PUBLICATION 1 BAN ON FIXED DOSE COMBINATION (FDC) DRUGS Prepared by Smt. Sunanda Das Mohanty, Additional Director ( ) and Shri Rajkumar Patton, Junior Library Assistant of Lok Sabha Secretariat under the supervision of Smt. Kalpana Sharma, Joint Secretary and Dr. P. J. Antony, Director. The reference material is for personal use of the Members in the discharge of their Parliamentary duties, and is not for publication. This Service is not to be quoted as the source of information as it is based on the sources indicated at the end/in the text.

2 BAN ON FIXED DOSE COMBINATION (FDC) DRUGS The Government of India banned 344 Fixed Dose Combination (FDC) drugs on 10 March citing health reasons and lack of therapeutic justification. FDCs are drugs with two or more active pharmaceutical ingredients combined in a fixed dose to form a single drug 2. For over 30 years pharmaceutical companies have been selling these FDCs with scant regard for their efficacy, safety or rationality for use. Process for marketing a drug- Any new drug requires prior approval from the Drugs Controller General (India) [DCGI] before these are licensed by the State Licensing Authorities (SLAs) for manufacture and sale in the country. As FDCs are combinations of certain drugs that are combined together for the first time, these are treated as New Drugs. Many SLAs granted licences to some new FDCs without the approval of the DCG (I) on assessment of safety, efficacy and rationality. This led to availability of a number of FDCs in the Indian market without any knowledge about their safety and efficacy on Indian population. Report of Parliamentary Committee on Health and Family Welfare In their 59 th Report, Department-related Parliamentary Standing Committee on Health and Family Welfare observed that some SLAs had issued manufacturing licences for a very large number of FDCs without prior clearance from Central Drugs Standard Control Organization (CDSCO) 3 and this had resulted in the 1 Vide Gazette Notifications S.O. Nos. 705(E) to 1048(E). 2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent or reduce fever). Cough syrups Phensedyl and Corex, the widely advertised Vicks Action 500, antibiotic combination Zimnic AZ are some of the popular FDCs, which involve commonly used medications such as paracetamol, aceclofenac and nimesulide. 3 CDSCO-(Central Drugs Standard Control Organization )- is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

3 2 availability of many FDCs in the market which had not been tested for efficacy and safety. The Committee had also noted that this could put patients at risk. It pointed out that 'Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk. On an average DCGI is approving one drug every month without trials. This cannot be in public interest by any stretch of imagination.' The Parliamentary Standing Committee expressed the view that those unauthorized FDCs that pose risk to patients and communities, such as a combination of two antibacterials, need to be withdrawn immediately due to the danger of developing resistance that would affect the entire population. (ANNEXURE II). Government s Action The Government accepted many of the recommendations of the Parliamentary Committee and the Ministry of Health and Family Welfare issued statutory directions to the State Governments to instruct their respective drugs licensing authorities to refrain from granting such licenses. However, the practice was still not discontinued by some of the SLAs. Further, in a letter dated 15 January 2013, the DCGI asked manufacturers to produce safety and efficacy data of their FDC products from the central government or stand the risk of their licences being cancelled. This direction was given for all products approved after 29 September 1988 and before 1 October Most manufacturers complied only after a lot of hesitation and procedural wrangling, and after several extensions of deadlines and reminders. An 18-month window ending on 14 July 2014 was given for applications from manufacturers justifying the safety, efficacy and rationality of their products.

4 3 CDSCO also set up 10 professional committees in February 2014 to analyze the rationality as well as safety and efficacy of the FDCs. After careful consideration of the recommendations of the Committee and of the entire matter, the Government issued show cause notices to the manufacturers whose products were found to be irrational. At the request of the manufacturers, additional time of three months was also given to them to respond to the show cause notice. Ultimately, after due consideration of the report and replies, the Government of India banned 344 FDCs on10 March Following the ban, the drug companies continue to insist on marketing grossly irrational, unsafe and ineffective products. Pharmaceutical companies have teamed up to mount an intense battle with claims that the future of the industry and Make in India are threatened. They are doing everything in their power to prevent the government from acting in the public s interest. In a major relief to them, the Delhi High Court quashed the Government Ban in December The Centre has now moved the Supreme Court on 30 January 2017 seeking to enforce the ban once again. It is hoped that the Apex Court will see this as a matter concerning life and death and will not allow any legal wizardry by pharmaceutical company counsels. That will be the beginning of the long overdue clean-up of the pharma industry in India. Conclusion As the matter is now before the Supreme Court, it is hoped that it will take into account the serious public health implications of the sale of certain drugs and allow regulatory intervention banning uncertified combination drugs.

5 4 SOURCES CONSULTED 1. Cleaning Up the Pharma Industry : A Landmark Ban on Irrational Drugs, Economic & Political Weekly, dated: ; vol II no Banning of FDC Drugs, PIB Fifty-ninth report on the functioning of the central drugs standard control organisation (CDSCO), Rajya Sabha, dated: th Report Action taken by the Government on the recommendations contained in the 59 th Report, Gazette notifications ( , S.O 705(E) TO 1048(E) on Ban of FDC Drugs, 6. Curb on illegal sale of banned drugs and medicines, Rajya Sabha, starred Question no. 172, dated: CDSCO establishes 10 expert committies to examine safety of FDCs, Ethics in Clinical Research, dated: Centre moves SC seeking to enforce ban on 344 fixed-dose-combination drugs, livemint, dated:

6 ANNEXURE I 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 Complete list of 344 drugs banned by the Ministry of Health Family welfare A gazette notification by Ministry of Health and Family Welfare has banned 344 medicines of fixed drug combinations. The Health Ministry banned 344 fixed drug combinations through a gazette notification. The ban, which comes into effect immediately, follows recommendations of an expert committee formed to examine the efficacy of these drug combinations. Here is the complete list of all drug combinations banned by the ministry: 1. fixed dose combination of Aceclofenac + Paracetamol + Rabeprazole 2. fixed dose combination of Nimesulide + Diclofenac 3. fixed dose combination of Nimesulide + Cetirizine + Caffeine 4. fixed dose combination of Nimesulide + Tizanidine 5. fixed dose combination of Paracetamol + Cetirizine + Caffeine 6. fixed dose combination of Diclofenac + Tramadol + Chlorzoxazone 7. fixed dose combination of Dicyclomine + Paracetamol + Domperidone 8. fixed dose combination of Nimesulide + Paracetamol dispersible tablets 9. fixed dose combination of Paracetamol + Phenylephrine + Caffeine 10. fixed dose combination of Diclofenac + Tramadol + Paracetamol 11. fixed dose combination of Diclofenac + Paracetamol + Chlorzoxazone + Famotidine 12. fixed dose combination of Naproxen + Paracetamol 13. fixed dose combination of Nimesulide + Serratiopeptidase 14. fixed dose combination of Paracetamol + Diclofenac + Famotidine 15. fixed dose combination of Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol 16. fixed dose combination of Omeprazole + Paracetamol + Diclofenac 17. fixed dose combination of Nimesulide + Paracetamol injection 18. fixed dose combination of Tamsulosin + Diclofenac 19. fixed dose combination of Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine 20. fixed dose combination of Diclofenac + Zinc Carnosine

7 21. fixed dose combination of Diclofenac + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate 22. fixed dose combination of Paracetamol + Pseudoephedrine + Cetrizine 23. fixed dose combination of Phenylbutazone + Sodium Salicylate 24. fixed dose combination of Lornoxicam + Paracetamol + Trypsin 25. fixed dose combination of Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine 26. fixed dose combination of Nimesulide + Dicyclomine 27. fixed dose combination of Heparin + Diclofenac 28. fixed dose combination of Glucosamine + Methyl Sulfonyl Methane + Vitamin D3 + Manganese + Boron + Copper + Zinc 29. fixed dose combination of Paracetamol + Tapentadol 30. fixed dose combination of Tranexamic Acid + Proanthocyanidin 31. fixed dose combination of Benzoxonium Chloride + Lidocaine 32. fixed dose combination of Lornoxicam + Paracetamol + Tramadol 33. fixed dose combination of Lornoxicam + Paracetamol + Serratiopeptidase 34. fixed dose combination of Diclofenac + Paracetamol + Magnesium Trisilicate 35. fixed dose combination of Paracetamol + Domperidone + Caffeine 36. fixed dose combination of Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol 37. fixed dose combination of Paracetamol + Prochlorperazine Maleate 38. Combikit of 3 tablets of Serratiopeptidase (enteric coated units) + Diclofenac Potassium & 2 tablets of Doxycycline 39. fixed dose combination of Nimesulide + Paracetamol Suspension 40. fixed dose combination of Aceclofenac + Paracetamol + Famotidine 41. fixed dose combination of Aceclofenac + Zinc Carnosine 42. fixed dose combination of Paracetamol + Disodium Hydrogen Citrate + Caffeine 43. fixed dose combination of Paracetamol + DL Methionine 44. fixed dose combination of Disodium Hydrogen Citrate + Paracetamol 45. fixed dose combination of Paracetamol + Caffeine + Codeine 46. fixed dose combination of Aceclofenac (SR) + Paracetamol 47. fixed dose combination of Diclofenac + Paracetamol injection 48. fixed dose combination of Azithromycin + Cefixime 49. fixed dose combination of Amoxicillin + Dicloxacillin 50. fixed dose combination of Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5 mg 51. fixed dose combination of Azithromycin + Levofloxacin

8 52. fixed dose combination of Cefixime + Linezolid 53. fixed dose combination of Amoxicillin + Cefixime + Potassium Clavulanic Acid 54. fixed dose combination of Ofloxacin + Nitazoxanide 55. fixed dose combination of Cefpodoxime Proxetil + Levofloxacin 56. Combikit of Azithromycin, Secnidazole and Fluconazole 57. fixed dose combination of Levofloxacin + Ornidazole + Alpha Tocopherol Acetate 58. fixed dose combination of Nimorazole + Ofloxacin 59. fixed dose combination of Azithromycin + Ofloxacin 60. fixed dose combination of Amoxycillin + Tinidazole 61. fixed dose combination of Doxycycline + Serratiopeptidase 62. fixed dose combination of Cefixime + Levofloxacin 63. fixed dose combination of Ofloxacin + Metronidazole + Zinc Acetate 64. fixed dose combination of Diphenoxylate + Atropine + Furazolidone 65. Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets 66. fixed dose combination of Ciprofloxacin + Phenazopyridine 67. fixed dose combination of Amoxycillin + Dicloxacillin + Serratiopeptidase 68. Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets 69. fixed dose combination of Ciprofloxacin + Phenazopyridine 70. fixed dose combination of Amoxycillin + Dicloxacillin + Serratiopeptidase 71. fixed dose combination of Azithromycin + Cefpodoxime 72. fixed dose combination of Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone 73. fixed dose combination of Cefuroxime + Linezolid 74. fixed dose combination of Ofloxacin + Ornidazole + Zinc Bisglycinate 75. fixed dose combination of Metronidazole + Norfloxacin 76. fixed dose combination of Amoxicillin + Bromhexine 77. fixed dose combination of Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin 78. fixed dose combination of Metronidazole + Tetracycline 79. fixed dose combination of Cephalexin + Neomycin + Prednisolone 80. fixed dose combination of Azithromycin + Ambroxol 81. fixed dose combination of Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate 82. fixed dose combination of L-Arginine + Sildenafil 83. fixed dose combination of Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine 84. fixed dose combination of Metformin + Atorvastatin

9 85. fixed dose combination of Clindamycin + Telmisartan 86. fixed dose combination of Olmesartan + Hydrochlorothiazide + Chlorthalidone 87. fixed dose combination of L-5-Methyltetrahydrofolate Calcium + Escitalopram i 88. fixed dose combination of Pholcodine + Promethazine 89. fixed dose combination of Paracetamol + Promethazine 90. fixed dose combination of Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam 91. fixed dose combination of Cetirizine + Diethyl Carbamazine 92. fixed dose combination of Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol 93. fixed dose combination of Drotaverine + Clidinium + Chlordiazepoxide 94. fixed dose combination of Imipramine + Diazepam 95. fixed dose combination of Flupentixol + Escitalopram 96. fixed dose combination of Paracetamol + Prochloperazine 97. fixed dose combination of Gabapentin + Mecobalamin + Pyridoxine + Thiamine 98. fixed dose combination of Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl 99. fixed dose combination of Chlorpromazine + Trihexyphenidyl 100. fixed dose combination of Ursodeoxycholic Acid + Silymarin 101. fixed dose combination of Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride1/2/1/2mg 102. fixed dose combination of Gliclazide 80 mg + Metformin 325 mg 103. fixed dose combination of Voglibose+ Metformin + Chromium Picolinate 104. fixed dose combination of Pioglitazone 7.5/7.5mg + Metformin 500/1000mg 105. fixed dose combination of Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/ mg/1000mg 107. fixed dose combination of Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg 108. fixed dose combination of Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg 109. fixed dose combination of Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg 110. fixed dose combination of Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg 111. fixed dose combination of Voglibose + Pioglitazone + Metformin 112. fixed dose combination of Metformin + Bromocriptine

10 113. fixed dose combination of Metformin + Glimepiride + Methylcobalamin 114. fixed dose combination of Pioglitazone 30 mg + Metformin 500 mg 115. fixed dose combination of Glimepiride + Pioglitazone + Metformin 116. fixed dose combination of Glipizide 2.5mg + Metformin 400 mg 117. fixed dose combination of Pioglitazone 15mg + Metformin 850 mg 118. fixed dose combination of Metformin ER + Gliclazide MR + Voglibose 119. fixed dose combination of Chromium Polynicotinate + Metformin 120. fixed dose combination of Metformin + Gliclazide + Piogllitazone + Chromium Polynicotinate 121. fixed dose combination of Metformin + Gliclazide + Chromium Polynicotinate 122. fixed dose combination of Glibenclamide + Metformin (SR)+ Pioglitazone 123. fixed dose combination of Metformin (Sustainded Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg 124. fixed dose combination of Metformin (SR) 500mg + Pioglitazone 5mg 125. fixed dose combination of Chloramphenicol + Beclomethasone + Clomitrimazole + Lignocaine 126. fixed dose combination of Clotrimazole + Ofloxaxin + Lignocaine + Glycerine and Propylene Glycol 127. fixed dose combination of Chloramphennicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + Antipyrine 128. fixed dose combination of Ofloxacin + Clotrimazole + Betamethasone + Lignocaine 129. fixed dose combination of Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine 130. fixed dose combination of Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine 131. fixed dose combination of Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drops 132. fixed dose combination of Flunarizine + Paracetamole + Domperidone 133. fixed dose combination of Rabeprazole + Zinc Carnosine 134. fixed dose combination of Magaldrate + Famotidine + Simethicone 135. fixed dose combination of Cyproheptadine + Thiamine 136. fixed dose combination of Magaldrate + Ranitidine + Pancreatin + Domperidone 137. fixed dose combination of Ranitidine + Magaldrate + Simethicone

11 138. fixed dose combination of Magaldrate + Papain + Fungul Diastase + Simethicone 139. fixed dose combination of Rabeprazole + Zinc + Domperidone 140. fixed dose combination of Famotidine + Oxytacaine + Magaldrate 141. fixed dose combination of Ranitidine + Domperidone + Simethicone 142. fixed dose combination of Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium Hydroxide 143. fixed dose combination of Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone 144. fixed dose combination of Furazolidone + Metronidazole + Loperamide 145. fixed dose combination of Rabeprazole + Diclofenac + Paracetamol 146. fixed dose combination of Ranitidine + Magaldrate 147. fixed dose combination of Norfloxacin + Metronidazole + Zinc Acetate 148. fixed dose combination of Zinc Carnosine + Oxetacaine 149. fixed dose combination of Oxetacaine + Magaldrate + Famotidine 150. fixed dose combination of Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets) 151. fixed dose combination of Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + Simethicone 152. fixed dose combination of Zinc Carnosine + Sucralfate 153. fixed dose combination of Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium butyricum + Bacillus mesentricus + Lactic Acid Bacillus) 154. fixed dose combination of Clindamycin + Clotrimazole + Lactic Acid Bacillus 155. fixed dose combination of Sildenafil + Estradiol Valerate 156. fixed dose combination of Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene + Selenium + Levocarnitine Tartrate + L-Arginine 157. fixed dose combination of Thyroxine + Pyridoxine + Folic Acid 158. fixed dose combination of Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin 159. fixed dose combination of Dextromethorphan + Levocetirizine + Phenylephrine + Zinc 160. fixed dose combination of Nimesulide + Loratadine + Phenylephrine + Ambroxol

12 161. fixed dose combination of Bromhexine + Phenylephrine + Chlorepheniramine Maleate 162. fixed dose combination of Dextromethorphan + Bromhexine + Guaiphenesin 163. fixed dose combination of Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine 164. fixed dose combination of Nimesulide + Phenylephrine + Caffeine + Levocetirizine 165. fixed dose combination of Azithromycin + Acebrophylline 166. fixed dose combination of Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + Menthol 167. fixed dose combination of Nimesulide + Paracetamol + Cetirizine + Phenylephrine 168. fixed dose combination of Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine 169. fixed dose combination of Chlorpheniramine Maleate + Dextromethorphan + Dextromethophan + Guaiphenesin +Ammonium Chloride + Menthol 170. fixed dose combination of Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate 171. fixed dose combination of Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate 172. fixed dose combination of Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + Menthol 173. fixed dose combination of Dextromethorphen + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin 174. fixed dose combination of Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin 175. fixed dose combination of Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate 176. fixed dose combination of Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Menthol 177. fixed dose combination of Chlorpheniramine + Phenylephrine + Caffeine 178. fixed dose combination of Dextromethorphan + Triprolidine + Phenylephrine 179. fixed dose combination of Terpinhydrate + Dextromethorphan + Menthol 180. fixed dose combination of Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol

13 181. fixed dose combination of Chlorpheniramine + Codeine + Sodium Citrate + Menthol Syrup 182. fixed dose combination of Enrofloxacin + Bromhexin 183. fixed dose combination of Bromhexine + Dextromethorphan + Phenylephrine + Menthol 184. fixed dose combination of Levofloxacin + Bromhexine 185. fixed dose combination of Levocetirizine + Ranitidine 186. fixed dose combination of Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol 187. fixed dose combination of Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol + Menthol 188. fixed dose combination of Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine 189. fixed dose combination of Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine 190. fixed dose combination of Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol 191. fixed dose combination of Dextromethorphen + Promethazine 192. fixed dose combination of Diethylcabamazine Citrate + Cetirizine + Guaiphenesin 193. fixed dose combination of Pseudoephedrine + Dextromethorphan + Cetirizine 194. fixed dose combination of Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol 195. fixed dose combination of Ambroxol + Terbutaline + Dextromethorphan 196. fixed dose combination of Dextromethorphan + Chlorpheniramine + Guaiphenesin 197. fixed dose combination of Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan 198. fixed dose combination of Dextromethorphan + Tripolidine + Phenylephirine 199. fixed dose combination of Paracetamol + Dextromethorphan + Chlorpheniramine 200. fixed dose combination of Pholcodine + Phenylephrine + Promethazine 201. fixed dose combination of Codeine + Levocetirizine + Menthol 202. fixed dose combination of Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine

14 203. fixed dose combination of Cetirizine + Phenylephrine + Dextromethorphan + Menthol 204. fixed dose combination of Roxithromycin + Serratiopeptidase 205. fixed dose combination of Paracetamol + Phenylephrine + Triprolidine 206. fixed dose combination of Acetaminophen + Loratadine + Ambroxol + Phenylephrine 207. fixed dose combination of Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc Gluconate 208. fixed dose combination of Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol 209. fixed dose combination of Chlopheniramine Maleate + Codeine Syrup 210. fixed dose combination of Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol 211. fixed dose combination of Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol 212. fixed dose combination of Levocetirizine + Montelukast + Acebrophylline 213. fixed dose combination of Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol 214. fixed dose combination of Dextromethorphan + Bromhexine + Guaiphenesin + Menthol 215. fixed dose combination of Acrivastine + Paracetamol + Caffeine + Phenylephrine 216. fixed dose combination of Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine 217. fixed dose combination of Dextromethorphan + Cetirizine 218. fixed dose combination of Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine 219. fixed dose combination of Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol 220. fixed dose combination of Codeine + Chlorpheniramine + Alcohol Syrup 221. fixed dose combination of Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine 222. fixed dose combination of Ammomium Chloride + Bromhexine + Dextromethorphan 223. fixed dose combination of Diethylcarbamazine + Cetirizine + Ambroxol 224. fixed dose combination of Ethylmorphine + Noscapine + Chlorpheniramine 225. fixed dose combination of Cetirizine + Dextromethorphan + Ambroxol

15 226. fixed dose combination of Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol 227. fixed dose combination of Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine 228. fixed dose combination of Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate 229. fixed dose combination of Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine 230. fixed dose combination of Dextromethophan + Chlorpheniramine + Guaifenesin + Ammonium Chloride 231. fixed dose combination of Levocetirizine + Dextromethorphan + Zinc 232. fixed dose combination of Paracetamol + Phenylephrine + Levocetirizine + Caffeine 233. fixed dose combination of Chlorphaniramine + Ammonium Chloride + Sodium Chloride 234. fixed dose combination of Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine 235. fixed dose combination of Salbutamol + Bromhexine + Guaiphenesin + Menthol 236. fixed dose combination of Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate 237. fixed dose combination of Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin 238. fixed dose combination of Diethyl Carbamazine + Chlorpheniramine + Guaifenesin 239. fixed dose combination of Ketotifen + Cetirizine 240. fixed dose combination of Terbutaline + Bromhexine + Etofylline 241. fixed dose combination of Ketotifen + Theophylline 242. fixed dose combination of Ambroxol + Salbutamol + Theophylline 243. fixed dose combination of Cetririzine + Nimesulide + Phenylephrine 244. fixed dose combination of Chlorpheniramine + Phenylephrine + Paracetamol + Zink Gluconate 245. fixed dose combination of Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine 246. fixed dose combination of Cetirizine + Dextromethorphan + Phenylephrine + Tulsi

16 247. fixed dose combination of Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine 248. fixed dose combination of Guaifenesin + Dextromethorphan 249. fixed dose combination of Levocetirizine + Paracetamol + Phenylephirine + Caffeine 250. fixed dose combination of Caffeine + Paracetamol + Phenylephrine + Chlorpheniramine 251. fixed dose combination of Ketotifen + Levocetrizine 252. fixed dose combination of Paracetamol + Levocetirizine + Phenylephirine + Zink Gluconate 253. fixed dose combination of Paracetamol + Phenylephrine + Triprolidine + Caffeine 254. fixed dose combination of Caffeine + Paracetamol + Phenylephrine + Cetirizine 255. fixed dose combination of Caffeine + Paracetamol + Chlorpheniramine 256. fixed dose combination of Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol 257. fixed dose combination of Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine 258. fixed dose combination of Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride + Sodium Citrate + Menthol 259. fixed dose combination of Terbutaline + Etofylline + Ambroxol 260. fixed dose combination of Paracetamol + Codeine + Chlorpheniramine 261. fixed dose combination of Paracetamol+Pseudoephedrine+Certirizine+Caffeine 262. fixed dose combination of Chlorpheniramine+Ammonium Chloride + Menthol 263. fixed dose combination of N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocertirizine 264. fixed dose combination of Dextromethorphan + Phenylephrine + Tripolidine + Menthol 265. fixed dose combination of Salbutamol + Certirizine + Ambroxol 266. fixed dose combination of Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + Chlorpheniramine 267. fixed dose combination of Nimesulide + Certirizine + Phenylephrine 268. fixed dose combination of Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorobutol

17 269. fixed dose combination of Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaifenesin 270. fixed dose combination of Salbutamol + Bromhexine 271. fixed dose combination of Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen 272. fixed dose combination of Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol 273. fixed dose combination of Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol 274. fixed dose combination of Salbutamol + Choline Theophylinate + Ambroxol 275. fixed dose combination of Chlorpheniramine + Codeine Phosphate + Menthol Syrup 276. fixed dose combination of Pseudoephedrine + Bromhexine 277. fixed dose combination of Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide 278. fixed dose combination of Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride 279. fixed dose combination of Ambroxol + Salbutamol + Choline Theophyllinate + Menthol 280. fixed dose combination of Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine 281. fixed dose combination of Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate + Menthol 282. fixed dose combination of Bromhexine + Cetrizine + Phenylephrine IP+Guaifenesin + Menthol 283. fixed dose combination of Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + Menthol 284. fixed dose combination of Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol 285. fixed dose combination of Terbutaline + N-Acetyl L-Cysteine + Guaifenesin 286. fixed dose combination of Calcium Gluconate + Levocetirizine 287. fixed dose combination of Paracetamol + Levocetirizine + Pseudoephedrine 288. fixed dose combination of Salbutamol + Choline Theophylinate + Carbocisteine 289. fixed dose combination of Chlorpheniramine + Vitamin C 290. fixed dose combination of Calcium Gluconate + Chlorpheniramine + Vitamin C

18 291. fixed dose combination of Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine 292. fixed dose combination of Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as enteric coated granules) SP Units 293. fixed dose combination of Paracetamol + Pheniramine 294. fixed dose combination of Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate + lodochlorhydroxyquinoline(ichq) 295. fixed dose combination of Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate 296. fixed dose combination of Clobetasole + Gentamicin + Miconazole + Zinc Sulphate 297. fixed dose combination of Levocetirizine + Ambroxol + Phenylephrine + Paracetamol 298. fixed dose combination of Permethrin + Cetrimide + Menthol 299. fixed dose combination of Beclomethasone + Clotimazole + Neomycin + iodochlorohydroxyquinone 300. fixed dose combination of Neomycin + Doxycycline 301. fixed dose combination of Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol 302. fixed dose combination of Clobetasol + Ofloxacin + Ketoconazol + Zinc Sulphate 303. fixed dose combination of Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline 304. fixed dose combination of Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole 305. fixed dose combination of Allantoin + Dimethieone + Urea + Propylene + Glycerin + Liquid Paraffin 306. fixed dose combination of Acriflavine + Thymol + Cetrimide 307. fixed dose combination of Betamethasone + Neomycin + Tolnaftate + lodochlorohydroxyquinoline + Cholorocresol 308. fixed dose combination of Clobetasol + Neomycin + Miconazole + Clotrimazole 309. fixed dose combination of Ketoconazole + Tea Tree oil + Allantion + Zinc Oxide + Aloe Vera + Jojoba oil + Lavander oil + Soa noodels 310. fixed dose combination of Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine

19 311. fixed dose combination of Clobetasol + Neomycin + Miconazole + Zinc Sulphate 312. fixed dose combination of Beclomethasone Diproprionate + Neomycin + Tolnaftate + lodochlorhydroxyquinoline + Chlorocresol 313. fixed dose combination of Betamethasone + Gentamycin + Zinc Sulphate + Clotrimoazole + Chlorocresol 314. fixed dose combination of Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy Benzoate 315. fixed dose combination of Bromhexine + Dextromethorphan 316. fixed dose combination of Dextromethophan + Chlopheniramine + Bromhexine 317. fixed dose combination of Menthol + Anesthetic Ether 318. fixed dose combination of Dextrometharphan + Chlopheniramine + Ammonium + Sodium Citrate + Menthol 319. fixed dose combination of Ergotamine Tartrate + Belladona Dry Extract+Caffeine + Paracetamol 320. fixed dose combination of Phenytoin + Phenobarbitone 321. fixed dose combination of Gliclazide 40mg + Metformin 400mg 322. fixed dose combination of Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine 323. fixed dose combination of Oflaxacin + Ornidazole Suspension 324. fixed dose combination of Albuterol + Etofylline + Bromhexine + Menthol 325. fixed dose combination of Albuterol + Bromhexine + Theophylline 326. fixed dose combination of Salbutamol+Hydroxyethyltheophylline (Etofylline) + Bromhexine 327. fixed dose combination of Paracetamol+Phenylephrine+Levocetirizine+Sodium Citrate 328. fixed dose combination of Paracetamol + Propyphenazone + Caffeine 329. fixed dose combination of Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine 330. fixed dose combination of Dried Alumnium Hydroxie Gel + Prophantheline + Diazepam 331. fixed dose combination of Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol 332. fixed dose combination of Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline 333. fixed dose combination of Telmisartan + Metformin

20 334. fixed dose combination of Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate 335. fixed dose combination of Levothyroxine + Phyridoxine + Nicotinamide 336. fixed dose combination of Benfotiamine + Metformin 337. fixed dose combination of Thyroid + Thiamine + Riboflavin + Phyridoxine + Calcium Pantothenate + Tocopheryl Acetate + Nicotinamide 338. fixed dose combination of Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium Phosphate + Adrenochrome mono Semicarbazone 339. fixed dose combination of Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine 340. fixed dose combination of Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Aicd + Sodium Methyl Paraben + Propyl Paraben