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No.14/RN/Ref./March/2017 For the use of Members of Parliament NOT FOR PUBLICATION 1 BAN ON FIXED DOSE COMBINATION (FDC) DRUGS Prepared by Smt.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 (23035036) 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 The reference material is for personal use of the Members in the discharge of their Parliamentary duties, and is not for publication.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. REFERENCE NOTE MEMBERS' REFERENCE SERVICE LARRDIS LOK SABHA SECRETARIAT, NEW DELHI
Transcript
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No.14/RN/Ref./March/2017

For the use of Members of Parliament NOT FOR PUBLICATION1

BAN ON FIXED DOSE COMBINATION (FDC) DRUGS

Prepared by Smt. Sunanda Das Mohanty, Additional Director (23035036) 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The reference material is for personal use of the Members in the discharge of their Parliamentary duties, and is not for publication.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.

REFERENCE NOTE

MEMBERS' REFERENCE SERVICE LARRDIS

LOK SABHA SECRETARIAT, NEW DELHI

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BAN ON FIXED DOSE COMBINATION (FDC) DRUGS

The Government of India banned 344 Fixed Dose Combination (FDC) drugs

on 10 March 20161 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 drug2. 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 59th

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.

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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

2012. 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.

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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 2016.

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 2016. 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.

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4

SOURCES CONSULTED

1. Cleaning Up the Pharma Industry : A Landmark Ban on Irrational Drugs,

Economic & Political Weekly, dated: 02.04.2016; vol II no.14

2. Banning of FDC Drugs, PIB 26. 04.2016

3. Fifty-ninth report on the functioning of the central drugs standard control

organisation (CDSCO), Rajya Sabha, dated: 08.04.2012

4. 66th

Report Action taken by the Government on the recommendations

contained in the 59th

Report, 2013

5. Gazette notifications (10.03.2016, 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: 02.08.2016

7. CDSCO establishes 10 expert committies to examine safety of FDCs, Ethics

in Clinical Research, dated: 07.02.2014

8. Centre moves SC seeking to enforce ban on 344 fixed-dose-combination

drugs, livemint, dated: 30.01.2017

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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

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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 20000 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

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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

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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/

106. 1000mg/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

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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

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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

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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

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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

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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

Page 15: REFERENCE NOTE164.100.47.193/Refinput/New_Reference_Notes/English/BAN...2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent

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

Page 16: REFERENCE NOTE164.100.47.193/Refinput/New_Reference_Notes/English/BAN...2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent

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

Page 17: REFERENCE NOTE164.100.47.193/Refinput/New_Reference_Notes/English/BAN...2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent

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

Page 18: REFERENCE NOTE164.100.47.193/Refinput/New_Reference_Notes/English/BAN...2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent

291. fixed dose combination of Chlorpheniramine + Paracetamol +

Pseudoephedrine + Caffeine

292. fixed dose combination of Guaifenesin + Bromhexine + Chlorpheniramine +

Phenylephrine + Paracetamol + Serratiopeptidase (as enteric coated granules)

10000 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

Page 19: REFERENCE NOTE164.100.47.193/Refinput/New_Reference_Notes/English/BAN...2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent

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

Page 20: REFERENCE NOTE164.100.47.193/Refinput/New_Reference_Notes/English/BAN...2 For instance, a combination of nimesulide and paracetamol that is prescribed as an anti-pyretic (used to prevent

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


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