NEW DELHI: Domestic drug makers have agreed to withdraw 120 combination drugs—totalling over 270 brands—from the market. According to estimates, the drugs are worth around Rs 1,000 crore and account for a little over 3% of the Rs 30,000-crore domestic retail pharma market.

The companies, whose brands the domestic industry has agreed to phase out over the next 2-3 months, include Cipla, Sun Pharma, Nicholas Piramal, Dr Reddy’s, Wockhardt, Zydus Cadila, Torrent Pharma, Elder, Alkem, Glenmark, Emcure and Mankind, according to a letter sent to the government by industry bodies representing the drug industry.

These drugs include popular painkillers and cold medications. The industry bodies have asked ORG IMS to calculate the exact market size of the drugs that would be withdrawn.

The 120 drugs are part of a contentious list of 294 combination drugs, numbering 1,100 brands, worth Rs 3,500 crore that the health ministry wants withdrawn from the market. The ministry says the therapeutic efficacy of these drugs has not been vetted by the drug controller general of India (DCGI). State drug authorities have been granting manufacturing licences to these drugs without obtaining marketing approval from DCGI.

A combination drug consists of two or more molecules used to treat multiple ailments. For instance, pills that cure cold and also act as a painkiller are combination drugs.

Three industry bodies—the Indian Drug Manufacturers’ Association (IDMA), Indian Pharmaceutical Alliance (IPA) and the Organisation of Pharmaceutical Producers in India (OPPI)—have jointly written to the health secretary on Tuesday stating they have agreed to suspend the production of 120 combination drugs classified by DCGI as absurd (16), banned (15) and rejected (89). Most drug makers are members of at least one of these associations.

The associations have, however, requested the health ministry not to withdraw the 150 drugs that are under examination, which DCGI wants to be recalled from the market instantly. The industry wants them in the market till a fresh review on their status is completed.

The industry bodies have told the health secretary that if all the 294 drugs were withdrawn from the market overnight, there will be a sudden shortage of ‘essential’ drugs and companies would also incur huge financial losses. It may be mentioned that 19 combination drugs need to undergo clinical trials and bio-equivalent studies while five have been approved by DCGI.

According to some company officials who are withdrawing their drugs, the market size of the 120 FDC drugs is estimated to be around Rs 1,000 crore. IDMA sources said the association has asked the companies marketing these FDCs to “immediately stop their production” and expect the products to go off shelves “within 2-3 months”.

DCGI had categorised the 294 FDCs, sold under 1,184 brands as ‘absurd’, ‘banned’, ‘rejected’, ‘needing further examination’, ‘decision taken’ and ‘approved’ categories. For 150 drugs in the ‘need further examination’ category, the industry will have to submit a fresh application to DCGI to sell the drugs. 

Combination Drug Ban in india complete List 

1. 5-Bromosalicyl-4-Chiloranilide+Salicylic Acid

2. Aceclofenac + Paracetamol+Chlorzoxazone

3. Aceclofenac + Paracetamol+Serratiopeptidase

4. Aceclofenac + Paracetamol+Tizanidine

5. Aceclofenac + Paracetamol+Tramadol

6. Aceclofenac + Serratiopeptidase

7. Aceclofenac + Tramadol

8. Acetaminophen+Codine Phosphate

9. Acetyl Salicylic Acid+Ethoheptazine

10. Acetylcysteine+Selenomethionine+Choline

Bitartrate+Pyridoxine+Folic Acid+Vitamin-E

+Cynocobalamin+Chromium

11. Nicotinate+Manganese Sulfate+Zinc Sulfate

12. Acriflavine+Gentian Violet+Brilliant Green

13. Activated Charcoal+Fungal Distase+Lactic Acid

14. Adapalene+Methyl Paraben

15. Adenocyl Cobalamine+ Carbonyl +Folic

Acid+Zinc Ascorbate

16. Adenocynocobaiamine+Carbonyl Iron+Folic Acid

17. Alendronate Sodium+Calcium Carbonate+Vitamin-d3

18. Alendronate Sodium+Cholicalceferol+Calcium

Citrate+Magnesium Hydroxide

19. Allantoin+Dimethicone+Methylparaben+Propylparaben

20. Allantoin+Triclosan+Vit-E+Zinc Ozide

21. Allantoin+vit-E+Cammelina Sinensis

22. Aloe Extract+Allantocin+Alfa Tocoferal Acetate+D-

Panthemol+Vit-A

23. Aloe Extract + Vit-E+Dimethicone+Glycerine

24. Aloe Vera+Jojoba Oil+Vit-E

25. Aloe Vera+Orange Oil

26. Aloe Vera+Vit-E Acetate

27. Aloe +Tocopherol

28. Aloevera+Glycerine+PEG 100 Stearate+Vit-E

29. Aloe Vera+Jojoba Oil+ Wheat Germ Oil+Tea Tree Oil

30. Aloe Vera+Vit-E+Herbal

31. Alprazolam+Melatonin

32. Alprazolam+Propranolol

33. Amlodipine+Lovastatin

34. Amoxicillin+Cloxacillin+Lactic Acid Bacillus

35. Amoxicillin+Serratiopeptidase+Lactobacillus

Sporogenes

36. Amoxicillin+Clavulanic Acid+Lactic Acid bacillus

37. Amoxicillin+Clavulanic Acid+Lactobacillus

38. Amoxicillin+Clozacillin+Lactic Acid Bacillus

39. Amoxicillin+Clozacillin+Lactic Acid Bacillus

+Serrapeptase

40. Amoxicillin+Lactic Acid Bacillus

41. Amoxicillin+Lactbacillus

42. Amoxicillin+Lactbacillus Acidophilus

43. Amoxicillin+Lactbacillus Acidophilus+

Clavulanic Acid

44. Amoxicillin+Lactbacillus Acidophilus

+Flucloxacillin sodium

45. Amoxicillin+Serratiopeptidase

46. Ampicillin+Cloxacillin+Lactic Acid Bacillus

47. Ampicillin+Flucloxacillin sodium Salt+

Lactobacillus AcidoPhilus

48. Ampicillin+Lactic Acid Bacillus

49. Analgin+Diazepam

50. Analgin+Diazepam+Diphenhydremine

51. Analgin+Diazeparn+Paracetamol

52. Analgin+Diazeparn+Prapyleine Glycol

53. Analgin+Dicyclomine+Diazapam

54. Analgin+Dihydorelthaverine Chloride

55. Analgin+Ketoprofen

56. Analgin+KET-P-PIPERETH-O-CARB-M

57. Artesunate+Arteether+Artemether

58. Atenolol+Hydrochlorothiazide+Amilaride

60. Atenolol+Losartan+Hydrochlorothiazide

61. Atorvastatin+ Acetyl Salicylic Acid+Cafferine

62. Atorvastatin+Aspirin

63. Atorvastatin+Aspirin+Ramipril

64. Atorvastatin+Mecobalamine+Folic Acid

65. Atorvastatin+Mecobalamine+Folic Acid+Vit-B6

66. Atorvastatin+Omega 3 Fatty Acid

67. Atorvastatin+Ramipril

68. Atorvastatin+Ubidecarenone

69. Atorvastatin+Vitamin

70. Azithromycin+Ambroxol

71. Benfotimine+Pyridoxine+Mecobalamine+Inositol

+Alphalipoic Acid

72. Calcium Dobesilate+Decusate Sodium

73. Calcium Dobesilate+Lignocaine

74. Calcium Dobesilate+Lignocaine+Hydrocortisons

75. Calcium Dobesilate+Troxerutin

76. Cefadroxil+Ambroxol

77. Cefadroxil+Lactic Acid Bacillus

78. Cefadroxil+Probenecid

79. Cefdinir+Lactic Acid Bacillus

80. Cefixime+Lactic Acid Bacillus+Ambroxol

81. Cefixime+Lactobacillus acidophilus

82. Cefixime+Lactobacillus acidophilus+Ambroxol

83. Cefixime+Lactobacillus + Clavulanic Acid

84. Cefixime+Lactobacillus+Dicloxacillin

85. Cefixime+Ornidazole

86. Cefpodoxime Prozetil+Lactic Acid Bacillus

87. Cefpodoxime +Cloxacillin+Lactobacillus

88. Cefpodoxime+Lactobacillus

89. Cefprozil+Lactobacillus

90. Cefriaxone+Vancomycin

91. Cefuroxime+Vancomycin

92. Cefuroxime+Omidazole

93. Cefuroxime+Serratiopeptidase

94. Cepodoxime+Cloxacillin+Lactic Acid Bacillus

95. Chlorzoxazone+Nimesulide

96. Chlorzoxazone+Paracetamol

97. Chlorzoxazone+Paracetamol+Diclofenac

98. Chlorzoxazone+Paracetamol+Diclofenac Potassium

99. Chlorzoxazone+Paracetamol+Diclofenac Sodium

100. Chlorzoxazone+Paracetamol+Iboprafen

101. Chlorzoxazone+Paracetamol+Nimesulide

102. Ciprofloxacin+Tinidazole+Dicyclomine

103. Clopidogrel+Aspirin+Atorvastatin

104. Diclofenac Potassium+Serratiopeptidase

105. Diclofenac Sodium+Rabeprazole

106. Diclofenac Sodium+Serratiopeptidase

107. Diclofenac+Dextropropoxyphene+Paracetamol

108. Diclofenac+Famotidine

109. Diclofenac+Methyl Salicylate+Linoleic

Acid Menthol

110. Dicyclomine+Diclofenac Sodium+Paracetamol

111. Domperidone+Paracetamol

112. Domperidone+Paracetamol+Tramadol

113. Doxiycyline+Lactobacillus

114. Domperidone+Ranitidine

115. Drotaverine+Mefenamic Acid

116. Drotaverine+Nimesulide

117. Drotaverine+Omeprazole

118. Drotaverine+Paracetamol

119. Duloxetine+Mecobalamin

120. Gabapentin+Mecobalamin+Thioctic Acid

121. Flucosamine+Ascorbic Acid

122. Gliclazide+Chromium Picolinate

123. Glucosamine+Chondroitin+Vit-C+Vit-E+Manganese

124. Glucosamine+Mecobalamin

125. Ibuprofen +Corisoprodol

126. Ibuprofen +Codeine Phosphate

127. Ibuprofen +Paracetamol+Dextropropoxyphene

128. Ibuprofen +Paracetamol+Magnesium trisilicate

130. Ibuprofen +Pseudoephedrine+Chlorpheniramine maleate

131. Lansoprazole+Domperidone

132. Levocetrizine+Montelukast Sodium

133. Levocetrizine+Ornidazole

134. Levocetrizine+Ambroxol

135. Losartan+Hydroclorothiazide+Atenolol

136. Mecobalaminalphalipoic Acid+Folic Acid+

Vit-B6+Choline

137. Mecobalamine+Alphalipoic Acid

138. Mefenamic Acid+Dicyclomine

139. Meloxicam+Paracetamol

140. Nimesulide+Paracetamol+Chlorzoxazone

141. Nimesulide+Paracetamol+Serratipeptidase

142. Norfloxacin+Ornidazole

143. Ofloxacin+Metronidazole

144. Ofloxacin+Tinidazole

145. Ofloxacin+Prednisolone

146. Ofloxacin+Ornidazole+Lactobacillus Acidophilus

147. Ondansetron+Omeprazole

148. Ondansetron+Paracetamol

149. Paracetamol+Analgin

150. Paracetamol+Lignocaine

151. Paracetamol+Mecobalamine

152. Pregabalin+Mecolalamine+Pyridoxine+Thioctic

Acid+Folic Acid

153. Propranolol+Alprazolam

154. Ranitidine+Dicyclomine

155. Ranitidine+Domperidone

156. Roxithromycin+Ambroxol

157. Telmisartan+Ramipril+Hydrochlorthiazide

158. Tizanidine+Diclofenac Potassium+Paracetamol

159. Tizanidine+Nimesulide+Paracetamol

160. Torsemide+Spironolactone

161. Tramadol+Paracetamol+Domperidone