Combination Medicine banned in India

Combination medicine combines two or more salts into single-dose tablets or capsules. They are also called as fixed-dose combination drugs. Now the government has taken steps to ban combination medicine. Furthermore, the Government of India has banned 156 medicines. These include especially skin care, pain relievers, multivitamins and other medicines.

Generally, these medicines are found in homes. According to the government notification, these medicines can threaten humans. Safer alternatives are available, hence a ban on their production, sale, distribution and use is necessary. Furthermore, the committee of experts formed by the government found these medicines unsuitable. The Drugs Technical Advisory Board also stated that there is no medical justification for combining these medicines after testing the combination medicine.

Why combination medicine is harmful

Combination medicine, which contains two or more active ingredients in a single dosage form, can be harmful in certain circumstances due to several factors:

  1. Increased Risk of Side Effects: Since combination medicines contain multiple active ingredients, the risk of side effects or adverse reactions may increase. If a person is sensitive to one component, they may still experience unwanted effects even if the other component is necessary.
  2. Difficulty in Adjusting Dosages: With combination medicines, it can be difficult to tailor the dosage of each active ingredient to meet individual patient needs. If a patient requires a higher or lower dose of one component, they may end up taking too much or too little of the other, leading to inefficacy or toxicity.
  3. Drug Interactions: The combination of different drugs can lead to unintended interactions between the ingredients themselves or with other medications the patient is taking. Moreover, this can enhance toxicity, reduce efficacy, or cause unpredictable reactions.
  4. Allergic Reactions: If a person is allergic to one of the components, they might still be exposed to it, even though they need the other component of the medication. This can lead to allergic reactions, which could be severe.
  5. Masking of Symptoms: Combination drugs may mask certain symptoms, which could delay diagnosis or proper treatment. For example, a combination drug for pain and inflammation might reduce pain but also hide an underlying condition that needs medical attention.

Another reason for the ban

Overuse or Misuse: People might unintentionally overdose on one of the components of a combination drug if they are also taking another medication that contains the same ingredient. For example, taking a cold medicine and a painkiller that both contain acetaminophen could lead to an overdose of acetaminophen.

While combination medicines can be convenient and effective when prescribed properly, they do come with risks that need to be carefully considered by healthcare providers.

Pharmaceutical company’s reaction to the ban

Although pharmaceutical companies have already stopped producing some of the drugs included in the banned list. The pharmaceutical industry is currently analyzing what will be the economic impact of the ban. Moreover, companies like Cipla, Torrent, Sun Pharma, IPCA Lab and Lupine say this will affect their products.

The government had announced a ban on the manufacture, sale and distribution of 344 FDCs in 2016. As a result, the pharmaceutical companies in the court challenged this decision. However, 14 combination medicines were already banned in June 2023. Now the government has banned 153 medicines.

Combination medicine banned list

The drugs banned include the combination of the antibiotic azithromycin with adapalene, which is used to treat acne. At the same time, Aceclofenac 50mg Paracetamol 125 mg tablets have been banned. Above all, it is one of the popular combinations of pain relief medicines manufactured by top pharma companies. Furthermore, other drugs including combinations of paracetamol, tramadol, taurine and caffeine are banned. Here is the combination medicine banned list.

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1 Cobination medicine having amylase + protease + glucoamylase + pectinase + alpha galactosidase + lactase + beta-gluconase + cellulase + lipase + bromelain + xylanase + hemicellulase + malt diastase + invertase + papain.

2 Antimony Potassium Tartrate + Dry Ferrous Sulphate

3 Benfotiamine + Silymarin + L-Ornithine L-Aspartate + Sodium Selenite + Folic Acid + Pyridoxine Hydrochloride

4 Bismuth Ammonium Citrate + Papain

5 Cyproheptadine HCl + Thiamine HCl + Riboflavin + Pyridoxine HCl + Niacinamide

6 Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavin + Pyridoxine Hydrochloride

7 Rabeprazole sodium (as enteric coated tablets) + Clidinium bromide + Dicyclomine HCl + Chlordiazepoxide

8 Fungal Diastase + Papain + Nux Vomica Tincture + Cardamom Tincture + Casein Hydrolyzed + Alcohol

9 Mefenamic Acid + Paracetamol Injection

10 Combination medicine having Omeprazole Magnesium + Dicyclomine Hcl

11 S-Adenosyl Methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium Equivalent to L-Methylfolate + Choline Bitartrate + Silymarin + L-Ornithine L-aspartate + Inositol + Taurine

12 Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium Pantothenate + Vitamin B12

13 Silymarin + Pyridoxine HCL + Cyanocobalamin + Niacinamide + Folic Acid

14 Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic Acid + Tricholine Citrate

15 Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Cumin Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol

16 Sucralfate + Aceclofenac

17 Sucralfate + Domperidone + Dimethicone

18 Sucralfate + Domperidone

19 Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Fragrant Spirit of Ammonia + Chloroform + Alcohol

20 Ursodeoxycholic Acid + Metformin HCL

21 Weak Ginger Tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol

22 Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate

23 Aloe + Vitamin E Soap

24 Povidone Iodine + Metronidazole + Aloe

25 Azelaic Acid + Tea Tree Oil + Salicylic Acid + Allantoin + Zinc Oxide + Aloe Vera + Jojoba Oil + Vitamin E + Soap Noodles

26 Azithromycin + Adapalene

27 Calamine + Aloe + Allantoin

28 Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerin + Camphor

29 Chlorphenesin + Zinc Oxide + Starch

30 Clindamycin Phosphate + Zinc Acetate

31 gamma benzene hexachloride + benzocaine

32 Glucosamine Hydrochloride + Diaserine + Menthol + Camphor + Capsaicin

33 Hydroxyquinone 2.0% w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w

34 Ketoconazole + Zinc Pyrithione + D-Panthenol + Tea Tree Oil + Aloe

35 Ketoconazole + Aloe Vera + Vitamin A Acetate

36 Ketoconazole + Aloe + ZPTO

37 Kojic Acid + Arbutin + Octinoxate + Vitamin E + Mulberry

38 Lornoxicam + Capsaicin + Menthol + Camphor

39 Lornoxicam + Thiocolchicoside + Oleum Linii + Menthol + Methyl Salicylate

40 Menthol + Aloe Vera Topical Spray

41 Menthol + Lignocaine Hcl + Aloe Vera Gel + Clotrimazole + Diphenhydramine

42 Miconazole Nitrate + Gentamicin + Fluocinolone Acetonide + Zinc Sulphate

43 Miconazole + Tinidazole

44 minoxidil + aminexil + alcohol

45 Minoxidil + Azelaic Acid + Saw Palmetto

46 Minoxidil + Aminexil

47 Pine Bark Extract + Kojic Acid + Sodium Ascorbyl Phosphate

48 Povidone Iodine + Tinidazole + Zinc Sulphate

49 Povidone Iodine + Ornidazole + Dexpanthenol

50 Salicylic Acid + Aloe Vera + Allantoin + D-Panthenol

51 Silver Sulfadiazine + Chlorhexidine Gluconate Solution + Allantoin + Aloe Vera Gel + Vitamin E Acetate

52 Sodium Salicylate + Zinc Gluconate + Pyridoxine HCl

53 Tetracycline + colistin sulphate

54 Clomiphene + Ubidecarenone

55 Combikit of Clomiphene Citrate + Estradiol Valerate

56 Flavoxate HCl + Ofloxacin

57 Clomiphene Citrate +N-Acetylcysteine

58 Primrose Oil + Cod Liver Oil

59 Sildenafil Citrate +Papaverine +L-Arginine

60 Tranexamic Acid + Mefenamic Acid + Vitamin K1

61 Divalproex Sodium +Oxcarbazepine

62 Divalproex Sodium + Levetiracetam

63 Ergotamine Tartrate + Caffeine + Paracetamol + Prochlorperazine Maleate

64 Piracetam + Ginkgo Biloba Extract + Vinpocetine

65 Ginkgo Biloba + Methylcobalamin

66 Ginkgo Biloba + Methylcobalamin + Alpha Lipoic Acid + Pyridoxine HCl

67 Ginseng Extract + Ginkgo Biloba Dry Extract

68 Meclizine Hcl + Paracetamol + Caffeine

69 Nicergoline + Vinpocetine

70 Gamma Linolenic Acid + Methylcobalamin

71 Beclomethasone dipropionate + neomycin sulphate + clotrimazole + lignocaine HCl

72 Boric Acid + Phenylephrine Hcl + Naphazoline Nitrate + Menthol + Camphor

73 Naphazoline Hcl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose

74 Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose

75 Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose

76 Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl

77 Chlorpheniramine Maleate + Phenylephrine Hcl + Antipyrine

78 Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine Hcl + Hydroxy Propyl Methyl Cellulose

79 Ketorolac Tromethamine + Fluorometholone

80 Naphazoline Hcl + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorpheniramine Maleate

81 Naphazoline Hcl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor

82 Naphazoline Hcl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate S.N. Fixed dose combination (FDC)

83 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Menthol + Camphor

84 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Hydroxy Propyl Methyl Cellulose

85 Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Sodium Chloride + Methylparaben

86 Methenamine + Sodium Benzoate + Benzyl Alcohol

87 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate

88 Paracetamol + Phenylephrine Hydrochloride + Chlorpheniramine Maleate + Caffeine

89 Propoxyphene + Chlorpheniramine Maleate

90 Propoxyphene + Phenylephrine Hydrochloride + Chlorpheniramine Maleate

91 Propoxyphene + Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride

92 Sodium Benzoate + Sodium Citrate + Citric Acid

93 Vitamin A Palmitate + Vitamin C + Vitamin E + Vitamin B6 + Vitamin B12

94 Vitamin A Palmitate + Vitamin C + Vitamin E + Niacinamide

95 Vitamin B6 + Vitamin B12 + Vitamin C

96 Vitamin B6 + Vitamin B12 + Niacinamide

97 Vitamin B12 + Vitamin B6 + Vitamin C + Folic Acid

98 Vitamin B12 + Vitamin B6 + Niacinamide + Folic Acid

99 Vitamin C + Vitamin E + Vitamin A + Niacinamide

100 Vitamin D + Calcium + Magnesium

101 Vitamin D + Calcium + Magnesium + Zinc

102 Calcium + Vitamin D + Vitamin K

103 Calcium + Vitamin D + Magnesium + Zinc

104 Calcium + Vitamin D + Vitamin K + Magnesium

105 Calcium + Vitamin D + Vitamin K + Magnesium + Zinc

106 Vitamin E + Vitamin A + Vitamin C + Niacinamide

107 Vitamin E + Vitamin A + Vitamin C + Folic Acid

108 Vitamin E + Vitamin A + Vitamin C + Biotin

109 Vitamin E + Vitamin A + Vitamin C + Vitamin B12

110 Vitamin E + Vitamin C + Folic Acid

111 Vitamin E + Vitamin C + Biotin

112 Vitamin E + Vitamin C + Vitamin B12

113 Vitamin E + Vitamin C + Zinc

114 Calcium + Vitamin D + Omega-3 Fatty Acids

115 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K

116 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Magnesium

117 Calcium + Vitamin D + Omega-3 Fatty Acids + Vitamin K + Zinc

118 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene

119 Vitamin A + Vitamin C + Vitamin E + Beta-Carotene + Zinc

120 Vitamin C + Vitamin E + Beta-Carotene

121 Vitamin C + Vitamin E + Beta Carotene + Zinc

122 Vitamin C + Vitamin E + Selenium

123 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids

124 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Magnesium

125 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Zinc

126 Vitamin D + Calcium + Vitamin K + Omega-3 Fatty Acids + Biotin

127 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium

128 Vitamin E + Vitamin A + Vitamin C + Zinc

129 Vitamin E + Vitamin A + Vitamin C + Selenium

130 Vitamin E + Vitamin A + Vitamin C + Biotin

131 Vitamin E + Vitamin A + Vitamin C + Folic Acid + Niacinamide

132 Vitamin E + Vitamin C + Beta Carotene + Zinc

133 Vitamin C + Vitamin E + Biotin + Folic Acid

134 Vitamin C + Vitamin E + Beta Carotene + Folic Acid

135 Vitamin C + Vitamin E + Beta-Carotene + Selenium

136 Vitamin E + Vitamin C + Beta-Carotene + Biotin

137 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Biotin

138 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Selenium

139 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B12

140 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Vitamin B6

141 Vitamin D + Calcium + Omega-3 Fatty Acids + Vitamin K + Folate

142 Calcium + Vitamin D + Magnesium + Vitamin K + Omega-3 Fatty Acids

143 Calcium + Vitamin D + Magnesium + Vitamin K + Biotin

144 Calcium + Vitamin D + Magnesium + Vitamin K + Selenium

145 Calcium + Vitamin D + Magnesium + Vitamin K + Vitamin B12

146 Calcium + Vitamin D + Magnesium + Vitamin K + Folate

147 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B6

148 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Vitamin B12

149 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Folic Acid

150 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Biotin

151 Calcium + Vitamin D + Vitamin K + Omega-3 Fatty Acids + Selenium

152 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids

153 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Zinc

154 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Biotin

155 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Selenium

156 Vitamin A + Vitamin C + Vitamin E + Omega-3 Fatty Acids + Vitamin B12

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