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:
- 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.
- 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.
- 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.
- 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.
- 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.
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