Govt Bans 35 FDC Drugs: See Full List Inside

General Medicine
The Central Drugs Standard Control Organisation (CDSCO) has instructed the drug controllers of the state to cease the manufacture of 35 fixed-dose combinations (FDCs). The list has commonly used antibiotics, antidiabetics, painkillers and many more drugs. The usage of such drugs is perceived as a threat to public health and is found to violate provisions of the New Drugs and Clinical Trials (NCDT) rules, 2019. The issue of a show cause notice for several manufacturers has led to the surfacing of the fact that there is an absence of consistency among the state listening authorities and the CDSCO. Moreover, the CDSCO has directed state drug controllers to reassess the FDCs approval process and submit a detailed report on compliance with the NDCT rules and the Drugs & cosmetics Act,1940.[1][2][3]

List of Unapproved FDCs with Cancelled/Surrendered Product Permission

Serial No.
Name of FDC
1
Combipack of each film-coated extended release tablet contains: Mirabegron 25 mg, and each film-coated tablet contains: Solifenacin Succinate 5 mg
2
Nefopam Hydrocholride 30 mg + Paracetamol 325 mg tablets
3
Metformin Hydrochloride IP 500 mg (as extended release form) + Glimepiride IP 3 mg + Dapagliflozin Propanediol MONOhydrate IP eq. to Dapagliflozin 10 mg film-coated bilayered tablets
4
FDC of: (i) Dextromethorphan Hydrobromide IP 10 mg + Phenylephrine Hydrocholride IP 5 mg per 5 ml syrup & (ii) Diphenhydramine Hydrochloride IP 12.5 mg + Phenylephrine Hydrocholride IP 5 mg per 5 ml syrup
5
Clinidipine IP 20 mg + Metoprolol Succinate IP 47.5 mg eq to Metoprolol TarTrate 50 mg film-coated bilayered tablet
6
Ketoconazole IP 2.0% w/w + NeomycinSulphate 0.5% w/w + Iodochlorhydroxyquinoline IP 1% w/w + Tolnaftate IP 1% w/w + Clobetasol Propionate IP 0.05% w/w cream
7
Dehydroepiandrosterone SR 75 mg + Melatonin BP 3 mg + Ubidecarenone (Coenzyme Q 10) BP 100 mg capsules
8
Cefixime IP 200 mg + Ofloxacin IP 200 mg + Lactic acid bacillus 60 million spores tablets
9
Aluminium Hydroxide Gel IP eq. to Aluminium Hydroxide 365 mg + Magnesium Hydroxide Paste 1 USP eq. to Magnesium Hydroxide 80 mg + Simethicone USP 100 mg + Deglycyrrhizinated Liquorice eq. to Liquorice 400 mg per 5 ml oral suspension
10
Alpha amylase IP (1:800): 28. 125 mg (fungal diastase derived from Apergillus oryzae) Digest not less than 22.5 g of cooked starch, Papain IP 15 mg + Anise Oil IP 1 mg + Caraway oil IP 1 mg + Cinnamon Oil BP 1 mg + Dil oil BP 1 mg syrup
11
Omega-3 fatty acids BP 300 mg eq. to EPA 90 mg eq. to DHA 60 mg + Wheat germ oil BP 100 mg + Green tea extracts eq. to polyphenols 25 mg + Zinc sulphate monohydrate IP eq. to elemental zinc 12.5 mg + Biotin BP 5 mg + Lutein USP 5 mg + Zeaxanthin 1 mg + Copper sulphate pentahydrate BP eq. to elemental copper 1 mg + Selenium Dioxide USP eq. to elemental selenium 75 mcg soft gelatin capsules
12
Pregabalin (SR) IP 75 mg + Nortriptyline HCl IP 10 mg + Vitamin D3 IP 2000IU + Mecobalamin IP 1500 mcg tablet
13
Acebrophylline (SR) 200 mg + Montelukast Sodium IP 10 mg + Fexofenadine Hydrochloride IP 120 mg tablet
14
Dehydroepiandrosterone 75 mg (as sustained release) + Folic Acid IP 4.5 mg tablet
15
Dyhdroepiandrostrone 75 mg + Melatonin BP 5 mg + Ubidecarenone BP 100 mg tablet
16
Sertraline Hydrochloride IP eq. to Sertraline 50 mg + Clonazepam IP 0.5 mg tablets 
17
Sertraline Hydrochloride IP eq. to Sertraline 50 mg + Clonazepam IP 0.25 mg tablets
18
Rosuvastatin Calcium IP eq. to Rosuvastatin 20 mg (As Immediate Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (As Immediate Release Pellets) & Aspirin IP 150 mg (As Gastro-Resistant Pellets) Capsule
19
Rosuvastatin Calcium IP eq. to Rosuvastatin 10 mg (As Immediate Release Pellets), Clopidogrel Bisulphate IP eq. to Clopidogrel Bisulphate IP eq. to Clopidogrel 75 mg (As Immediate Release Pellets) & Aspirin IP 150 mg (As Gastro-Resistant Pellets) Capsule
20
Tamsulosin Hydrochloride IP 0.4 mg & Finasteride IP 5 mg Tablet
21
Metoprolol Succinate USP 23.75 mg eq. to Metoprolol Tartrate 25 mg and Ramipril IP 2.5 mg Tablet
22
Bisoprolol Fumarate IP 5 mg & Cilnidipine IP 10 mg tablets
23
Chlorpheniramine Maleate IP 4 mg + Codeine Phosphate IP 10 mg + Sodium Citrate IP 75 mg Syrup
24
Rifaximin BP 200 mg & Metronidazole Benzonate IP eq. to Metronidazole 400 mg Tablets
25
Cefixime (as Trihydrate) IP eq. to Anhydrous Cefixime 200 mg + Azithromycin Dihydrate Ip eq. to Anhydrous Azithromycin 250 mg + Lactic Acid Bacillus 60 million spores film-coated tablets
26
Norfloxacin IP 125 mg + Metronidazole Benzoate IP eq. to Metronidazole 120 mg + Simethicone IP 10 mg suspension
27
Cyproheptadine HCl IP 4 mg + Zinc Sulphate Monohydrate IP eq. to Elemental Zinc 5 mg uncoated tablet
28
Meropenem 1 gm + EDTA for injection
29
Glimepiride IP 1 mg & Metformin HCl IP 500 mg Tablet
30
Glimepiride IP 2 mg, Metformin Hydrochloride IP (As Sustained Release form) 500 mg and Voglibose IP 0.3 mg Tablet
31
Metformin Hydrochloride IP (As Prolonged-Release) 500 mg & Voglibose IP 0.2 mg Tablet
32
Ofloxacin IP 50 mg, Ornidazole IP 125 mg and Racecadrotril IP 15 mg syrup
33
Ambroxol Hydrochloride IP 20 mg + Dextromethorphan Hydrobromide IP 10 mg + Chlorpheniramine Maleate IP 2 mg per 5 ml syrup
34
Ketcoconazole IP 2.0% w/w + Iodochlorhydroxyquinoline IP 1% w/w + Tolaftate IP 1% w/w + Clobetasol Propionate IP 0.05% w/w + Neomycin Sulphate IP 0.10% w/w cream base
35
Meropenem 1000 mg + Avibactam (sterile) IP eq. to Avibactam 500 mg Injection
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