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    • Rationalisation of 294...

    Rationalisation of 294 FDC drugs: CDSCO issues Fresh directions to manufacturers

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-08-23T12:27:47+05:30  |  Updated On 16 Aug 2021 2:12 PM IST

    New Delhi: In a move to regularise Fixed Dose Combinations (FDCs), the Central Drugs Standard Control Organization (CDSCO) has notified the process to be followed by all the manufacturers and stakeholders of the 294 FDC drugs that were declared rational by the organisation earlier this year.


    The manufacturers and stakeholders of the 294 FDC drugs have been directed to submit their application along with the requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019 by 2nd December 2019.


    These 294 FDCs were declared rational by the country's top advisory on drugs and medical devices Drug Technical Advisory Board (DTAB) which were licensed to manufacture and market by State Licensing Authority without prior approval from DCGI.


    The CDSCO notice in this regard reads;




    "In continuation to this Directorate letter 04-146/2007-DC (Part-I) dated 27.02.2019 and various representations received in the matter, it has been decided that manufacturers/stakeholders who are holding a license for these FDCs from State Licensing Authority (SLA) may submit their applications by 02.12.2019. Further, all the applicants are requested to submit their applications along with requisite fees as specified in the Sixth Schedule of the New Drugs and Clinical Trial Rules, 2019."



    Also Read:


    The details of the 294 FDCs released by CDSCO read;






















































































































































































































































































































































    Sr.

    no.
    Name of FDC
    1Aceclofenac+Serratiopeptidase
    2Aceclofenac+Tramadol
    3Acetaminophen+Codine phosphate
    4Acetylcysteine+Selenomethionine+CholineBitartrate+Pyridoxine+FolicAcid+VitaminE+Cyano cobalamin+ChromiumNicotinate+ManganeseSulfate+Zinc Sulfate
    5AdenocylCobalamine+CarbonylIon+FolicAcid+ZincAscorbate
    6Adenocynocobalamine+Carbonyliron+Folic acid
    7Alendronate sodium+Calcium Carbonate+Vit-D3
    8Alendronate sodium+Cholicalceferol+CalciumCitrate+Magnesium Hydroxide
    9Amlodipine+Lovastatin
    10Atenolol+Hydrochlorothiazide+Amiloride
    11Atorvastatin+Acetyl Salicylic acid
    12Atorvastatin+Aspirin+Ramipril
    13Atorvastatin+Mecobalamine+Folic acid
    14Atorvastatin+Mecobalamine+Folic acid+Vit-B6
    15Atorvastatin+Ramipril
    16Benfotimine+Pyridoxine+Mecobalamine+Inositol+Alphalipoic acid
    17Cefadroxyl+Ambroxol
    18Cefixime+ambroxol+lactic acid
    19Chlorzoxazone+Nimesulide
    20Chlorzoxazone+Paracetamol
    21Clindamycin+Clotrimazole+Metronidazole
    22Clonidine+Chlorthalidone
    23Clonidine+Hydrochlorothiazide
    24Clopidogrel+Aspirin+Atorvastatin
    25Diclofenacpotassium+Serratiopeptidase
    26DiclofenacSodium+Rabeprazole
    27Diclofenac+Famotidine
    28Diclofenac+MethylSalicylate+Linoleicacid+Menthol
    29Diclofenac+Tizanidine
    30Dicyclomine+Mefenamicacid+Paracetamol
    31Domperidone+Ranitidine
    32Drotaverinehydrochloride+Mefenamic Acid
    33Gabapentin+Mecobalamin+Thioctic acid
    34Gabapentin+Mecobalamin+Thiocticacid+FolicAcid+Pyridoxine
    35Gabapentin+Mecobalamine+Pyridoxine+Folic Acid
    36Ibuprofen+Carisoprodol
    37Ibuprofen+Codeine
    38Ibuprofen+Dextropropoxyphene
    39Ibuprofen+Paracetamol+Caffeine
    40Ibuprofen+Pseudoephedrine+Chlorpheniramine maleate
    41Ibuprofen+Tizanidine
    42Lansoprazole+Amoxycillin+Clarithromycin
    43Lansoprazole+Amoxycillin+Tinidazole
    44Lansoprazole+Domperidone
    45Lansoprazole+Tinidazole+Clarithromycin
    46Levocetrizine+Montelukast
    47Levofloxacin+Ambroxol
    48Levofloxacin+Ornidazole
    49Losartan+Perindopril
    50Mebeverine+PlantagoOvata
    51Mecobalaminalphalipoicacid+Folic acid+Vit-b6+Choline
    52Mecobalamine+Alphalipoic acid
    53Mecobalamine+Alphalipoicacid+Folic acid
    54Mecobalamine+Alphalipoic acit+Vit-b1+Folic acid
    55Mecobalamine+Biotin
    56Mecobalamine+CalciumPantothenate
    57Mecobalamine+Folic acid
    58Mecobalamine+Vit-A+Vit-E+Vit-C+Vit-B1+Vit-B6+Vit-D3+Selenium
    59Mecobalamine+Vit-b1+Vit-b2+Vit-b6+Folic acid
    60Mecobalamine+Vit-B1+Vit-B6+Folic acid+Alphalipoic acid
    61Mecobalamine+Vit-b1+Vit-b6+Nicotinamide+D-panthenol
    62Mefenamicacid+Dicyclomine
    63Meloxicam+Paracetamol
    64Metformin hydrochloride+Mecobalamine
    65Methocarbamol+Ibuprofen
    66Methocarbamol+Nimesulide
    67Methocarbamol+Paracetamol
    68Metoclopramide hydrochloride+Paracetamol
    69Mupirocin+Metronidazole
    70Naproxen+Domperidone
    71Norfloxacin+Ornidazole
    72Norfloxacin+Tinidazole+Lactobacillus
    73Ofloxacin+Metronidazole
    74Ofloxacin+Ornidazole+Lactobacillus
    75Ofloxacin+Prednisolone
    76Ofloxacin+Tinidazole
    77Paracetamol+Dicycloverine+Mefenamic
    78Pregabalin+Mecobalamine
    79Pregabalin+Mecobalamine+Pyridoxine+ThiocticAcid+Folic Acid
    80Pregabalin+ThiocticAcid+FolicAcid+Pyridoxine
    81Roxithromycin+Ambroxol
    82Roxithromycin+Carbocisteine
    83Satranidazole+Ofloxacin
    294 fdcs6th schedule clinical trial rulesAspirinAtorvastatinCDSCOCentral Drugs Standard Control OrganizationDTABFDCfds drugsfixed dose combo drugibuprofenMetforminNew Drugs and Clinical Trial RulesNorfloxacinParacetamolpharmapharma newspharma news indiaSLAState Licensing Authority

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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