Amidopyrin and its combinations.
Phenacetin and its combinations.
Clioquinol and its combinations.
Combination of vitamins with tranquilisers and / or anti-inflammatory agents.
Combination of antispasmodic atropine wth analgesics and antipyretics.
Combinations of yohimbine and / or strychnine with testosterone and / or vitamins.
Combinations of iron with strychnine and / or yohimbine and / or arsenic.
Combinations of sodium bromide or chloral hydrate with other drugs.
Combinations of antihistamines with antidiarrhoels or with antiamoebic.
Combinations of vitamins with analgesics.
Combinations of penicillins with sulfonamides.
Combinations of vitamins C with tetracycline.
Combinations of steroids with other drugs except with ephedrine and xanthines.
Combinations of chloramphenicol except in combination with streptomycin.
Combinations of vitamins with antitubercular drugs except in combinations of antitubercular drug isoniazide with vitamin B6.
Combinations of ergot except with caffeine.
Combinations of strychnine and / or caffeine in tonics.
Composition : (gm/litre) as recommended by WHO
Sodium chloride |
3.5 gm |
3.5 gm |
Potassium chloride |
1.5 gm |
1.5 gm |
Sodium bicarbonate |
1.2 gm |
OR - |
Trisodium citrate (dihydrate) |
- |
2.9 gm |
Glucose |
20.0 gm |
20.0 gm |
Oxyphenbutazone and Its Combinations.
Phenylbutazone In Combination with other Drugs.
Sulphaguanidine and Its Combinations.
Tetracycline Liquid Oral Preparation
Methapyrilene and Its Combinations.
Nialamide and Its Combinations.
Practolol and Its Combinations.
Alcofenac and Its Combinations.
Methaqualone and Its Combinations.
Benoxaprofen and Its Combinations.
Pipradrol and Its Combinations.
Nitrofural and Its Combinations.
Chlornaphazine and Its Combinations.
Chlorphentermine and Its Combinations.
Cloferex and Its Combinations.
Diendestrol and Its Combinations.
Hexextrol and Its Combinations.
Xenazoic Acid and Its Combinations.
Aminores and Its Combinations.
Aristolochic Acid and Its Combinations.
Santonin and Its Combinations.
Azaribine and Its Combinations.
Amphetamine and Its Combinations.
Phenformin and Its Combinations.
Diphenoxylate and Its Combinations in Liquid Dosage Forms.
Lopermide and Its Combinations in Liquid Dosage Forms.
Combinations of Narcotic Drugs Except the Following:
Combinations Containing Pholcodine and Codeine and their Salts as Cough Sedative.
Combinations of Codeine with Paracetamol and/or Aspirin in Ratio not Exceeding 1 : 50.
Combinations Containing an Antispamodic.
Combination of Antipsychotic Drug (Neuroleptic) with Other Drugs Except with Anticholinergic Trihexyphenidyl.
Combination of Antispamodic with Vitamin, Mineral and/or Enzyme.
Combination of Antacid with Vitamins or Anti-Inflammatory Drugs.
Combination of Antidiarrhoeal/Antibacterial with Electrolytes.
Combination of Antitussive with an Expectorant in Cough syrup.
Combination Containing Two or More Antihistamines.
Combination of a Hormone with Vitamin.
Combination of Disodium Hydrozen Citrate with Other Drugs.
Combination of Ginseng with Modern Drugs.
Combination of a Bronchodilator with Analgesic or Antipyretic.
Combination of Cyproheptadine with Strychnine.
Combination Product Containing Active Ingredients of Two or More
Systems of Medicine (e.g. Ayurvedic, Allopathic, Unani, Homeopathic).
Oral Liquid Vitamins, Vitamin - Enzyme/Vitamin - Amino Acid/Vitamin - Mineral, which do not Contain Vitamin in Therapeutic Dose as per Indian Drugs and Cosmetic Act (Volume not Exceeding 250 ml).
Combination of Two or More Antibacterials Except the Following:
Combination Used for the Treatment of Tuberculosis.
Combination Used for the Treatment of Leprosy.
Combination of Two Antibiotics of the Penicillin Group.
Combination of Two or More Therapeutic Agents as Recognised by Standard Pharmacopoeia (as per the Rule No. 5 Appendix 1 of Star Niyamabali 2043 (Regulation on Standard of Drugs).
Therapeutic dose for vitamin based multi ingredient vitamin or tonic preparations.
Vitamin unit preparations containing vitamins for Therapeutic use
Liquid (Pack size not exceeding 250ml); in single dose of 5,10 or 15ml; or maximum 30ml in daily divided dose of two to three times each in a multiple of 5ml.
Tablet/capsule
One tablet / capsule maximum up to 3 times a day.
|
Adult |
Paedatric |
Vitamin A, I.U |
not less than 5000 & not more than 10000 |
not less than 1500 & not more than 5000 |
Vitamin D, I.U |
not less than 400 |
not less than 100 |
|
and not more than 1000 |
& not more than 400 |
Vitamin B1 mg |
not less than 4.5 & not more than 10 |
not less than 1 & not more than 4.5 |
Vitamin B2 mg |
not less than 5 & not more than 10 |
not less than 1 & not more than 5 |
Vitamin B6 mg |
not less than 1.5 & not more than 3 |
not less than 1 & not more than 3 |
Niacinamide mg |
not less than 45 & not more than 100 |
not less than 10 & not more than 40 |
d-panthenic mg acid or its salts & Panthenol, mg |
not less than 5 & not more than 50 |
not less than 2.5 & not more than 10 |
Folic acid mcg |
not less than 1000 & not more than 1500 |
not less than 100 & not more than 500 |
Vitamin B12 mcg |
not less than 5 & not more than 15 |
not less than 1 & not more than 5 |
Vitamin C mg |
not less than 75 & not more than 150 |
not less than 30 & not more than 80 |
Vitamin E I.U |
not less than 15 & not more than 25 |
not less than 5 & not more than 20 |
Vitamins intended for therapeutic use shall bear on the label the words
"for therapeutic use-adult 'or' for therapeutic use-paediatric" as the case may be.
The above standards shall not be applied to any preparation containing single vitamin only & also to any preparation containing vitamins intended for parenteral use.
Codeine or codeine based cough syrup except cough Syrup containing single codeine (active ingredient) 3 mg/5ml in a bottle not exceeding 60ml.).
Combination of any antibacterial with another drug except the following
Combination used for the treatment of tuberculosis
Combination used for the treatment of Leprosy
Combination of two antibiotics of the penicillin group
Combination of two or more therapeutic agents of antibacterial group included in Pharmacopoeia, recognised as per the regulation on standards of drugs 2043, rule 5, appendix- 1)
Streptomycin in oral dosage from
Combination of Paracetamol or Aspirin except in the following
Combination of Paracetamol or Aspirin with one nasal decongestant and one antihistamine
Combination of Paracetamol or Aspirin (not exceeding 500mg) with codeine not exceeding 10mg in a tablet)
Combination of Paracetamol either with Ibuprfen or with one muscle
relaxant
Combinations of Paracetamol or Aspirin with another drug, those are included in Pharmacopoeia recognised as per the Regulation on Standards of Drugs 2043, rule 5, appendix - 1
Meprobamate or its combination
Combination of anti-amoebic or anti-diarrhoeal drug except the following
Combination of Metronidazole or Tinidazole with Diloxanide furoate
Combination of diphenoxylate 2.5mg with Atropine 0.025mg in a tablet
All combinations of antiflatulant except with antacid or antispasmodic
Combination of cyproheptadine with another drug
All multi-ingredient based vitamin or Tonic preparations except the following
Vitamin product in therapeutic dose as denoted in appendix-1 of this notice
Therapeutic B-complex based product (Appendix-1) containing enzyme & / or aminoacid or protein or mineral)
Combinations, of vitamin in therapeutic dose with another drug,
that are included in pharmacopoeia, recognised as per the regulation on standards of drugs 2043.
Note: The following amendments have been made on the above ban list on 2050/9/5.
The statement on 4(a) of the above notice has been defined as " Combination of paracetamol or aspirin with one decongestant and / or
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one antihistamine."
The following catagories of formulations will be exempted from the provision of 9 of the above notice.
Liquid preparations containing sodium bicarbonate intended for use in children.
Analgin (Metamizole) and its combinations