GOVERNMENT OF NEPAL
Department of Drug Administration —
Banned Medicines & Regulatory Standards
1. Notice Dated 2040/3/13
Government of Nepal has banned
the following medicines for production, sale-distribution and import (oral and
parenteral use) on 2040/3/13:
·
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 with 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 antidiarrhoeals or
with antiamoebic.
·
Combinations of vitamins with analgesics.
·
Combinations of penicillins with sulfonamides.
·
Combinations of vitamin 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.
2. Notice Dated 2043/2/19
Government of Nepal has banned
oral rehydration salts for production, sale-distribution, storage,
transportation and import/export on 2043/2/19 which are not composed according
to WHO's formula.
Composition as recommended by WHO (gm/litre):
|
Ingredient |
Formula Standard 1 |
Formula Standard 2 |
|
Sodium chloride |
3.5 gm |
3.5 gm |
|
Potassium chloride |
1.5 gm |
1.5 gm |
|
Sodium bicarbonate OR Trisodium
citrate (dihydrate) |
1.2 gm |
2.9 gm |
|
Glucose |
20.0 gm |
20.0 gm |
3. Notice Dated 2047/8/3
Government of Nepal has banned
the following medicines for production, sale-distribution, storage,
transportation and import/export on 2047/8/3. The ban should not be applicable
to the veterinary products and topical preparations.
·
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:
a)
Combinations Containing Pholcodine and Codeine and their Salts as Cough
Sedative.
b)
Combinations of Codeine with Paracetamol and/or Aspirin in Ratio not
Exceeding 1: 50.
c)
Combinations Containing an Antispasmodic.
·
Combination of Antipsychotic Drug (Neuroleptic) with
Other Drugs Except with Anticholinergic Trihexyphenidyl.
·
Combination of Antispasmodic 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 Hydrogen 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:
a)
Combination Used for the Treatment of Tuberculosis.
b)
Combination Used for the Treatment of Leprosy.
c)
Combination of Two Antibiotics of the Penicillin Group.
d)
Combination of Two or More Therapeutic Agents as Recognised by Standard
Pharmacopoeia (as per 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:
a)
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.
b)
Tablet/capsule: One tablet / capsule maximum up to 3 times a day.
Vitamin Dosing Limits (Adult vs.
Paediatric):
|
Vitamin |
Adult Dose Limits |
Paediatric Dose Limits |
|
Vitamin A, I.U |
Not less than 5,000 & not
more than 10,000 |
Not less than 1,500 & not
more than 5,000 |
|
Vitamin D, I.U |
Not less than 400 & not more
than 1,000 |
Not less than 100 & 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-Pantothenic acid or its salts
& Panthenol, mg |
Not less than 5 & not more
than 10 |
Not less than 2.5 & not more
than 50 |
|
Folic acid, mcg |
Not less than 1,000 & not
more than 1,500 |
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 |
Notes on Vitamin
Regulations:
·
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.
4. Notice Dated 2049/11/18
Government of Nepal has banned
the following medicines for production, sale-distribution, storage,
transportation and import/export (not applicable to veterinary products and
topical preparations) on 2049/11/18:
·
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:
a)
Combination used for the treatment of tuberculosis.
b)
Combination used for the treatment of leprosy.
c)
Combination of two antibiotics of the penicillin group.
d)
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 form.
·
Combination of Paracetamol or Aspirin except in the
following:
a)
Combination of Paracetamol or Aspirin with one nasal decongestant and one
antihistamine.
b)
Combination of Paracetamol or Aspirin (not exceeding 500mg) with codeine
not exceeding 10mg in a tablet.
c)
Combination of Paracetamol either with Ibuprofen or with one muscle
relaxant.
d)
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:
a)
Combination of Metronidazole or Tinidazole with Diloxanide furoate.
b)
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:
a)
Vitamin product in therapeutic dose as denoted in appendix-1 of this
notice.
b)
Therapeutic B-complex based product (Appendix-1) containing enzyme &
/ or aminoacid or protein or mineral.
c)
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: Amendments made to the above ban list on
2050/9/5: 1. The statement on 4(a) of the above notice has been defined as: "Combination
of paracetamol or aspirin with one decongestant and / or one
antihistamine." 2. The following categories of formulations will be exempted from
the provision of 9 of the above notice. |
5. Notice Dated 2054/4/16
Government of Nepal has banned
the following medicines for production, sale-distribution, storage,
transportation and import/export on 2054/4/16. The ban should not be applicable
to the veterinary products and topical preparations:
·
1. Liquid preparations containing sodium bicarbonate
intended for use in children.
·
2. Analgin (Metamizole) and its combinations.
Refrence:
https://dda.gov.np