| 1.
Government of Nepal has banned the folowing 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 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. |
|
| |
| 2. 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 : (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 |
|
|
| |
| |
| |
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 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: |
|
| 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 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
|
| 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.
| |
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 and not more than 1000 |
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-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 |
|
| |
| 1. |
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. |
| 2. |
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. Government
of Nepal has banned the folowing medicines for production,
sale-distribution, storage, transportation and import/export.
The ban should not be applicable to the 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) |
|
| |
| 3. |
Streptomycin
in oral dosage from |
| 4. |
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 Ibuprfen 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 |
|
| |
| 5. |
Meprobamate
or its combination |
| 6. |
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 |
|
| |
| 7. |
All
combinations of antiflatulant except with antacid
or antispasmodic |
| 8. |
Combination
of cyproheptadine with another drug |
| 9. |
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: The following
amendments have been made on 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
catagories of formulations will be exempted from
the provision of 9 of the above notice. |
|
|
| |
5. 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 |
|
| |
