What are the drugs, medicines, or pharmaceutical products that are banned for production and distribution in Nepal? Today’s topic is all about Banned Drugs in Nepal (Medicines banned or restricted in Nepal).
Banned Drugs
Many drugs or medicines are withdrawn or banned from production and distribution to the commercial markets due to several reasons. The Risk to patients and the cost of drugs are two main reasons behind some medicines being banned in the health care market.
Some drugs pass their Phase III clinical trials without or with minimal risks to patients. But when they enter the commercial markets they need to be promptly withdrawn or banned if unexpected adverse effects are detected from post-marketing surveillance data collected from the community over longer periods.
Drugs or medicines with relatively high production costs and minimal demand (or lack of demand) are also banned from production and distribution in particular countries.
The main objective of presenting the list of drugs that are banned in Nepal is to make health care professionals aware of the current scenario of the medicine market based on the regulations imposed by the government of Nepal.
This helps to avoid the possibility of potential harmful effects of drugs and also allows the medical personnel to look for viable alternatives to these banned drugs.
The list of drugs banned in Nepal also provides an idea to the general public about why some medicines available in other countries are not available in Nepal.
The government of Nepal has prepared this list to make the country free from risks that might be caused by the production and consumption of potentially hazardous medicines.
List of Banned Drugs in Nepal
The government of Nepal (or the then His Majestic Government of Nepal) has banned the production, distribution, import, and use (oral or parenteral) of the following medicines or drugs on different dates.
- On 13-03-2040 B.S. Nepal Government Banned following Drugs (Medicines)
The government of Nepal banned the following drugs for production, sale-distribution, and import:
- Amidopyrin and its combinations.
- Phenacetin and its combinations.
- Clioquinol and its combinations.
- Combination of vitamins with tranquilizers and/or anti-inflammatory agents.
- Combination of antispasmodic atropine with analgesics and anti-pyretics.
- 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 anti-diarrheal or with anti-amoebic.
- 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
- On 19-02-2043 B.S., the following Drugs are banned in Nepal
The government of Nepal banned the production, sale-distribution, storage, transportation, import, and export of the following oral rehydration salts which are not composed according to WHO’s formula:
Composition: gm/liter 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 | – |
| Trisodium citrate (dihydrate) | – | 2.9 gm |
| Glucose | 20.0 gm | 20.0 gm |
- 03-08-2047 B.S.
The government of Nepal banned the following drugs for production, sale-distribution, storage, transportation, import/export, and use (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:
- 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 Anti-bacterial agents 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 Recognized by Standard Pharmacopoeia
- The 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 a single dose of 5,10 or 15ml; or maximum 30ml in a 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 | Pediatric | |
| Vitamin A (I.U.) | not less than 5,000 and not more than 10,000 | not less than 1,500 and not more than 5,000 |
| Vitamin D (I.U.) | not less than 400 | not less than 100 |
| Vitamin B1 (mg) | not less than 4.5 and not more than 10 | not less than 1 and not more than 4.5 |
| Vitamin B2 (mg) | not less than 5 and not more than 10 | not less than 1 and not more than 5 |
| Vitamin B6 (mg) | not less than 1.5 and not more than 3 | not less than 1 and not more than 3 |
| Niacinamide (mg) | not less than 45 and not more than 100 | not less than 10 and not more than 40 |
| d-panthenic (mg) acid or its salts and Panthenol (mg) | not less than 5 and not more than 50 | not less than 2.5 and not more than 10 |
| Folic acid (mcg) | not less than 1000 and not more than 1500 | not less than 100 and not more than 500 |
| Vitamin B12 (mcg) | not less than 5 and not more than 15 | not less than 1 and not more than 5 |
| Vitamin C (mg) | not less than 75 and not more than 150 | not less than 30 and not more than 80 |
| Vitamin E (I.U.) | not less than 15 and not more than 25 | not less than 5 and not more than 20 |
- Vitamins intended for therapeutic use shall bear on the label the words “for therapeutic use-adult ‘or’ for therapeutic use-pediatric” as the case
maybe. - The above standards shall not be applied to any preparation containing
single vitamin only & also to any preparation containing vitamins
intended for parenteral use.
- 18-11-2049 B.S.
Nepal Government banned the following medicines for production, sale-distribution, storage, transportation, and import/export:
- Codeine or codeine-based cough syrup except cough Syrup containing single codeine (active ingredient) 3 mg/5 ml in a bottle not exceeding 60 ml.).
- Combination of any antibacterial with another drug except the following
- The combination used for the treatment of tuberculosis
- The combination used for the treatment of Leprosy
- Combination of two antibiotics of the penicillin group
- Combination of two or more therapeutic agents of the antibacterial group included in Pharmacopoeia
- Streptomycin in oral dosage form
- 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 Ibuprofen or with one muscle relaxant
- Combinations of Paracetamol or Aspirin with another drug, those are included in Pharmacopoeia
- Meprobamate or its combination
- Combination of anti-amoebic or anti-diarrheal 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 anti-flatulent 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 amino acid or protein or mineral
- Combinations, of vitamin in therapeutic dose with another drug, that is included in pharmacopeia
05-09-2050 B.S.
The following amendments were made to the above-banned drug’s list
- “Combination of Paracetamol or Aspirin with one nasal decongestant and one antihistamine” was defined as “Combination of paracetamol or aspirin with one decongestant and / or one antihistamine”
- 16-04-2054 (Banned Drugs in Nepal)
The government of Nepal banned the production, sale-distribution, storage, transportation and import/export of the following medicines or drugs:
- Liquid preparations containing sodium bicarbonate-intended for use in children
- Analgin (Metamizole) and its combinations
Source
- List of Banned drugs Published by Department of Drug Administration, Ministry of Health and Population, Government of Nepal.
