List of Drugs Banned in India by the Ministry of Health and Family Welfare

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List of Drugs Prohibited for Manufacture and Sale through Gazette Notifications under Section 26a of Drugs & Cosmetics act 1940 by the Ministry of Health and Family Welfare

Drugs Prohibited from the date of Notification

  1. Amidopyrine.
  2. Fixed dose combinations of vitamins with anti–inflammatory agents and tranquilizers.
  3. Fixed dose combinations of Atropine in Analgesics and Antipyretics.
  4. Fixed dose combinations of Strychnine and Caffeine in tonics.
  5. Fixed dose combinations of Yohimbine and Strychnine with Testosterone and Vitamins.
  6. Fixed dose combinations of Iron with Strychnine, Arsenic and Yohimbine.
  7. Fixed dose combinations of Sodium Bromide/chloral hydrate with other drugs.
  8. Phenacetin.
  9. Fixed dose combinations of antihistaminic with anti-diarrhoeals.
  10. Fixed dose combinations of Penicillin with Sulphonamides.
  11. Fixed dose combinations of Vitamins with Analgesics.
  12. Fixed dose combinations of any other Tetracycline with Vitamin C.
  13. Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use.
  14. Fixed dose combinations of Corticosteroids with any other drug for internal use.
  15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.
  16. Fixed dose combinations of crude Ergot preparations except those containing Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headaches.
  17. Fixed dose combinations of Vitamins with Anti TB drugs except combination of Isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
  18. Penicillin skin/eye Ointment.
  19. Tetracycline Liquid Oral preparations.
  20. Nialamide.
  21. Practolol.
  22. Methapyrilene, its salts.
  23. Methaqualone.
  24. Oxytetracycline Liquid Oral preparations.
  25. Demeclocycline Liquid Oral preparations.
  26. Combination of anabolic Steroids with other drugs.
  27. Fixed dose combination of Oestrogen and Progestin (other than oral contraceptive) containing per tablet estrogen content of more than 50 mcg (equivalent to Ethinyl Estradiol) and progestin content of more than 3 mg (equivalent to Norethisterone Acetate) and all fixed dose combination injectable preparations containing synthetic Oestrogen and Progesterone. (Subs. By Noti. No. 743 (E) dt 10-08-1989)
  28. Fixed dose combination of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.
  29. Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide, except those which provide daily adult dose given below:

    Drugs Minimum Maximum
    Rifampicin 450 mg 600 mg
    Isoniazid 300 mg 400 mg
    Pyrazinamide 1000mg 1500 mg
  30. Fixed dose combination of Histamine H-2 receptor antagonists with antacids except for those combinations approved by Drugs Controller, India.
  31. The patent and proprietary medicines of fixed dose combinations of essential oils with alcohol having percentage higher than 20% proof except preparations given in the Indian Pharmacopoeia.
  32. All Pharmaceutical preparations containing Chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
  33. Fixed dose combination of Ethambutol with INH other than the following: INH Ethambutol 200 mg. 600 mg. 300 mg. 800 mg.
  34. Fixed dose combination containing more than one antihistamine.
  35. Fixed dose combination of any anthelmintic with cathartic/purgative except for piperazine/Santonim.
  36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.
  37. Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.
  38. Fixed dose combination of Metoclopramide with systemically absorbed drugs except fixed dose combination of metoclopramide with aspirin/paracetamol
  39. Fixed dose combination of centrally acting, antitussive with antihistamine, having high atropine like activity in expectorants.
  40. Preparations claiming to combat cough associated with asthma containing centrally acting antitussive and/ or an antihistamine.
  41. Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and / or central nervous system stimulant and such preparations containing alcohol more than 20% proof.
  42. Fixed dose combination containing Pectin and/or Kaolin with any drug which is systemically absorbed from GI tract except for combinations of Pectin and/or Kaolin with drugs not systemically absorbed.
  43. Chloral Hydrate as a drug.
  44. Dovers Powder I.P.
  45. Dover’s Powder Tablets I.P.
  46. Antidiarrhoeal formulations containing Kaolin or Pectin or Attapulgite or Activated Charcoal.
  47. Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole.
  48. Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.
  49. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate Lorloperamide or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.
  50. Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.
  51. Fixed dose combination of antidiarrhoeals with electrolytes.
  52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the
  53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
  54. Fixed dose combination of Analgin with any other drug.
  55. Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).
  56. Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.
  57. Mepacrine Hydrochloride (Quinacrine and its salts) in any dosage form for use for female sterilization or contraception.
  58. Fenfluramine and Dexfenfluramine.
  59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.
  60. Rimonabant.
  61. Rosiglitazone
  62. Nimesulide formulations for human use in children below 12 years of age.
  63. Cisapride and its formulations for human use.
  64. Phenylpropanolamine and its formulation for human use.
  65. Human Placental Extract and its formulations for human use.
  66. Sibutramine and its formulations for human use, and
  67. R-Sibutramine and its formulations for human use.
  68. Gatifloxacin formulation for systemic use in human by any route including oral and injectable
  69. Tegaserod and its formulation for human use.

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Comments

Anonymous (not verified)

Thu, 2011-10-06 15:25

Practolol is selective beta blocker and structurally similar as propanolol but it is banned because of toxic effect.
* practolol disaster is considered the worst medical blunders since thalidomide.
It may cause oculomucocutaneous syndrome which is a severe syndrome whose signs include conjunctivitis sicca and psoriasiform rashes, otitis and sclerosing serositis.

- Rohit Pagare

Anonymous (not verified)

Thu, 2011-10-06 15:32

Bacterial resistance is the main reason behind banning penicillin and sulphonamide combination.

Anonymous (not verified)

Thu, 2011-10-06 15:52

Analgin known to cause agranulocytosis , widely used in Indian mmarket....

Anonymous (not verified)

Thu, 2011-10-06 16:24

Anticholinergic agents may delay and/or decrease the gastrointestinal absorption of acetaminophen by reducing gastric motility and delaying gastric emptying. However, the clinical relevance is probably minimal.

Anonymous (not verified)

Thu, 2011-10-06 16:31

Nialamide is an irreversible and non-selective monoamine oxidase inhibitor
Banned May be due to extreme side effects: euphoria, psychomotor agitation, insomnia, anxiety, headache, vertigo, tremor, hyperreflexia, manic state, or turnig a depression into mania in bipolar disorder. Other side effects are arterial hypotension, orthostatic hypotension, arterial hypertension, palpitations, hyperhidrosis, dry mouth, nausea, vomiting, epigastric pain, constipation, vision problems, retrobulbar optic neuritis, polyneuritis, weight gain, acute cardiac insufficiency, tachycardia, peripheral neuropathy, jaundice, hepatomegaly, hyperbilirubinemia, urinary retention, elevated transaminases, cutaneous eruptions, impotence, and delayed ejaculation.

Dangerous side effects are drug-induced hepatitis and hepatocellular insufficiency.

Anonymous (not verified)

Thu, 2011-10-06 23:10

Hi, I am Karan Mistry

A Canadian study published in the New England Journal of Medicine in March 2006 claims Tequin {brand name of gatifloxacin} can have "life threatening" side effects including serious diabetes.

Other serious side effects reported with gatifloxacin include hallucinations, liver damage and purpura. Union Health and Family Welfare Ministry of India on 18 march 2011 banned the manufacture, sale and distribution of Gatifloxacin as it caused certain adverse side effects

Anonymous (not verified)

Mon, 2011-10-10 00:18

68

Anonymous (not verified)

Thu, 2011-10-06 23:19

Hello,
Good evening

Sibutramine is a centrally-acting serotonin-norepinephrine reuptake inhibitor structurally related to amphetamines.

Sibutramine can substantially increase blood pressure and pulse in some patients. In 2010 the FDA noted the concerns that sibutramine increases the risk of heart attacks and strokes in patients with a history of cardiovascular disease.

Sibutramine has been associated with increased cardiovascular events and strokes and has been withdrawn from the market in countries and regions including Australia, Canada, China, the European Union, Hong Kong, India, Mexico, Thailand, the UK and the United States.

---
Kamal Patel
Manipal

Anonymous (not verified)

Thu, 2011-10-06 23:27

Rimonabant is anorectic antiobesity drug. It is -1 agonist for the cannabinoid receptor CB1.

Shortly after market introduction, press reports and independent studies suggested side effects occurred more intensely and more commonly than shown by the manufacturer in their clinical studies. Resulting from drug actions at CB1 receptors in the brain, reports of severe depression and suicidal thoughts are frequent.

AND IT IS WITHDRWN FROM THE MARKET.

Anonymous (not verified)

Thu, 2011-10-06 23:46

In high amount chloroform can be carcinogenic and also have severe harmful effect on CNS

Anonymous (not verified)

Fri, 2011-10-07 15:12

Some common side effects linked with Nimesulide use are nausea, vomiting, diarrhea, pruritis, skin rashes, headaches and dizziness. Some serious side effects when used in newborns are renal failure and hepatic failure.
According to International Society of Drug Bulletins (ISDB), this non-steroidal anti-inflammatory drug (NSAID) offers no therapeutic advantage or better gastrointestinal safety compared with other NSAIDs, whereas it exposes patients to a higher risk of fatal hepatic disorders.
Nimesulide has been drawn aside from the pharmaceitical market because of its hepatic effects (risk of hepatatoxicity) on patients.

Mahendra singh
from Panjab University, Chandigarh

Anonymous (not verified)

Fri, 2012-02-17 12:28

Rosiglitazone is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin.
The main reason behind banning this drug was associated with a significantly increased risk of heart attack.
A meta-analysis of observational studies released in March, 2011 provides more evidence that rosiglitazone is associated with a higher risk of heart failure, myocardial infarction (MI) and death.

Datta Nirmal
Pune

drmaulik77 (not verified)

Tue, 2013-06-25 00:38

Good job..:)

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