More than 60,000 branded formulations are available in India. These preparations contain either single drug or drugs in fixed dose combination (FDC). All formulations are used for treatment or prevention of diseases. Out of it only few drugs are lifesaving and essential drugs, otherwise maximum of them are available as alternative or substitute to each other.
At the same time it is clinically proved that almost all the drugs have side effect at therapeutic level besides toxic effect. The unwanted side effect is referred to as adverse drug reaction (ADR). Hence a drug is used or prescribed by physician on seeing risk-benefit ratio.
Though the drug is approved by the Drugs Controller General India for manufacturing and marketing in country only after consideration of all aspects such as therapeutic effect, side effect, toxic effect etc; the physician has to follow rational prescription practice in consideration of drugs available in the market.
The DCGI has allowed so many drugs having serious ADR after considering their therapeutic justification but those drugs are allowed with an indication to be printed on label of product i.e. Erythromycin, Chloramphenicol, Metronidazole, Iodo-chlorohydroxy quinoline etc.
It is a fact that on seeing serious hazardous effect of drug Thalidomide in 1960 in UK, the FDA of all the countries gave a thought on banning of drugs. Accordingly in our country, after amendment of Drugs Act in 1982, Government has acquired the power to prohibit the manufacture and sale of drugs and fixed dose combinations or irrational drugs. The government, subsequently, issued a first gazette notification in July 1983 banning several drugs and their FDC after due consideration. A ban or restricted use order is being issued on a continuous basis on seeing ADR on Indian patients. This is being done in the interest of common people of India and also to safeguard their health from menace of ADR of drugs.
Till date the Indian government has banned several FDCs and imposed restriction on many drugs and their combinations with other drugs for its manufacturing and marketing in India. Following is the list:
1. Amidopyrine
2. Phenacetin
3. Sulphanilamide
4. Practolol
5. Methapyrilence and its salts
6. Penicillin skin/ eye ointment
7. Tetracycline liquid
8. Oxytetracycline liquid oral preparation
9. Demeclocycline liquid oral preparation
10. Methaqualone
11. FDC of chloramiphericol with other drugs for internal use
12. FDC of Ergot with any drugs
13. FDC of Vitamins with anti-inflammatory agents and tranquilisers
14. FDC of Atropine with analgesics and antipyretics
15. FDC of Yohimbine and strychnine with Testosterone and vitamins.
16. FDC of iron with Strychnine, Arsenic and Yohimbine.
17. Chloral hydrate
18. FDC of sodium bromide with other drugs.
19. FDC of Tetracycline with vitamin C.
20. FDC of antihistamins with antidiarrhoeals.
21. FDC of Penicillins with Sulfonamides
22. FDC of vitamins with analgesics
23. FDC of prophylactic vitamins with Anti TB drugs except isoniazid with Pyridoxine Hydrochloride (Vitamin B6).
24. FDC of Strychnine and Caffeine in Tonic.
25. FDC of Hydroxy Quinolines groups of drugs with other drugs and liquid oral antidiarroheal or any other dosage form for paediatric use except for external use.
26. FDC of corticosteroid for internal use
27. FDC of Anabolic steroid with other drugs.
28. Combination of high dose of Estrogen and Progesterone (low dose combination is allowed for its use as contraceptive)
29. FDC of Sedatives/ hypnotics/ anxiolytics with analegesic and antipyretics.
30. FDC of anti-TB drugs except the under-stated combinations.
I II
(a) (I) Pyrizinamide 1000mg; 1500mg
(II) Rifampicin 450mg; 600mg
(III) Isoniazid 300mg; 300mg
(b) (I) Ethambutol 600mg; 800mg
(II) Isoniazid 200mg; 300mg.
31. FDC of Histamin H2 receptor antagonists with antacid except any combination approved by DCGI.
32. Patent and proprietary medicines having alcohol more than 20% except preparation listed in IP.
33. All preparations containing chloroform exceeding 0.5% w/w or v/v whichever is appropriate.
34. FDC of anthelmintics with cathartics or purgatives except for piperazine.
35. FDC containing more than one antihistaminic drug.
36. FDC of Salbutamol or any other bronchodilator with central acting antitussives and/ or antihistamines.
37. FDC of Laxatives and/ or antispasmodic drugs in enzyme preparations.
38. FDC if metoclopramide with other drugs except with Aspirin/ Paracetamol.
39. FDC of centrally acting antitussives with antihistamin as having atropine like activity in expectorent.
40. Preparations claiming to combat cough associated with asthma that contain a centrally acting antitusive and/ or antihistamine.
41. Liquid oral tonic having glycerol phosphates and other phosphates and/ or CNS stimulants and such preparations having alcohol more than 20%.
42. FDC containing Pectin and/ or Kaolin with any drug which is systemically absorbed through GI tract.
43. Toothpaste/ toothpowder containing tobacco.
44. Dovers powder IP Dovers Powder IP Tablets.
45. Antidiarrohoeal preparations containing kaolin/ pectin/ attapulgite/ activated charcoal.
46. Antidiarrohoeal preparations having phthalye sulphathiozole, Sulphaguinidine, succinic sulphathiozole, Neomycin, streptromycin, dihydro streptomycin or their salt.
47. Antidiarrhoeal formulation in any form for Pediatric use containing Diphenoxylate or Loperamide or Atropine or belladonna including their salts, esters or metabolites or their extracts or alkaloids.
48. FDC of antidiarrhoeals with electrolytes,
49. Oral Rehydration salts (ORS)-other than conforming to WHO formula or Pharmacapoeial preparation.
50. FDC of Analgin with any other drugs.
51. FDC of Dextropropoxyphene with any other drug except with antispasmodics and or NSAID
52. FDC of Phenylbutazone or Oxyphenbutazone with other drugs.
53. FDC of allopathic drugs with Ayurvedic, Siddha or Unani drugs.
54. Mepacrine Hydrochloride (Quina-crine and its salts) in any dosage form for use for female sterilization or contraception.
55. Fenfluramine and Dexfenfluramine.
56. FDC of streptomycin with penicillin.
57. FDC of Vitamin B1, B6 & B12.
58. Fixed dose combination of Nitrofuratoin and Trimethoprim.
59. Fixed dose combination of Phenobarbitone with any antiasthamatic drugs.
60. Fixed dose combination of Phenobarbitone with Hyoscin and/or
Hyoscyamine.
61. Fixed dose combination of Phenobarbitone with Ergotamine and/or
Belladona.
62. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propentheline Bromide.
63. Fixed dose combination of Nalidixic acid with any antiramoebics including Metronidazole.
64. Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
65. Fixed dose combination of Cyproheptadine with Lysine or Peptone.
66. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.
67. Cisapride- Only qualified gastro-enterologists such as super specilists holding DM in gastro-enterology are permitted to prescribe cisapride.
68. Astemizole
69. Terfenadine
70. Sildenafil citrate. To be prescribed by endocrinologists, Urologists and Psychiatrist only.
The safety of health of a patient from drug is a vital aspect during treatment. The health professionals -- physicians, pharmacists and nurses have to prescribe, handle and administer the medicines respectively. So it is imperative for them to acquaint themselves with the above list. In addition to it, they should also go through the notification issued time to time by DCGI. This helps them to use proper medicines only and also to save patients from unsafe drug. Further it is also imperative for the industrial pharmacists and marketing professionals to keep themselves abreast with list of banned drugs, drugs of restricted use and banned FDCs. This ultimately helps them in formulating right products mix and a proper marketing strategy. Lastly it saves the Indian patients from hazardous drugs.