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.
1. Amidopyrine.
         2. Fixed dose combinations of  vitamins with       anti-inflammatory agents and tranquilizers.
2. Fixed dose combinations of  vitamins with       anti-inflammatory agents and tranquilizers.
         3. Fixed dose combinations of  Atropine in Analgesics and       Antipyretics.
3. Fixed dose combinations of  Atropine in Analgesics and       Antipyretics.
         4. Fixed dose combinations of  Strychnine and Caffeine in       tonics.
4. Fixed dose combinations of  Strychnine and Caffeine in       tonics.
         5.Fixed  dose combinations of Yohimbine and       Strychnine with Testosterone and  Vitamins.
5.Fixed  dose combinations of Yohimbine and       Strychnine with Testosterone and  Vitamins.
        6. Fixed dose combinations of Iron with Strychnine,       Arsenic and Yohimbine.
 6. Fixed dose combinations of Iron with Strychnine,       Arsenic and Yohimbine.
        7. Fixed  dose combinations of Sodium Bromide/chloral       hydrate with other drugs.
7. Fixed  dose combinations of Sodium Bromide/chloral       hydrate with other drugs. 
        8. Phenacetin.
8. Phenacetin. 
        9. Fixed dose combinations of  antihistaminic with anti-diarrhoeals.
9. Fixed dose combinations of  antihistaminic with anti-diarrhoeals. 
                  10. Fixed  dose combinations of Penicillin with Sulphonamides.
10. Fixed  dose combinations of Penicillin with Sulphonamides. 
        11. Fixed dose combinations of  Vitamins with Analgesics.
11. Fixed dose combinations of  Vitamins with Analgesics. 
           B      12.Fixed  dose combinations of  any other Tetracycline with Vitamin       C.
12.Fixed  dose combinations of  any other Tetracycline with Vitamin       C.   
           E      13.Fixed       dose combinations of Hydroxyquinoline group of drugs with any  other       drug   except for       preparations meant for external use.
13.Fixed       dose combinations of Hydroxyquinoline group of drugs with any  other       drug   except for       preparations meant for external use. 
               ccc     14. Fixed dose combinations of  Corticosteroids with any       other drug for internal use.
14. Fixed dose combinations of  Corticosteroids with any       other drug for internal use. 
               ccc     15. Fixed dose combinations of  Chloramphenicol 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.
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).
17.Fixed dose combinations of Vitamins with Anti TB drugs       except combination of Isoniazid with       Pyridoxine Hydrochloride (Vitamin B6). 
        18. Penicillin skin/eye  Ointment.
18. Penicillin skin/eye  Ointment. 
        19. Tetracycline Liquid Oral  preparations.
19. Tetracycline Liquid Oral  preparations. 
        20. Nialamide.
20. Nialamide. 
        21. Practolol.
21. Practolol. 
             22. Methapyrilene, its salts.
22. Methapyrilene, its salts.
            
      c    23. Methaqualone. 
       &   24. Oxytetracycline       Liquid Oral preparations. 
       &   25. Demeclocycline Liquid Oral preparations. 
       T    26. Combination       of anabolic Steroids with other drugs. 
       cc  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. 
       J*    29.Fixed dose combination of       Rifampicin, 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. 
          B**35.Fixed dose combination of any       anthelmintic with cathartic/purgative  except for 
                      piperazine/Santonim. 
          J **36. Fixed dose combination of Salbutamol or any other  drug       having primarily bronchodilatory activity with centrally acting  anti-tussive       and/or antihistamine. 
           **  37.Fixed dose combination of  laxatives and/or       anti-spasmodic drugs in enzyme preparations. 
               G** 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. 
           b    44. Dovers       Powder I.P. 
           b    45. Dover’s  Powder Tablets  I.P. 
           A   46.Antidiarrhoeal formulations containing  Kaolin or Pectin or Attapulgite or Activated Charcoal. 
           A  47.Antidiarrhoeal formulations containing Phthalyl Sulphathiazole or Sulphaguanidine or Succinyl Sulphathiazole. 
           A  48.Antidiarrhoeal formulations containing  Neomycin or Streptomycin or Dihydrostreptomycin  including       their respective salts or esters. 
           A  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. 
           A  50.Liquid Oral antidiarrhoeals or       any other dosage form for pediatric use containing halogenated hydroxyquinolines. 
           A   51. Fixed dose combination of antidiarrhoeals with electrolytes. 
           C   52. Patent       and Proprietary Oral Rehydration Salts other than those conforming  to the  
           D   53. Fixed       dose combination of Oxyphenbutazone or Phenylbutazone with any  other       drug. 
          H.D54. Fixed dose combination of Analgin with       any other drug. 
                  D 55. Fixed       dose combination of dextropropoxyphene with any other drug other  than       anti-spasmodics and/or non-steriodal       anti-inflammatory drugs (NSAIDS). 
            D 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. 
            F 57. Mepacrine       Hydrochloride (Quinacrine and its salts) in any dosage form for  use for female  sterilization or contraception. 
            F  58. Fenfluramine and Dexfenfluramine. 
            I  59. Fixed dose combination of Diazepam       and Diphenhydramine Hydrochloride . 
                  K  60. Rimonabant.
       LIST       OF GAZETTE NOTIFICATION PUBLISHED
        The Principal       Notification GSR 578 (E) dt.23.7.83.
    The Principal       Notification GSR 578 (E) dt.23.7.83.
       c    Added b GSR 4(E) dated       31.01.1984
       &   Added b GSR 322(E) dated       03.05.1984\
       T    Amended  by GSR 863(E)       dated 22.11.1985 
       cc   Amended by GSR 743(E)  dated       10.08.1989
       ccc       Amended  by GSR 1057(E) dated 03.11.1988
       *    Added  by GSR 999(E)       dated 26.12.1990
                      *   Added by GSR 69(E) dated       11.02.1991
              xxx     Added  by GSR 304(E)       dated 7.06.1990
            @   Added by GSR 444(E)       dated 7.06.1992
             b   Added by GSR 111(E)       dated 22.02.1994
             A    Added by GSR 731(E)       dated 30.09.1994
             B   Added by GSR 848(E)       dated 7.12.1994
             C   Added by GSR 57(E) dated       7.02.1995
             D   Added by GSR 633(E)       dated 13.09.1995
             E   Added by GSR 793(E)       dated 13.03.1995
                   Added by GSR  93(E) dated       25.05.1997
             F   Added by GSR 499(E)       dated 14.08.1998
             G   Added by GSR 394(E)       dated 19.05.1999
             H   Added by GSR 405(E)       dated 3.06.1999
             I     Added by GSR 169(E)       dated 12.03.2001 
                    J   Added       by GSR 290(E) dated 16.04.2008
                    K   Added by GSR 885(E) dated 11.12.2009
       LIST        OF DRUGS       PROHIBITED FOR IMPORT 
                        1. Nialamide
                     2. Practolol
                     3. Amidopyrine
                     4. Phenacetin
                     5. Methapyrilene and its salts
                a   6. Methaqualone
                b   7. Chloral Hydrate as a drug
                c   8. Mepacrine Hydrochloride ( Quinacrine and its Salts)       in any dosage form for use for female sterilization or  contraception.
                     9. Fenfluramine and Dexfenfluramine]
                d   10. Rimonabant
       LIST        OF GAZETTE NOTIFICATION PUBLISHED
                 a  Added by GSR 48(E) dated 31.1.1984
                 b  Added by GSR 303(E) dated 7.6.1991
                 c  Added by GSR 498(E) dated 14.8.1998
                 d Added by GSR 884(E) dated 11.12.2009
        
       DRUGS       PROHIBITED FOR MANUFACTURE , SALE  AND DISTRIBUTION FROM  SUBSEQUENT       DATE 
                             Drugs Formulation                                   Effective  date           Notification   
        
       1.Cosmetics  Licensed as toothpaste/tooth           With  immediate         GSR       444(E)  
          powder containing tobacco.                                   effect                             dt.30.4.92 
       2.Parenteal Preparations fixed       dose                     Jan       1,1998                     GSR 93(E)
          combination of streptomycin with                                                            dt.25.2.97
          Pencillin 
       3.Fixed        dose combination of Vitamin B1,                     Jan 1,2001                     GSR 702(E)
          Vitamin B6 and Vitamin B12 for                                                              dt.14.10.99
          human use  
       4.Fixed dose combination of       haemoglobin                   Sep 1,2000                     GSR 814(E) 
          in  any form (natural or       synthetic).                                                          dt.16.12.99 
       5.Fixed dose combination of       Pancreatin or                  Sept. 1,2000                   GSR 814(E)
         Pancrelipase containing amylase,  protease                                                dt.16.12.99  
         and lipase with any other enzyme. 
       6.       Fixed dose combination of Nitrofurantoin          Jan        1,2002                      GSR 170(E) 
           and trimethoprim.                                                                                 dt.12.3.01 
       7.Fixed dose combination of       Phenobarbitone         Jan       1,2002                      GRS 170(E)   
          with  any anti-asthmatic       drugs.                                                                  dt.12.3.01 
       8.Fixed dose combination of       Phenobarbitone         Jan       1,2002                      GSR 170(E) 
          with Hyoscin       and/or Hyoscyamine                                                            dt.12.3.01 
       9.Fixed dose combination of Phenobarbitone         Jan       1,2002                      GSR 170(E)
          with  Ergotamine and/or Belladona                                                            dt.12.3.01 
       10.Fixed dose combination       of Haloperidol                    Jan 1,2002                       GSR 170(E) 
            with any anti-cholinergic agent       including                                                dt.12.3.01
            Propantheline Bromide. 
       11.Fixed dose combination       of Nalidixic Acid           Jan       1,2002                         GSR 170(E)
            with any anti-amoebic including Metronidazole.                                          dt.12.3.01  
       12.Fixed dose combination       of Loperamide                   Jan 1,2002                        GSR 170(E) 
            Hydrochloride  with Furazolidone                                                             dt.12.3.01 
       13.Fixed dose combination of Cyproheptadine       Jan 1,2003                        GSR 170(E)
           with        Lysine or Peptone.                                                                           dt.12.3.01 
       14.Astemizole                                                 Apr.1,2003                         GSR 191(E)
                                                                                                                       dt.5.3.03 
       15.Terfinadine                                                 Apr.1,2003                         GSR 191(E)
                                                                                                                       dt.5.3.03 
       16.Fenformin                                                         Oct.1,2003                          GSR 780(E)
                                                                                                                    dt.1.10.03   
       17.Rafecoxib                                                        Dec       13,2004                        GSR 810(E)
                                                                                                                    dt. 13.12.04
       18.Valdecoxib                                                      July       25,2005                         GSR 510(E)
          and it's        formulation                                                                                                     dt. 25.07.05
       19.Diclofenac       and its       formulations                           July 4,       2008                          GSR 499(E)
                 for animal        use                                                                                       dt.4.07.08