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PHARMACIST

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PHARMACIST

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PHARMACY ANTHEM

NPPA revises Prices of 63 more Formulation Packs under New DPCO 2013

HAPPY DASARA AND VIJAYADASHAMI

Gazzette Notification - Schedule H1 Drugs

ANTIBIOTICS AND ANTIBIOTIC RESISTANCE

Schedule H1 Notified

Drug Storage as per IP and Product Labelling

DRUGS TO BE STORED

1.In a Frozen State:	Ceftazidime Inj
2° to 8° C:	Antisera Biphasic Isophane Insulin Inj BCG Vaccine Carbenicillin Sodium Inj. [Biopence™ Carbelin™ Pyopen™] Carboprost Tromethamine Inj. USP [Endoprost™, Prostodin™] Desferrioxamine Mesylate Inj. [Desferal 0.5 g™] Dilzem™ Inj. Dinoprostone Gel [Cerviprime 0.5mg.™Primiprost™] Ergometrine Maleate Inj. Gas-Gangrene Antitoxin (Oedematiens) Gas-Gangrene Antitoxin (Perfringes) Gas-Gangrene Antitoxin (Septicum) Hepatitis B Virus Vaccine (H B Vac™ Enivac HB™ Engerrix B™ Heppacine-B™ Shanvac-B™) Human Normal Immunoglobulin [Histaglobulin ™ (lyophillised) Insulin Inj. (e.g. Insuman ™ 50/50) Measles Vaccine, Live (M-Vac™) Methylergometrine Maleate Inj. Mixed Gas Gangrene Antitoxin Plague Vaccine Poliomyelitis Vaccine, Live (oral)[Polio Sabin™ Oral Polio™] Protamine Sulphate Inj. Rabies Anti-serum-Equine Rabies Immuno Globulin (Human) EP [Kamrab™] Rabies Vaccine Human (Neural Tissue) Rabies Vaccine, Human (Cell Culture)[Abhayrab™] Recombinant Streptokinase (r-Streptokinase) Inj. 1,500,000 IU Rho (D) Immune Globulin (Human) 50µg, 150µg, 300µg Rubell Vaccine Live BP [R-Vac™ (lyophillised)] Sandoglobulin™ Schick Control Schick Test Toxin Scorpion Venom Antiserum Snake Venom Antiserum Soluble Insulin Inj. Streptokinase Inj. [Embokinase™ Kabikinase™ Streptase™] Succinylcholine Chloride Inj. [Midarine™ Scoline™] Tetanus Immunoglobulin BP (Human) [Tetglob™] Tetanus Vaccine (Adsorbed) Typhoid Paratyphoid A Vaccine Typhoid Vaccine Oral [Typhoral™] Typhoid Vaccine [Typhim VI™] Typhus Vaccine Vaccines Vasopressin Inj. [Petresin™] Vinblastine Sulphate Inj. [Cytoblastin™] Vincristine Sulphate Inj. [Cytocristn™ Vincristine™ Oncristine AQ™] Yellow Fever Vaccine, Live
3. Below 10° C:	Japanese Encephalitis Vaccine, Human (Mouse Brain) Methylprednisolone Acetate Inj.
4.At a temp. Not exceeding 20° C:	Chorionic Gonadotrophin Inj. (Pubergen 2000 IU ™) Urokinase™
5. Between 2° & 25° C:	Human Plasma Protein Fraction
6.Between 20° & 30° C:	Mannitol Inj.
7.In a Refrigerator:	Velocite ™ & Pregcolor ™ Test Kits
8.23° or below:	Desferrioxamine Inj.
9.Store below 30° :	Dobutamine Inj. USP 50 mg/ml Propofol Inj.™
10.Store in Cool Place :	Heparin Inj. Morphine Inj.
11.To Be Stored Below 25° C:	Cefotaxime Sodium Inj. Cefuroxime Sodium Inj. Dopamine Hydrochloride Inj. USP [Dopasys™] Enoxaparin Sodium Inj. Human Chorionic Gonadotrophin [Profasi™] Human Normal Albumin Soln [Alburel™] Menotrophin (hMG)[Pergonal 75™] Meropenam Inj. Naloxone Inj. 400mcg/ml Nifedipine Sustained Release Tab (Calcigard-10 Retard Tab™) Urofolliotrophin (FSH) 75 IU [Metrodin 75]
PRECAUTIONS
1.Should not be allowed to freeze Antisera Inj. Cortisone Acetate Inj. Fluorouracil Inj. Gas Gangrene Antitoxin (Oedematiens) Gas-Gangrene Antitoxin (Perfringens) Gas-Gangrene Antitoxin (Septicum) Hepatitis B Virus Vaccine [H B Vac™ Inj., Shanvac-B™] Histaglobulin™ [lyophillised] Insulins Methylprednisolone Acetate Inj. Mixed Gas-Gangrene Antitoxin Oxytocin Inj. Plague Vaccine Rabies Vaccine, Human (Neural Tissue) Scorpion Venom Antiserum Snake Venom Antiserum Succinylcholine Chloride Inj. Typhoid Paratyphoid A Vaccine Typhoid Vaccine Vaccines 2.Avoid Long Exposure above 30° C Cyclophosphamide Inj.

New DPCO 2013 - Ceiling Price List of Drugs (till date) - 25 Drugs

Schedule H1 Antibiotics

List of Drugs Banned for Marketing in India

The Government of India vide notifications published in the Gazette of India vide G.S.R. No. 578 (E) dated 23/07/1983 and subsequent amendments, made under Section 26 A of Drugs and Cosmetics Act, 1940 has prohibited the manufacture, sale and distribution of the following categories of fixed dose combinations which do not have any therapeutic justification or are likely to involve risk to human beings:

G.S.R. No. 578 (E) dt 23-07-1983
1. Amidopyrine.
2. Fixed dose combinations of vitamins with anti-inflammatory agents and tranquilizers.
3. Fixed dose combinations of Atropine and Analgesic 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 Tetracycline with Vitamin C.

G.S.R. No. 793 (E) dt 13-12-1995
13. Fixed dose combinations of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use only.

G.S.R. No. 1057 (E) dt 03-11-1988
14. Fixed dose combinations of Corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers.[Substituted vide GSR 738 (E) dated 9.10.2009] 
15. Fixed dose combinations of Chloramphenicol with any other drug for internal use.

G.S.R. No. 304 (E) dt 07-06-1991
16. Fixed dose combinations of crude Ergot preparation except those containing  Ergotamine, Caffeine, analgesics, antihistamines for the treatment of migraine, headache.
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.

G.S.R. No. 49 (E) dt 31-01-1984
23. Methaqualone.

G.S.R. No. 322 (E) dt 03-05-1984
24. Oxytetracycline Liquid Oral preparations.
25. Demeclocycline Liquid Oral preparations.

G.S.R. No. 863 (E) dt 22-11-1985
26. Combination of anabolic Steroids with other drugs.

G.S.R. No. 743 (E) dt 10-08-1989
27. Fixed dose combination of Oestrogen and Progestin (other than oral contraceptives) 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)

G.S.R. No. 999 (E) dt 26-12-1990
28. Fixed dose combinations of Sedatives/ hypnotics/anxiolytics with analgesics-antipyretics.

G.S.R 100 (E) dt 11-02-2003 (with effect from 11-02-2003)
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 1000 mg              1500  mg”

G.S.R. No. 999 (E) dt 26-12-1990 
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.

G.S.R. No. 69 (E) dt 11-02-1991
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 anthelmintic with cathartic/purgative except for piperazine.

Substituted vide G.S.R 290 (E) dt 16-04-2008
36. Fixed dose combination of Salbutamol or any other bronchodilator with centrally acting anti-tussive and/or antihistamine.

G.S.R. No. 69 (E) dt 11-02-1991
37. Fixed dose combination of laxatives and/or anti-spasmodic drugs in enzyme preparations.

Substituted vide G.S.R 603 (E) dt 24-08-2001 (with effect from 01-09-2002)
38. Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol with effect from 1st September, 2002.

G.S.R. No. 395 (E) dt 19-05-1999 
39. Fixed dose combination of centrally acting, antitussive with antihistamine, having 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 combination of Pectin and/or Kaolin with drugs not systemically absorbed.

G.S.R. No. 304 (E) dt 07-06-1991
43. Chloral Hydrate as a drug.

G.S.R. No. 612 (E) dt 09-08-1994
44. Dovers Powder I.P.
45. Dover's Powder Tablets I.P.

G.S.R. No. 731 (E) dt 30-09-1994
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 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.

G.S.R. No. 57 (E) dt 07-02-1995
52. Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:
      (a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:- Sodium - 50 to 90 millimoles. Total osmolarity - 240 - 290 milli osmoles. Dextrose : Sodium molar ratio - Not less than 1:1 and not more than 3:1
      (b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose.
      (c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only.
      (d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.

G.S.R. No. 633 (E) dt 30-09-1995, GSR No. 123 (E) dt 11-03-1996 and GSR No. 230 (E) dt 04-06-1996
53. Fixed dose combination of Oxyphenbutazone or Phenylbutazone with any other drug.
54. Fixed dose combination of Analgin with any other drug. [Words "other than antispasmodics"omitted vide 

G.S.R. No. 405 (E) dt 03-06-1996]
Clarification: Fixed dose combination of Analgin with any other drug other than antispasmodics were banned by the Government of India vide G.S.R. No. 633(E), dated 13.09.1995. However, the Drug Action Forum contended before the Supreme Court that the preparations of Analgin and antispasmodics should also be banned. Dr. J.S. Bajaj, being directed by the court, submitted his report supporting these contentions.

     On 17th Dec. 1996, a learned additional Solicitor submitted that the Central Government has decided that all State/U.T. Drug Licensing Authorities will be given directions by the Government under Section 33-P of the Drugs and Cosmetics Act, to suspend manufacturing licenses of all fixed dose formulations of Analgin including Analgin with Antispasmodics till further notice. Accordingly, the Government of India, under letter dated 17th Dec.1996, issued such directives. In view of the above directives, the manufacture, sale and distribution of fixed dose combinations of Analgin and antispasmodics is prohibited.

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.

G.S.R. No. 93 (E) dt 25-02-1997
57. Parenteral preparations containing fixed dose combination of streptomycin with penicillins with effect from 01-01-1998.

G.S.R. No. 499 (E) dt 14-08-1998
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 haemoglobin in any form (natural or synthetic).
60. Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease, and lipase with any other enzyme.

(Both 59 & 60 added by G.S.R. 590 (E) dt. 17-8-1999.
Sr. No. 59 & 60 omitted by G.S.R. 704(E) dt. 20-10-1999.)]

G.S.R. No. 169 (E) dt 12-03-2001
59. Fixed dose combination of Diazepam and Diphenhydramine Hydrochloride.

G.S.R. No. 885  (E) dt 11-12-2009 (with effect from 11-12-2009) 
60. Rimonabant.

G.S.R. No. 702 (E) dt 20-10-1999 (with effect from 1-1-2001) 
61. Fixed dose combination of Vitamin B1, Vitamin B6 and Vitamin B12 for human use with effect from 01-01-2001

G.S.R. No. 814 (E) dt 16-12-1999 (w.e.f. 01-09-2000)
62. Fixed dose combination of haemoglobin in any form (natural or synthetic).
63. Fixed dose combination of Pancreatin and Pancrelipase containing amylase, protease and lipase with any other enzyme.

G.S.R. No. 170 (E) dt 12-03-2001 (with effect from 01-01-2002)
64. Fixed dose combination of Nitrofurantoin and trimethoprim.
65. Fixed dose combination of Phenobarbitone with any anti-asthmatic drug.
66. Fixed dose combination of Phenobarbitone with Hyoscin and/or Hyoscyamine.
67. Fixed dose combination of Phenobarbitone with Ergotamine and/or Belladona.
68. Fixed dose combination of Haloperidol with any anti-cholinergic agent including Propantheline Bromide.
69. Fixed dose combination of Nalidixic Acid with any anti-amoebic including Metronidazole.
70. Fixed dose combination of Loperamide Hydrochloride with Furazolidone.
71. Fixed dose combination of Cyproheptadine with Lysine or Peptone.

G.S.R 603 (E) dt 13-08-2001 (with effect from 01-09-2002)
72. Fixed dose combination of Metoclopramide with other drugs except combination of Metoclopramide with Aspirin/ Paracetamol with effect from 1st September, 2002.

G.S.R. No. 732 (E) dt 29-10.2002, Amended vide GSR 191(E) dt 05-03-2003 (with effect from 01-08-2003)
73. Astemizole

74. Terfinadine

G.S.R 100 (E) dt 11-02-2003 (with effect from 11-02-2003)
75. 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 1000 mg              1500  mg”

G.S.R. No. 780 (E) dt 01-10-2003 (with effect from 01-10-2003)
76. Phenformin for human use.

G.S.R. No. 810 (E) dt 13-12-2004 (with effect from 13-12-2004)
77. Rofecoxib and its formulations for human use.

G.S.R. No. 510 (E) dt 25-7-2005 (with effect from 25-7-2005)
78. Valdecoxib and its formulations for human use.

G.S.R. No. 499 (E) dt 4-7-2008 (with effect from 5-7-2008)
79. Diclofenac and its formulations for animal use.

G.S.R. No. 910 (E) dt 12-11-2010 (with effect from 12-11-2010)
80. Rosiglitazone and its formulations for human use.

G.S.R. No. 82 (E) dt 10-2-2011 (with effect from 10-2-2011)
81. Nimesulide formulations for human use in children below 12 years of age.
82. Cisapride and its formulations for human use.
83. Phenylpropanolamine and its formulations for human use,*
84. Human Placental Extract and its formulations for human use except its,   
      (i) Topical application for wound healing, and  (ii) Injection for pelvic inflammatory disease (Substituted vide 

G.S.R. No. 418 (E) dt 30-5-2011 (with effect from    30-5-2011)
85. Sibutramine and its formulations for human use, and
86. R-Sibutramine and its formulations for human use. 

G.S.R. No. 218 (E) dt 16-3-2011 (with effect from 16-3-2011)
87. Gatifloxacin formulation for systemic use in human by any route including oral and injectable; and
88. Tegaserod and its formulations for human use.

G.S.R. No. 752 (E) dt 12-10-2011 (with effect from 12-10-2011)
89. Letrozole for induction of ovulation in anovulatory infertility. 

G.S.R. No. 432 (E) dt 7-6-2012 (with effect from 7-6-2012)
90. Serodiagnostic test kits for diagnosis of tuberculosis. 

G.S.R. No. 332 (E) dt 23-5-2013 (with effect from 23-5-2013)
91. Dextyropropoxyphene and formulations containing Dextropropoxyphene for human use. 

G.S.R. No. 377 (E) dt 18-6-2013 (with effect from 18-6-2013)
92. Fixed dose combination of Flupenthixol+Melitracen for human use. 

G.S.R. No. 378 (E) dt 18-6-2013 (with effect from 18-6-2013)
93. Analgin and all formulations containing Analgin for human use. 

G.S.R. No. 379 (E) dt 18-6-2013 (with effect from 18-6-2013)
94. Pioglitazone and all formulations containing Pioglitazone for human use. 

In addition to the above-mentioned drugs, manufacture and sale of all Cosmetics and all Ayurvedic Drugs licensed as toothpaste, tooth powders containing tobacco have been prohibited under G.S.R. 443 (E) and 444(E) dated 30.4.92

New DPCO 2013 - Ceiling Price List of Drugs (till date) - 51 drugs

Analgin Formulations, & Flupenthixol + Melitracen Combination

Pioglitazone Brands - 1

Pioglitazone Brands - 2

Gazzette Notification - Ban of Analgin & De-Anxit

Drugs Ban - Analgin, Pioglitazone, De-anxit

GAZETTE NOTIFICATION - PIOGLITAZONE BAN

Health ministry bans two drugs Analgin and Pioglitazone

New DPCO 2013 - Ceiling Price List of Drugs (till date)

Sale & Distribution of Dextyropropoxyphene and formulations containing Dextropropoxyphene for human use drugs with immediate effect.

Dengue

NPPA to start announcing revised prices of essential drugs as per new DPCO

Drug prices set to fall by up to 25%

ELECTION

STRIKE AND AGITATION

Protest & Strike Against including Medicines into Life Saving Drugs on May 10th 2013

STRIKE AND AGITATION ON 10TH MAY 2013

STRIKE AND AGITATION ON 10TH MAY 2013