Drugs and Cosmetics Rules 1945

1
[SCHEDULE P

[See Rule 96]

LIFE PERIOD OF DRUGS

Sl. Name of the drug Period in months (unless Condition of storage

No. otherwise specified)
between date of
manufacture and date of
expiry which the labelled
potency period of the drug
shall not exceed under the
conditions of storage
specified in Column No.4

1 2 3 4

ANTIBIOTICS
1. Adramycin 30 In a cool place
2. Ampicillin 36 In a cool place
3. Ampicillin Capsules 24
4. Ampicillin Dry Syrup 24
5. Ampicillin Injection 24
6. Ampicillin Sodium 36 In a cool place
7. Ampicillin Trihydrate 30 In a cool place
8. Amoxycillin Trihydrate 36 In a cool place
9 Amoxycillin Trihydrate Capsules 24
10. Amoxycillin Trihydrate Dry Syrup 18
11. Bacitracin 18 In a cool place
12. Bacitracin or Zinc Bacitracin Tablets 12
13. Bacitracin Lozenges 12
14. Carbenicillin Sodium Injection 24 At temperature not
Exceeding 5°C
15. Carbenicillin Sodium Powder 24 At temperature not
Exceeding 5°C
16. Cephalexin 24 In a cool place
17. Chloramphenicol 60 In a cool place
18. Chloramphenicol Capsules & Tablets 48
19. Chloramphenicol Palmitate 48
20. Chloramphenicol Palmitate Oral Suspension 36
21. Chloramphenicol Eye drops 24
22. Chloramphenicol Sodium Succinate Powder 48 In a cool palace
23. Chloramphenicol Sodium Succinate Injection 36 In a cool place
24 Chlortetracycline Hydrochloride 60 In a cool place
25. Chlortetracycline Hydrochloride Capsules 60
26. Chlortetracycline Hydrochloride Tablets 24
27. Chlortetracycline Hydrochloride Ointment 24
28. Cloxacillin (Oral) 36 In a cool place
29. Cloxacillin Sodium (Injection Grade) 36 In a cool place

1. Subs. by G.S.R. 17(E) , dt. 7.1.1986 ( w.e.f. 7.1.1986 ).

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 Drugs and Cosmetics Rules 1945

1 2 3 4
30. Colistin Sulphate 60 Protected from light
31. D-Cycloserine 48 In a cool place
32. Dimethyl Chlortetracycline Hydrochloride 48
33. Dimethyl Chlortetracycline Hydrochloride Capsules 36
34. Daunoblastin Injection. 36
35. Doxycycline Hydrochloride 48 In a cool place
36. Doxcycline Monohydrate 36 In a cool place
37. Doxycyline Monohydrate for Oral Suspension. 24
38. Doxycycline Monohydrate Capsules. 36
39. Erythromycin Estolate 36 In a cool place
40. Erythromycin Ethylsuccinate 60 In a cool place
41. Erythromycin Oral Suspension 36
42. Erythromycin Estolate for Oral Suspension 36
43. Erythromycin Ethyl Succinate Tablet 24
44. Erythromycin Estolate Tablets 24
45. Erythromycin Stearate 36 In a cool place
46. Framycetin Sulphate 48 In a well closed container
with temperature not
exceeding 30°C
47. Framycetin Sulphate Eye drops 24 In a well closed container
with temperature not
exceeding 30°C
48. Framycetin Sulphate Ointment 24 In a well closed container
with temperature not
exceeding 30°C
49. Gentamycin Sulphate 60 In a cool place.
50. Gentamycin Sulphate Injection 36
51. Gramicidin 60 In a cool place
52. Griseofulvin 48 In a cool place
53. Griseofulvin Tablets 36
54. Kanamycin Sulphate Injection. 24
55. Kanamycin Acid Sulphate Powder 48 In a cool place
56. Mitomycin C 48 In a cool place
57. Neomycin Sulphate. 48 In a cool place
58. Nystatin 36 At temperature not exceeding
5°C
59. Oleandomycin Phosphate sterile 24 In a cool place
60. Oleandomycin Phosphate non sterile 36 In a cool place
61. Oxytetracline Hydrochloride 36 In a cool place
62. Oxytetracycline Hydrochloride Capsules. 36
63. Oxytetracycline Hydrochloride Tablets 24
64. Oxytetracycline Hydrochloride Injection 24
65. Oxytetracycline Hydrochloride Ointment 36
66. Penicillin Crystalline 36 In a cool place
67. Penicillin Tablets 18 In a cool place
68. Procaine Penicillin G 36 In a cool place

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 Drugs and Cosmetics Rules 1945

1 2 3 4

69. Benzathin Penicillin G 48

70. Potassium Phenoxy Methyl Penicillin 48 InIna acool
coolplace
place
71. Potassium Phenoxy Methyl PenicillinTablets 24
72. Polymixin B Sulphate 48 In a cool place
73. Polymixin B Sulphate Ointment or Powder 24 In a cool place
74. Rifampicin 36 In a cool place
1
[75 Rifampicin Capsules 36]
76. Spramycin Base 24 In a cool place
77. Strepromycin Injection. 36
78. Streptomycin Ointment 24
79. Streptomycin Tablets 24
80. Streptomycin Sulphate 48 At temperature not exceeding 20oC
81. Tetracycline Base 24 In a cool place
82. Tetracycline Hydrochloride 36 In a cool place
83. Tetracycline Hydrochloride Capsules 36
84. Tetracycline Tablets 24
85. Tyrothricin 60 In a cool place.

VITAMINS
1. Vitamin A Injection 24
2. Vitamin B1 Injection 24
3. Thiamine Mononitrate Tablets 36
4. Thiamine Hydrochloride 48 In a well closed container, protected
from light, in a cool place.
5. Thiamine Mononitrate 48 In a well closed container, protected
from light, in a cool place.
6. Riboflavin 60 In a well closed container, protected
from light, in a cool place.
7. Riboflavin-5-Phosphate 24 In a well closed container, protected
from light, in a cool place.
8. Riboflavin Tablets 36
9. Vitamin B2 Injection 24
10. Vitamin B6 60 In a well closed container, protected
from light, in a cool place.
11. Vitamin B6 tablets 36
12. Cyanacobalamin 48 In a well closed container, protected
from light, in a cool place.
13. Hydroxycobalamin 48 In a well closed container, protected
from light, in a cool place.
14. Vitamin B12 Injection 36
15. Calcium Pantothenate 36 In a well closed container, protected
from light, in a cool place.
16. Vitamin C Injection 24
17. Calcium Pantothenate Tablets 36
2
18. Vitamin C 48 In a well closed container, protected
from light, in a cool place.

1. Subs. by G.S.R. 250(E), dt. 4.4.2002

2. Subs. by G.S.R. 626(E), dt. 14.10.1991

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 Drugs and Cosmetics Rules 1945

1 2 3 4
19. Vitamin D2 D3 36 In a well closed container, protected from
light, in a cool place.
20. Vitamin E or E-Acetate 60 In a well closed container, protected from
light, in a cool place.
21. Folic Acid 60 In a well closed container, protected from
light, in a cool place.
22. Folic Acid Tablets 36
23. Vitamin K 60 In a well closed container, protected from
light, in a cool place.
24. Vitamin K Injection 36
25. Niacinamide 60 In a well closed container, protected from
light, in a cool place.
26. Niacinamide Tablets 36
27. D-Panthenol 60 In a well closed container, protected from
light, in a cool place.
INSULIN PREPARATIONS
1. Globuline Zinc Insulin Injection 24 At temperature between 2oC and 8oC,
must not be allowed to freeze.
2. Insulin Injection 24 At temperature between 2oC and 8oC,
must not be allowed to freeze.
3. Insulin Zinc Suspension 24 At temperature between 2oC and 8oC,
must not be allowed to freeze.
4. Isophane Insulin Injection. 24 At temperature between 2oC and 8oC,
must not be allowed to freeze.
1
[5. Human Insulin Injection 30 At temperature between 2oC and 8oC,
must not be allowed to freeze.

NORMAL HUMAN PLASMA

1. Anti-Haemophillic Human Globulin 12 In a cool place

2. Dried Plasma 60 At a temperature not exceeding
25oC
3. Dried Normal Human Serum Albumin 60 At a temperature not exceeding
25oC
4. Frozen Plasma 60 In deep freeze
5. Liquid Plasma 24 In cold place
6. Liquid Normal Human Serum Albumin. 60 In cold place.
2
[7. Whole Human Blood-

(a) Collected in ACD solution 21days At temperature between 4oC and

6oC
(b) Collection in CPDA solution. 35days At temperature between 4oC and
6oC]

1. Subs. by G.S.R. 626(E) , dt. 14.10.1991.

2. Subs. by G.S.R. 626(E) , dt. 14.10.1991.

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 Drugs and Cosmetics Rules 1945

SERA TOXIN AND TOXOID

1. Alum Precipitated Diphtheria Toxoid 24 In cold place.

2. Alum Precipitated Diphtheria and
Tetanus toxoid and Pertusis vaccine combined 18 In cold place

3. Alum Precipitated Tetanus Toxoid 24 In a cold place

4. Aluminium Hydroxide 24 In a cold place.
Absorbed Diphtheria Toxoid
5. Aluminium Hydroxide Absorbed 18 In a cold place
Diphtheria Tetanus Toxoid and Pertussis
Vaccine combined.
6. Aluminium Phosphate Absorbed Diphtheria 24 In a cold place.
Toxoid.
7. Aluminium Phosphate absorbed 24 In a cold place.
Diphtheria and Tetanus Toxoid
8. Aluminium phosphate absorbed diphtheria 18 In cold place
Toxoid Tetanus Toxoid and
Pertussis vaccine combined.
9. Diagnostic Diphtheira Toxin (Schick Test) 12 In cold place
10. Cobra venom in solution 3 Between 2oC and 5oC protected
from light.
11. Diphtheria Toxoid 24 In cold place
12. Inactivted Diagnostic Diphtheria Toxin. 12 In cold place o
13. Liquid serum 12 Between 2oC and 10 C preferable
at the lower limit.
14. Lyophilised anti-snake venom serum 60
15. Lyophilised Schick test Toxin and control 60
16 Old Tuberculin 60 In cold place
17. Thrombin (Bovine origin) 36 In cold place.
1[ 18. Tetanus Toxoid 36 In cold place]
19. uberculin PPD 60 In cold place

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 Drugs and Cosmetics Rules 1945

OTHER VACCINES

1. Alum precipitatd pertussis Vaccine. 18 In cold place

2
[2. BCG Vaccine 24 In cold place]
3. Cholera Vaccine 18 In cold place
4. DHL Vaccine (for dog) 12 In cold place
5. Measles Vaccine 24 In cold place
6. Plague Vaccine 36 In cold place
7. Polio Vaccine 24 When stored at minus 20oC
6 When stored at Zero oC
3 When stored at 4 oC
8. Rabies vaccine 6 In cold place
9. Typhoid vaccine 18 In cold place
10. Typhoid and Para Typhoid Vaccine. 18 In cold place

11. Typhoid Para Typhoid A and B vaccine. 18 In cold place

1. Subs. by G.S.R. 26(E) , dt. 19.01.2006.

2. Subs. by G.S.R. 174(E) , dt. 16.03.2005.

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 Drugs and Cosmetics Rules 1945

1 2 3 4
12. Typhoid Para Typhoid A,B & C Vaccine 18 In cold place
13. Typhoid Para Typhoid A, B & C and 18 In cold place
Tetanus Vaccine.
14. Typhus vaccine 12 In cold place
15. Yellow Fever Vaccine 12 In cold place

1 [16. Anti-Rabies Vaccine (Cell Culture) 24 In cold place.]

ANTITOXIN

(For serum extracted preparations)

20% Excess potency 12 In cold place
30% Excess potency 24 In cold place
40% Excess potency 36 In cold place
50% Excess potency (for enzyme preparations) 48 In cold place
5% Excess potency 12 In cold place
10% Excess potency 24 In cold place
15% Excess potency 36 In cold place
20% Excess Potency 48 In cold place
MISCELLANEOUS DRUGS
2
[1. Andrenaline for Injection 12 [As prescribed in Indian Pharmacopoeia]
2. Chorionic Gonadotrophin for 36 At temperature not exceeding 20oC .
Injection (Lyophilised)
3. Corticotrophin 24 In cold place
4. Corticotrophin Lyophilised 36 In cold place
5. Heparin Injection 36 In a cool place.
6. Liquid Extract of Ergot 12 In cold place
7. Liver Extract Crude Injection 24 In a cool place
8. Oxytocin Injection 24 In cold place
9. Paraldehyde Injection 6 In cool place protected from light.
10. Pituitary Injection 24 In cold place.
11. Vasopressin Injection 24 In cold place.

Note : (1) The term ―cool place‖ means place having a temperature between 10oC and 25oC.
(2) The term ―cold place‖ means a place having a temperature not exceeding 8 oC.
(3) Capsules should be kept in a well-closed container at temperature not exceeding 30 o C.
(4) Wherever condition of storage is not specified in Column 4, it may be stored under normal room
temperature.]

1. Ins. by G.S.R. 215(E) , dt. 19. 3. 1999.

2. Subs. by G.S.R. 174(E) , dt. 16. 3.2005.

538