REGISTERED No. D. (D.N.)-72
The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 316] NEW DELHI, FRIDAY, AUGUST 10, 1984/SRAVANA 19, 1906 SeparatepagingisgiventothisPartinorderthatitmaybefiledasa
separate compilation
(1)
642 GI/84
2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 3 4 THE GAZETTE OF INDIA : EXTRAORDINARY t?ART tl—SEC 3(i)] 5 6 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)]MINISTRY OF HEALTH AND FAMILY WELFARL
NOTIFICATION
New Delhi, the 10th August, 1984
G.S.R. 601 KB) :—' The following draft of certain rules further to jmend the Drugs and Cosmetics Rulo, 1945,- which the Central GQvrernmcnt propose to make, after consultation with the Drugs Technical advisory Board, in excrete of the powers conferred by sections 12 and 11 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby publishe,d as re- quired by the- said- sections for the information of all persons likely' to be aOecUd thereby and notke is hereby given that the said draft rulei will be taken into consideration after the expiry of a period of ninety days from the date on which the copies of the Official Gazette jn which this notification is pub- lisho'i are made available to the public.
Any objection's °r suggestion which may be received fron} any person with respect 4o the said draft rules before the expiry of the period so specified will bo taken into cousi Jeration by the Centfal Government.
2, lti rule 96 or the Drugs and Cosmetics Rules, 1945 {hereinafter referred to as the said.rules), in sub-rule (1) in claus<; (vii) for the words, brackets and figures, "under the conditions of storage notified by the licensintf authority specified in sub- mie(l)of rule 59;" the following shall be substitute!, namely :— "under the conditions of storage specified therein. Any drug and its preparations including combination with other drills, not included in Schedule P, shall bear on its label the dale of manufacture and also the date ol'etpiry which shall not exceed sixty months from the date ol' manufacture:"
3(1) In Schedule A to the said rules;—
(i\ in Form 21. condition 3 shall be omitte-1;
(ii) in Forms 21A and.2l-B condition 2 shall be omitted,
(,1) For Schedule P to the said rules, the following Schedule
shall be substituted, namely :—
"SCHEDULE P
(See Rule 9b)
LIFE PERIOD OF DRUGS.
Sl.No. Name of the drug. Period in Conditions of sto-
months rage, (unles* otherwise specified) between date of manufacture and dale of expiry, which the labelled potency period of the drug shall not exceed, under tl le conditions of storage specified in column No. 4
3
2
±
ANTIBIOTICS
30 Ip a c ad place.
1.
36
Adrajuycin Ainpicillin
In a cool place.
Ampiullin cip=ulei
:4
i.
13
Ampicillin Dry Syrup
4.
24
5. Amptcillin Injection
36
Ampicillin Sodium
In a cool place, b.
30
7. Ampicillin TrihyJratc
In a cool place,
36
8, Amosycillin Trihydrate
In a cool place.
24
9. AmQ.fyirillin Ticihydratc Capsulci.
IK
10. Amoxycillm frihydrate Dry Syrup.
7 -> 1 3 4 4 \ . Erythromycin Estolatc 14. '24 24 tablets. Carbcnicillin Sodium Injedion. At temperature .not exceeding 5JC 60 45. In a cool place. liryth omycin Stearate 15..IS
24
46. Framycetin Sulphate
Carbenicillin Sodium Powder.
At temperature not exuding "j°C.
In a well closed container with temperature not
16
24
. Cephalxin
In a cool place.
exceeding JO C. 17.
c" In a cool place.
Chlorainphenicdl
18.
24
Framycttin Sulphate Eye dropi.
48
19.
Chlorampbenicol Capsules and Tablets. Chloramphenicol Palmitate
48
In a well closed Container with temperature not exceeding 30'C.
20.
48.
3.4
Framycetin Sulphate Ointment.
Chtoramphcnicol Palmitate Oral sus- pension.
36
21.
24
In a well closed container with temperature not exceeding 30*C.
Chlorarnpheniool Eye drops
2"1
60
Gentumycin Sulphate
In n cool place.
49,
50.
Chlorainplicnicol Sodium Succinate powder.
48 In a cool plac*.
36
Gentamycine Sulphate Injection.
23.
51,
60
52.
48
Gramicidin Griseofulvin
In H cool place. In a cool place.
Chlorampbenieol Sodium Succinct tc Injection.
36 In a cool place.
53.
36
24. Chlorietraeytline Hy- drochloriJc.
i4.
(Q In a cool place,
24
25
55,
60
-IS In a. cool place.
Griseofulvin tablets. Kanamycin Sulphate Injection. Kanamytin Acid Sul- phate Powder.
26.
56.
Chlortitracyciine Hy- drochioride capsules. Chlortetracyeline Hy- Urn.-hloride tablets.
24
Mitomycin C Neomycin Sulphate -
48 48
57.
In a cool place. In a cool place.
27. Chiortetracycline Hy- drodiloride Ointment,
36
!•!
Nystatin
58.
At temperature not ejeceedinff 5°P 28. Oo\acillin (Oral)
In a cool place.
59.
24.
2\
Oleandomycin Phos- phate sterile
In a cool place.
Cloxucillin Sodium (Injection Grade)
36
In a i:ool place.
60.
30. Calistin sulphate
WO
Piotci.tL-d from'light.
16
Oleandomycin Phos- phate nonstcrile.
In a cool place.
31.
4S
In a cool place.
61.
12.
AH
Oxytetracyclinc Hy- drochloride.
In a cool place.
4S
62.
3 V
36
Oxytetracycliric Ily- drochloride cnpstiles.
63.
D-Cycloscrlne Dimethyl Chlortetrucy- cliae Hy.lrochloriJc. Dimuihyl Chlortctiacy- cline Hyilrochloride Capsules.
36
24
Oxytetracycline Hy- drochlorii'e tablets.
36
64.
34. .15.
Oxytetracycline Hy- drochloride Injection.
24
Daunoblaslin Injection Doxycyclirif Hydro- chloride
43 In a cool place.
65.
3o.
36
Oxyteiracycline Hy- drochloride Ointment.
• Ooxycycline Minio-b Iiydr' 1.
!6
I 1 il i . i '1 pl'lc?
66. Penicillin Crystalline
36 In a cool place.
3 ,.
t
67.
18 36
6R.
Penicillin Tablets: Procainc Penicillin G
24
In a cool place. In a cool place.
1 O
48 In a cool place.
Doxycvclin.'' Ivtono- hydrnte for Oral Sus- pension. r>o\yc)i;!int Mono- hydra re rupsule.
36
69. 70.
F.rythroniycin Fstolute
CO
. 4S In a cool place.
In a LMOI place.
71.
40.
60 In a cool place.
18
Bcnzathin Penicillin G Potassium Phenoxy Methyl Penicillin. I'-vt'ssi'jin Pho!inxy Methyl Penicillin tab- lets.
41.
72,
48
Polymixin B Sulphste
In ;'. cool plncC- Erythromycip Ethylsuccinate. Erythromyfin Onii SuspensioTi
36
71.
8 THE GAZE1TE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 1 2 1 . 2 3 4 4 4 Streptomycin Injection Vitamin C 77. 48 1R. 36 Streptomycin Ointment 78. 24 Streptomycin tablets. 24In a well closed container pro- tected from light in a cool pi cc.
Streptomycin Sulphtitc
79. 80.
48 At temperature not
19, Vitamin D2, D3
36
81, Tetracycline Bi.sc.
74
eAccc^i^G *-u t.. In a c.icil pi ce.
la a well closed container pn> itxtcd from light in a cool plu.ee. 82.
48
Tetri cycline Hy- drochloride
In H cool phice.
20.
fiO
Vitamin E or E-acetate
83.
36
Tetracycline Hydro- chloride Capsulo^.
In a well closed container pro- tected frorn light in a cool place.
Tetracycline tablets
84.
24
21. Folic i'cid
r>o
TyrQthricin
85,
60 Tn a coo] pi; ce.
VITAMINS
In a well closed container pro- tected from light in a cool phec.
36
I. Vitamin A Injection
24
Folic Acid tablet'!
Vitamin K
23.
CO
/4
2. 3.
36
|n a well closed container pro- tected from light in a cool pli'ce.
4.
48
vitamin til injection. Thinmine Mononitrate- tablcts. Thiamine Hydrochlo- ride
24,
36
Vitamin K Injection
25.
60
Nifecin;itnidc
In a well closed containt-r pro- tected from light in a cor] plp.ee.
Thiaminj Mononitrf.te
5.
48
In a well closed container pro- tected from light in a cool place.
36
26, Niticinrmidc tablets
27.
60
D-Pa nthenol
In n well closed container pro- tected fiom light in d, coo] place.
60
6. Riboflavin
In n well closed container pro- tected from light in a cool pl'ce.
INSULIN PREPARATIONS
In u well closed container pro- tected from light in .i cool pbce.
24
Riboflavin 5 Phosphate
7.
1. Globulin Zinc Insulin
Injection
24
In a well closed .container pw~ tccted. from light in n cool place.
At temperature bet- ween 2° C and 8°C, must not be allowed to freeze.
36
, Riboflavin tn blots.
. 8.
2. Insulin Injection
24
24
Vitamin B2 Injection'
9.
. Vitamin B6
60
10.
Al temperature bet- ween 2° C and 8°C, must n/>t lie nllowod to freeze.
24
3. Insulin Zinc suspension
In a well closed container pro- tected from light in a cool place.
36
. Vitamin B6 tablets
11.
At temperature bet- ween 2°C and 8cr, must not be allowed to freeze.
48
, Cyanocobalnnfin
12,
4. Isophanc Insulin
24
Injection.
In ;i well closed container pro- tected from light in a cool place.
48
. HydroxycobaK mfn
13,
At temperature bet- ween 2"C und R°C, must not bo allowed to freeze.
NORMAL HUMAN PLASMA
In a well closed container pro- tected from light in a coo) pi; ce.
1. Anti-Hcemophillic
12 In >. cold pi >co.
Human Globulin.
. Vitamin B12 Injection
14
36
60
2. Dried Plasrrn
At temperature riot 15
?6
. Calcium PLittothetuiti"
exceeding ^5 C..
3. Dried Normal Human
9 1 3 4 2 1 2 3 4 6.OTHER VACCINES
1. Alum precipitated per-
60 21
7.
Liquid Normal Human Scrum Albumin, Whole Hurrnn Blood
tussis Vaccine.
18 In cold place.
la cold place. At temperature bet- ween days 4°and .
14 days In cold place.
1. BCG V;iccine 3. Cholew Vcccin
18 In cold place.
RA TOXIN AND TOXOID
12
4. DHL Vaccine (for dog)
in cold place.
SE 1 , Alum Precipitated
24 In cold place.
5. Measles Vaccine
24 In cold place.
36
6. Plague Vaccine
In cold place.
7. Polio Vaccine
24 6 3
When stored at 20°C When stored at 0 °C When stored at 4°C.
6
In cold place.
IS In cold pUce.
8. Rabies Vaccine
_v
18 fn cold place.
9. Typhoid Vaccine
24 In cold pU'ce.
10. Typhoid and Para
18 In cold place.
Typhoid Vaccine
4.
11. Typhoid Para Typhoid
Diphtheria Toxoid. Alum prccipit ited Diphthoria ..nd Teta- nus toxoid ;• nd per- tussis vaccine com- bined. Alum Precipitated TeUnus Toxoid. Aluminium Hydroxide Absorbed Diphtheria Toxoid.
24 In cold place.
18 In cold place.
A and B Vaccine
12. Typhoid Para Typhoid
,S.
18 In cold place.
A,B, and C Vaccine.
IR In cold place.
18 In cold place.
13. Typhoid Para Typhoid A.B.C and Tetanus Vaccine
6.
12 In cold place.
14. Typhus Vaccine
12 In cold place.
15. Yellow Fever Vaccine
Aluminium hydroxide Absorbed Diphtheria Totanus Toxoid and Pertussis Voccine combined. Aluminium Prmsphitc Absorbed Diphtherin Toxoid.
24 In cold place.
ANTI-TOXIN
7.
preparations)
(For serum extracted j
24 In cold plac-:.
12 Jn cold place.
20 % Excess potency
S.
24 In cold place.
30 % Bxccss potency
L, is
3 b In cold place.
40 % Excess Potency
Aluminium Phosphate absorbod Diphtheria arvl Tot mus Toxr>id. Aluminium ph^sph'Uc absorbed Diphtrwin Toxoic T<;tanu> T">VMd ind Pertussi V-^cci'ic combind.
In cold place.
18
48 Tn cold place.
50 % Excess Potency
9 . Di; p,nos tic Diphthe-
(for enzyme preparations)
12
12
In cold pl.ico.
In cold place.
5 "J Excess potency
10.
24 In cold place.
10% Excess potency
ria Toxin (SchicktesU CobrJ Veiium in Solution
3
36 In cold place.
15% Excess potency
In cold place.
48
20% Excess potency
Bctwcfi) 2"C and 5°C protected from lighi.
MISCRLLANEOUS DRUGS
]].
24 In cold pi ix.
12 In cold place.
1. Adrenaline for Injection
12.
12
Diplithor, TixtiJ In cUv LvJ Di gnostic [Jiphtfir.ri • Toxin. Liquid >:.:iTii
12
13.
In cold pUcc. Between 2"C and 10"C preferably
Years
2. Cliorionic Gonado— trophin for injection (Lyopholiscd) 3
;ot the lower
At temperature not exceeding 20°C.
limit.
24 In cold place.
3. Corticotrophin
1-1.
36 In cold place.
4. Corticotrophin Lyophiliscd
60
15.
In a cool place,
36
5. Hcparin Injection
Lyi'phili'wd 'tni-sn.ke vcti M".i sc'um. . Lyophilised, Schick Tost Toxin :nid control.
60
12 In cold place.
6. Liquid Extract of Ergot
16.
60 In cold pl.ee.
17.
7. Liver Extract Crude In-
Od Tuberculin Thrombin (Bovine origin)
24 In a cool place.
jection
24 In cold place.
8. Oxytocin Injection
In a cool place
b
9. Paraldehyde Injection
18. 19. 20.
Tot-inus Toxoid Tuberculin PPD V.iccinc Lymph
36 24 60 6 3 10 THE GAZETTE OF INDIA ; EXTRAORDINARY [PART II—SEC. 3(i)]
NOTE
1. The term "cool place" means a place having a temperature
between 10°C and 25°C,
2. The term "cold place" means a place having a temperature
not exceeding 8°C.
3. 4. 5. 6. 7. 8. 9.
G.S.R. G.S.R. G.S.R. G.S.R. G.S.R. G.S.R. G.S.R.
1243 1281 430 779 540(E) 680(E) 681(E)
dated 6-10-79 dated 12-10-79 dated 19-4-80 dated 26-7-80 dated 22-9-80 dated 5-12-80 dated 5-12-K0
3. Capsules should be kept in a well-closed container at
] 0.
temperature not exceeding 30°C.
G.S.R.
682(E) dated 5-12-80
G.S.R.
11.
27(E) dated 17-1-81
4. Wherever condition of storage is not specified in column 4, it may he stored under normal room temperatulrc."
12. G.S.R.
478(E) dated 6-8-81
13. G.S.R.
dated 15-2-82
NOTE
14. G.S.R.
62(E) 462(E) dated 22-6-82
15. G.S.R.
5 WE) dated 26-7-82
16. G.S.R.
13(E) dated 7-1-83
17. G.S.R.
318(E) dated 1-5-84
18. G.S.R.
331(6) dated 8-5-84
19. G.S.R.
460(E) dated 20-6-84
20. G.S.R.
487(E) dated 2-7-84 The Drugs and Cosmetics Rules, 1945, as amended upto 1-5-1979, is contained in the publication of thoj Ministry of Health and Family Welfare (Department of Health) containing the Drugs and Cosmetics Acts and the Rules (PDGHS-61), Subsequently the said rules have been amended by the following notifications published in part-II, section 3 (i) of the Gazette of India, namely :—
[No. X-11014/8/83-DMS & PFA]
S.V. SUBRAMANIYAN, Jt. Secy.
1. 2.
G.S.R. G.S.R.
1241 1242
dated 6-10-79 dated 6-10-79