Amendment in the notification… Bare Act

The source publishes this enactment as a single document rather than provision by provision, so the whole text is below and there are no per-section pages for it. Nothing has been shortened.

Type	Notification
Year	1940
Jurisdiction	Central
Ministry	Ministry of Health and Family Welfare
Status	In force as published by the source
Text	Published as one document, as the source published it
Subjects	health, social

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84. m.vr.fr, 8is(w),m^rw 9-8-94. MINISTRY OF HEALTH AND FAMILY 7 WELFARE (Department of Health) NOTIFICATION New Delhi, the 7th February, 1995 ' G.S.R. 57(E).—Whereas the Central Govern ment is satisfied that the use of certain Patent and Proprietary Oral Rehydration Salt preparations do not have therapeutic justification and are likely to involve ris^: to human beings and it is necessary and expedient to prohibit the manufacture, sale and distribution of these drugs in public interest; Now, therefore, in exercise of the powers con ferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby makes the following further amendment in the Notification of the Government of India in the Ministry of Health and Family Welfare GSR 578 <E) dated the 23rd July, 1983. In the said notification, in the table, after serial number 51 and the entries relating thereto, the following shall be inserted, namely;— "52. Patent and Proprietary Oral Rehydra tion Salts other than those conforming to the following parameters :

(a) Patent and Proprietary Oral Rehydra tion Salts on reconstitution to one litre shall contain :— Sodium—50 to 90 millimoles Total osmolality—240 to 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:—• Sodium—50 to 90 vnillimoles. Total osmolarhy—Not more 290 milli osmoles. than Precooked rice—Equivalent to not less than 50 gms and not more than 80 gms as total replacement of Dextrose.

(c) Patent and Proprietary Oral Rehydra tion Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labelled with the indication for "Adult Choleratic Diarrhoea only".

(d) Patent and Proprietary Oral Rehydra tion Salts shall not contain mono or Polysaccharides or saccharin sweeten ing agent. [No. X. 110I4[8]9-1-DMS&PFA] SHAILAJA CHANDRA, Joint Secy. Foot Note : The Principal notification was published in the Gazette of India vide GSR No. 578(E) dated 23-7-83 and subsequently amended by :—

1. GSR No. 49(E) , dated 31-1-1984.

2. GSR No. 322(E), dated 3-5-1984.

3. GSR No. 863(E), dated 22-11-1985.

4. GSR No. 700(E), dated 15-6-1988.

5. GSR No. 1057(E), dated 3-11-1988.

6. GSR No. 743(E), dated 10-8-1989.

7. GSR No. 999(E). dated 26-12-1990.

8. GSR No. 69(E), dated 11-2-1991-

9. GSR No., 304(E), dated 7-6-1991.

10. GSR No. 444(E), dated 30-4-1992.

11. GSR No. 111(E). dated 22-2-1994.

Note : The Drugs & Cosmetics Rules, 1945 as amended upto 1-5-1979 is contuined in the pub lication of the Ministry of Health & Family Wel fare (Department of Health) containing the Drugs & Cosmetics Act and the Rules (PDGHS-61) Sub sequently the said rules have been amended by the following notifications published in Part II, Section 3, Sub-section (i) of the Gazette of India, name ly : -

1. GSR 1241 dated 6-10-1979

2. GSR 1242 dated 6-10-1979

3. GSR 1243 dated 6-10-1979 http://OT.qT.fr http://TVT.fr http://OT.TT.fr http://OT.TI.f5r http://PI.fr http://PT.fr http://OT.TT.fr http://OT.vr.fr http://vr.fr THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)]

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

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29.

30.

31.

32. 33:

34.

35.

36.

37.

38.

39.

40.

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43.

44. GSR 1281 dated 12-10-1979 GSR 430 dated, 19-04-1980 GSR 779 dated 26-7-1980 GSR 540(E) dated 22-9-1980 GSR 680(E) dated 5-12-1980 GSR 631(E) dated 5-12-1980 GSR 682(E) dated 5-12-1980 GSR 27(E) dated 17-1-1981 GSR 478(E) dated 6-8-1981 GSR 62(E) dated 5-2-1982 GSR 462(E) dated 22-6-1982 GSR 510(E) dated 26-7-1982 GSR 13(E) dated 7-L-1983 GSR 318(E) dated 1-5-1984 GSR 331(E) dated 8-5-1984 GSR 460(E) dated 20-64984 GSR 487(E) dated 2-7-1984 GSR 89(E) dated 16-2-1985 GSR 788(E) dated 10-10-1985 GSR 17(E) dated 7-1-1986 GSR 1049(E) dated 29^8-1986 GSR 1060(E) dated 5-9-1986 GSR 1115(E) dated 30-9-1986 GSR 71(E) dated 30-1-1987 GSR 570(E) dated 12-6-1987 GSR 626(E) dated 2-7-1987 GSR 792(E) dated 17-9-1387 GSR 371(E) dated 24-3-1988 GSR 75(E) dated 2-6-1988; GSR 675(E) dated 2-6-1988 GSR 676(E) dated 2-6-1988 GSR 677(E) dated 2-6-1988 GSR 680(E) dated 6-6-1988 GSR 735(E) dated 24-6-1988 GSR 813(E) dated 27-7-1988 GSR 944(E) dated 2-9-1988 Corrigen dum GSR 43(E) dated 20-1-1989 Corrigen dum GSR 44(E) dated 20-1-1989 Corrigen dum GSR 100(E) dak-d 14-2-1989 Corrigen dum GSR 443(E) dated 12-4-1989 GSR 588(E) dated 2-6-1980 Corrigen dum 45,

46.

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56. 57,

58. 59

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64. 65;

66. 67, 68,

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73.

74. 75 76

77. 78 T n 79 80, 81 S2 83 84 GSR 691(E) dated 11-7-1989 GSR 784(E) dated 28-8-1989 GSR 16(E) dated I0-1-I990 GSR 731(E) dated 23-8-1990 GSR 865(E) dated 25-10-1990 GSR 11(E) dated 7-1-1991 GSR 223(E) dated 19-4-1991 GSR 246(E) dated 1-5-1991 GSR 301(E) dated 7-6-1991 GSR 302(E) dated 7-6-1991 GSR 49(E) dated 25-7-1991 GSR 495(E) dated 25-7-1991 GSR 532(E) dated 14-8-1991 GSR 626(E) dated 1-10-1991 GSR 688(E) dated 1-11-1991 GSR 730(E) dated 10-12-1991 GSR 59(E) dated 22-1-1992 GSR 305(E) dated 4-3-1992 Corrigen dum GSR 445(E) dated 30-4-1992 GSR 5 9 7 © dated 17-6-1992 GSR 663(E), dated 3-7-1992 GSR 723(E) dated 11-8-1992 GSR 796(E) dated 1-10-1992 GSR 877(E) dated 17-11-1992 GSR 904(E) dated 2-12-1992 GSR 923(E) dated 14-12-1992 GSR 27(E) dated 22-1-1993 (Corrigen dum) GSR 28(E) dated 22-1-1993 GSR 86(E) dated 26-2-1993 GSR 296(E) dated 24-3-1993 GSR 373(E) dated 13-4-1993 (Corrigen dum) GSR 374(E) dated 13-4-1993 (Corrigen dum) GSR 447(E) dated 10-6-1993 (Corrigen dum) GSR 588(E) dated 19-10-93 GSR 673(E) dated 27-10-93 GSR 108(E) dated 22-2-94 GSR 109(E) dated 22-2-94 GSR 370fE) dated 7-4-94 GSR 466(E) dated 17-5-94 GSR 615(E) dated 9-8-94. Printed by the Manager, Govt, of Iniia Press, Ring Road. Maya Puri, New Delhi-110064 and Published by the Controller of Publicntions, DeIhi-110054. 1995

Amendment in the notification regarding Prohibition of the manufacture, sale of ORS_Section

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