REGD. NO. D, L.-33004/99

The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 321]

NEW DELHI, FRIDAY, JULY 12, 2002/ASADHA 21,1924

2209 GI/2002

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THE GAZETTE OF INDIA: EXTRAORDINARY

[PART H—SEC. 3(i)l

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THE GAZETTE OF INDIA: EXTRAORDINARY

[PART II—SEC. 3(ifl

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MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Indian Systems of Medicines and Homoeopathy)

NOTIFICATION

New Delhi, the 1 lth July, 2002

G4R4«fl*- THe following draft of certain rules further to amend the Drugs and

Cosmetics Rules, 1945, which the Central Government, proposes to make, in

exercise of the powers conferred by clause (a) of sub-section (1) of section 33-N

of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as

required by the said sections for the information of all persons likely to be

affected thereby and notice is hereby given that the said draft rules will be

taken into consideration after the expiry of a period of 30 days from the date on

which copies of the Official Ga**te in which this notification is published, are

made available to the public;

Objections or suggestions, if any, may be addressed to the Secretary,

Department of Indian System of Medicine and Homoeopathy, Ministry of Health

and Family Welfare, Indian Red Cross Society Building, New Delhi - 110001;

Any objection or suggestion, which may be received from any person with

respect to the said draft rules within the period specified above will be taken

into consideration by the Central Government.

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DRAFT RULES

(1) These rules may be called the Drugs and Cosmetics (

Amendment)

Rules, 2002.

(2) They shall come into force on the date of final publication in the Official

Gazette.

(3) In the Drugs and Cosmetics Rules, 1945 in Rule 160 B{c) after the last

word "Standards" of the paragraph, the following shall be inserted:

"List of equipment recommended is given below".

Chemistry Section

1.

Alcohol determination apparatus complete set.

2.

Volatile oil determination apparatus.

3.

Boiling point determination apparatus.

4.

Melting point determination apparatus.

5.

Refractometer.

6.

Polarimeter.

7.

Viscometer (ostwalds, Redwood viscometer).

8.

Tablet disintegration apparatus;

9.

Moisture determination apparatus (IC filtrator).

10.

U.V. Spectro-Photometer.

11.

Muffle furnace.

12.

Electronic Balance.

13.

Hot air oven(s) different range of temperature/vacuum oven.

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THE GAZETTE OF INDIA: EXTRAORDINARY

[PART II—SEC. 3(i)]

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Refrigerator.

15.

Glass distillation apparatus.

16.

Water supply demineralised exchange equipment.

17.

Air conditioner for sophisticated equipment.

18.

LPG-Gas Cylinder with burners.

19.

Water bath (temperature controlled).

20.

Heating mantle (4).

21.

TLC apparatus with all accessories.

22.

Sieves 10 to 120 with sieve shaker.

23.

Centrifuge machine.

24.

Dehumidifier.

25.

PH meter.

26.

Microphotography scope.

27.

G.L.C. with P.I. detector.

28.

Platinum crucible.

29.

Electrophoresis.

30.

Tablet hardness tester.

31.

Tablet friability tester.

32.

Tablet dissolution tester.

33.

Other related equipment, reagents, chemicals and glasswares.

"Instruments like HPLC, HPTLC, Atomic Absorption spectrophotometer could be

arranged by tie up with other laboratories.

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Pharmacognosy Section

1.

Microscope binocular

2.

Dissecting Microscope

3.

Microtome

4.

Chemical balance

5.

Microslide cabinet

6.

Aluminium slide trays

7.

Hot air oven

8.

Occular Micrometer.

9.

Stage micrometer.

10.

Camera Lucida Prism type and mirror type.

11.

Hotplates.

12.

Refrigerator.

13.

LPG Cylinder with burners.

14.

Other related equipments, reagents, glasswares etc.

Microbiology Section

1.

Laminar air flow bench (L.A.F.)

2.

B.O.D. Incubator.

3.

Plain incubator.

4.

Serological water bath.

5.

Oven.

6.

Autoclave/Sterilizer.

7.

Microscope (high power).

8.

Colony counter.

9.

Other related equipment and reagents.

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THE GAZETTE OF INDIA: EXTRAORDINARY

[PART II—Sue. 3(Q]

(4) In Rule 160 E:

(i)

the words "or designated" shall be added after the word "appointed";

(ii)

the words and figure "under Section 33-G^M shall be omitted;

(iii)

the words "for this purpose" shall be added after the words "State

Government".

(No.K. 11020/3/2000-DCC(ISM)]

L. PRASAD, Jt. Secy.

Footnote :The Drags and Cosmetics Rules, 1945, as amended upto 1-5-1979 are contained in the publication of the

Ministry of Health and Family Welfare (Department of Health) containing the Drugs and Cosmetics Act, 1940 and the "!

Rules (PDGHS-61) and last amended vide GSR 423(E), dated 12-6-2002.

Printed by the Manager, Govt. of India Press, Ring Road, Mayapuri, New Delhi-110064

and Published by the Controller of Publications, Delhi-110054.