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(iii)

FT: iJJJT PI^H

THE GAZETTE OF INDIA: EXTRAORDINARY

[PART n—SEC. 3(i)]

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MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTmCATION

New Delhi, the 4th April, 2002

C.S.R. 248(E).—The following draft of certain rules further to amend the Drags and Cosmetics Rules, 1945, which

the Central Government proposes to make, after consultation with the Drugs Technical Advisory Board, in exercise of the,

powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as

required by the said sections for the information of all person's 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 forty-five days from the date on which the

copies of the Official Gazette in which this notification is published, are made available to the public;

Objections or suggestions, if any, may be addressed to the Secretary, Ministry of Health and Family Welfare,

Government of India, Nirman Bhavan, New Delhi-110011;

Any objection or suggestion which may be received from any person with respect to the said draft rules before the

expiry of the period as specified above will be taken into consideration by the Central Government

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 their publication in the Official Gazette.

2. In the Drugs and Cosmetics Rules, 1945, in Schedule K,—

(i)

in item number 5A, under the column "Extent and Conditions of Exemption' after entry number (3), the

following shall be inserted, namely:—

"(4). The Drugs shall be purchased from a manufacturer or a dealer licensed under these rules or

received as transferred stocks from hospital stores for distribution. Records of such purchases or

receipts shall be maintained."

(ii)

in item number 15, under the column 'Class of Drugs', after entry number (3), the following shall tje

inserted, namely :—

"(4).

Desogestrel

0.150mg.

Ethinyloestradiol

0.030mg.

(5)

Levonorgestrcl

01 meg.

Ethinyloestradiol

• 0.02 mg."

(iii)

after item number 3 0 and the entries relating thereto, the following shall be inserted, namely :—

"31. First Aid kit supplied alongwith motor The provisions of Chapter IV of the Act and rules made

vehicle by the manufacturer or its distri-

thereunder which require them to be covered by a sale

butor at the time of first sale of vehicle.

licence, subject to the condition that the drug items are

procured from a dealer licensed under the rules."

[F. No.X 11014/14/2001-DMS &PFA]

DEEPAK GUPTA, Jt. Secy.

Foot Note: The Principal Rules were published in the Official Gazette vide notification No. F. 28-10/45-H(l)

dated21-12-1945andlastamendcdvideG.S.R 909 (E) dated 20-12-2001.

Printed by the Manager. Oovt. of India Preis, Ring Road, Miyapuri, Now Delhi-110064

and Published by the Controller of Publication*, Delhi-110054.