Notification, 2015

Text

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EXTRAORDINARY

PUBLISHED BY AUTHORITY

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 17th July, 2015

G.S.R. 558(E).—Whereas certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published vide notification of the Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare vide number

G.S.R. 503(E), dated the 14 th July, 2014, as required by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a period of forty-five days from the date on which the copies of the Official Gazette of the said notification were made available to the public;

And whereas copies of the Gazette were made available to the public on the 14 th July, 2014;

And, whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:—

1. (1) These rules may be called the Drugs and Cosmetics (Sixth Amendment) Rules, 2015.

(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 rule 105, in sub-rule (2),

(i) in the second proviso, for the words “Provided also that”, the words “Provided further that” shall be substituted;

(ii) in the third proviso, for the words “Provided further that”, the words “Provided also that” shall be substituted;

(iii) after the third proviso, the following proviso shall be inserted namely:— “Provided also that Diclofenac injection for human use shall be in single unit dose pack only.” ;

Note.- The principal rules were published in the Gazette of India, vide notification No. F.28-10/45-H (1), dated the 21 st December, 1945 and last amended vide notification published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide

G.S.R. 390 (E), dated the 18 th May, 2015.

Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

Provisions this notification answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Drugs and Cosmetics Act, 1940