Ministry of Health and Family Welfare

21.08.2018

Law of Medicine

Drugs and Cosmetics (Seventh Amendment) Rules, 2018

MANU/HFAM/0114/2018

Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 763(E), dated the 10th August, 2018, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of 7 days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas, copies of the Gazette were made available to the public on the 10th August, 2018;

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

And whereas, circumstances have arisen making it necessary to publish this notification without prior consultation of the Drugs Technical Advisory Board and the consultation shall be made in accordance with section 12 and section 33 of the said Act.

Now, therefore, in exercise of the powers conferred under sections 12 and 33 of the Drugs and Cosmetics Act, 1940, the Central Government 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 (Seventh Amendment) Rules, 2018.

(2) They shall come into force on the First day of September, 2018.

2. In the Drugs and Cosmetics Rules, 1945, -

(a) In Schedule H the entry at serial number 382 relating to Oxytocin shall be omitted;

(b) In Schedule H1 at the end after entry at serial number 46 the following entry shall be inserted, namely,-

"47. Oxytocin".

Tags : Draft Amendment Rules

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