Notification, 2018

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 1st June, 2018

G.S.R. 521(E).—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. 1367(E), dated the 3 rd November, 2017, 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 thirty 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 3 rd November, 2017;

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 under sections 12 and 33 of the Drugs and Cosmetics Act, 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, 2018.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Drugs and Cosmetics Rules, 1945 (hereinafter to be referred as the said rules), in rule 36, in the second proviso, in clause (iii), after the word, figures and letter “Form 12 B”, the words “requiring the permit holder to give details of drugs imported and utilised on yearly basis” shall be inserted.

3. In the said rules, in Schedule A, in Form 12B, in paragraph 3, for the words “for a period of six months”, the words “till such time as the patient requires the drug as per the prescription of a registered medical practitioner and the permit holder shall submit details of drugs imported and utilised to the licensing authority on yearly basis” shall be substituted.

SUDHIR KUMAR, Jt. Secy.

Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H(1), dated the 21st December, 1945 and was last amended vide notification number

G.S.R. 408(E), dated the 26th April, 2018. and Published by the Controller of Publications, Delhi-110054.

ALOK KUMAR

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