MANU/HFAM/0114/2018

Ministry : Ministry of Health and Family Welfare

Department/Board : Health and Family Welfare

Notification No. : GSR795(E)

Date of Notification : 21.08.2018

Date of Publication : 21.08.2018

Notification/ Circulars Referred : Number G.S.R. 763(E), dated the 10th August, 2018 MANU/HFAM/0109/2018;Notification number G.S.R. 602(E), dated the 29th June, 2018 MANU/HFAM/0082/2018

Industry: Health Care

Citing Reference:
Number G.S.R. 763(E), dated the 10th August, 2018 MANU/HFAM/0109/2018  Referred

Notification number G.S.R. 602(E), dated the 29th June, 2018 MANU/HFAM/0082/2018  Referred

Drugs and Cosmetics (Seventh Amendment) Rules, 2018

G.S.R.795(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. 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".

[F. No. X.-11014/3/2018-DR]
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. 602(E), dated the 29th June, 2018.