Executive Summary:
This notification from the Ministry of Health and Family Welfare announces amendments to the Drugs and Cosmetics Rules, 1945. The amendments follow a draft publication on March 11, 2019, with a period for public feedback, and come into force on the date of publication in the Official Gazette (September 13, 2019). No objections were received, leading to the finalization of these amendments.
Key Points / Main Content:
Amendments to the Drugs and Cosmetics Rules, 1945:
* These rules are called the Drugs and Cosmetics Twelfth Amendment Rules, 2019.
* The rules come into force on the date of their publication in the Official Gazette.
* In rule 43A, after the words "Mundra Port in Gujarat," the words "and Inland Container Depot Dhannad, Indore in Madhya Pradesh" shall be inserted.
Impact Analysis:
Stakeholders: Manufacturers, distributors, importers, and regulatory bodies involved with drugs and cosmetics.
Impact: The inclusion of "Inland Container Depot Dhannad, Indore in Madhya Pradesh" in rule 43A affects the import/export and regulatory oversight related to these locations.
Action Required: Stakeholders need to note the inclusion of the new depot and ensure compliance with the updated regulations for imports/exports through this location.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics. It is the principal legislation governing these areas in India.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
Drugs Technical Advisory Board: A statutory body constituted by the Government of India to advise on technical matters related to drugs and cosmetics.
Drugs and Cosmetics Twelfth Amendment Rules, 2019: The title of the amendment rules being introduced.
Mundra Port, Gujarat: A port located in the state of Gujarat, India.
Inland Container Depot Dhannad, Indore, Madhya Pradesh: An inland container depot located in Indore, Madhya Pradesh, India.
New Delhi: The location where the notification was issued.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 13th September, 2019
G.S.R. 653(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,
1945 was published as required under sub-section (1) of section 12 and sub-section (1) of section 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. 214(E), dated the
11th March, 2019, 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 forty-five 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 Official Gazette were made available to the public on the 12th March, 2019;
And whereas, no objections or suggestions were received from the public on the said rules for
consideration by the Central Government;
Now, therefore, in exercise of the powers conferred under sections 12 and 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 (Twelfth Amendment) Rules, 2019.
(2) They shall come into force on the date of their publication in the Official Gazette.
In the Drugs and Cosmetics Rules, 1945, in rule 43A, after the words “Mundra Port in Gujarat”, the
words “and Inland Container Depot Dhannad, Indore in Madhya Pradesh” shall be inserted.
[F. No. X.11014/5/2019-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H (1),
dated 21st the December, 1945 and last amended vide notification number G.S.R. 499(E),
dated the 17th July, 2019.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.