Executive Summary:
This notification announces amendments to the Drugs and Cosmetics Rules, 1945, as per the Drugs and Cosmetics Act, 1940. These amendments are enacted by the Central Government after consulting the Drugs Technical Advisory Board, following a period of public review where no objections were received. The amendments are effective from the date of publication in the Official Gazette.
Key Points / Main Content:
Amendments to the Drugs and Cosmetics Rules, 1945:
* These rules are called the Drugs and Cosmetics Sixth Amendment Rules, 2019.
* The rules come into force on the date of their publication in the Official Gazette.
* In rule 96, in subrule 1, in clause i, in subclause A, the words in brackets shall be omitted.
Impact Analysis:
Central Government:
* Impact: Responsible for enacting and implementing the amendments to the Drugs and Cosmetics Rules, 1945.
* Action Required: Ensure the amendments are published in the Official Gazette and enforced.
Drugs Technical Advisory Board:
* Impact: Consulted by the Central Government in making the amendments.
* Action Required: Provide guidance and recommendations to the Central Government regarding the implementation of the amended rules.
Stakeholders Affected by the Drugs and Cosmetics Rules:
* Impact: Must comply with the amended Drugs and Cosmetics Rules, 1945.
* Action Required: Review and understand the amendments to the rules, specifically regarding rule 96, subrule 1, clause i, subclause A, and ensure compliance.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, amended by this notification.
Drugs and Cosmetics Act, 1940: An act governing drugs and cosmetics, under which the rules are framed and amended.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare policies.
Department of Health and Family Welfare: A department within the Ministry of Health and Family Welfare.
New Delhi: The location of the notification, likely the capital of India.
Drugs Technical Advisory Board: A board consulted by the Central Government for amending the Drugs and Cosmetics Rules.
Drugs and Cosmetics Sixth Amendment Rules, 2019: The title of the amendment rules introduced by this notification.
Sudhir Kumar: Joint Secretary in govt
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[फा. स.ं ए5स . 11014/3/2019 –डीआर]
सधु ीर कुमार, संयु5त सिचव
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 8th March, 2019
G.S.R. 205(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. 88(E), dated the 4th February, 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 fifteen 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 5th February, 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 (Sixth Amendment) Rules, 2019.
(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 96, in sub-rule (1), in clause (i), in sub-clause (A), the words
“in brackets” shall be omitted.
[F. No.X.11014/3/2019-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 last amended vide notification number G.S.R. 186(E), dated the 6th March, 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.