Executive Summary:
This document publishes draft rules to amend the Drugs and Cosmetics Rules, 1945, regarding cosmetics. The Central Government proposes these amendments after consulting with the Drugs Technical Advisory Board. The public has forty-five days from the date the draft rules are available in the Official Gazette to submit objections or suggestions to the Ministry of Health and Family Welfare.
Key Points / Main Content:
* **Amendment Title and Effective Date:**
* These rules are called the Drugs and Cosmetics Fourth Amendment Rules, 2014.
* They will come into force on the date of their final publication in the Official Gazette.
* **Amendment to the Drugs and Cosmetics Rules, 1945:**
* After rule 135A, rule 135B is inserted.
* **Rule 135B: Import of Cosmetics Tested on Animals Prohibited:**
* No cosmetic tested on animals shall be imported.
Impact Analysis:
* **Cosmetics Importers:**
* Impact: Prohibited from importing cosmetics tested on animals.
* Action Required: Ensure that imported cosmetics have not been tested on animals.
* **Ministry of Health and Family Welfare:**
* Impact: Responsible for considering objections and suggestions regarding the draft rules.
* Action Required: Review and address objections/suggestions received from the public within the specified period.
* **General Public:**
* Impact: Affected by the new regulations on imported cosmetics.
* Action Required: Submit objections and suggestions regarding the draft rules to the Ministry of Health and Family Welfare within forty-five days of the rules being available in the Official Gazette.
Key Entities Referenced
Drugs and Cosmetics Rules, 1945: A set of rules related to drugs and cosmetics, which are being amended by the current notification.
Drugs and Cosmetics Act, 1940: An act of the Indian parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics. Section 12 and 33 of this act confer powers to the Central Government.
Drugs Technical Advisory Board: A board consulted by the Central Government in making amendments to the Drugs and Cosmetics Rules, 1945.
Ministry of Health and Family Welfare: The Indian government ministry to which objections and suggestions regarding the draft rules should be addressed.
Nirman Bhawan, New Delhi-110011: The location of the Ministry of Health and Family Welfare.
Drugs and Cosmetics Fourth Amendment Rules, 2014: The name of the rules that are being proposed.
Arun K. Panda: Joint Secretary in the Government of India.
Delhi: Place of publication of gazette.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 5th May, 2014
G.S.R.311(E).— The following draft rules further to amend the Drugs and Cosmetics
Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred
by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation
with the Drugs Technical Advisory Board, is hereby published for the information of all persons
likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into
consideration on or after the expiry of a period of forty-five days from the date on which the copies
of the Official Gazette containing these draft rules are made available to the public;
Objections and suggestions, if any, may be addressed to the Secretary, Ministry of Health
and Family Welfare, Government of India, Nirman Bhawan, New Delhi-110011.
The objections and suggestions which may be received from any person with respect to the
said draft rules within the period specified above, shall be considered by the Central Government;
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (Fourth Amendment) Rules, 2014.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, after rule 135-A, the following rule shall be
inserted, namely:—
“135-B. Import of cosmetics tested on animals prohibited.— No cosmetic tested on
animals shall be imported.”.
[No. X-11014/11 /2013-DFQC]
ARUN K. PANDA Jt. Secy.
Note: The principal rules were published in the Gazette of India vide notification No. F.28-10/45-H (1)
dated the 21st December, 1945 and last amended by notification published in the Gazette of India,
Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 153(E), dated the 5th March, 2014.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.