Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-31072025-265135
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 470]
NEW DELHI, TUESDAY, JULY 29, 2025/SHRAVANA 7, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 29th July, 2025
G.S.R. 513(E).—Whereas a draft of certain rules to amend the Cosmetics Rules, 2020 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. 371 (E), dated the 15th May, 2023, published in the Gazette of India,
Extraordinary, Part II, Section 3, sub-section (i), dated the 17th May, 2023, 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 the said Official Gazette were made available to the public on the 17th May, 2023;
And whereas, objections and suggestions received from the public on the said draft rules have been
considered by the Central Government;
Now, therefore, in exercise of the powers conferred by section 12 and section 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 to amend the Cosmetics Rules, 2020, namely:-
1. Short title and commencement.- (1) These rules may be called the Cosmetics (Amendment) Rules, 2025.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Cosmetics Rules, 2020 (hereinafter referred to as the said rules), in rule 3, in clause (w), the following
explanation shall be inserted, namely:-
"Explanation:-For the purposes of this clause, the expression“use before” means, use before the first day
of a month mentioned on label and the expression "date of expiry" mean the cosmetic expires on the
last day of the month.".
3. In the said rules, in rule 6, for the words "controlling officer"at both the places, where they occur, the words
"Controlling Authority" shall be substituted.
4. In the said rules, for rule 7, the following rule shall be substituted, namely:-
"7. Government Analyst:- The Government Analyst appointed under section 20 of the Act (23 of 1940) shall be
the Government Analyst for the purposes of these rules."
5. In the said rules, in rule 9, for the words “controlling officer", wherever they occur, the words "Controlling
Authority" shall be substituted.
6. In the said rules, in rule 11, for the heading and sub-rule (1), the following heading and sub-rule shall respectively
be substituted, namely:-
"11. Central Cosmetics Laboratory and its function.- (1) The Central Drugs Laboratory established under
the Act shall function as the Central Cosmetics Laboratory for the purposes of,
(a) analysing or testing such samples of cosmetics as may be sent to it under sub- section (2) of section 11
or under sub-section (4) of section 25 of the Act; or
(b) functioning as an appellate laboratory; or
(c) carrying out any other function as may be specifically assigned to it by the Central Government."
7. In the said rules, in rule 26,-
(i) in clause (c), in sub-clause (ii), for the words ‘Central Licensing Authority', the words "State Licensing
Authority" shall be substituted;
(ii) for clause (f), the following clause shall be substituted, namely:-
"(f) The licensee shall keep record of the details of each batch of cosmetic manufactured and of the
raw materials used therein as per the particulars specified in the Eighth Schedule either as hardcopy
or through electronic means and such records shall be retained for a period of three years or six
months after expiry of the batch whichever is later.";
(iii) for clause (h), the following clause shall be substituted, namely:-
"(h) The licensee shall test each batch or lot of the raw materials used for manufacturing the
cosmetics and also each batch of final product and shall maintain records or registers, showing the
particulars in respect of such tests and the records or registers either as hardcopy or through
electronic means shall be retained for a period of three years or six months after expiry of the batch
whichever is later.";
(iv) in clause (m), for the proviso, the following proviso shall be substituted, namely:-
"Provided that clauses (f) and (h) shall not apply to the manufacture of soap and the procedure for
testing of raw materials and the records to be maintained by a manufacturer of soap shall be such as
are approved by the Licensing Authority.".
8. In the said rules, in rule 31, in sub-rule (2), for the words “Controlling officer", the words "Controlling Authority"
shall be substituted.
9. In the said rules, after rule 31, the following rule shall be inserted, namely:-
"31A. Cancellation or suspension of licence.- (1) If a licensee fails to comply with any of the conditions
of license or with any provision of the Act or the rules made thereunder, the State Licensing Authority
may, after giving the licensee an opportunity to show cause as to why an order for cancellation or
suspension of license should not be passed and after giving an opportunity of being heard, by an order in
writing, stating the reasons thereof, cancel a licence issued under these rules or suspend it for such period
as he thinks fit, either wholly or in respect of some of the substances to which it relates.
(2) A licensee whose licence has been suspended or cancelled, may, within a period of ninety days from
the date of the order, appeal to the State Government which shall, after considering the appeal and after
giving an opportunity of being heard to the said appellant for hearing, pass such order as it deems fit which
shall be final".
10. In the said rules, in rule 34, for sub-rule (10), the following sub-rule shall be substituted,
namely:-
"(10) In case, the cosmetic is meant for export, then the label on package or container of cosmetic shall
comply with the law of the country to which the cosmetic is to be exported:
Provided that where a cosmetic is required by the consignee to be not labeled with the name and
address of the manufacturer, the label on package or container shall bear a code number as approved by
the State Licensing Authority.".
11. In the said rules, in rule 49, -
(i) in sub-rule (1), the words "or by courier" shall be omitted;
(ii) in sub-rule (3), the words "or courier" shall be omitted.
12. In the said rules, in rule 53, in sub-rule (2), for the words "or adulterated cosmetic", the words
"or spurious cosmetics under section 17D or adulterated cosmetic" shall be substituted.
13. In the said rules, in rule 60,-
(i) in sub-rule (1), (a) for the words "A licence issued", the words "An approval issued" shall be substituted;
(b) for the words “a licence retention", the words "approval retention" shall be substituted;
(ii) in sub-rules (2) and (3), for the word "licence", wherever it occurs, the word "approval" shall be
substituted.
14. In the said rules, in rule 61,-
(i) for the words “premises licensed", the words “approved premises” shall be substituted;
(ii) for the word "licence”, the word "approval"shall be substituted.
15. In the said rules, in rule 62, in clause (e), for the words "renewal of approval", the words "end of retention period
of approval shall be substituted.
16. In the said rules, in rule 63, for the word "Part", the word "Chapter"shall be substituted.
17. In the said rules, in rule 69, in sub-rule (2), for the words "Central Licensing Authority", the words "Licensing
Authority'shall be substituted.
18. In the said rules, in First Schedule, in paragraph (6), for the words "withdraw of this Power of Attorney", the
word "withdrawal of authorisation" shall be substituted.
[F. No. X.11014/16/2021-DR]
RAJIV WADHAWAN, Advisor (Cost)
Note: The principal rules were published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) vide
notification number G.S.R.763 (E), dated the 15th December, 2020.
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. GORAKHA NATH YADAVA
Digitally signed by GORAKHA NATH
Date: 2025.07.31 16:17:52 +05'30'