The Ministry of Health and Family Welfare has notified the Cosmetics (Amendment) Rules, 2025, making several key changes to the Cosmetics Rules, 2020, including clarification on expiry labelling, redefining regulatory terminology, updated recordkeeping norms, and introducing a new provision for licence cancellation or suspension.
The notification, published as G.S.R. 513(E) in the Gazette of India on 29th July 2025, states:
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“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.”
One of the significant changes is the insertion of a clear definition regarding expiry labels:
“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.”
The amendment also replaces the term “controlling officer” with “Controlling Authority” across multiple rules including Rules 6, 9, and 31(2). Further, Rule 7 has been substituted entirely to clarify that:
“The Government Analyst appointed under section 20 of the Act (23 of 1940) shall be the Government Analyst for the purposes of these rules.”
A major structural change has been introduced with the insertion of Rule 31A titled “Cancellation or suspension of licence.” It empowers the State Licensing Authority to cancel or suspend a licence in case of violations, stating:
“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... cancel a licence issued under these rules or suspend it... wholly or in respect of some of the substances to which it relates.”
It also allows for an appeal:
“A licensee whose licence has been suspended or cancelled, may, within a period of ninety days... appeal to the State Government... and the order... shall be final.”
In another key compliance update, new clauses under Rule 26 mandate that:
“The licensee shall keep record of the details of each batch of cosmetic manufactured and of the raw materials used therein... and such records shall be retained for a period of three years or six months after expiry of the batch whichever is later.”
“The licensee shall test each batch or lot of the raw materials used... and also each batch of final product... and shall maintain records... retained for a period of three years or six months after expiry...”
However, these provisions exempt soap manufacturers:
“Provided that clauses (f) and (h) shall not apply to the manufacture of soap... approved by the Licensing Authority.”
Among other changes:
1. Rule 11 now designates the Central Drugs Laboratory to also serve as the Central Cosmetics Laboratory for analysis and appellate functions.
2. In cases of export, Rule 34(10) has been revised to clarify that:
“The label on package or container of cosmetic shall comply with the law of the country to which the cosmetic is to be exported... where a cosmetic is required by the consignee to be not labeled with the name and address of the manufacturer, the label... shall bear a code number as approved by the State Licensing Authority.”
Several terminologies across the rules have also been aligned—replacing “licence” with “approval,” and “licensed premises” with “approved premises,” in relevant provisions, including Rules 60, 61, and 62. Additionally, courier-based provisions in Rule 49 have been omitted.
The notification concludes:
“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.”
