Amendment: Know About the Cosmetics (Amendment) Rules, 2025

Last Updated on August 13, 2025 by The Health Master

Cosmetics (Amendment) Rules, 2025

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) has published the Cosmetics (Amendment) Rules, 2025.

These new rules come into force immediately upon their publication in the Official Gazette on July 29, 2025.

These new rules introduce important changes to the existing Cosmetics Rules, 2020, impacting manufacturers, distributors, and consumers alike.

Key Amendments:

Clarity on “Use Before” and “Date of Expiry”

One of the notable changes provides a precise definition for “use before” and “date of expiry” on cosmetic labels.

“Use before” indicates the first day of the month mentioned.

“Date of expiry” indicates that the cosmetic expires on the last day of the month mentioned.

Controlling Authority

The term “Controlling Officer” has been replaced with “Controlling Authority.”

This replacement aims to centralize and clarify the regulatory oversight for cosmetic manufacturing and distribution.

Role of Government Analyst

The amendments clarify that the Government Analyst appointed under section 20 of the Drugs and Cosmetics Act, 1940, will serve as the Government Analyst for the purposes of these rules.

Central Cosmetics Laboratory

The Central Drugs Laboratory established under the Act shall now function as the Central Cosmetics Laboratory.

The responsibilities of the laboratory are as under:

• Testing and analysis of cosmetic samples.
• Functioning as an appellate laboratory.

Record Keeping for Manufacturers

The amended rules introduce stricter requirements for licensees regarding record-keeping with respect to the product manufacturing and raw materials.

The manufacturer now has to maintain records of each batch of cosmetics manufactured and the raw materials used, either as hard copies or through electronic means.

Furthermore, manufacturers are mandated to test each batch or lot of raw materials and each batch of the final product.

Licensees must now maintain records of each batch of cosmetic manufactured and tested and the raw materials used and tested, either as hard copies or through electronic means.

Exception for Soap Manufacturers:

The record-keeping and testing requirements (clauses (f) and (h) of rule 26) shall not apply to the manufacture of soap.

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.

License Cancellation or Suspension:

An important addition is Rule 31A, which details the process for the cancellation or suspension of a license.

Cancellation or Suspension of License:

If a licensee fails to comply with any of the conditions of license or with any provision of the Drugs and Cosmetics Act, 1940, or the rules made thereunder, the State Licensing Authority may take action as per Rule 31A, Sub-rule 1.

Before doing so, the State Licensing Authority must give the licensee an opportunity to show cause as to why an order for cancellation or suspension of the license should not be passed and also provide an opportunity to be heard.

After this process, the State Licensing Authority may, by an order in writing stating the reasons thereof, cancel a license issued under these rules or suspend it for such period as he thinks fit.

This cancellation or suspension can apply either wholly or in respect of some of the substances to which it relates.

Appeal Against Suspension or Cancellation

A licensee whose license has been suspended or cancelled has the right to appeal as per Rule 31A, Sub-rule 2.

The appeal must be made within a period of ninety days from the date of the order to the State Government.

The State Government, after considering the appeal and after giving an opportunity of being heard to the said appellant, shall pass such order as it deems fit, and this order shall be final.

Labeling for export:

For cosmetics that are to be exported, the label on the package or container of cosmetics 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 not be labeled with the name and address of the manufacturer, the label on the package or container shall bear a code number as approved by the State Licensing Authority.

Omission of “Courier” Service

The words “or by courier” shall be omitted from sub-rule (1) and sub-rule (3) of rule 49.

Scope for Spurious Cosmetics

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.

Transition from “License” to “Approval”

In rule 60, in sub-rule (1), for the words “A licence issued“, the words “An approval issued” shall be substituted.

Also, for the words “a licence retention“, the words “approval retention” shall be substituted.

In sub-rules (2) and (3) of rule 60, for the word “license,” wherever it occurs, the word “approval” shall be substituted.

In rule 61, for the words “premises licensed,” the words “approved premises” shall be substituted, and for the word “license,” the word “approval” shall be substituted.

In rule 62, in clause (e), for the words “renewal of approval,” the words “end of retention period of approval” shall be replaced.

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Compiled by:
Rakesh Dahiya, Asstt. State Drugs Controller, FDA Haryana

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