The Ministry of Health and Family Welfare has officially published the Cosmetics (Amendment) Rules, 2025, which introduce a series of changes to the existing Cosmetics Rules, 2020. These new rules were finalized after a public consultation period and are aimed at strengthening regulatory oversight and ensuring greater clarity for manufacturers, authorities, and consumers. The amendment rules come into effect from July 29, 2025.
The draft amendments were initially published on May 15, 2023, inviting objections and suggestions from stakeholders, which have now been considered by the Central Government in consultation with the Drugs Technical Advisory Board.
Key Amendments:
The rules now provide a clear explanation for the expressions “use before” and “date of expiry”. “Use before” means use before the first day of the month mentioned on the label, while “date of expiry” means the cosmetic expires on the last day of the month.
The Central Drugs Laboratory is now designated as the Central Cosmetics Laboratory. It will be responsible for analyzing and testing cosmetic samples, functioning as an appellate laboratory, and performing other duties assigned by the Central Government.
Manufacturing and Record-Keeping
Licensees must now keep records of each batch of cosmetic manufactured and the raw materials used, either in hardcopy or through electronic means. These records must be retained for a period of three years or six months after the expiry of the batch, whichever is later.
The same retention period also applies to records of tests conducted on each batch of raw materials and final products.
A significant exception is made for soap manufacturers: the rules for record-keeping and testing of raw materials for soap will be as approved by the Licensing Authority, making clauses (f) and (h) of rule 26 inapplicable to them.
Licence Cancellation and Suspension
A new rule, Rule 31A, has been inserted to formally outline the process for the cancellation or suspension of a licence. If a licensee fails to comply with any of the conditions, the State Licensing Authority may issue a show-cause notice and, after a hearing, can suspend or cancel the licence. A licensee whose licence is suspended or cancelled has the right to appeal to the State Government within ninety days.
Labeling for Export
For cosmetics meant for export, the label must comply with the laws of the destination country. If a consignee does not require the manufacturer’s name and address on the label, a code number approved by the State Licensing Authority must be used instead.
The term “controlling officer” has been replaced with the more formal and consistent term “Controlling Authority” throughout rules 6, 9, and 31.
The rules have been amended to explicitly include spurious cosmetics under section 17D alongside adulterated cosmetics, strengthening the regulatory language.
These amendments aim to improve transparency, accountability, and the overall quality control framework for cosmetic manufacturing in India.