India Regulatory News

On 29 July 2025, the Government of India notified the Cosmetics (Amendment) Rules, 2025, through publication in the Official Gazette. The amendments, which revise select provisions of the Cosmetics Rules, 2020, entered into force immediately on the same date. The updated rules aim to enhace regulatory clarity, streamline procedures, and strengthen oversight of cosmetic products in India.

Highlights of Key Amendments

Clarification of “Use before” and “Expiry Date”

• “Use before” now means the cosmetic must be used before the first day of the month indicated on the label.
• “Date of expiry” means the product expires on the last day of the month mentioned.

Revised Terminology

• The term “controlling officer” has been replaced with “Controlling Authority” for consistency across the rules.

Appointment of Government Analyst

• Only a Government Analyst appointed under Section 20 of the Drugs and Cosmetics Act will now be recognized as the Government Analyst for cosmetics-related assessments.

Central Cosmetics Laboratory Functions

The Central Drugs Laboratory will now function as the Central Cosmetics Laboratory for:

• Product testing and analysis.
• Appellate laboratory functions.
• Any additional roles assigned by the Central Government.

Licensing Amendments

• All mentions of the “Central Licensing Authority” in specific sub-clauses have been changed to “State Licensing Authority” for clarity.
• Records and batch data can now be maintained electronically or in hardcopy and must be retained for three years or six months after expiry, whichever is later.
• Requirements for testing and documentation do not apply to the manufacture of soap. Soap manufacturers follow procedures approved by the Licensing Authority.

License Cancellation or Suspension

• The State Licensing Authority can suspend or cancel a license for non-compliance after giving the licensee a chance to be heard.
• An appeal against suspension or cancellation must be made within 90 days to the State Government. The State Government’s decision shall be final.

Labelling Requirements for Export

• Labels on cosmetics intended for export must comply with the importing country's laws.
• If the consignee requests, the manufacturer’s name and address may be omitted on the label, replaced by an approved code number.

Other Notable Changes

• References to “courier” in relation to sample transportation have been omitted.
• Definitions for spurious and adulterated cosmetics are now aligned with Section 17D of the Act.
• The terms “license” and “licensed premises” are changed to “approval” and “approved premises” in licensing and quality control related rules.

These amendments provide greater clarity for industry, streamline regulatory procedures and reinforce consumer protection within the cosmetics sector. All stakeholders are hereby advised to ensure strict compliance with the revised provisions, especially those pertaining to record retention, licensing procedures, labelling standards, and definitions of competent authorities.