5th August, 2025

The Ministry of Health and Family Welfare has issued G.S.R. 513(E) dated 29th July 2025, announcing pivotal amendments to the Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940. These changes aim to strengthen the regulatory framework by bringing more clarity to labelling requirements, tightening documentation norms, and reinforcing licensing protocols.

Below is a concise summary of the key amendments:

  1. Clear Definitions for “Use Before” and “Expiry Date” – Rule 3(w)

To eliminate ambiguity in product labelling, the following definitions have been introduced:

  • “Use before”: Refers to usage before the “first day of the month” mentioned on the label.
  • “Expiry date”: Indicates the product expires “on the last day of the month” mentioned.

đź’ˇ This clarification aligns Indian labelling standards with international norms and ensures consistency across the industry.

  1. Enhanced Recordkeeping Protocols – Amendments to Rule 26

Clause (f): Batch and Raw Material Records

  • Licensees must maintain detailed records of each cosmetic batch and associated raw materials, as per the Eighth Schedule.
  • Records can be maintained in physical or electronic form.
  • Records must be retained for 3 years or 6 months after the batch expiry, whichever is later.

Clause (h): Batch Testing Records

  • Each batch of raw materials and final product must undergo mandatory testing.
  • Test data must be recorded in registers or electronic systems.
  • Records must be retained for 3 years or 6 months after the batch expiry, whichever is later.

Clause (m): Exemption for Soap Manufacturers

  • Provisions under clauses (f) and (h) do not apply to soaps.
  • Soap manufacturers must follow procedures approved by the Licensing Authority.
  1. Rule 31A – Cancellation or Suspension of Licence

A new provision empowers regulatory authorities to act decisively in cases of non-compliance:

  • If a licensee fails to meet licence conditions or regulatory provisions, the State Licensing Authority may suspend or cancel the licence—either in full or for specific products.
  • Before any action:
    • The licensee must be given a chance to respond (show cause).
    • A hearing opportunity must be provided.
  • The final decision must be:
    • Documented in writing, with reasons clearly stated.
  • The licensee may appeal the decision to the State Government within 90 days.
  1. Export-Specific Labelling – Revised Rule 34(10)

For cosmetics intended for export:

  • Labels must comply with the laws of the destination country.
  • If requested by the consignee, the manufacturer’s name and address may be omitted, provided:
    • A code number approved by the State Licensing Authority is included on the package.

🧳 This supports traceability while offering flexibility in international trade labelling standards.

  1. Additional Noteworthy Amendments
  • Terminology Refined: “Controlling Officer” has been replaced with “Controlling Authority” in multiple sections.
  • Rule 7 – Government Analyst Defined: Clearly designates the Government Analyst under the Drugs and Cosmetics Act as the official authority for cosmetic testing.
  • Rule 11 – Central Laboratory’s Role Specified: The Central Drugs Laboratory will serve as the Central Cosmetics Laboratory for product analysis, appeals, and other designated responsibilities.
  • Licensing Terminology Updated: The term “Licence” has been replaced with “Approval” in Rules 60–63, reflecting a more streamlined and modern administrative framework.

For More Detail Kindly Refer to the Official Letter.

🔍 Why These Amendments Matter

  • âś… Transparency: Labelling definitions are now crystal-clear for both regulators and consumers.
  • âś… Compliance-Driven: Stringent recordkeeping and testing requirements protect public health.
  • âś… Enforcement Power: Rule 31A equips state authorities with the legal tools to handle non-compliance efficiently.
  • âś… Global Competitiveness: Export-oriented labelling rules enhance flexibility for Indian manufacturers in international markets.

 

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