The cosmetics industry in India is growing remarkably due to various factors, including increased consumer awareness, expanding disposable incomes, exposure to global trends through digital platforms, and others. In 2025, the industry’s revenue is estimated to reach US$6.90 billion. There is a forecast for this evolving sector to reach USD 3.17 billion by 2030
The industry in India is regulated by the Drugs and Cosmetics Act, 1940, and Rules, 1945, and Cosmetics Rules, 2020, enforced by the Central Drugs Standard Control Organisation (CDSCO). Key regulations include product registration for imports and manufacturing, compliance with Good Manufacturing Practices, restrictions on harmful materials like lead and mercury, and specific labelling requirements under the Legal Metrology (Packaged Commodity) Rules, 2011.
The Ministry of Health and Family Welfare (MoH&FW) issued the Cosmetics (Amendment) Rules, 2025. The amended rules aim to provide clarification on labelling, redefining regulatory terminology, updating record-keeping norms, and introducing a new provision for license cancellation or suspension.
The following changes have been made through the amended rules:
- Clarification of definitions- The amendment clarifies the meaning of “use before” and “expiry date” under Rule 3(w). Going forward:
- “Use before” implies the first day of the mentioned month.
- “Date of expiry” implies the last day of that month.
- Change in terminology- What may appear to be minor adjustments in terminology are, in fact, critical to ensuring legal clarity and consistency. The amendment replaces the term “Controlling Officer” with “Controlling Authority” at various places in Rules 6, 9, 31. Additionally, the amendment updates the terminology in Rules 60 to 62, which govern the recognition and oversight of testing institutions for cosmetics. By replacing the term “licence” with “approval,” the amendment clarifies that such entities are not subject to the same licensing regime as cosmetic manufacturers. This change brings greater administrative precision and avoids confusion between manufacturing licences and regulatory approvals granted to testing laboratories.
- Recordkeeping and Batch Traceability: A revision of Rule 26 demands licensees to maintain batch-wise records of both raw materials and final products for a period of three years or six months beyond expiry, whichever is longer.
Records may be in hardcopy or electronic format. Notably, the amendment carves out an exemption for soap manufacturers, who may follow separate procedures approved by the licensing authority.
- Centralisation with Defined Roles: Under the substituted Rule 11, the Central Drugs Laboratory is officially designated to act as the Central Cosmetics Laboratory, empowered to:
- Analyse and test samples under the Act,
- Function as an appellate testing authority, and
- Perform any specific function assigned by the Central Government.
- Licensing as a Tool of Enforcement: The newly inserted Rule 31A empowers the State Licensing Authority to suspend or cancel a cosmetic licence for non-compliance with licence conditions or the Act, following due process. A show-cause notice and an opportunity to be heard are mandatory.
The order must be reasoned and issued in writing. Licensees may appeal such decisions to the State Government within 90 days from the date of the order.
- Facilitating Export, Without Sacrificing Accountability: Rule 34(10) is amended to allow cosmetic products meant for export to carry labeling that complies with the law of the importing country. Where the consignee requires omission of the manufacturer’s name and address, the container may bear a state-approved code number instead.
- Other Notable Changes
Rule 53, which deals with the disposal of confiscated cosmetics, has been amended to specifically include references to spurious cosmetics as defined under Section 17D of the Drugs and Cosmetics Act, 1940. This ensures that enforcement authorities have a clear statutory basis to seize and destroy counterfeit cosmetic products in addition to adulterated ones, thereby strengthening regulatory action against fraudulent goods.
Separately, Rule 49 has been amended to remove references to sample dispatch via courier services. While the rule does not state a reason, the omission appears intended to encourage the use of more secure and traceable methods for transporting official cosmetic samples such as hand delivery by authorised personnel or regulated logistics providers to preserve a chain of custody and evidentiary integrity.
A comparison of the changes made:
| Area | What Changed in 2025 | Implications |
| Enforcement Power | New Rule 31A empowers State Licensing Authorities (SLAs) to suspend or cancel licenses without central approval. | Regulatory action can now be swift and local, increasing compliance pressure. |
| Definition of ‘Use Before’ and ‘Expiry’ | Clarified that “use before” means the first day of the month and “expiry” is the last day of the month. | Avoids ambiguity in labeling, especially for exports. |
| Digital Compliance | Records for batch testing and raw materials can now be maintained in digital or hard copy format, retained for 3 years or 6 months post-expiry, whichever is later. | Push toward digital documentation to reduce paperwork and ensure traceability. |
| Labeling for Exports | Export cosmetics need not bear manufacturer name/address if consignee requests, but must carry code number approved by SLA. | Eases export barriers, especially for contract manufacturers or white-label producers. |
| Government Analyst & Laboratory Oversight | Clarified definitions and centralized lab designation to Central Drugs Laboratory. | Reduces duplication in authority, but raises the bar for analytical standards. |
What benefits can the different stakeholders of the cosmetics industry derive from these changes?
- Enhanced Consumer Safety- The amendments clarify terms like to ensure consumers understand product shelf life. The rules require manufacturers to maintain records of each batch of cosmetics, including raw materials and testing data, either in hard copy or electronically. The Central Drugs Laboratory, established under the Drugs and Cosmetics Act, 1940, is designated as the Central Cosmetics Laboratory, streamlining testing processes and ensuring quality control. This may ensure Good Manufacturing Practices and prohibit the manufacturing and circulation of counterfeit or subpar drugs and cosmetics in the market.
- Improved Regulatory Clarity and Efficiency- The amendments simplify licensing procedures and clarify the roles of regulatory authorities, making it easier for businesses to comply with the regulations. They aim to align India’s cosmetic regulations with international standards, facilitating trade and promoting consumer confidence.
- Addressing Industry Needs- Licensees are given the option to maintain records in either hard copy or electronic format, providing flexibility in compliance. The amendments provide a recourse for appeal to state authorities against license suspension or cancellation, ensuring fairness and transparency.
In essence, the Cosmetics (Amendment) Rules, 2025 are profound efforts by the government to modernise and strengthen the regulatory framework for cosmetics. The rules promise an effectively regulated cosmetics industry and bring standardised products to the market by promoting safety, transparency, and efficiency.
