India Cosmetic Regulation

For decades, cosmetics in India were regulated under Drugs and Cosmetics Act 1940 and the Drug and Cosmetics Rules 1945. However, these rules, especially the latter, primarily focused on pharmaceuticals, with limited provisions for cosmetics. To establish a more comprehensive and modernized regulatory framework specifically for cosmetics, India launched a regulatory reform, introducing the Cosmetics Rules 2020 on December 15, 2020 with immediate effect.

Under the updated framework, cosmetics are now governed by the Drugs and Cosmetics Act 1940, the Cosmetics Rules 2020, and other supporting regulations. The new regulatory framework streamlines and clarifies the regulatory requirements for the import, manufacture, and distribution of cosmetics in India, and places greater accountability on importers and manufacturers to ensure the quality of their products. Additionally, the digitalization of regulatory processes is expected to increase efficiency, making the application process smoother and less time-consuming for industry stakeholders.

Part 1 Regulatory Framework and Competent Authority

1.1 Existing Main Cosmetic Regulations

1.2 Competent Authority

In India, the oversight of cosmetics involves multiple authorities at both the central and state levels. The primary national regulatory body is the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare (MoHFW). The Drugs Controller General of India (DCGI) heads the CDSCO and serves as the Central Licensing Authority, responsible for amending the 2020 Rules, granting Import Registration Certificates, and regulating cosmetic imports into India, among other duties.

At the state level, State Licensing Authorities (SLAs) are responsible for implementing the 1940 Act and 2020 Rules, issuing manufacturing licenses, conducting inspections, and monitoring regulatory compliance within their respective jurisdictions.

In addition, the Bureau of Indian Standards (BIS), although not a dedicated cosmetics authority, plays a key role by setting standards for various products, including certain cosmetic categories. While BIS establishes these standards, the responsibility for enforcement and regulation remains primarily with the CDSCO.

Part 2 Cosmetic Products

2.1 Definition

According to the 1940 Act, cosmetics in India are defined as any article intended to be rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Articles intended for use as a component of cosmetic are also included in the scope of cosmetics.

2.2 Manufacturing of Cosmetics in India

The manufacture of cosmetics is regulated under a system of inspection and licensing by respective State Licensing Authority (SLA) appointed by State Governments. The SLA ensures that cosmetic manufacturers meet all regulatory requirements for their products.

Any individual or company intending to manufacture cosmetics in India must obtain a valid manufacturing license from the respective SLA. Depending on the circumstances, the entity can apply for one of the following types of manufacturing licenses:

• License (i.e., Own Manufacturing License): This license is granted to individuals or companies having their own manufacturing facilities. The application for the license is filed using Form COS-5, and the license is issued in Form COS-8.

• Loan License: This option is available to manufacturers without their own manufacturing facilities, allowing them to use premises owned by others to produce cosmetics. Applications are submitted via Form COS-6, and the loan license is issued in Form COS-9.

2.2.1 Application Process

The procedure for obtaining a cosmetic manufacturing license for the first time is as follows:

• Application Submission: Applicants must submit the manufacturing license application (Form COS-5 for own facilities or Form COS-6 for loan licenses) and required documents to the SLA via an identified online portal. If the portal is unavailable, applications can be submitted offline at the SLA office. If cosmetics are manufactured at more than one premises, a separate application and license are required for each manufacturing premise.

• Review and License Issuance: After all documents are submitted, the SLA will scrutinize the application. license (Form COS-8) or loan license (Form COS-9) will be granted, or the application may be rejected if incomplete, within 45 days from the application date.

• Uploading of License Online: Upon receiving the license, the applicant shall upload a copy of such license to the CDSCO website for transparency and public record. Once uploaded, the manufacturer may commence production.

• Site Inspection: Within 30 days of license issuance, the SLA may inspect the manufacturing premises to verify the information in the submitted GMP self-certificate (Form COS-7). If the self-certificate contains false information, the licence may be cancelled. If correctable deficiencies are identified, the SLA will direct the licensee to stop manufacturing until the issues are resolved. If the SLA does not conduct the inspection within 30 days, the licence is considered valid for all purposes.

2.2.2 Validity of Manufacturing License

The cosmetic manufacturing licence or loan licence remains valid permanently, as long as the retention fee is paid every five years. If the licensee does not pay the retention fee on time, they may still pay it within 180 days, but a late fee of 2% per month will apply. If the fee is not paid within this 180-day grace period, the licence is deemed canceled.

2.2.3 Application Fees

2.3 Cosmetic Import Registration

The import of cosmetics into India is regulated through a registration system by the CDSCO following the 1940 Act and the 2020 Rules. Any article that falls within the definition of cosmetics and is manufactured at a foreign site must be registered before being imported.

2.3.1 Eligible Applicants

The eligible applicant for the registration of a cosmetic product intended for import into India can be the manufacturer himself, the authorized agent of the manufacturer, the India subsidiary of the manufacturer, or the importer in India.

2.3.2 Initial Registration Application Process

For first-time registrations of imported cosmetics, the following steps apply:

1. Determining the Cosmetic Categories: The applicant must first identify the specific category under which the final product and its variants fall. Variants refer to product variations such as colors, shades, flavors, or fragrances, but do not include differences in pack sizes. The CDSCO has provided a list of approximately 80 categories for the classification of imported cosmetic products in India.

2. Appointing an Indian Agent (For Foreign Manufacturers): For a foreign manufacturer, it shall be necessary to appoint an authorized agent in India to acts on his behalf in matters related to approvals, registration, and importation of cosmetics.

3. Application and Document Submission: In the next step, the appointed Indian agents shall submit the import registration application in Form COS-1 along with necessary documents through the SUGAM Portal of CDSCO. A single application can cover the import of one or more cosmetic products from the same manufacturer if they are produced in a single factory or in multiple factories operating conjointly as one manufacturing unit. However, if the applicant seeks to import the same brand belonging to different manufacturers, he needs to submit separate application for each manufacturer and must pay separate fees.

4. Review and Certificate Granting: After receiving the application and required documents, the CDSCO reviews the submission. If satisfied, it issues the import registration certificate in Form COS-2; otherwise, it may reject the application, providing written reasons. This decision must be made within six months from the date of application.

2.3.3 Application Fees

2.3.4 Validity of Import Registration Certificate

The cosmetic import registration certificate remains valid permanently, provided the retention fee is paid every five years. If the fee is not paid on time, a late fee of 2% per month applies for up to 180 days. If the fee is still not paid within this period, the registration certificate is deemed canceled.

2.4 Secondary Import Registration

Under the 2020 Rules, cosmetics manufactured overseas and already registered for import and sale in India can be imported by any individual or entity through a secondary registration process. This involves submitting an application via the SUGAM Portal using Form COS-4. Along with the necessary documentation, an undertaking specific to the importation of the registered cosmetic product must be provided. The CDSCO reviews the application and may either grant the Import Registration Number (IRN) in Form COS-4A, titled "Import Registration Number for Import of Already Registered Cosmetics into India," or reject the application, providing reasons for the decision within six months from the date of submission.

Once issued, the IRN is valid for three years from the date of issuance, unless it is suspended or canceled due to non-compliance with regulatory conditions. Holders of the IRN are obligated to adhere to all conditions set forth in Form COS-4A and submit an annual statement to the CDSCO, detailing the cosmetics imported during the year. This statement shall include the number of consignments or bill of entries of each consignment, the quantity and total cost of imported cosmetics per consignment, and warehouse details where the products are stored for further distribution and sale, etc. 

2.5 New Cosmetics’ Manufacture and Import

The 2020 Rules introduced the concept of "new cosmetics," which referw to products containing a novel ingredient that has either never been used in cosmetics worldwide or is not recognized for cosmetic use in any national or international literature.

The manufacture and import of such new cosmetics require prior permission from the Central CDSCO. Applicants must apply using Form COS-12, submit necessary data regarding the product’s safety and efficacy, and pay a fee of $500 for the grant of permission. Once this permission is granted (in Form COS-3), applicants can proceed with applying for a manufacturing license and import registration.

The safety evaluation of new cosmetics shall be conducted by the manufacturer in line with the IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics, ensuring that the product meets all safety and regulatory requirements before entering the market.

2.6 Animal Testing Ban

India has taken significant steps to promote animal welfare in the cosmetics industry, officially banning the import of animal-tested cosmetics and the testing of cosmetics on animals within the country as of 2014. These prohibitions are outlined in the 2020 Rules nd include the following mandates:

• No cosmetic tested on animals after November 12, 2014, can be imported into India.

• No individual or entity may use animals for testing cosmetics.

During the import registration or manufacturing license application process, applicants must submit a self-declaration confirming that their cosmetic products, including individual ingredients, have not been tested on animals. This declaration must be signed and stamped, and submitted to the CDSCO or the SLA along with the other required documents.  Additionally, during the clearance of cosmetic consignments at Indian ports, an undertaking issued from the manufacturer confirming non-animal testing is required for submission to the concerned port office.

Violations of the animal testing ban can result in penalties under the 1940 Act, including imprisonment for up to three years, a fine of up to INR 5,000, or both (only applies to non-compliant imports).

Part 3 Cosmetic Labeling and Claims

Cosmetic labeling and packaging in India are regulated by the 2020 Rules, the Legal Metrology (Packaged Commodities) Rules, 2011, and the BIS standards. All cosmetic products, whether manufactured domestically or imported, must follow these labeling requirements before being placed on the Indian market.

3.1 Labeling

Cosmetic products typically feature two types of labels: the outer label (the wrapper or box visible to consumers on shelves) and the inner label (attached to the immediate packaging or container). In some cases, there may also be a leaflet providing instructions or additional information.

The 2020 Rules stipulate both the mandatory labeling items and their positions. All cosmetics in India must clearly and prominently display the following information on the label. If a cosmetic package has only a single label, it must include all information required for both the inner and outer labels.

• Product name

• Name and address of the manufacturer

• Use Before or Expiry Date

• Batch number

• Manufacturing license number

• Net Content

• List of Ingredients (using INCI names)

• Directions for use and applicable warnings, where required

• Import registration certificate number and the name and address of the importer (for imported cosmetics)

3.2 Claims

India does not yet have dedicated regulations specifically addressing cosmetic efficacy claims, only the 2020 Rules contains a few relevant provisions on this matter:

• Prohibition against false or misleading claims: No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.

• New Cosmetic Claims: For new cosmetics, supporting data justifying the claimed benefits must be available to substantiate the product's effects. Additionally, no claims beyond those permitted may be made on the product label without the prior approval of the CDSCO.

Part 4 Cosmetic Ingredient Lists

The safety of cosmetic ingredients in India is governed by stringent regulations aimed at ensuring the safety of the products. For both domestically manufactured and imported cosmetic products, compliance with the standards set by the Bureau of Indian Standards (BIS) and the 2020 Rules is mandatory.

4.1 BIS Standards

As per the BIS's IS 4707 standards, cosmetic ingredients in India are broadly classified into two categories: Generally Recognized as Safe (GRAS) and Generally Not Recognized as Safe (GNRAS). Under the standards, there are five listings of cosmetic ingredients designated, namely prohibited substances, restricted substances, permitted preservatives, colorants, and sunscreens, as shown in the table below. 

Notes: On August 21, 2025, the Bureau of Indian Standards (BIS) announced significant revisions to Indian Standard IS 4707 (Part 2): 2017, which sets out the list of substances generally not recognized as safe (GNRAS) for use in cosmetics—excluding dyes, colors, and pigments. These revisions led to the publication of IS 4707 (Part 2): 2025 – List of GNRAS and Restricted Ingredients (Fifth Revision), alongside a new companion standard, IS 4707 (Part 3): 2025 – List of Preservatives Allowed in Cosmetics with Restrictions. Both standards became publicly available on September 3, 2025. For a detailed discussion of the latest amendments, please refer to Indian Standard IS 4707 Part 2: A Comparative Analysis of the 2017 and 2025 Editions.

4.2 Individual ingredient prohibitions/restrictions

Moreover, India also prohibits or restricts the manufacture and importation of any cosmetic products containing certain harmful ingredients like hexachlorophene, lead, arsenic, or mercury compounds, as directed by the 2020 Rules.

• Hexachlorophene: Prohibited for use in cosmetics, except in soaps where it may be utilized in concentrations not exceeding 1% weight by weight. A cautionary note must be prominently displayed on the wrapper of the packaging of each soap containing hexachlorophene, namely “Contains Hexachlorophene – not to be used on babies”.

• Lead and arsenic compounds: Prohibited for use in coloring cosmetics

• Heavy Metals Limits: Refer to the Cosme-list for the limits of heavy metals in cosmetics in India.

Further Reading

• India’s Cosmetic Ingredient Regulations: A Practical Guide for Market Entry

• Indian Standard IS 4707 Part 2: A Comparative Analysis of the 2017 and 2025 Editions 

• India Plans to Introduce a New Drugs, Medical Devices and Cosmetics Act

• India Publishes 2025 Amendments to the Cosmetics Rules 2020

• India Finalizes Rules for Compounding of Offences under the Drugs and Cosmetics Act

• India Considers Mandatory BIS Certification for Cosmetics