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, which came into 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 rules have streamlined and clarified the regulatory requirements for the import, manufacture, and distribution of cosmetics in India. They also place 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, or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

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. Applications are submitted via Form COS-6, and the loan license is issued in Form COS-9.

2.2.1 Conditions for Obtaining a Manufacturing License

To obtain a manufacturing license for cosmetics, companies must fulfill a set of conditions, including company registration, submission of necessary documents, fee payment, and adherence to specific health, safety, and environmental standards. Below are some of the key criteria for safety and quality assurance outlined in the 2020 Rules:

• Personnel Requirements: Manufacturers must ensure that competent and qualified technical staff are on hand throughout the production process, and at least one of those staff members is a full-time employee and possess one of the following qualifications:

1. Holding a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948, or

2. Be registered under the Pharmacy Act, 1948, or

3. Having passed the Intermediate Examination with Chemistry as one of the subjects, or an examination recognized by the Licensing Authority as equivalent to it.

4. Holding a bachelor’s degree in Cosmetic Technology from recognized university.

• Factory premises: The factory premises shall comply with the GMP guidelines. This includes ensuring a clean, safe, and well-maintained production environment.

• Laboratory facilities: Manufacturers shall provide and maintain adequate staff, premises, and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture. Alternatively, they can arrange for testing at an institution approved by the Central Licensing Authority and accredited by the National Accreditation Board for Testing & Calibration Laboratories (NABL).

2.2.2 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 through the SLA's 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 compliance with Good Manufacturing Practices (GMP). If compliance is unsatisfactory, the license may be canceled. If deficiencies can be rectified, the SLA will instruct the license holder to halt manufacturing until corrections are made. If the SLA does not inspect within 30 days, the license is deemed valid for all purposes.

2.2.3 Validity of Manufacturing License

The manufacturing license is valid for five years and can be renewed. License holders must pay a retention fee before the expiration date to maintain validity. If the fee is not paid on time, a late fee of 2% per month (or part thereof) will apply, for up to 180 days. Failure to pay during this period will result in the license being canceled.

2.2.4 Application Dossiers

The following documents or information are required for obtaining a cosmetic manufacturing license:

2.2.5 Application Fees

2.3 Cosmetic Import Registration

The import of cosmetics into India is regulated through a system of registration 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 Cosmetic Classification

Currently, imported cosmetics in India are classified into approximately 80 product families based on intended use and application areas, including skin products, hair and scalp products, nail and cuticle products, and oral hygiene products. 

2.3.2 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 subsidiary of the manufacturer, or any other importer.

2.3.3 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. Proper classification is critical as it dictates the regulatory requirements, applicable standards, documentation, and government fees for cosmetic registration. 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. The Indian agent serves as a liaison between the manufacturer and the CDSCO, assisting with document submission and ensuring compliance with regulatory requirements. The authorization from the foreign manufacturer should be duly authenticated by a first-class Magistrate in India, the Indian Embassy in the country of origin, or an equivalent authority through apostille.

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 multiple cosmetic products from the same manufacturer if they are produced in the same factory (or multiple factories working conjointly). However, if the applicant seeks to import the same brand belonging to different manufacturers, separate applications must be submitted for each, along with the respective fees.

4. Review and Certificate Granting: Once the application and required documents are submitted, CDSCO initiates a review process to examine the documents submitted and the information provided in the application form. During the review, CDSCO may request additional information or clarifications from the manufacturer or the Indian agent. The import registration certificate is granted in Form COS-2 if the application satisfies all requirements. If not, the application is rejected. This process is typically completed within six months from the date of application submission.

2.3.4 Application Dossiers

To apply for a cosmetic import registration certificate, applicants are required to submit a comprehensive set of documents, as listed below. 

2.3.5 Application Fees

2.3.6 Prohibition of Import and Exemption from Import Registration

Certain cosmetic products are prohibited from being imported into India, while others may be exempt from the import registration requirements. It is essential for companies to evaluate their products carefully to avoid violations of import regulations.

2.3.7 Validity of Import Registration Certificate

The Import Registration Certificate issued by CDSCO is valid for five years and can be renewed unless it is suspended or canceled by CDSCO. To maintain the certificate’s validity, the retention fee must be paid before expiration.

In cases where the retention fee is not paid on time, a late fee of 2% per month (or part thereof) will be charged for up to 180 days. Failure to pay within this grace period will result in the cancellation of the certificate.

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.

2.4.1 Required Application Documents

Applicants seeking secondary import registration must provide the following documents:

1. Covering Letter

2. Application in Form COS-4 “Application for Issue of Import Registration Number for Import of Already Registered Cosmetics”.

3. Undertaking as per Sixth Schedule of the 2020 Rules, for the import of cosmetics to be submitted by the importer with application form for IRN.

4. Details of IEC and GSTIN (enclose copy).

5. Copy/Image of Label of the Product showing name of manufacturer and list of Ingredients. 

2.4.2 Validity and Conditions

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. 

Below are the conditions of the IRN oulined in Form COS-4A:

1. This Import Registration Number shall be produced by the importer as and when required by the Licensing Authority or regulatory authority.

2. The importer shall inform to the Licensing Authority forthwith in the event of any administrative action taken namely, market withdrawal, deletion of product from the original Registration Certificate holder's or any regulatory restrictions of any cosmetics pertaining to this registration.

3. The importer shall provide the statement of details of cosmetics imported by them annually to the Central Licensing Authority.

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

3.1.1 General Labeling Requirements

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.

• For Domestically Manufactured Cosmetics

The 2020 Rules stipulate both the mandatory labeling items and their positions. All cosmetics manufactured in India must clearly and prominently display the following information on the label. If a product has only one label, all required labeling information (from both the outer and inner labels) must appear on that single label.

• For Imported Cosmetics

In addition to the above requirements, the following additional information must be displayed on the label of imported cosmetics:

1. Name and address of the importer or import registration certificate holder

2. Import registration certificate number, preceded by letter “RC”, “RC No.”, “Reg. Cert. No.”

3. If the importer prefers not to disclose the manufacturing site, a simple “Made in … (Country)” label suffices.

4. In cases where the manufacturing license number is not required by the country of origin, it is not mandatory to include this information on the label.

3.1.2 Special Labeling Provisions for Certain Cosmetics

In addition to the general labeling requirements outlined in the previous section, certain cosmetics in India require additional warnings and information due to potential safety risks.

Besides, the Ninth Schedule of the 2020 Rules specifies mandatory BIS standards that apply to 37 types of cosmetics, including skin powders, creams, hair oils, shampoos, soaps, lipsticks, and foundations. If there are labeling and packaging requirements in any of these standards, compliance is mandatory for both domestic and 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. 

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.