To meet regulatory requirements, it is necessary to apply for cosmetic license, whether you are a manufacturer, importer, or distributor of beauty products. Indian cosmetic market is growing rapidly, leading to the increase in demand for skincare, haircare, makeup, and personal care products. Setting up your cosmetic business needs approval from the regulatory authority on submission of required documents while following the registration process.
This comprehensive guide explains every step of obtaining a cosmetic registration certificate in India effectively And efficiently.
What Is A Cosmetic License?
A cosmetic license is a legal document that gives businesses the permit to manufacture, import, distribute, or retail beauty products in the market. This license is issued by the State Licensing Authority & regulated by the Central Drugs Standard Control Organization in India. It ensures that beauty products meet safety, quality, and efficacy standards as defined by the Drugs and Cosmetics Act of 1940 and Rule 1945.
Who Can Apply For A Cosmetic Registration Certificate
- Manufacturer Itself (Located Outside India): A foreign cosmetic manufacturer can apply for the registration certificate directly, provided they designate an authorized agent in India.
- Authorized Indian Agent of the Manufacturer: An Indian entity or individual appointed by a foreign manufacturer can apply on their behalf. This agent must possess a valid wholesale license and a registered office in India. ELT Corporate Pvt. Ltd. frequently fulfills this role.
- Subsidiary or Registered Office of the Foreign Manufacturer in India: If the manufacturer has a branch office or wholly-owned subsidiary in India, it is eligible to apply directly.
- Importer or Distributor: An Indian importer or distributor holding the required authorization from a foreign manufacturer is also qualified to apply for the registration certificate.
Registration Process To Apply For Cosmetic License| Step-By-Step Guide
If you’re planning to import or manufacture cosmetic products in India, it’s mandatory to obtain a Cosmetic Registration Certificate (Form 43) from the Central Drugs Standard Control Organization (CDSCO). At ELT Corporate Pvt. Ltd., we provide end-to-end consultancy to help you navigate the process with ease.Â
Step 1: Identify The Type Of License Required
Depending On Your Business Activity, Select The Appropriate License:
Import License: For importing cosmetics into IndiaÂ
Manufacturing License: For manufacturing cosmetics within IndiaÂ
Step 2: Appoint An Authorized Indian Agent (For Importers)
Foreign manufacturers must appoint an Authorized Indian Agent who holds a valid wholesale license and local presence. ELT Corporate can act as your official agent in India to represent your interests.
Step 3: Prepare Required DocumentsÂ
The following documents are needed:
Application Cover Letter Power of Attorney in the prescribed formatÂ
Free Sale Certificate (FSC) from the country of originÂ
Manufacturing LicenseÂ
Product formulation and specificationsÂ
Product labels and artwork as per Rule 148Â
Product test reports and safety dataÂ
Leaflet or pack insert, if applicable
Self-declaration on non-use of banned or harmful substancesÂ
Details regarding packaging and shelf lifeÂ
Our experts assist in compiling, verifying, and organizing all necessary documents to ensure compliance.
Step 4: Register And Submit The Application Via The Sugam Portal
The application to apply for a cosmetic license must be submitted online through the CDSCO SUGAM portal using:Â
Form COS-1: For Import LicenseÂ
Relevant form: For Manufacturing License (varies by state)Â
We handle the entire registration process on your behalf, including digital signature setup and online submission.
Step 5: Pay The Government Fee
Fees are paid through the Bharatkosh portal. The structure includes:
For Import License: USD 250 per product variantÂ
For Manufacturing License: State-wise fee as applicableÂ
We provide clear instructions for hassle-free payment and referencing.
Step 6: Application Review By Cdsco
CDSCO officials review the submitted application. If any queries are raised, we coordinate directly with the department to address them promptly and accurately.
Step 7: Grant Of Registration Certificate (Form 43)
Upon successful review and approval, the CDSCO issues the Cosmetic Registration Certificate in Form 43, which remains valid for five years.
Types Of Cosmetics Registration For Certificate In India
There are mainly two types of cosmetic licenses including cosmetic manufacturing licenses and cosmetic Import licenses:
Cosmetic Manufacturing Certificate
Businesses that intend to manufacture beauty products must require a cosmetic manufacturing license. The entity can for the following manufacturing licenses, such as
- Cosmetic manufacturing license: This license is required for the manufacturing & sale of cosmetics products in their manufacturing unit.
- Cosmetic loan license: This license is a type of cosmetic manufacturing license issued under the Form 32 Drugs and Cosmetics Rule, 1945. It allows businesses to manufacture cosmetics legally in the third party’s manufacturing unit, which holds a valid manufacturing certificate for beauty products.
Cosmetic Import Registration Certificate
Cosmetic import certification is a legal document issued by the Central Drug Standard Control Organization under the Drugs & Cosmetic Rule, 1945. This license allows the entity to import beauty products legally in India for the sale and distribution of cosmetics.
This license is granted under Form 32 upon submission of the application using Form COS 1 through CDSCO’s SUGAM portal online.
Regulations To Apply For Cosmetic License
Before issuing a cosmetics manufacturing license or certifying the import of cosmetics, the licensing authority will perform a thorough inspection of the entire facility. The inspection officer will provide a detailed report to the licensing authority, which will determine whether to grant the license. Manufacturers or importers are required to adhere to the regulations listed below, as outlined in the Rules.
Qualification Criteria For Working Staff In A Cosmetic Manufacturing Unit
The manufacturers need to ensure that the production of cosmetics is done in the presence of a qualified and competent technical staff. Ensures that at least one staff person should possess the below educational requirements:
- Pharmacy Diploma approved by the Pharmacy Council of India under the Pharmacy Act, 1948
- Registered under the Pharmacy Act, 1948
- Passed intermediate examination with Chemistry as one of the subjects or any other equivalent examination recognized by the licensing authority.
Rules Concerning The Labeling Of Products
The manufacturers must comply with the following cosmetics labeling requirements:
- The product name, manufacturer’s name, and the complete address of the manufacturing premises should be clearly stated on the inner and outer labels. However, if the container is small in size, the principal place of manufacture and pin code can be provided instead of the complete address.
- The outer label must include details of the ingredients used in the product’s manufacturing process.
- The inner label should specify directions for use, existing hazards, and necessary warnings to ensure safety.
- A separate batch number preceded by the letter ‘B’ and a manufacturing license number marked with ‘M’ must be included on the label.
- The cosmetic labeling requirements as provided by the Bureau of Indian Standards (BIS) must also be followed.
Documents Required For Cosmetic Registration
Documents required to apply for cosmetic certification can vary according to the type of cosmetics licenses you want to register for, such as:
Documents Required To Apply For Cosmetic License To Manufacture Beauty Products Are:
- Declaration form
- Blueprint of key and site plan
- Proof of ownership of the manufacturing premises
- Proof of registration/constitution of the firm
- Affidavit of non-conviction of partners, proprietors, or directors under the Act
- Certified copy of the registration certificate of Pharmacy Council of India, experience certificate of the registered pharmacist or competent person, and their qualification certificates
- Bio-data form
- Affidavit of a registered pharmacist or competent person regarding full-time working with the firm duly attested by a Notary public
- Appointment letter of the registered pharmacist or competent person in charge
- Downloaded PDF of the filled application form (Form 31, 31-A, or 36)
Documents Required To Apply For Cosmetic License For Importing Cosmetic Products Are:
- Covering letter by the importer
- Original copy of power of attorney showing the connection between the importer and manufacturer
- Certificate of free sale, manufacturing license, or marketing authorization letter
- Copy of the label of the product
- Downloaded PDF filled form 42
- Schedule D III signed by the manufacturer or authorized agent
- Product specification and testing protocols
- NOC from the pollution control board
- Layout plan of the premises
- Rental agreement, in case of rented premises
- List of laboratory equipment
- List of machines installed for manufacturing, if any
How Do I Apply For A CDSCO Cosmetic License In India?
To apply for a CDSCO cosmetic license, you must register your cosmetic products on the SUGAM portal and submit required documents like Form COS-1, Free Sale Certificate (FSC), product ingredient list, and label artwork. Registration fees are required as well.
What Is The Cost Of Getting A CDSCO Cosmetic License For Imported Products?
The government fee for CDSCO registration is USD 250 per brand and USD 1,000 per variant.
How Long Does It Take to Get A CDSCO Cosmetic License In India?
The CDSCO registration process typically takes 3 to 6 months, depending on document accuracy and any additional clarifications needed by CDSCO.
Is It Mandatory To Apply For Cosmetic License To Sell Cosmetics In India?
Yes, if you are a manufacturer, importer, or distributor of beauty products then it is compulsory to obtain a relevant cosmetic license to sell cosmetics legally in India.
