What is CDSCO?
Under the rules of the Drugs and Cosmetics Act, 1940, the Drugs Controller General (India) serves as the Central Licensing Authority, granting the Import Registration Certificate and regulating the import of cosmetics into India by Gazette notification G.S.R 763(E).
What is CDSCO Cosmetic Registration
The Cosmetic Registration is a certificate issued by the Central Drugs Standard Control Organization (CDSCO). The registration certificate is an essential document for businesses and individuals in the cosmetic industry. It provides information about the product’s ingredients, manufacturing process, and safety data. It is mandatory to have this document when selling or importing cosmetics in India.
In case you are planning to import cosmetics into India, you must register with CDSCO. This registration can be done by following these steps:
- File an application form with CDSCO along with details such as your contact information, product description, and manufacturing process.
- Wait for your application to be approved by CDSCO and receive your certificate of registration within three months of filing your application form
Form 42 For Import Of Cosmetics
The import of cosmetics is regulated under the Drugs and Cosmetic Act. The Act defines “cosmetic” as a substance or mixture intended to be rubbed, poured, sprinkled or sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.
The import of cosmetics requires prior approval from the Drug Controller General of India (DCGI). One can apply for an import license by submitting Form 42 along with other documents required for the import license application. Under the Drugs and Cosmetics Rules, Form-42 is an application for the granting of a Registration Certificate for the Import of Cosmetics into India. It is used for claiming exemption from customs duty on the import of goods. The importer has to submit Form 42 along with the original invoice and packing list while making entry at the customs office. The original invoice should be issued by the manufacturer or exporter located outside India.
What is the purpose of regulating the import of cosmetics in India?
Cosmetics imports into India must be regulated to protect the quality of imported cosmetics and the safety of customers who use them.
Who can import Cosmetics into India?
- The Manufacturer himself
- The Authorized Agent of the Manufacturer
- The Subsidiary of the Manufacturer
Registration Certificate In Form 43
Under the Drugs and Cosmetics Rules, 1945, Form-43 is a Registration Certificate that must be issued for the import of cosmetics into India. This form is also called a “Registration Certificate”.
The registration certificate is issued by DGCI. During this period, the applicant can submit form 42 and further information, data, and samples to DGCI for review. Once the application is approved, the applicant will be issued a Registration Certificate in Form 43 which will be valid for five years from its date of issue.
Checklist for Pre-Screening Applications for the Grant of a Form 43 Registration Certificate
- Application ( Form-42)
- Duly filled, signed & stamped original application by the Indian Agent/ importer/Manufacturer.
- Power Of Attorney(in Original)
- Labels of proposed products:- includes the following:- Name of Cosmetics, Name of Manufacturer, and Complete address, Use Before Direction for safe use/Caution Batch no, Manufacturing License no., Registration Number and Importer name and address, Other Information(if any)
Regulatory Certificates:
- Authenticated copy of manufacturing licenses
- Original Free Sale Certificate issued by National Regulatory Authority of Country of origin for the applied products
Chemical Information of cosmetics:-
- Test protocol for testing of cosmetics
- Specification
- Test report including the result of Pb, As, Hg, and microbiological test. (Wherever applicable)
Cosmetic Manufacturing License
A cosmetic manufacturing license is required in most states and territories to manufacture cosmetics, except for soap. A cosmetic is defined as a substance or preparation intended to be rubbed, poured, sprinkled, or sprayed on external parts of the human body or on the hair or scalp to cleanse, beautify, promote attractiveness or alter the appearance without affecting the body’s structure or functions.
Some states require a separate license for each establishment where cosmetics are manufactured, but others only require one license for all locations. The requirements vary widely from state to state. Most states have different requirements for manufacturing facilities that produce food and those that produce non-food products.
Cosmetic Manufacturing License Requirements
If you are going to start a cosmetics business, then you must know about the cosmetic manufacturing license requirements. There are different types of licenses required for different types of cosmetics. The cosmetic manufacturing process begins with the formulation of a product. This involves determining what ingredients are needed to achieve the desired results, including color and texture. The finished product is then packaged and labeled before it is sold to consumers.
Documents required for the grant of a cosmetic license in India for the sale of drugs and cosmetics are as follows:
- Application forms
- Challan of fee deposited and Declaration form
- Key plan and site plan
- Basis of possession of the premises
- Proof of ownership, if rented
- Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940
- Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates
- Affidavit of Registered Pharmacist/Competent person
- Experience of working with the firm duly attested by Notary
- Appointment letter of Registered Pharmacist/Competent person in charge, if the employed person
