How to get CDSCO cosmetics registration? How do We Import Cosmetics in India?
Introduction
Across the world, cosmetics are used by people in order to beautify and cleanse their body. Such products are directly applied on the human body. Therefore, it is very important to ensure the quality and safety of these cosmetic products. For this, a central licensing authority, CDSCO was established to regulate the import of cosmetic products in India.
It is quite important for every company to take CDSCO License of their cosmetic products before entering into the Indian market. Even if the products are being imported from any other company to India, even then the cosmetic registration is required as to make sure that such products are good to use on the human body and it won't harm or affect the body of any person in any case.
What is CDSCO?
Central Drugs Standards Control Organisation or CDSCO is a body which comes under the Ministry of Health and Family Welfare. This body is responsible for managing the import of cosmetics and other medical products into India. Drugs Controller General of India is the person who issues a license for medical devices, cosmetics, homeopathy, and allopathic drugs et cetera under the CDSCO. The main aim of this body is to protect and promote public health in India. Moreover, apart from this, the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 are the two major laws that are responsible to regulate drugs and cosmetics in India.
What is a Cosmetics License?
As per Section 3(aaa) of the Drugs and Cosmetics Act, 1940, cosmetics can be defined as any product or item, which is used to sprinkle, poor, rub, or spray, applied to any part of the human body, in order to beautify, cleanse, or promote attractiveness to the human appearance. any other component which is used in making a cosmetic product is also considered as a component of cosmetic.
As per the Drugs and Cosmetics Act, 1940 and its Rules of 1945, if a person has to manufacture cosmetics, then there is a system of inspection that is governed by the State Licensing Authorities of each state government. To import cosmetic products in India, the Central Licensing Authority will regulate this process. Before importing any cosmetic product, it is important to get it registered along with the variant, manufacturing premises and packaging size.
No person is allowed to import or manufacture any cosmetic products until it is registered and follows the standards that has been mentioned under the Ninth Schedule of the Cosmetic Rules, 2020 and any other applicable standards of any other provisions or rules. for the import of cosmetic products in India. Import registration certificate is issued by the central licensing authority under Rule 13 of the New Cosmetic ules, 2020 and then the cosmetic product is deemed to be registered and it can be imported and use in India.
For the purpose of importing cosmetics into India, an application for the issuance of an import registration certificate may be submitted by the manufacturer directly, by the manufacturer's authorized agent, by the manufacturer's authorized subsidiary in India, or by any other importer in India. In accordance with the Cosmetics Rules, 2020, an online application in Form COS-1 on SUGAM Portal must be submitted to the Central Licensing Authority together with the necessary paperwork and cost.
Documents required for CDSCO Cosmetics Registration
The documents required for CDSCO cosmetics registration are mentioned below:
Cover letter submitted by the applicant.- Power of attorney.
- Form 42 duly filled.
- Certificate of free sale, authorization letter of marketing, manufacturing license.
- Testing protocols and product specifications.
- Treasury challan.
- Soft copies that furnish details about the brand, manufacturer and product.
- Test reports with all the test, including heavy metal and microbiological testing.
- Labels of the product that are proposed to be imported
Process of CDSCO Cosmetics Registration
A cosmetic or license is required by manufacturer who manufacturers in any other country and sells this product in India by the way of import. The process of getting a cosmetic import registration certificate or license is as follows:
Gathering Documents: The very first step is to gather all the important documents, verify the labelling of the products and then the documents are submitted to the regulating authority.
Submission of application: After gathering all the important documents, the applicant has to move ahead to the Sugam portal, sign up with the login credentials and submit the application. After submitting the application all the documents shall also be uploaded successfully on the portal as per the requirement.
Payment of fees: After submitting the application and the documents, you will have to pay the required fees which will depend on the site of your manufacturing products and the number of categories that you import to India.
Filling and Submitting Form 42: Next, the applicant has to fill form 42 and upload it on the Sugam Portal. After the online application has been filed, the same will be forwarded to the appropriate designated officer.
Application review: Now, the designated officer will review your application and the documents that you have submitted. If in case he finds anything is not correct or up to the mark, the same will be communicated to the applicant on the Sugam portal and then you will have to respond to the queries. Once all the queries have been answered, and they designated officer find everything to be correct and he satisfied, then the application will proceed ahead for the approval.
Inspection of the premises: Inspection of premises is only done in case the manufacturer is in India. Then, the inspection will be done by the state licensing authority. Also, the inspection process will not take place in case of foreign manufacturer or importer.
Grant of cosmetic import license: Once the application has been approved and the licensing authority is satisfied, the importer will be granted the import license for cosmetics and he can sell his registered cosmetic products in India.
Conclusion
According to Cosmetics Rule 2020, all cosmetic items need to be registered in order to guarantee consumer safety and dependability. But, fulfilling compliance may be challenging. It is not as easy as it may appear to obtain a cosmetic license since you need to work with the authorities, submit papers, undergo inspection, and meet CDSCO standards. To ensure that the entire procedure is handled properly and that you are able to receive a Cosmetic Registration Certificate, it is advisable that you seek professional assistance from Agile Regulatory.
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