Introduction: Cosmetic Import Licenses COS-1 and COS-2
Hey Corpseed readers, today we are going to talk about what are COS-1 and COS-2 and why they are so important. In India, CDSCO (central drug standard control organization) is a regulatory body of drugs and cosmetics. CDSCO manage the complete import of cosmetics in India. CDSCO does issue a cosmetic import license to the cosmetic importers of India and COS-1 and COS-2 forms plays an important role for that. COS-1 and COS-2 are two majorly required forms for cosmetic import in India. According to the cosmetic rules 2020 in India, Form COS-1 is a registration form for cosmetic import in India and Form COS-2 is issued form of cosmetic import certificate in India. In this blog, you would get a brief understanding about COS-1 and COS-2 of CDSCO.
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What are the Required Documents for Form COS-1 and Form COS-2 Submission?
The following documents are required to be attached with Forms COS-1 and COS-2
- Primarily, applicant must form a covering letter for all the documents for the submission of the application.
- A letter of authorization from the manufacturer is also a very important document for the submission of COS-1 and COS-2 and this letter of authorization must be properly authenticated by the manufacture of the product.
- Applicant need to fill the Part 1 of the second schedule D before filing for the COS-1 and COS-2.
- Applicant must have a specified detail list of all the ingredients used in product.
- Applicant need to specifically mention the complete Percentage and weight of all the used ingredients of the cosmetic products.
- Applicant must have authentic label details of the proposed cosmetic product.
- Applicant need to present the complete details about the testing and specification of proposed cosmetic product. Importer need to give the complete testing details of proposed cosmetic product.
- If applicant need to give the complete details about the additional items of proposed cosmetic product. Import need to fill these details in Pack insert details. For example: if a cosmetic product contains an additional product in the package to apply that cosmetic product then that additional product must be specifically mentioned in package insert details.
- Importer need to show the manufacturing license of proposed cosmetic product and if importer don’t have the manufacturing license of proposed cosmetic product then importer must have am undertaking from the importing country of cosmetic product.
- Importer need to attach an authenticated copy of Free Sale Certificate of the proposed cosmetic product along with the COS-1 and COS-2 forms.
- A declaration of from the manufacturer that shows no animal testing had performed with proposed cosmetic product.
- A declaration of from the manufacturer that shows there is no use of hexachlorophene content and heavy metal in the making of proposed cosmetic product.
- Applicant need to present some other documents as per the requirement given by the authority.
- A completely filled application in Form COS-1 is a major document of cosmetic import license.
- Applicant need to give the original receipt of Bharatkosh payment portal which confirms the payment of cosmetic import license fee.
How to Get COS-1 Registration Certificate
- CDSCO has given a prescribed Performa for COS-1 registration. This prescribed Performa must be completely filled by the importer in order to acquire a cosmetic import license.
- Cos-1 has to be filled online through the CDSCO "Sugam" portal.
- COS-1 form will consist the complete information about the manufacturing facilities of cosmetic product, Brief description of the proposed cosmetic product, brand name of the product, Size of packaging of the product, and other required information.
- Cos1 form will require a number of documents as we have already mentioned above.
What is the Procedure after Submitting the Form COS-1?
- Once the importer have filled the from COS-1 form , then that form would be submitted to the Drugs Controller General (I) office of CDSCO in New Delhi along with other required documentation.
- Applicant need to submit a copy of challan including the required information of the importer and the license fees amount has to be paid in INR and that paid receipt would be submitted in support along with the application.
How to get COS-2 Registration Certificate?
- According to the cosmetic rules 2020 in India, COS-2 certificate is also known as the Registration Certificate.
- Whenever the licensing authority such or customs authority ask for the cosmetic import license from the importer the proposed product then the importer, distributor, or Indian authorized agent who have a legal cosmetic import license from CDSCO must show the Registration Certificate in the form of COS-2.
- As per the revised Cosmetic Rules for 2020, the approval process for registration certificate process will now take up to 180 working days from the day of registration.
- As per the revised Cosmetic Rules for 2020, COS-2 (registration certificate) would be valid only for five years.
As per the latest Third Schedule of Cosmetics Rules, 2020 of India, A fee of $1,000 US dollars or its equivalent in Indian Rupees is mandatory to pay to acquire the registration certificate (COS-2) for each category of cosmetics and an fess amount of $600 US dollars is required for the registration of each cosmetic manufacturing site in India. An $50 US dollar fees amount has to be submitted for the registration of each variant of proposed cosmetic product and If importer want to register an additional product in the different category then have to pay an another fees amount of $1,000 US to get the Cosmetic import registration certificate. As per the directorate's circular CDSCO/IT/2018-(37) dated 09.01.2019, all the payments after the date of February 15, 2019 would be paid through Bharatkosh only.
Applicant have to pay the requisite fee amount through the Bharatkosh gateway under Head of Account “0210041040000-00-1” Import and Registration and once applicant paid the requisite fees amount through the Bharatkosh gateway then applicant or importer would receive an acknowledgement receipt which have to submitted along with the application to complete the process of cosmetic registration.
In this article, we talked about the complete submission process of COS-1 and COS-2 and we have shared the complete methodology for the cosmetic import license in India. This article talks about the required documents for the submission of COS-1 and COS-2. We talked about the guidelines, objectives and methods of CDSCO for cosmetic import license and how an importer can avail the benefits of a registered cosmetic product in India. You can learn the procedure of application of cosmetic import license in India. If you want any help regarding the submission of COS-1 and COS-2 or any other regulatory compliances for your business then you can visit our website Corpseed. We shall be glad to help you. Thank you for reading this blog, goodbye.
To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally. As per Drugs Act, 1940, License is mandatory throughout India. A particular license is required based on business requirement.
CDSCO Online Registration
Team Corpseed will help you to get CDSCO registration / DCGI approval for your products as per CDSCO guidelines. Under the Drugs and Cosmetics Act, CDSCO has many responsibilities which includes approval of Drugs.
Medical Devices Registration
Also, CDSCO regulates the manufacturing and import of medical devices in India. As per Drug and Cosmetic act, the medical devices are categorized under the category of drugs.
This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.
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