Imported cosmetics have a major impact on the Indian market. Indian consumers tend to look towards international brands as lifestyle enhancement products. Foreign products have enhanced the growth of the Indian market by attracting aspirational consumers. The strong growth of organized retail in India is also creating a demand for more imported cosmetics products.
Antriksh Technosys Pvt Ltd offers a one-stop solution for cosmetic license application & registration in India. We assist cosmetic companies to help them to overcome the challenges within the provisions under the Drug and Cosmetics Act, 1945.
Our team of experts is extremely skilled to get your company Cosmetic license and registration in India. We have the expertise to help you get the cosmetic registration certificates which were proposed from 1st April 2011 as per the modified Rules of Drugs & Cosmetics Act, 1945.
The following licenses are required for cosmetic product manufacturing & market in India according to the Drug and Cosmetics Act, 1940 –
- License on form 32 is issued for the manufacture/ sale distribution of cosmetics. (Form no 31)
- License on Form 32-A is issued for loan license for manufacture/ sale distribution of cosmetics. (Form no. 31-A)
- License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Form no. 36)
The following are the requirement of documents for the grant of cosmetic license in India for sale of drugs and cosmetics –
- Application forms
- Challan of fee deposited
- Declaration form
- Key plan (Blueprint)
- Site plan (Blueprint)
- Basis of possession of the premises
- Proof of ownership of the premises, if rented
- Proof of constitution of the firm (Certified copy)
- Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940
- Certified copy of Registration Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent person and qualification certificates.
- Bio-data form
- Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary
- Appointment letter of Registered Pharmacist/Competent person in charge, if the employed person
The licensing authority appointed by the State Government gives the license to manufacture any cosmetic products. The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least one of the staff persons should possess the following educational requirements:
- Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
- Is registered under the Pharmacy Act, 1948; or
- Has passed the intermediate examination with one of the subjects as Chemistry or any other examination which is recognized by the Licensing Authority as equivalent to it.
The Licensing Authority also orders an inspection by the inspectors appointed under the act, of the whole premises, where the operations are to be carried out before granting or refusing the cosmetic license in India. A detailed report is submitted to the Licensing Authority which then decides whether to grant the cosmetic license in India and or not.
Antriksh Technosys Pvt Ltd helps to make the foray into the Indian market safe, hassle-free, and well planned. There are many challenges and legal red tape often faced by companies who are foraying into the cosmetic business in India be it an importer, trader marketer, etc.
We hand holds our clients as one of the most seasoned regulatory service providers in the country and guides cosmetic companies with all details and formalities, assisting them in clearing off all paperwork hitch-free.
- Authorized Agent/ Registration Approval
- Cosmetic Registration Approval
- Amendment in Cosmetic Registration Certificate
- Re-Registration of Cosmetic Product
AUTHORIZED AGENT/ REGISTRATION HOLDER SUPPORT
The cosmetics in India are regulated by the Central Drugs Standard Control Organization (CDSCO). The Drug and Cosmetic Act 1940 and Rules 1945 were passed by India’s parliament to regulate the import, manufacture, distribution, and sale of drugs and cosmetics.
Prior to March 31, 2013-No no registration of the cosmetic product was required to import them in India. Registration became mandatory from April 1, 2013, for all the cosmetics imported in the country. As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, after amendment, all cosmetic products that are imported for sale in India need to be registered with the licensing authority.
In order to legally register, import and market, sell cosmetic products in India one needs to be compliant with the Indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses in India, a legal Indian Authorized Representative / Agent needs to be formally appointed.
An “Authorized Agent” means a person or entity in India authorized by the manufacturer. The authorized agent will be responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act in all respects.
The appointed Authorized Representative is also responsible for pre-certification and post-market surveillance inquiries.
Only one Indian Authorized Representative office is needed for the whole country.
We will represent your organization as your official Indian Authorized Representative/ Agent in accordance with India applicable regulatory legislation: The Drugs and Cosmetics Act and Rules.
We can be your ideal Authorized Agent in India and can represent you legally in India without any commercial conflict of interest activities like product distribution, product marketing, product sales, etc.
COSMETIC REGISTRATION AND APPROVAL (FORM 42, 43)
As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, all cosmetic products imported for sale in India need to be registered with the licensing authority.
The application for Registration of Import of Cosmetics can be made by-
- The Manufacturer himself having registered office in India
- The Authorized Agent of the Manufacturer
- The Subsidiary of the Manufacturer
- Any other importer
The application for registration (Form-42) with required documents are submitted to Drugs Controller General (I), CDSCO, New Delhi. This application is accompanied by the fee specified along with information and undertaking in Schedule D-III. A single application is made in Form 42 for any number of brands manufactured at one or more locations by a single manufacturer (legal).
The Registration (Form 43) may be obtained in approximately three months, whereas the validity of the registration is for three years.
The process of obtaining a Cosmetic Registration can be cumbersome and time-consuming. Antriksh Technosys Pvt Ltd can smoothen the process and help you obtain the Cosmetic Registration.
AMENDMENT IN COSMETIC REGISTRATION CERTIFICATE
The Government of India has issued a gazette notification G.S.R. 426(E) dated 19th May 2010 making it mandatory to register all imported cosmetics. This amendment was notified in the gazette amending Rule 129 of Drugs & Cosmetics Rules. The amendment and the provisions as in the amendment came into force from 1st April 2012.
After obtaining a Cosmetic Registration Certificate, The following changes require a fresh registration –
1. Any change with respect to the manufacturer (legal/ actual) like change in name, change in the constitution, change in address, etc. Any change with respect to importer/ Indian Agent like change in name, change in the constitution, etc.
2. The manufacturer or his authorized agent in India should inform the licensing authority as soon as possible if any change in the constitution of the firm and/or address of the registered office/factory premises functioning under this Registration Certificate. In such cases, the current Registration Certificate shall be valid for a maximum period of three months from the date on which the change has taken place from the date on which the change has taken place unless, in the meantime, a new Registration Certificate has been given by the licensing authority in the name of the firm with the changed constitution of the firm and/or changed the address of the registered office or factory premises (as per condition no.4 of Form 43).
3. In case of acquisition/merger of one company by another company, the Indian agent/ Importer has to inform the licensing authority immediately in writing and has to submit a fresh application as per Rules, as acquisition/merger of one company is considered as a change in the constitution of the company.
Following changes do not require a new/fresh registration and only notification or amendment may be obtained –
1. Change in the method of testing
2. Change in composition
3. Updating in packaging and labels (provided proper justification should be provided for the above changes).
4. Minor changes in the manufacturing process that will not affect the final product specifications.
5. The timeline for a response to a change in the notification is about 90 working days. If the applicant has applied for Registration Certificate and still not issued but in between a change has happened in the constitution of either Indian Agent or the Manufacturer or, address of manufacturer a fresh application has to be submitted including the fees.
A one-time self-declaration that the products applied for registration has not been tested on animals on and after 12.11.2014 along with import registration dossiers should be submitted to the CDSCO by the manufacturer either legal or actual/brand owner of the products/Indian subsidiaries. For the clearing of consignments, the acknowledgment copy as received by the applicants from CDSCO shall be submitted at the port offices.
In response to a better lifestyle approach, high purchasing capacity, and self-care, the demand for cosmetic products in India has risen expeditiously. To protect and maintain the worth of cosmetics in India, the cosmetic products are regulated under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945 vide Gazette notification G.S.R 426(E). A registration certificate of a cosmetic product is valid for a period of three years from the date of its issue. It required to be renewed after the given validity. However, it can be suspended or canceled, in case of violence of rules. The registration as well as re-registration of cosmetic products is required to ensure its quality, efficacy, and safety, but, it brings along tedious paperwork that has to be accomplished to maintain the registration of a cosmetic product under a Brand. Antriksh Technosys Pvt Ltd bestows an easy- hassle-free approach to resolve technical as well as non-technical challenges associated with the renewal of registration of Cosmetic products. We own the expertise and skills required to achieve goals in stringent timelines, that too in a smooth and tranquil way. Our regulatory specialists are striving all day to make the process of re-registration smooth to avoid unwanted frictions and anomalies, so as to accomplish the task well in time.
- Application Submission
- After the final submission View the form details and click on the “Continue” button to proceed further. It will be re-directed to the “Preview” page. In the preview, the user can view complete information filled by the user till now. Click on the “Edit” button to do any modifications in the filled form. View the form details and click on the “Save and Continue” button to proceed further. It will be redirected to the “Checklist” page.
- Once moved to the “Checklist” page, any further modifications in the application form will not be allowed.
- Click on each point to upload documents electronically. Documents that need to be uploaded will vary from point to point.
- Upload all the documents and click on the “Submit” button on the checklist page to proceed further. It will be re-directed to the “Payment”.
- Fill the form details and click on the “Submit” button to proceed further. It will be re-directed to the ” Preview” page.
- Multiple challans’ can be uploaded, up to a maximum limit of five challans’.
- Click on the ” PDF” button to generate the PDF of the filled form. Full Preview will consist of Details of the payment done by the user. Click on the “Continue ” button to proceed further. It will be re-directed to the Upload Form.
- To submit the documents electronically click on the ‘Browse’ button and select the file from your system. Click on the “Submit” button to proceed further.
- Upload Form 42 here, which was downloaded as PDF earlier in the Full Preview page.
- RC Application will be submitted successfully and online application will be forwarded to the respective Designated Officer. Please note down the Reference Number generated for future reference.
- The submitted application will be reviewed by the Designated Officer for compliance of required documents registration
- If the application is found to be satisfactory in all respect, the same will be forwarded for approval of the Licensing Authority. Once approved, the approval letter will be available in the Applicants SUGAM dashboard.
- If the application is not found satisfactory, then discrepancies in the application are intimated to the applicant in the SUGAM Portal. Once the discrepancies comply, it is then processed for approval.
Yes, imports of cosmetic products are regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945 vide Gazette notification G.S.R 426(E).
Import of cosmetics in India needs to be regulated to ensure quality and safety of cosmetics being imported in India and safety of consumers using these cosmetics.
The copy of the Gazette notification G.S.R 426 (E) is available under Cosmetics Section on CDSCO website.
The copy of the Drugs & Cosmetics Act 1940 & Rules 1945 is available on CDSCO website.
Yes, all imported cosmetic products which come under the definition of Cosmetic as per Drugs & Cosmetic Act 1940 are regulated in India.