Cosmetics Import Registration-Amendment 2018

30/12/2018

Dated: 30.12.2018

The Recent Changes in Cosmetics Import Regulations in India

Cosmetics is defined under Section 3(aaa) of Drugs and Cosmetics Act, 1940 as any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.

Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments while the import of cosmetics is regulated under a system of registration by the Central Licensing Authorities appointed by Central Government. The office of Drugs Controller General (India) i.e Central Drugs Standard Control Organization functions as the Central Licensing Authority grants the registration certificate and regulates the import of cosmetics in India vide Gazette notification G.S.R 426(E) under the provisions of Drugs and Cosmetics Act 1940 and Rules made there under.

 Steps for Online application for registration of cosmetics

  • Access the portal by using the link http://cdscoonline.gov.in.
  • Signup and create login credentials.
  • Submit all the details with valid e-mail id and mobile number (for alerts) and complete the signup process.
  • After successful signup login into the portal.
  • In form submission section, select department and select type of form.
  • Choose the type of application need to be submitted ex. Fresh, Endorsement etc.
  • After final submission View the form details and click on “continue” button to proceed further. It will be re-directed to the “Preview” page. In preview user can view complete information filled by the user till now. Click on “Edit” button to do any modifications in the filled form. View the form details and click on “Save and Continue” button to proceed further. It will be redirected to the “Checklist” page.
  • Once moved to “Checklist” page, any further modifications in the application form will not be allowed.
  • Click on each points to upload document electronically. Documents which needs to be uploaded will vary from point to point.
  • Upload all the documents and click on “Submit” button on the checklist page to proceed further. It will be re-directed to the “Payment”.
  • Fill the form details and click on “Submit” button to proceed further. It will be re-directed to the ” Preview” page.
  • Multiple challan’ can be uploaded, upto a maximum limit of five challan’.
  • Click on ” 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 “Continue ” button to proceed further. It will be re-directed to the Upload Form.
  • To submit the documents electronically click on ‘browse’ button and select the file from your system. Click on “Submit” button to proceed further.
  • Upload Form 42 here, which was downloaded as PDF earlier in 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.
  • 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 Licensing Authority. Once approved, the approval letter will be available in 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 are complied, it is then processed for approval.

 

Key Points to Remember:

  1. Create a Profile on Sugam Online portal

          Documents Needed for this are as follows-

  1. Adhaar (for Indian nationals)-self attested
  2. Passport and PAN Card (for Indian nationals) self-attested
  3. Copy of Company Incorporation/Trade License-self attested
  4. CDSCO affidavit format (attached below) to be printed on company letter head-signed & stamped

             Seek the following documents from the Manufacturer:

  1. Power of Attorney- Apostilled from Country of Origin by a Public Notary & attested by Indian Embassy of the country of Origin
  2. Certificate of Free Sales (FSC) – Apostilled from Country of Origin by a Public Notary & attested by Indian Embassy of the country of Origin
  3. GMP Certificate, if available- Apostilled from Country of Origin by a Public Notary & attested by Indian Embassy of the country of Origin
  4. Exporting Countries List and Declaration on Manufacturer’s Letter Head
  5. Copies of Regulatory Permits obtained by the Manufacturer in their country of Origin – Apostilled from Country of Origin by a Public Notary & attested by Indian Embassy of the country of Origin
  6. NOT TESTED On Animal Declaration by the Manufacturer
  7. Declaration by Manufacturer regarding the absence of Heavy Metals & BSE Risk Raw Materials in all their proposed products
  8. Art Labels both Outer & Inner if they are different
  9. Formulation Details of each Product separately
  10. MSDS for each product separately
  11. Ingredients listing as per INCI nomenclature for each product separately
  12. Certificate of Analysis (CoA) for each product separately
  13. CoA for Heavy Metals Test for each product separately & Declaration regarding absence of Heavy Metals (Pb, As, Hg, Cd)
  14. Test Methodology adopted for each product or the Testing Protocol adopted for each test type for each product separately
  15. Any other additional info/Safety precaution instructions as issued by Manufacturer on the Package Insert if any

  1. Please Ensure all the documents are in place before you file for the main FORM-42 application
  2. Apply for Fresh FORM-42/Endorsement license as the case maybe
  3. Check back status after 45 days to see if there is any query/deficiency being raised by the CDSCO
  4. Reply for the Query online by login in to CDSCO (Sugam portal)
  5. License is approved in 120 days provided the application is complete in all aspect & there is no query raised by the CDSCO authorities during the application processing period
  6. In case of any clarification/grievance redressal please visit the CDSCO office and meet only the Public Relations officer (PRO) to lodge your grievance or seek clarity- as the meeting with ADC or DDC has been stopped

 

Upcoming suggested Changes:

  1. For Cosmetics Import regn the CDSCO fee of USD 250 is now enhanced to USD 2000 vide GSR 1193 (E) dtd: 12.12.2018- Read Section 8 clause a of the above notification, also refer to the OM F. No. 18-68/2018-DC dtd: 17.12.2018- already implemented with immediate effect
  2. It shall be shortly made mandatory for the manufacturer to produce the documents related to the test trials made on actual consumers in their country of manufacturing before approval is granted for the Import license
  3. The Expiry date/Best before date mentioned on the product labels imported should not be older than 6 months from the date of Import in India- to be notified shortly

 

List of Notifications:

  1. Fee Enhancement: GSR FOR FEES
  2. CDSCO Office Memorandum (OM): IMG-20181218-WA0004

 

Source: MoHFW, CDSCO, Govt of India

FOR FURTHER ASSISTANCE PLEASE CONTACT–
CP: Mr. Ravi Jha
Mob: +91-9999005379

Web: www.sjeximtech.com

Email: rsj@sjeximtech.com  or intelconsul@gmail.com

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