Amendment in Cosmetic Registration Certificate

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.

Fresh Registration

After obtaining a Cosmetic Registration Certificate, The following changes require a fresh registration –

  1. Any change with respect to manufacturer (legal/ actual) like change in name, change in constitution, change in address, etc. Any change with respect to importer/ Indian Agent like change in name, change in 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 firm and/or changed address of 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 change in constitution of the company.

 

Changes that require fresh registration:

Following changes do not require a new/fresh registration and only notification or amendment may be obtained –
 Change in the method of testing
 Change in composition
 Updating in packaging and labels (provided proper justification should be provided for the above changes)
 Minor changes in the manufacturing process that will not affect the final product specifications

The timeline for response to a change in notification is about 90 working days. If applicant has applied for Registration Certificate and still not issued but in between a change has happened in constitution of either Indian Agent or the Manufacturer or, address of manufacturer a fresh application has to be submitted including the fees.

Amendments for products not tested on animals

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 clearing of consignments, the acknowledgement copy as received by the applicants from CDSCO shall be submitted at the port offices.

References

  1. The Drugs and Cosmetics ACT, 1940 and Rules 1945. Available at- http://www.mohfw.nic.in/WriteReadData/l892s/43503435431421382269.pdf. Accessed on – 21st May 2016.
  2. The Drugs and Cosmetics Rules, 1945. Available at- http://www.cdsco.nic.in/writereaddata/drugs&cosmeticact.pdf, Accessed on – 21st May 2016.
  3. Clarification for import and registration of cosmetics in addition to existing guidelines (dated 15.10.2015). Available at- http://www.cdsco.nic.in/writereaddata/Clarification%20for%20import%20and%20registration%20of%20cosmetics.pdf. Accessed on 20th July 2016
  4. Frequently Asked Questions (Faq’s)- Cosmetics Import Registration. Available at- http://www.cdsco.nic.in/writereaddata/FAQ10.pdf. Accessed on 20th July 2016.

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