We are specialize in Cosmetics Import
Registrations with the FDA India.
We, COSMETICS REGISTRATION (INDIA) are a consultancy subsidiary of ARHAM CONSULTANTS (INDIA) PTY, New Delhi and are focused on the regulatory compliance of Cosmetics Imports Registration in India.
Cosmetic Industry in India has grown leaps and bounds and this has caught the attention of the global firms. The market in India offers a huge market for personal care products, especially in the cosmetics segment. It is however very important that the safety profile is maintained and consumers are benefited in the long run. The Government of India, Ministry of Health & Family Welfare has proposed a regulatory framework under which it is mandatory for every importer to obtain a RC ‘Registration Certificate’ before the product reaches the market.
Mentioned below are some questions which may come to an applicants mind when proceeding to obtain a RC ‘Registration Certificate’ for its Cosmetic Products :
Qs.: Who can file an application for the Registration Certificate ?
Ans.: The Manufacturer or his Authorized Representative / Agent in India
Qs.: Where does the application form need to be submitted for product registration?
Ans.: The application form along with the necessary documents should be submitted to the DGCI ‘Drugs Controller General of India’, Ministry of Health & Family Welfare, New Delhi as both – soft copy and hard copy
Qs.: Do we need to comply with any specific forms for filling in the Registration Application?
Ans.: Form-42, along with the covering letter by the applicant Payment receipt of the specified fees, in Original.
Qs.: Do we have any specific requirements for the application cover letter?
Ans.: The covering letter should be on the official letterhead of the Manufacturer, Authorized Representative / Agent of the Importer The content on the covering letter should be duly attested, stamped and signed by the designated authority or person
Qs.: Does the application form require any receipt acknowledgement from the Licensing Authority?
Ans.: As a Receipt Acknowledgement, the copy of the covering letter will be duly attested, signed and stamped by the office of the DCGI [Drug Controller General of India]
Qs.: Is there any specified fees for Product Registration ?
Ans.: Yes, U.S. $250 or its equivalent in Indian Rupees for each brand of the cosmetics.
Qs.: Where does the fee for Product Registration need to be submitted?
Ans.: At any of the designated branches of Bank of Baroda.
Qs.: How the Manufacturer pay the registration fees in his own country?
Ans.: An EFT ‘Electronic Fund Transfer’ can be made from the country of origin to Bank of Baroda, Kasturba Gandhi Marg, New Delhi, India.
Note: The receipt must be attached to the application form as the proof of payment.
Qs.: How much time is taken for the issuance of the RC ‘Registration Certificate’?
Ans.: Post submission, a maximum of 6 months is taken by the DCGI ‘Drug Controller General of India’ for issuing an RC
Qs.: For what time period does the Registration Certificate remains valid?
Ans.: The RC ‘Registration Certificate’ remains valid for a period of 3 years
Qs.: What are the required documents for Product’s Registration at DCGI ‘Drug Controller General of India’?
Ans.: The generally required documents are :
The applicants must read through the list of documents and the procedures so that the product registrations are availed easily and without any unintended errors. A comprehensive pre-submission appraisal of the required documents should curtail the time taken on generating the Registration Certificate
All the information on various aspects of Cosmetics Registration process and regulations in India is the personal interpretation of the author as gathered from various online & offline source materials. None of the information on this site, in part or whole, is claimed to be an authoritative opinion or summary extract of any law or regulations ; readers are requested to validate the information from their own informed sources and act so on their own wise decision.
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