Cosmetic Registration and Manufacturing License
As per the Drug and cosmetic act 1940, “cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applicated 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.
Cosmetic Regulation in India
The cosmetic products in India are regulated under the Drugs and Cosmetics Act 1940 and Rules 1945 and Labelling Declarations by the Bureau of Indian Standards (BIS). BIS sets the standards for cosmetics for the products listed under Schedule ‘S’ of the Drugs and cosmetics Rules 1945. BIS has also provided the specification for Skin Creams and Lipstick in the Indian Standards (IS) 6608:2004 and 9875:1990 respectively.
According to IS 6608:2004, all the raw materials requiring test for heavy metals have been so tested and comply with the requirements, then the manufacturer may not test the finished cosmetic for heavy metals and arsenic.
The Rule 134 of Drugs and Cosmetics Rules has laid down restrictions on use of cosmetics containing dyes, colours and pigments other than those specified by the Bureau of Indian Standards (IS: 4707 Part 1 as amended) and Schedule Q. The Rule 145 of the Drugs and Cosmetics Rules prohibits use of lead and arsenic compounds in cosmetics for the purpose of colouring. Rule 135 prohibits import of cosmetics in which a lead or arsenic compound has been used for the colouring purpose. Rule 145 D and 135 A prohibits manufacture and import respectively of cosmetics containing mercury compounds.
Registration of Import of Cosmetics
A Gazette Notification G.S.R 426(E) dated 19 th May 2010 has been issued by the Government of India for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country. This provision was to come into effect from the 1st April, 2011. But in view of the various possible difficulties apprehended by the stakeholders, its implementation was deferred till the 31 st March, 2013.
All cosmetic products that are imported for sale in India now need to be registered with the Central Drugs Standard Control Organisation (CDSCO) which has been appointed as the licensing authority for the purpose of these rules. This new ‘registration’ requirement is primarily to regulate indiscriminate import of beauty and personal care products by traders with no accountability for contents and no mechanism to fix responsibility in case a consumer is not satisfied with the quality. The new regulation is an attempt to check the sale of sub-standard cosmetic products and also to harmonise import requirements with products manufactured in India.
What is the Registration Procedure?
The trade mark owner, who has no manufacturing unit in India but intends to sell his goods by way of import through their appointed importers/distributors/marketers in India, is now required to obtain registration certificate to continue with their marketing activities in India. An application for registration on Form-42, along with all requisite documents needs to be submitted to Drugs Controller General (I), CDSCO, FDA office in New Delhi.
How should one apply?
An application for the issue of a Registration Certificate for cosmetics intended to be imported into India need to be made on a specified form, i.e. Form 42 either by:
Further, the documents to be provided along with the application include:
What is the timelines for processing of application?
Within 90 days from the date of submission of the application form and submission of the required documents (especially details required with schedule D III), the registration certificate will be issued.
What is the validity of the registration certificate?
Registration certificate for import of cosmetics is valid for a period of three years from the date of its issuance.
With a view to implementing the provisions of the aforesaid notification and facilitate the registration process for import of cosmetics, there are various guidelines/clarifications and requirements for the grant of Registration Certificate.
Cliniexperts has a team of experienced regulatory professionals who help smoothen down the process of getting the Registration Certificate. For more details/inquiry send us your details here and we shall get back to you at the earliest.
Manufacturing of Cosmetics
The procedure to be followed in order to manufacture cosmetics in India has been laid down under the Drugs and Cosmetics Rules, 1945. A license has to be obtained from a Licensing Authority appointed by the State Government to manufacture any of the cosmetics classified under Schedule M-II. The application has to be submitted in Form 31 along with a license fee and an inspection fee. The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff. The Licensing Authority is required to order an inspection of the whole premises where the operations are to be carried out, before granting or refusing the license. The inspectors are appointed under the Act are required to submit a detailed report to the Licensing Authority which can then decide whether to grant the license or not.
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