Registration and Importation of Cosmetic Products in India

Introduction – Registration and Importation of Cosmetic Products in India

Registration and Importation of Cosmetic Products in India is governed by the Drugs & Cosmetics Act, 1940. The Cosmetic Industry is a booming Industry in India with a huge market for cosmetic and personal care products. Import of cosmetics in India needs to be regulated to ensure safety, quality and performance of cosmetics being imported into India requires a registration certificate from the Ministry of Health & Family welfare as defined under Rule 21 of Drugs and Cosmetics Rule 1945. Registration certificate is required from the primary regulatory authority or body for Cosmetic Registration in India, which is obtained from The Central Drug Standard Control Organisation (CDSCO). Using this Licence import activities and sales of the cosmetic products can be carried out in India without any hassle. This article deals with the Registration and Importation of Cosmetic Products in India in India based on the amendment on 15th December 2020. 

Import of cosmetics

The word “Cosmetic” means any substance which is intended to be poured, scrubbed, sprayed, or introduced into the human body which is used for cleansing, beautifying, or altering the appearance which also includes any article used as a component of cosmetic products”. All cosmetics imported into India must be registered in accordance with  rules by the Central Licensing Authority through the online portal of the Central Government in Form COS-1. The following documents need to be specified:

• A valid manufacturing license for the finished formulation of the cosmetic ready to fill in finished form from the State Licensing Authority; and 
• Details of registered brand owners of the finished product in India; A single application may be made and a single registration certificate in Form COS-2 may be issued in respect of import of one or more cosmetics from the same Manufacturer

Procedure for import of cosmetics

Step 1  : Determination of Classification of Cosmetics

When a manufacturer decides to get their products registered in India, he/she must review the CDSCO’s gazette notifications prior to making a final determination of a device’s regulatory status and classification

Step 2 : Appointment of Indian Agent 

The manufacturer must appoint an India Authorized Agent to interact with the CDSCO. The agent chosen must have a wholesale license (Forms 20B and 21B/21C). The Indian Agent will then be granted a Power Of Attorney to manage registration and importation in India.

Step 3: Compilation of Documents and Process to Obtain Certificate for Import

The documents needed are 

1. Form COS-1/COS-2 along with the covering Letter
2. Challan
3. Power of Attorney (POA)
4. Schedule DIII (DMF)
5. Original or Copy of a Label
6. FSC /Marketing authorisation Letter/Manufacturing License(if any)
7. Product specification and Testing Protocol
8. List of countries where Market authorisation or Import Permission or Registration has been granted
9. Pack Insert (if any)
10. Soft copies of the information about the brands, products and manufacturer,
11. Receipt of the Application Form
12. The Drug Controller General Office will issue an acknowledgement i.e, Duly stamped cover letter 
13. Registration Fee to be deposited in designated branches of the Bank of Baroda.

The process of obtaining approval is as following :

1. The licensing authority may or may not grant the import registration certificate for which reasons shall be recorded in writing within a period of six months from the date of application.
2. If the application is rejected, the applicant can appeal to the CDSCO within 45 days for which the Government responds within 90 days from the date of appeal.
3. If the product is a new cosmetic product, the applicant has to obtain permission in Form COS- 3 
4. One application may be submitted and one registration certificate in Form COS-2 may be issued in respect of import of one or more cosmetics manufactured by the same manufacturer
5. A registration certificate granted under Rule 13 shall remain valid in perpetuity, however it has to be renewed every 5 years unless it is cancelled or suspended by the Authority.
6. If the renewal fee is not paid, then the late fee is calculated at the rate of 2% of the registration certificate retention fee for every month for 180 days. If the manufacturer fails to make the payment even then, the license will be cancelled.

List of categories of cosmetics for import :

Step 4 : Import of Cosmetics

1. During import, if the officer believes that any cosmetic contravenes the Act, the product can be taken for inspection.
2. If there is any defect which is noticed, further action will be taken. These samples can also be taken to the Laboratory for performing tests and the consignment will be detained for this time until the test reports are obtained. 
3. If the importer who has given an undertaking under sub-rule (1) is required by the Commissioner of Customs to return the consignment, it has to be returned within ten days of receipt of the notice. 
4. If the imports officer does not clear the goods after the test results are obtained, the importer will have to return the goods within 2 months to the place of manufacturing. 
5. Sometimes, in some a few cases, the officer may also permit for the import clearance on the importer giving an undertaking in writing not to dispose of the cosmetic without the permission of the officer authorised in this behalf by the Central Government.

Prohibition of import of certain cosmetics

• If a cosmetic is prohibited in the country of origin, it cannot cannot be manufacturers, sold or distributed in India under the same name or different name unless it is used for the purpose of examination, test or analysis. 
• No cosmetics shall be imported unless the ―Use Before or use by‘‘ date shown on the label is later than six months from the date of import. 
• No cosmetic containing hexachlorophene can be imported
• No cosmetics that have been tested on animals after the 12th day of November 2014 can be imported into the country.

Conclusion

The growth of the cosmetic industry in India has been huge in the last few years. The demand is equally strong and pervasive in Tier 2 and 3 cities. Naturally, people are entering this industry to grab a share of the market but many are ignorant about the ingredients or the possible health risk from spurious products. The Indian government, envisioning the huge demand for products and large number manufacturers, importers and distributors being present in cosmetics, has come up with sweeping changes in regulation of Registration and Importation of Cosmetic Products in India

How can Morulaa Help 

Morulaa Health tech provides assistance in applying Cosmetic Registration Certificate, Master Importer, (Customs Clearance and Supply Chain Logistics) analysis and testing of cosmetics. In addition we also assist manufacturers in setting up E-commerce portals  for the sale of cosmetics products in India. Contact us to know more.

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