Rapid change in lifestyle and rise of purchasing power in India are leading to the percentage of cosmetic imports from outside of the region. Many cosmetics are designed and manufactured for the use of applying to the face and body. They are generally mixtures of chemical compounds derived from natural sources (such as coconut oil) and many synthetic or artificial ingredients. Earlier, there were no strict laws regarding cosmetic products in India. The Government of India has made stringent provisions regarding import, Manufacturing, Sale, and Distribution of Cosmetics through the Drug and Cosmetic act 1940 and rules 1945. These regulations look after the import license, manufacturing of cosmetics and also the Good Manufacturing Practices (GMPs) of cosmetic products. These guidelines have also covered certain categories of cosmetics whose import and sale are prohibited by the Law. These guidelines made a list of the 28 cosmetics whose import is allowed only on to the conformance to the Indian standards. Moreover, these regulations have also lied down the offences and penalties in case of contravention of the provisions of the Drug and Cosmetic Act 1940.
This article offers some reflections on some import questions related to import of cosmetic product in India.
What is a cosmetic raw material?
Cosmetic raw material means a base substance and auxillary materials used for the production of cosmetics.
Who are qualified as importers of cosmetic products?
- Registrant or marketing authorization holder of a cosmetic product.
- Cosmetic wholesalers appointed by the Registrant or manufacturer of the cosmetic product.
- Cosmetic manufacturers for import of cosmetic raw materials
What are the benefits of Cosmetic License?
- Credibility: Cosmetic license gives credibility to the cosmetic business.
- Avoiding penalty for Non-Compliance: The Government of India is taking strict procedures and rules for the Drug and Cosmetic industry. Cosmetic license avoids penalties for non-compliance with license requirements.
What are the required Documents for getting Import license of a cosmetic product?
- Covering letter: The purpose of the application has to be mentioned clearly. This document is provided by the importer.
- Form 42: This is generated online after payment of the government fee and signed and stamped copy of the same must be provided by the importer
- Challan: Document indicating the fee paid in support of the application in INR and also includes some details of the applicant.
- Power of Attorney by the manufacturer: is a document that indicates the legal relationship between the manufacturer and importer and lists out the products, the categories being registered and the pack sizes to be imported.
- Schedule D (III): Gives the details of the manufacturer and manufacturing premises
- Original or a copy of the Label of the product.
- Free Sale Certificate (FSC)/Marketing Authorization letter/Manufacturing License for all variants need to be submitted: lists the products and is a declaration that the enlisted products are freely sold in the country of origin .
- Product specification and testing protocol of the product.
- The list of countries where Market Authorization or import permission or Registration was granted.
- Package inserts of the product. Soft copies of the information about the brands, products, and manufacturer of the product.
- According to the laws, from the filing of the registration application the grant of the registration certificate is within six months.
How to import cosmetics for research and non-commercial purposes?
- The organization that is importing the cosmetic product has to give information about the cosmetics product(s), quantities to be imported along with justification for the amount to be imported, and reason for importing.
- Submission of a protocol of the studies to be conducted to the registration authority.
- There is no payment of fees.
- The registration authority may issue a NOC for showing to the custom for clearing the imported products.
- The imported material should clearly mention “Not for Sale, for R & D Studies only” OR “Not for Sale, for consumer Studies only”.
- The applicant needs to give an undertaking that such cosmetics will not be sold, offered for sale distributed or displayed.
The Central Drugs Standard Control Organization (CDSCO) will take necessary actions if imported cosmetics packs are found to be non-compliant as per provisions of the Drugs & Cosmetics Act and Rules as applicable and can penalize if there is non-compliance of the NOC issued.
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References:
- Guidance for Import Registration of Cosmetics in India Available at:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/cosmetics/Guidancedoccos.pdf .Accessed on 24 rth November, 2002.
- Guidelines on Registration Clarification for import
Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/cosmetics/Guidelines_on_Registration_of_Import_of_Cosmetics.pdf .Accessed on 24th November, 2002.
