The Indian cosmetics industry is emerging as immense growth potential, almost twice the US and European markets' size. With the growth of the cosmetic industry, the parallel sale of spurious items is also increasing. Lack of regulations on imported cosmetics in India led to the proliferation of sub-standard and spurious cosmetics, worth millions annually. The Ministry of Health and Family Welfare in India has a compulsory registration certificate for importing cosmetic products in India to ensure safety.
In India, all cosmetic products imported for sale need to be registered with the Central Drugs Standard Control Organization (CDSCO) as per the Drug and Cosmetics Rules 1945. Exemption from the new regulation and registration are those cosmetics products imported in India in bulk for re-packaging and re-processing and 100 percent export to other countries. However, bulk imports of cosmetics into India for re-packaging and sale in the Indian market are not exempted and need to be registered.
Who can apply for Registration of Importing Cosmetic products in India?
- The Manufacturer himself has registered office in India.
- The Authorized Agent of the Manufacturer
- The Subsidiary of the Manufacturer
- Any other importer
An “Authorized Agent” means a person or entity in India authorized by the manufacturer. The authorized agent will be responsible for the business activities of the manufacturer in India, including compliance with the provisions of “Drug and Cosmetic Act in all respects” . “Subsidiary” means an entity in India owned by the manufacturer. “Any other importer” means any person or entity purporting to import cosmetic products other than the manufacturer, its authorized agent and its subsidiary.
Documents required for Cosmetic Registration in India
- Power of Attorney
- Schedule D (III)
- List of Ingredients
- Labels of proposed products
- Package inserts
- Manufacturing License of the cosmetic product
- Free Sale Certificate
- Non-Animal Testing Declaration
- Declaration for Heavy Metal and Hexachlorophene content.
- Application (Form-42)
- Fee: TR-6 Challan
Each application will be accompanied by a fee of USD 2000 for each category and USD 50 for every variant or its equivalent India rupees for each brand of cosmetic product.
Prohibitions or Restrictions for Cosmetic Raw materials in India
The Drug and Cosmetic Act1940 & Rules1945 also laid several prohibited items in manufacturing and cosmetic imports to align with the standards of Bureau of Indian Standards (BIS).
- Prohibition of manufacturing or cosmetic import to contain dyes, colors, and pigments apart from prescribed by BIS
- Regulation of manufacture and import of cosmetics containing mercury. The proportion of mercury in the cosmetics manufactured domestically or imported to India
- The level of mercury not exceeding seventy parts per million (0.007 per cent.) of mercury in cosmetics for use only in the area of eye.
- in other finished cosmetic products, unintentional mercury shall not exceed one part per million (1 ppm).
- Cosmetics with Hexachlorophene, Lead or Arsenic compounds are prohibited to be manufactured and imported in India.
- Cosmetics tested on animals are prohibited from import into India.
After the commencement of the Drugs and Cosmetics (Fifth Amendment) Rules, 2014, no cosmetic that has been tested on animals shall be imported into the country.
If you are planning to start or already run an import business of cosmetics in India and need assistance related to Cosmetic Regulation in India, you can contact CliniExperts.
- Guidelines on Registration of Import of Cosmetics. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf- documents/cosmetics/Guidelines_on_Registration_of_Import_of_Cosmetics.pdf . Accessed on September 22nd, 2020.
- Requirements for Grant of Registration Certificate For Cosmetics. Available at: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf- documents/cosmetics/Documents_required_for_registration.pdf . https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/cosmetics/Guidelines_on_Registration_of_Import_of_Cosmetics.pdf .Accessed on September 22nd, 2020.