Cosmetic- Authorized Agent/ Registration Holder Support

Cosmetic- Authorized Agent/ Registration Holder Support

The cosmetics in India are regulated by the Central Drugs Standard Control Organization (CDSCO). The Drug and Cosmetic Act 1940 and Rules 1945 were passed by the India’s parliament to regulate the import, manufacture, distribution and sale of drugs and cosmetics.

Prior to March 31, 2013-No registration of the cosmetic product was required to import them in India. Registration became mandatory from April 1, 2013 for all the cosmetics imported in the country. As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, after amendment, all cosmetic products that are imported for sale in India need to be registered with the licensing authority.

In order to legally register, import and market, sell cosmetic products in India, one needs to be compliant with the Indian regulations and legislation. When a Foreign manufacturer does not have a registered office in India, under these circumstances, an Indian Authorized Representative / Agent needs to be formally appointed.

An “Authorized Agent” means a person or entity in India authorized by the foreign manufacturer. The authorized agent will be responsible for the import and business activities of the manufacturer in India including compliance to the provisions of the Drugs and Cosmetics Acts in all respects.

The appointed Authorized Representative is also responsible for pre-certification and post-market surveillance inquiries.

Only one Indian Authorized Representative office is needed for the whole country.

CliniExperts can act as an authorised agent and can represent your organization as your Authorized Indian Representative/ Agent in accordance to Indian Regulatory Requirements without any commercial conflict of interest activities like product distribution, product marketing, product sales etc.

References

    1. The Drugs and Cosmetics Act, 1940 and Rules 1945. Available at- https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf . Accessed on – 21st May 2016.

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