Import of cosmetics was previously regulated by Drugs and Cosmetic Act, 1940 but Indian government has released Cosmetic Rules, 2020 in December, 2020 for regulating Cosmetic products in India.
Key regulatory updates and changes that importers should be aware of include:
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Regulation of Medical Devices: All Class A and B medical devices are now regulated under the licensing regime, effective October 1, 2022.
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Licensing Requirements: Importers must obtain a license from the Central Licensing Authority to import medical devices, including those classified as low-risk.
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Labeling and Packaging: Importers must comply with labeling and packaging regulations, including the requirement for barcodes or QR codes on certain products.
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Testing and Evaluation: Importers must ensure that their products comply with Indian standards and regulations, and may be required to undergo testing and evaluation by designated laboratories.
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Adverse Event Reporting: Importers must report any adverse events related to their products to the Central Drugs Standard Control Organisation (CDSCO).
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Cosmetic Regulations: Importers of cosmetics must comply with the Cosmetics Rules, 2020, which regulate the manufacture, import, and sale of cosmetics in India.
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Registration Requirements: Importers of cosmetics must register their products with the CDSCO before they can be sold in India.