South Asia · India
What does it take to sell cosmetics in India? Entry route, responsibility, labeling
Pre-market import registration: a Form COS-1 application via SUGAM leads to a COS-2 Impor…; Responsible person: A foreign manufacturer must appoint an Indian authorised ag…; Labeling: English and/or Hindi label with product name, man….
Latest change 2025-07-29 — Cosmetics (Amendment) Rules 2025 clarified 'use before' and 'date of expiry' definitions, allowed electronic batch records and shifted some powers to State Licensing Authorities; BIS revised IS 4707 Part 2 (list of substances) on 2025-08-21 and on 2026-07-02 proposed banning 64 fragrance raw materials (consultation to 2026-08-31). Source
Factory-side digest; the official text prevails; not legal advice.
- Authority
- Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare; State Licensing Authorities for manufacturing
- Main regulation
- G.S.R. 763(E) of 2020-12-15; Cosmetics (Amendment) Rules 2025 notified 2025-07-29 · Cosmetics Rules, 2020 under the Drugs and Cosmetics Act, 1940 (as amended by the Cosmetics (Amendment) Rules, 2025)
- In force
- 2020-12-15
- Market entry
- Pre-market import registration: a Form COS-1 application via SUGAM leads to a COS-2 Import Registration Certificate (valid 5 years, product by product), while domestic manufacture needs a state licence.
- Responsible person
- A foreign manufacturer must appoint an Indian authorised agent, subsidiary or importer that holds the COS-2 registration and is named on the label.
- Safety file
- No PIF as such; the applicant submits product specifications, test methods, labels and an undertaking that the product conforms to the applicable BIS standard listed in the Ninth Schedule.
- Labeling
- English and/or Hindi label with product name, manufacturer and importer name/address (incl. 'Made in ...'), batch number, manufacturing and use-before/expiry date, net content, registration number and an 'INGREDIENTS' list (ingredients above 1% in descending order); no fragrance-allergen rule.
- Animal testing
- Animal testing of cosmetics banned in India (Rule 148-C, 2014) and import of cosmetics tested on animals prohibited since 2014-11-13 (Rule 135-B).
- Ingredient lists
- BIS standards in the Ninth Schedule of the Cosmetics Rules 2020, notably IS 4707 Part 1 (colourants) and Part 2 (prohibited/restricted substances, revised 2025), plus product-specific IS specifications.
- Notes
- The Gazette G.S.R. number of the 2025 amendment was not found; a CDSCO circular effective 2026-01-16 reportedly auto-rejects SUGAM applications whose queries stay unanswered for 90 days (consultancy source).
- Official text
- https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Cosmetics-Rules/
FAQ
Does India require notification or registration before sale?
Pre-market import registration: a Form COS-1 application via SUGAM leads to a COS-2 Import Registration Certificate (valid 5 years, product by product), while domestic manufacture needs a state licence.
Is a local responsible person mandatory in India?
A foreign manufacturer must appoint an Indian authorised agent, subsidiary or importer that holds the COS-2 registration and is named on the label.
What are the labeling requirements in India?
English and/or Hindi label with product name, manufacturer and importer name/address (incl. 'Made in ...'), batch number, manufacturing and use-before/expiry date, net content, registration number and an 'INGREDIENTS' list (ingredients above 1% in descending order); no fragrance-allergen rule.
What changed recently in India cosmetic regulation?
2025-07-29 Cosmetics (Amendment) Rules 2025 clarified 'use before' and 'date of expiry' definitions, allowed electronic batch records and shifted some powers to State Licensing Authorities; BIS revised IS 4707 Part 2 (list of substances) on 2025-08-21 and on 2026-07-02 proposed banning 64 fragrance raw materials (consultation to 2026-08-31).
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