Three changes that matter
First, claim-substantiation dossiers must now be retained for 5 years and produced on inspector demand. Brands using 'clinically proven' or 'dermatologically tested' without files face product withdrawal.
Second, the banned-ingredient list adds 27 substances including specific PFAS and certain Parabens not previously listed.
Third, import registration moves from 120-day to 90-day track for amendments; new registrations remain 9–12 months.
§ KEY TAKEAWAYS
- 01Audit your claim substantiation files now
- 02Cross-check formulations against the 27-substance addition
- 03Re-baseline import-registration timelines in your launch plan
- 04Maintain 5-year archive of all substantiation evidence
§ GLOSSARY
Technical jargon, acronyms and scientific terms used in this file — decoded.
- CDSCO
- Central Drugs Standard Control Organisation — India's cosmetics, drugs and devices regulator.
- Substantiation dossier
- File of evidence (clinical, instrumental, scientific literature) supporting a marketing claim.
- PFAS
- Per- and Polyfluoroalkyl Substances — 'forever chemicals' increasingly restricted globally.
- Paraben
- Class of preservatives (methyl, ethyl, propyl, butyl) under scrutiny for endocrine disruption.
- Import registration
- CDSCO certificate required to import any cosmetic finished good into India; brand+manufacturer specific.