An operational guide for foreign cosmetics brands and Indian importers navigating CDSCO's Form COS-2 screening under the Cosmetics Rules, 2020 and BIS IS 4707 heavy metal compliance.
If you are filing for a Form COS-2 import registration on the SUGAM portal today, expect your ingredient lists to be vetted line-by-line before your dossier even reaches a senior review officer's desk. The Central Drugs Standard Control Organisation (CDSCO) has tightened its operational review process under the Cosmetics Rules, 2020. What used to be a routine document verification workflow has evolved into an uncompromising technical audit centered on Indian Standard (IS) 4707 (Parts 1 & 2) and the Ninth Schedule of the Bureau of Indian Standards (BIS).
For foreign brand owners and Indian importers aiming to launch international beauty formulations, this shift changes your pre-filing checklist. A global product that easily clears EU or US FDA requirements can still hit a wall on SUGAM if its raw material profile does not explicitly match local parameters.
Under current CDSCO screening protocols, review officers evaluate every single raw material against two distinct technical benchmarks:
1. IS 4707 (Part 1): Focuses strictly on dyes, pigments, and colorants. Using a color additive that is accepted in Western markets but omitted from India’s approved positive list triggers an immediate deficiency query or outright rejection.
2. IS 4707 (Part 2): Sets strict boundaries on restricted ingredients, maximum safe concentration limits, and approved lists of preservatives and UV filters for leave-on and rinse-off products.
Additionally, compliance with the Ninth Schedule of BIS demands that imported cosmetics contain zero prohibited heavy metals—specifically lead, arsenic, mercury, and cadmium—beyond strict micro-trace levels. If your Certificate of Analysis (CoA) omits quantitative heavy metal testing down to parts-per-million (ppm) levels, your submission will be flagged during pre-screening.
At CosmeTech, our regulatory team regularly handles dossiers flagged by CDSCO deficiency letters. Most rejections do not stem from unsafe product formulations; they stem from operational mismatches between global raw material dossiers and local compliance expectations.
The most frequent pain points include:
Nominal INCI Discrepancies: Using trade names or non-standard INCI terms that do not match the exact chemical nomenclature listed in IS 4707.
Preservative Overages: Formulations containing leave-on concentrations that exceed local limits under Indian regulations.
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