Regulatory

BIS and CDSCO Compliance for Indian D2C Cosmetics 2026

Indian D2C cosmetics are regulated by CDSCO (Central Drugs Standard Control Organisation) under the Drugs and Cosmetics Act. Imported cosmetics require import registration. Claim substantiation for active-ingredient products is scrutinised heavily.

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What's required

Manufacturing license (Form 32) for in-India manufacturing.
CDSCO import registration for imported finished goods or actives.
Label compliance under the Legal Metrology Rules — Indian-language usage, MRP, batch, manufacturer details.
Claim substantiation for actives — clinical or in-vitro data filed with product file.

Common claim risks

'Clinically proven' without filed clinical study.
'Dermatologist tested' without dermatology endorsement record.
'Anti-ageing' / 'wrinkle-reducing' without efficacy data.
These attract notices from CDSCO and consumer-court complaints.

Frequently asked questions

Is BIS mark mandatory for cosmetics?↓

Specific categories (toothpaste, soap variants) require BIS certification. Most D2C beauty SKUs fall under CDSCO, not BIS.

What happens if I make a claim without substantiation?↓

Possible notices from CDSCO, advertising regulator (ASCI), and consumer complaints. Worst case: product recall and penalties.

Do I need separate compliance for marketplace vs D2C site?↓

No. Compliance is at the product/manufacturing level, not the channel level.

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