India has one of the most rapidly expanding markets in the world when it comes to the cosmetics and skincare sector. India has implemented structured cosmetic regulatory controls under the Drugs & Cosmetics Act, 1940 and the Cosmetics Rules, 2020.
According to the 1940 Drugs and Cosmetics Act and the Cosmetics Rules 2020, India does not allow the importing of cosmetics without first obtaining permission from India’s Central Drugs Standard Control Organisation (CDSCO).
To obtain CDSCO approval, international skincare brands must engage with an India-licensed authorised agent, importer, subsidiary, or their own registered Indian office.
What Is CDSCO Cosmetic Registration?
To import cosmetic items into India, one must obtain a CDSCO cosmetic registration, which is a compulsory requirement.
- This registration is done by filling out Form COS-1, which is available online.
- Form COS-2 is issued by CDSCO. COS-2 acts as the official Import Registration Certificate and is mandatory for customs clearance in India.
- Cosmetic products cannot be imported, customs cleared, distributed, or sold in the Indian territory until an approval is granted.
Cosmetic import registration is regulated under the Cosmetics Rules, 2020, framed under the Drugs and Cosmetics Act, 1940.
Why International Skincare Brands Cannot File Applications Independently from Outside India?
Under Indian law, CDSCO requires the applicant for cosmetic import registration to be an entity located within India. This is because:
- Indian regulators must have a legally accountable party within Indian jurisdiction
- Foreign entities located entirely outside India cannot be directly regulated or enforced against
- Compliance, safety reporting, inspections, and recalls must be handled by a locally responsible entity
Therefore, international skincare brands cannot submit cosmetic registration applications directly unless they have an established presence in India.
Who Can Apply for CDSCO Cosmetic Registration on Behalf of a Foreign Brand?
As per CDSCO guidance and the Cosmetics Rules, 2020, the application for cosmetic import registration can be submitted by:
- The foreign manufacturer, through its authorised Indian agent
- An importer or distributor based in India
- An Indian subsidiary of the foreign manufacturer
- The foreign manufacturer, if it has its own registered office in India
In practice, most international skincare brands appoint an authorised Indian agent or importer, as they do not have a registered establishment in India.
Role and Responsibilities of the Indian Entity
The Indian entity acts as the regulatory representative of the international skincare brand and serves as the primary point of contact with CDSCO.
1. Filing Cosmetic Registration Applications
The Indian entity submits Form COS-1 on the CDSCO portal along with all required documents, including product details, ingredient lists, labeling information, and safety certificates.
2. Import and Customs Compliance
Only cosmetic products covered under a valid COS-2 registration certificate can be imported. The Indian entity ensures compliance during customs clearance.
3. Regulatory Communication with CDSCO
All regulatory queries, deficiency letters, inspections, and notices from CDSCO are handled by the Indian entity.
4. Post-Approval Compliance and Record Maintenance
The Indian entity maintains import records, distribution details, and compliance documentation as required under Indian law.
5. Safety Reporting and Product Recall
In the event of adverse reactions, safety concerns, or product recalls, the Indian entity coordinates corrective actions with CDSCO.
Legal Accountability Under the Cosmetics Rules, 2020
Under the Cosmetics Rules, 2020, the Indian entity is legally responsible for:
- Compliance with labeling and packaging requirements
- Accuracy of product information and ingredient declarations
- Product safety and quality
- Regulatory violations and non-compliance issues
This framework ensures that Indian authorities always have a locally accountable party responsible for imported cosmetic products.
Benefits of Engaging a Competent Indian Agent or Importer
For international skincare brands, engaging a knowledgeable Indian entity offers several advantages:
- Faster and smoother CDSCO approvals
- Reduced risk of application rejection
- Proper labeling and documentation compliance
- Efficient customs clearance
- Ongoing regulatory and post-market compliance support
A well-informed Indian agent helps brands avoid delays, penalties, and regulatory disruptions.
Common Mistakes International Skincare Brands Should Avoid
- Assuming that cosmetic products can be imported without CDSCO registration
- Appointing agents without regulatory experience
- Submitting incomplete or incorrect documentation
- Non-compliant ingredient lists or labeling
- Ignoring post-approval compliance obligations
These mistakes often result in application rejection, customs detention, or regulatory action.
Why Choose ELT Corporate?
ELT Corporate provides end-to-end regulatory support for international skincare brands seeking to enter the Indian market. As an experienced Indian regulatory partner, ELT Corporate assists with:
- CDSCO cosmetic registration (Form COS-1 and COS-2)
- Documentation preparation and review
- Ingredient and labeling compliance as per Indian regulations
- Import coordination and regulatory communication
- Post-approval compliance and ongoing support
With strong regulatory expertise and practical experience, ELT Corporate helps international brands achieve compliant, timely, and hassle-free entry into the Indian cosmetics market.
Is CDSCO cosmetic registration mandatory for importing cosmetics into India?
Yes, all imported cosmetic products must be registered with CDSCO before import.
Can a foreign skincare brand apply directly to CDSCO from outside India?
No, the application must be submitted by an entity established in India.
Is appointing an Indian agent mandatory in all cases?
An Indian agent is required unless the foreign manufacturer has its own registered office or subsidiary in India.
Which forms are used for cosmetic import registration?
Form COS-1 is used for the application, and Form COS-2 is issued as the registration certificate.
Can CDSCO cancel a cosmetic registration certificate?
Yes, CDSCO may suspend or cancel registration in case of non-compliance or safety issues.
