The Indian cosmetics market is thriving, driven by both domestic innovations from cutting-edge Indian companies as well as the entry of foreign companies into this market. Nonetheless, for a product that is chemically referred to as a cosmetic to be lawfully marketed or imported into India and placed into trade, it must comply with Indian law. Essentially, in India, cosmetics are regulated by CDSCO (Central Drugs Standard Control Organization), because it protects the consumer by ensuring all imported cosmetics are safe, of quality, and effective as claimed.
This article will elaborate on how CDSCO regulates cosmetic in India, as well as discuss the import process and regulatory requirements for importing compliant cosmetics.
What Is CDSCO And Its Role In Cosmetic Imports?
The Central Drugs Standard Control Organization (CDSCO), as the National Regulatory Authority, is under the Ministry of Health and Family Welfare (MHFW), which is responsible for the original approval/regulation of drugs and cosmetics. The CDSCO, as the national regulatory authority, must ensure that all imported cosmetic products adhere to Indian standards of safety before entering the distributive market in India.
Why CDSCO Regulates Cosmetic Imports?
CDSCO regulates cosmetic imports, to:
- Protect consumers by examining chemicals (Ingredients/formulation)
- Provide consistency and quality of cosmetic products and adherence to Indian labelling requirements
- Prevent the importation of banned/unsafe materials
- Allow importation in trade while providing health protection to the public
- Uncover manufacturer processes and supply chains
Every cosmetic imported to India, including skin products, make-up, fragrances, and oral care products, must be compliant with the CDSCO guidelines.
Which Cosmetic Products Require CDSCO Import Approval?
The CDSCO will register & approve all types of imported cosmetics to India. Cosmetics include:
- Skin preparations
- Hair preparations
- Colour cosmetics
- Fragrance
- Oral hygiene products
Products that are NOT CDSCO-approved will be subject to, or may be subject to, import seizures, may constitute fines, and may be prohibited from being imported.
Step-by-Step Process TO Import Cosmetics Under CDSCO
The CDSCO regulates cosmetic imports in India, for which there is a well-defined procedure that needs to be followed under the Drugs and Cosmetics Act. These steps are as follows:
Step 1: Product classification
While importing cosmetics into India, it is first important to classify whether the specified products are considered cosmetics under the Drugs and Cosmetics Act. According to CDSCO, a cosmetic means any article intended for application to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.
Step 2: Registration of the importer
The importer will have to register as a user in the CDSCO SUGAM portal and upload the required documents, such as PAN and IEC (Import Export Code), and GST registration.
Step 3: Preparing documents
Collect all the documents necessary to import cosmetics into India, and ensure that the documents uploaded, if applicable, are accurate. If no documentation is uploaded, then delays or rejection can happen.
Step 4: Fee payment
Registration fees are paid online via the Bharatkosh portal at a fixed rate for each type of product and each type of variant.
Step 5: Application submission
The COS 1 application and completed documents must be submitted via the SUGAM portal for review by CDSCO. As of August 2024, a single application on the SUGAM portal is limited to 50 products, but multiple applications can be filed to register all the products.
Step 6: Respond to queries
On reviewing applications, CDSCO may raise clarifications or ask for more documents. It is important to respond timely and accurately to avoid rejection or penalty.Â
Step 7: Request for Approval and Registration Certificate IssuanceÂ
Once approved, CDSCO will issue the registration certificate (Form COS-2) for 5 years. The Product Registration Certificate is required for customs clearance and the importation process.Â
Step 8: Importation and Customs ClearanceÂ
After ensuring the cosmetic import registration certificate and relevant documents, importers now move forward to customs clearance.
Consequences Of Non-Compliance With CDSCO Regulations
The consequences of importing cosmetics without obtaining CDSCO approval may be:
- Customs seizure or confiscation of shipments
- Significant financial penalties and costs
- Suspension or cancellation of import licenses
- Recalls and bans on sale or use in India
- Pursuing criminal prosecution under the Drugs and Cosmetics Act
How ELT Corporate Can Help with CDSCO Cosmetic Imports
Navigating CDSCO’s regulatory process can be complex. ELT Corporate specializes in assisting importers and manufacturers with:
- End-to-end CDSCO Regulates Cosmetic Imports compliance
- Preparing and submitting registration applications
- Handling document preparation, including Free Sale Certificates and Power of Attorney
- Coordinating with CDSCO for queries and approvals
- Post-registration support, including renewals and label compliance
Do I Need CDSCO Registration To Provide Samples Or Testers?
Yes, if you are importing the samples for commercial gain. As for a tester for testing or clinical evaluation, you may have a different process to follow.
How Long To Get A COS-2 Certificate?
It varies, but it can take 2-4 months depending on how your documentation is constructed and CDSCO’s backlog.
Do Cosmetics Manufactured In India Require CDSCO Registration?
No, the manufacturer must honour or comply with the respective BIS standards and labelling.
