CDSCO Registration For Oral Care Products

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Launching an oral care product, such as toothpaste or mouthwash, in India’s market? You require CDSCO registration for oral care products to compete at the same standard as regulations. What it signifies is that your business meets the same level of health and safety guidelines that India’s most regulatory cosmetics regulatory body requires. Are you an importer, manufacturer, or start-up company? Learning how CDSCO clears your dental products is step one in coming into the country legally and with confidence.

In this guide, we will take you through every stage of the registration process, from documentation and classification to portal submission and authorization. This will allow you to address regulatory requirements in one sitting and avoid costly delays.

What Is CDSCO And Its Role In Oral Care Product Regulation

The CDSCO is the national regulatory authority for cosmetic products, pharmaceuticals, and medical devices in India. The Drugs and Cosmetics Act, 1940, regulates and administers the CDSCO. The act regulates approval, inspection, and compliance of cosmetic oral care products, toothpaste, and mouthwash that are not medicated.

Oral care products that are not claiming to make a therapeutic benefit & not contain active medicinal ingredients are considered cosmetics. It must be registered with the CDSCO to be legally sold in the Indian market.

Why Is Cosmetic Registration Necessary For Oral Care Products?

Cosmetic registration of dental care cosmetics is a legal and regulatory requirement in India, particularly if imported. With greater consumer awareness and government regulation, all dental care cosmetics must conform to the Central Drugs Standard Control Organization (CDSCO) guidelines before they are released into the Indian market.

Which Oral Care Products Require CDSCO Registration?

Under the Drugs and Cosmetics Act, 1940, as well as regulation by way of control imposed by the Central Drugs Standard Control Organisation (CDSCO), certain oral care items covered under the meaning of a cosmetic are required to be registered mandatorily before import into India or sale within India. Examples of these are cleansing, guarding, or improving preparations for the mouth and teeth, as long as they do not claim to be of therapeutic or medicinal benefit (if so, then they would be drug products, not cosmetics).

The following oral care items need CDSCO registration as cosmetics:

Toothpaste and Toothpowder (non-medicated): Standard formulations used for everyday oral care that do not purport to prevent or treat diseases.
Mouthwash and Oral Rinses (cosmetic only): If sold as deodorizing agents and not antiseptic or antibacterial solutions.
Whitening Gels and Strips: When sold for cosmetic whitening only and not for clinical or therapeutic purposes.
Breath Fresheners (non-medicated): Like sprays or strips used for freshening breath, but which have no active drug ingredients.
Tooth Polishes: Applied to improve the appearance of teeth without making health claims.

Step-by-Step Process for CDSCO Registration for Oral Care Products

Successfully navigating CDSCO registration for oral care products involves several steps:

Determine Product Classification : Compiling all the necessary Check if the product is a cosmetic under Indian law. A cosmetic is any article to be placed on the human body for cleansing, beautifying, or modifying appearance without altering its functions.

Appoint an Authorized Indian Agent: Confirm that your product falls Foreign manufacturers must appoint an Authorized Indian Agent with a valid wholesale license to file for registration.

Submit the Online Application (Form COS-1) : The authorized agent or manufacturer must submit Form COS-1 on the SUGAM portal, CDSCO’s official online platform.

Compile Required Documents : Gathering all the necessary documents is the necessary step to apply for cosmetic registration for oral care products. Below we have atteched the list of required documents for obtaining CDSCO approval.

Pay Registration Fees : Fees vary depending on the number of products and manufacturing sites. Payment is made online and acknowledged through the portal.

Inspection and Evaluation : In some cases, CDSCO may inspect the manufacturing premises or verify the documentation in detail.

Grant of Registration Certificate (Form COS-2) : Upon successful verification, CDSCO issues the registration certificate (COS-2) valid for 3 years.

Documents Required To Obtain Cosmetic Registration For Oral Care Products In India

Here is a simple list of documents required to obtain cosmetic registration for oral care products in India:

Documents Required For All Applicants:

Covering Letter : A letter addressed to the Drugs Controller General of India stating the intent to register the product.

Form COS-1 : The official application form as per the Cosmetic Rules, 2020.

Power of Attorney : A document authorizing the Indian agent to act on behalf of the foreign manufacturer. It must be notarized and apostilled or legalized.

Payment Receipt : Proof of payment of registration fees made through the Bharatkosh portal.

Product List : A detailed list of oral care products to be registered, including names, variants, and packaging sizes.

Free Sale Certificate : Issued by the regulatory authority in the country of origin, confirming the product is sold freely in that market.

Certificate of Manufacturing : A Document showing the product is manufactured under a valid license in the country of origin.

Product Labels : Labels from the product packaging in both the original language and English, following Indian labeling rules.

Product Specifications : Details of physical and chemical properties, along with testing methods.

Ingredients List : Complete list of ingredients with their percentages. Must comply with Indian cosmetic regulations.

Safety and Stability Data : Reports confirming the safety and shelf life of the product under normal storage conditions.

Pack Insert or Leaflet : Any instruction manual or information leaflet included with the product.

Undertaking Letter : A declaration confirming that the product complies with Indian regulations and does not contain banned substances.

Timeline and Cost for CDSCO Registration

To help you plan better, here is an overview of the timeframe and cost involved in cosmetic registration for oral care products in India:

Stage/Component	Estimated Duration	Estimated Cost	Remarks
Document Preparation	2 to 4 weeks	Varies	Depends on how quickly documents are gathered and verified
Application Submission	1 to 2 weeks	Included in consultant fee	Submission via CDSCO SUGAM portal
CDSCO Evaluation and Approval	3 to 6 months	No extra cost	Subject to CDSCO workload and application completeness
Government Fees (per brand)	–	USD 250	As per Cosmetic Rules, 2020
Government Fees (per variant)	–	USD 1,000	Applies to each product under the same brand
Legalization Charges	–	Varies by country	Covers notarization and apostille of documents
Consultant/Service Fee	–	INR 25,000 to INR 1,00,000+	Optional, based on services required
Total Registration Time	3 to 6 months	Depends on number of products	From start to approval

Key CDSCO Labeling Requirements for Oral Care Products

One of the most essential elements of cosmetic compliance is labeling correctly. CDSCO requires each cosmetic product to adhere to certain labeling according to the Drugs and Cosmetics Rules, 1945: