Toothpaste and tooth powder are cosmetics under the Cosmetics Rules, 2020 and must be registered with CDSCO before import. Oral-care products carry a distinctive mix of requirements — fluoride reporting, a specific safety declaration on diethylene glycol and melamine, and a claim boundary between cosmetic whitening and therapeutic treatment.
The application is Form COS-1, granted as Form COS-2. As with skin care and hair oil, the recurring risk is claims: anti-cavity, desensitising and gum-treatment claims can convert the product into a drug, and children's fluoride toothpaste has its own labelling expectations.
📌 The diethylene-glycol contamination scares of the past mean CDSCO expects an explicit declaration on the absence of diethylene glycol and melamine for imported toothpaste — it is a standard, not optional, part of the dossier.
📋 Is CDSCO Registration Mandatory for Toothpaste & Tooth Powder?
Yes. Toothpaste and tooth powder are cosmetics within the Fourth Schedule category of oral-care preparations, and import registration is mandatory. IS 6356 covers toothpaste and IS 5383 covers tooth powder.
Where the product makes whitening, anti-cavity, desensitising or gum-treatment claims, CDSCO reviews whether the claim converts the product into a drug — so the claim set has to be settled before filing.
📘 The Indian Standard That Applies
The Ninth Schedule points toothpaste to IS 6356 and tooth powder to IS 5383. The Certificate of Analysis against IS 6356 must report pH, abrasiveness, moisture and volatile matter, freedom from foreign matter, heavy metals, spreadability and stability.
Where fluoride is present, a fluoride-content report expressed in ppm F is required, and the fluoride level must be appropriate for the intended user group. A declaration on the absence of diethylene glycol and melamine, a microbiological report, and a sweetener-and-colourant declaration complete the product-specific set.
🗂️ Documents Required for Toothpaste & Tooth Powder
Every Form COS-1 application carries the same core set — covering letter; First Schedule authorisation; Part-I of the Second Schedule; ingredient list with percentages; inner and outer labels; specification and method of testing; finished-product Certificate of Analysis; country-of-origin manufacturing licence or marketing authorisation; original Free Sale Certificate; non-animal-testing declaration; heavy-metal and hexachlorophene declaration; GMP / ISO 22716 certificate; correlation chart; Bharatkosh receipt; and the signed Form COS-1. On top of that base, this product needs:
- Certificate of Analysis against IS 6356 — pH, abrasiveness, moisture and volatile matter, freedom from foreign matter, heavy metals, spreadability and stability.
- Fluoride-content report expressed in ppm F where fluoride is present.
- Declaration on the absence of diethylene glycol and melamine.
- Microbiological report.
- Sweetener and colourant declaration.
- Substantiation for any whitening, anti-cavity, desensitising or gum-treatment claim, with a review of whether the claim converts the product into a drug.
🏷️ Product-Specific Label Requirements
Oral-care labels are checked for these product-specific points:
- Fluoride content stated on the pack.
- Supervision and quantity guidance for children where fluoride is present.
- Net content stated by weight.
- The general Chapter VI content — manufacturer or “Made in”, batch number, expiry and RC number.
🛠️ Step-by-Step Registration Process
- Classify the productConfirm the article meets the definition of a cosmetic under Section 3(aaa) and is not a drug, then map it to the correct category under the Fourth Schedule — this drives both the fee and the certificate scope.
- Appoint the Authorised Indian AgentExecute the authorisation in the format of the First Schedule, signed jointly by the manufacturer and the agent on every page, then notarised and apostilled (Hague states) or attested by the Indian Embassy.
- Assemble the technical dossierIngredient list with percentages, specification and method of testing, finished-product test reports, inner and outer labels, GMP / ISO 22716 evidence and the Free Sale Certificate.
- Align the label to Chapter VIIndian labelling is one of the top rejection reasons. India-specific content may be stickered onto the unit pack at a bonded warehouse before clearance.
- Pay the fee on BharatkoshCompute the category, site and variant fees, pay online under head 0210041040000-00-1 and retain the Bharatkosh acknowledgement receipt for upload.
- File Form COS-1 on SUGAMUpload the full checklist, including the correlation chart that ties each product serial number in COS-1 to the Free Sale Certificate and the authorisation.
- Respond to CDSCO queriesQueries typically concern apostille defects, Free Sale Certificate scope mismatch, ingredient limits and label non-compliance. Reply within the stipulated period.
- Receive Form COS-2Print the Registration Certificate number on every unit pack, alongside the holder’s name and address, before the goods are cleared for sale.
💰 Government Fees
CDSCO cosmetic registration is priced under the Third Schedule and paid product-family by product-family, not as a single flat licence. The headline components are:
Each cosmetic category
USD 1,000 for the grant or retention of the Registration Certificate, per Fourth Schedule category.
Each additional category
USD 1,000 for every further category of cosmetic added to the same application.
Each variant
USD 50 for each shade, fragrance or formulation variant declared.
Each manufacturing site
USD 500 for every overseas manufacturing premises covered by the certificate.
Fees are paid online through the Bharatkosh gateway under head of account 0210041040000-00-1, and the acknowledgement receipt is uploaded with the application. As a worked example, an importer registering one category from a single factory with six shade or fragrance variants would pay USD 1,000 (category) + USD 500 (site) + 6 × USD 50 (variants) = USD 1,800 in government fees, before professional and testing costs. Inspection of an overseas site, if ordered, is a further USD 5,000.
⏱️ Timeline & Validity at a Glance
A complete, well-drafted application is typically cleared in about four to six months. The single biggest lever on that timeline is the quality of the first filing: every query CDSCO raises effectively restarts the clock, so a dossier that pre-empts the common objections is worth far more than one filed quickly and corrected later. The certificate is valid for five years and should be re-registered before expiry — an application filed after lapse is treated as a fresh registration.
⚠️ Where Applications Usually Get Queried
Toothpaste queries concentrate on claims and fluoride:
- Therapeutic oral-health claims that convert the product into a drug.
- Fluoride levels exceeding what is acceptable for the intended user group.
- Toothpaste for children not carrying appropriate supervision wording.
- A missing diethylene-glycol and melamine declaration.
🔗 Related Approvals Alongside CDSCO
Alongside the CDSCO registration, imported oral care usually needs:
- Importer-Exporter Code (DGFT) — mandatory for any importer of record, obtained before the first consignment.
- LMPC registration (Legal Metrology) — importers of pre-packaged commodities must register under the Legal Metrology (Packaged Commodities) Rules, 2011 and carry MRP, net quantity, importer details, country of origin, consumer-care details and date of import on the pack.
- Wholesale drug licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
- Drug import licence (Form 10) — if the product contains a pharmacologically active ingredient or carries a therapeutic claim, it is a drug, not a cosmetic, and this route no longer applies.
❓ Frequently Asked Questions
Is toothpaste a cosmetic or a drug in India?
Toothpaste is a cosmetic and is registered with CDSCO under IS 6356. But anti-cavity, desensitising or gum-treatment claims can convert it into a drug, so CDSCO reviews the claim set as part of the application.
Do I have to declare fluoride?
Yes. Where fluoride is present, a fluoride-content report in ppm F is required and the fluoride content must be stated on the pack. Children's toothpaste must also carry supervision and quantity wording.
Why is a diethylene-glycol declaration needed?
Because of past contamination incidents in oral-care and related products, CDSCO expects an explicit declaration on the absence of diethylene glycol and melamine as a standard part of the toothpaste dossier.
Is CDSCO registration mandatory to import toothpaste & tooth powder into India?
Yes. Under Rule 12(1) of the Cosmetics Rules, 2020, no cosmetic may be imported into India unless the product is registered with the Central Licensing Authority. The registration is granted product by product in Form COS-2 and must be in place before the first consignment lands.
Which form and portal are used?
The application is Form COS-1, filed online on the CDSCO SUGAM portal by the overseas manufacturer or, far more commonly, by an Authorised Indian Agent. The approval is issued as an Import Registration Certificate in Form COS-2.
How long does registration take and how long is it valid?
A complete application is usually cleared in about four to six months, and each CDSCO query effectively restarts the clock. The certificate is valid for five years from the date of issue and must be re-registered before it lapses.
Do we need an Indian agent?
Almost every application is filed through an Authorised Indian Agent, appointed on the First Schedule format. The agent carries statutory liability for the product in India even after the power of attorney is withdrawn, so this is a substantive appointment, not a formality.
Oral-Care Import Registration, Claims and Fluoride Cleared
Global Approbation manages CDSCO registration for imported toothpaste and tooth powder — IS 6356 review, fluoride and DEG declarations, and the whitening-versus-treatment claim assessment — so your oral-care range is filed correctly the first time.
Talk to Our CDSCO Team Global Market Access