Anti-dandruff shampoos and lotions are Fourth Schedule hair and scalp preparations, and an imported cosmetic anti-dandruff product must be registered with CDSCO under the Cosmetics Rules, 2020 before the first consignment. Registration is product-level and tied to the specific formulation and manufacturing site.
The shampoo base is covered by IS 7884, but the filing really turns on the anti-dandruff active. India treats anti-dandruff products as cosmetics only while the active stays cosmetic — several of the strongest dandruff agents are drugs, and a product built on them cannot travel the cosmetic route.
📌 Under Rule 12(1) of the Cosmetics Rules, 2020, no cosmetic anti-dandruff product may be imported into India unless it is registered by the Central Licensing Authority. The application is Form COS-1 on the CDSCO SUGAM portal and the approval is issued as an Import Registration Certificate in Form COS-2. A medicated anti-dandruff product follows the drug route under Form 10 instead.
📋 Is CDSCO Registration Mandatory for Anti-Dandruff Products?
Yes, for a cosmetic anti-dandruff product. An anti-dandruff shampoo or lotion on a cosmetic active is a Fourth Schedule scalp-care preparation and needs CDSCO registration before import. The IS 7884 CoA is the technical base; the active and the claim keep it on the cosmetic route.
The application is filed by the overseas manufacturer or, in practice, its Authorised Indian Agent.
📘 The Standard in Detail
The applicable Ninth Schedule standard for the shampoo base is IS 7884, and the Certificate of Analysis reports pH, active-detergent content, foaming, stability and microbiological limits. On top of the base CoA, CDSCO expects the anti-dandruff active to be declared with its concentration, and the anti-dandruff claim to be substantiated.
The active is where the route is decided. Cosmetic anti-dandruff actives — zinc pyrithione, piroctone olamine, climbazole and cosmetic-level salicylic acid — keep the product a cosmetic. Drug actives — ketoconazole, selenium sulphide and coal tar — are medicated agents that move the product to the drug route under Form 10, whatever the format.
🗂️ The Core Document Set — Required for Every Application
Whatever the product, Form COS-1 carries the same core dossier. Getting this base right is what decides whether the file clears in one pass or comes back as a query letter; the product-specific documents in the next section sit on top of it.
- Covering letter — states the purpose (fresh registration, endorsement of a product, site or pack size, or re-registration), references any earlier certificate and points to the correlation charts.
- Authorisation from the manufacturer (First Schedule) — names the manufacturer, every manufacturing premises, the Authorised Indian Agent and each product, variant and pack size; signed jointly on every page, then notarised and apostilled (Hague states) or embassy-attested.
- Part-I of the Second Schedule — company and product particulars, chemical information and the nine statutory undertakings, completed afresh for each COS-1.
- Ingredient list with percentages — INCI nomenclature, percentage of each ingredient, signed by a competent person; must exclude anything listed in Annex A of IS 4707 (Part 2).
- Inner and outer labels — legible originals for the product and every variant, compliant with Chapter VI.
- Specification and method of testing — the finished-product specification and test method, signed and stamped.
- Finished-product Certificate of Analysis — a batch CoA against the applicable Ninth Schedule Indian Standard, or against country-of-origin standards where no Indian Standard exists.
- Manufacturing licence / marketing authorisation — an authenticated copy from the country-of-origin regulator, or a manufacturer's undertaking where no such regime exists.
- Free Sale Certificate (FSC) — original, from the National Regulatory Authority of the country of origin; if issued by a chamber of commerce, apostilled or embassy-attested, and the product list signed and stamped.
- Non-animal-testing declaration — that the products have not been tested on animals after 12 November 2014.
- Heavy-metal and hexachlorophene declaration — a test report for Pb, As, Hg and other heavy metals plus microbiological results, or a manufacturer's undertaking of compliance.
- GMP / ISO 22716 certificate — evidence of cosmetic Good Manufacturing Practice at the overseas site.
- Correlation chart — maps each product serial number in COS-1 against the FSC and the Authorisation; missing or inconsistent charts are among the most common causes of query letters.
- Bharatkosh fee receipt — acknowledgement of the fee paid under head of account 0210041040000-00-1.
- Duly signed Form COS-1 — original, with every detail matching the Authorisation and Second Schedule Part-I exactly.
➕ Extra Documents for Anti-Dandruff Products
On top of the core dossier above, a anti-dandruff product application needs:
- Certificate of Analysis against IS 7884 — pH, active-detergent content, foaming, stability and microbiological limits.
- Anti-dandruff active declaration with the concentration of zinc pyrithione, piroctone olamine, climbazole or salicylic acid.
- Confirmation that the active is a permitted cosmetic agent and not a drug substance (ketoconazole, selenium sulphide, coal tar).
- Claim-substantiation dossier for the anti-dandruff / flake-control claim.
- Preservative and microbiological data.
- Heavy-metals report or manufacturer undertaking.
⚗️ Composition & Safety Limits
Regardless of category, the finished cosmetic must respect the composition limits in the Cosmetics Rules, 2020. CDSCO checks these against the heavy-metal report or the manufacturer's undertaking:
- Arsenic (in permitted colours) — not more than 2 ppm, as arsenic trioxide.
- Lead (in permitted colours) — not more than 20 ppm, as lead.
- Other heavy metals (in permitted colours) — not more than 100 ppm as the total of the respective metals.
- Mercury — up to 70 ppm (0.007%) as a preservative in eye-area products only; unintentional mercury not to exceed 1 ppm in all other products.
- Hexachlorophene — prohibited, except in soaps up to 1% w/w with the prescribed caution.
- Lead and arsenic compounds as colourants — prohibited outright.
- Dyes, colours and pigments — only those specified in IS 4707 (Part 1) / IS 4707 (Part 2) and the Tenth Schedule.
The active concentration is the composition control that keeps an anti-dandruff product on the cosmetic route. Zinc pyrithione and piroctone olamine are cosmetic within their limits; ketoconazole and selenium sulphide are not cosmetic at any level. Declare the active and its concentration, and confirm it is a permitted cosmetic ingredient within range.
🏷️ Anti-Dandruff Products Label Requirements
In addition to the general Chapter VI requirements, anti-dandruff product labels are checked for these product-specific points:
- The anti-dandruff active and directions for use, including contact time.
- An anti-dandruff or flake-control claim consistent with the substantiation on file — not an anti-fungal-disease claim.
- Any caution for the active (eye contact, rinse thoroughly).
- Address of the actual manufacturer, or “Made in ____” where contract manufactured; for containers of 60 ml or less, manufacturer name and principal place of manufacture with PIN code is sufficient.
⚖️ The Cosmetic-versus-Drug Line for Anti-Dandruff
Anti-dandruff products live on the claim and active boundary. “Controls dandruff”, “reduces flakes” and “soothes an itchy scalp” are cosmetic claims on a cosmetic active. “Treats seborrhoeic dermatitis”, “anti-fungal” or “treats scalp infection” are therapeutic claims that make the product a drug.
The active can decide it independently of the wording: a ketoconazole or selenium sulphide shampoo is a drug even if it only says “anti-dandruff” on the front. Keep the active cosmetic and the claim at flake-control level, and the product stays a cosmetic; cross either line and it belongs on Form 10.
🛠️ 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 Fourth Schedule category — this drives both the fee and the certificate scope.
- Appoint the Authorised Indian AgentExecute the authorisation in the First Schedule format, signed jointly by manufacturer and 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 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, as each query restarts the effective clock.
- 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 category by category, 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 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.
Fees are paid online through the Bharatkosh gateway under head of account 0210041040000-00-1, and the acknowledgement receipt is uploaded with the application. A duplicate certificate is USD 200, permission for a novel ingredient not previously used in India is USD 500, and inspection of an overseas manufacturing 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, and a retention fee keeps the certificate alive across the term.
⚠️ Where Anti-Dandruff Products Applications Get Queried
Most anti-dandruff queries turn on the active and the claim:
- A drug active — ketoconazole, selenium sulphide or coal tar — in a product filed as a cosmetic.
- An anti-fungal or scalp-disease claim that makes the product a drug.
- The anti-dandruff active declared without a concentration.
- A CoA against IS 7884 that omits the microbiological limits or stability.
🔗 Related Approvals Alongside CDSCO
CDSCO registration rarely travels alone. Depending on the product and the importer, plan for these adjacent approvals in parallel, because any one of them can hold a consignment at the port even when the CDSCO certificate is in order:
- Importer-Exporter Code (DGFT) — mandatory for any importer of record, obtained before the first consignment.
- LMPC registration (Legal Metrology) — importers of pre-packaged commodities 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 licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
- Drug import licence (Form 10) — where the product contains a pharmacologically active ingredient or makes a therapeutic claim, it is a drug, not a cosmetic, and this route replaces COS-1.
✅ Post-Approval Obligations
The certificate is the start of an ongoing compliance duty, not the end of it. After grant, the registration holder must:
- Print the Registration Certificate number on every unit pack, with the name and address of the certificate holder.
- Report any change in labelling, composition, testing or specification within 30 days, with an undertaking of continued compliance with the Ninth Schedule standards.
- Report any market withdrawal, regulatory restriction, cancellation of authorisation or not-of-standard-quality finding in any country where the product is sold, and stop dispatch and marketing immediately.
- Allow the Licensing Authority to draw samples for testing and to inspect the overseas manufacturing premises.
- Track BIS standard revisions — a new or amended Indian Standard becomes mandatory six months after publication.
- Diarise re-registration well before the five-year expiry.
❓ Frequently Asked Questions
Is CDSCO registration mandatory for imported anti-dandruff shampoo?
Yes, for a cosmetic anti-dandruff product. It is a Fourth Schedule scalp-care preparation and cannot be imported until registered under Rule 12(1) of the Cosmetics Rules, 2020, with the certificate issued in Form COS-2. A medicated product follows the drug route instead.
Which Indian Standard applies to anti-dandruff shampoo?
IS 7884 for the shampoo base — pH, active-detergent content, foaming, stability and microbiological limits — with the anti-dandruff active declared and substantiated on top.
Is a ketoconazole anti-dandruff shampoo a cosmetic?
No. Ketoconazole, selenium sulphide and coal tar are drug substances, so those products are drugs under Form 10, not cosmetics. Only cosmetic actives such as zinc pyrithione and piroctone olamine keep the product on the CDSCO cosmetic route.
Can an anti-dandruff shampoo claim to treat a scalp condition?
No, not as a cosmetic. Treating seborrhoeic dermatitis or a scalp infection is therapeutic and moves the product to the drug route. A cosmetic may claim dandruff and flake control only.
How long does registration take and how long is it valid?
Around four to six months for a complete application; the certificate is valid for five years and must be re-registered before expiry.
Do we need an Authorised Indian Agent?
In practice yes — the agent files on the First Schedule format and carries statutory liability for the product in India.
Anti-Dandruff Import Registration, Handled End to End
Global Approbation manages the complete CDSCO cosmetic registration for imported anti-dandruff shampoos and lotions — active classification, IS 7884 CoA mapping, claim and label review, dossier assembly and query response — so your first consignment clears without avoidable delay.
Talk to Our CDSCO Team Global Market Access