CDSCO Cosmetic Import Registration in India: The Complete Guide

India is one of the largest and fastest-growing cosmetics markets in the world, but a foreign brand cannot simply ship product to a distributor and start selling. Every cosmetic imported into India must first be registered with the Central Drugs Standard Control Organisation (CDSCO) under the Cosmetics Rules, 2020. This is a product-level registration, not a one-time company licence: the certificate is tied to the specific product, its brand, its variants, its pack sizes and the exact manufacturing premises where it is made.

This guide is the overview of the whole route — the legal basis, who can apply, the fees, the process, the documents and the labelling rules that apply to every cosmetic. Where a product has its own standard and its own recurring query traps — shampoo, sunscreen, lipstick, hair dye and the rest — we link out to a dedicated guide so you can go straight to the detail that matters for your SKU.

📋 How Cosmetic Import Registration Works

Registration is governed by the Drugs and Cosmetics Act, 1940 read with the Cosmetics Rules, 2020 (G.S.R. 763(E), dated 15 December 2020), and administered by CDSCO's Cosmetics Division under the Drugs Controller General (India). One registration covers a defined family of products from a defined factory; a different factory, a new category or an undeclared variant each needs to be added to the certificate. Because the certificate is product-specific, the scope you declare at filing — categories, variants and pack sizes — is the scope you are allowed to import, so getting that mapping right at the outset is the single most important planning decision.

👥 Who Can Apply

An application may be made by the overseas manufacturer directly, by the manufacturer's Authorised Indian Agent or importer holding a valid wholesale drug or cosmetic licence, or by an Indian subsidiary authorised by the manufacturer. In practice almost all applications are filed through an Authorised Indian Agent, because the agent carries statutory liability for the product in India even after the power of attorney is later withdrawn. Appointing the right agent is therefore a substantive legal decision, not a box-ticking formality.

🧴 The Ten Cosmetics Covered — Go Straight to Your Product

Section by section, each of the ten most commonly imported cosmetics has its own guide covering the applicable Indian Standard under the Ninth Schedule, the documents needed on top of the core set, the product-specific label points and the issues that most often trigger a CDSCO query:

• CDSCO Registration for Shampoo — IS 7884 / 7669 / 17117, and the anti-dandruff "drug" trap.
• Skin Cream, Lotion & Moisturiser — IS 6608, and claims that stray into therapeutic territory.
• Sunscreen & Sun Care — no Ninth Schedule standard; SPF ISO 24444 / UVA ISO 24443.
• Lipstick & Lip Colour — IS 9875 / 10284, colourants and shade-wise variants.
• Kajal, Kohl, Eyeliner & Mascara — IS 15154 / 9832, lead and eye-area colours.
• Nail Polish & Nail Enamel — IS 9245, flammable dangerous-goods handling.
• Hair Oil — IS 7123, and the AYUSH line for Ayurvedic claims.
• Hair Dye & Hair Colour — IS 8481 / 15205 / 10350 / 11142, and the mandatory PPD caution.
• Toothpaste & Tooth Powder — IS 6356 / 5383, fluoride and DEG declarations.
• Perfume, Cologne & Deodorant — IS 8482 for cologne, IFRA and aerosol dangerous goods.

🗂️ The Core Document Set — Required for Every Product

The following documents accompany every Form COS-1 application regardless of product type. Each product guide then sets out what that specific cosmetic needs on top of this base:

• Covering letter — states the purpose (fresh registration, endorsement of product / site / pack size, or re-registration) and points to the correlation charts.
• Authorisation from the manufacturer (First Schedule) — names the manufacturer, all manufacturing premises, the Indian Agent and every product, variant and pack size; signed jointly on every page, then apostilled or embassy-attested.
• Part-I of the Second Schedule — company and product particulars, chemical information and nine statutory undertakings, completed afresh for each COS-1.
• List of ingredients with percentages — INCI nomenclature, percentage of each ingredient, signed by a competent person; must exclude anything in Annex A of IS 4707 (Part 2).
• Product labels — inner and outer — legible originals for the product and every variant, compliant with Chapter VI.
• Specification and method of testing — finished-product specification and test method for each product.
• Finished-product Certificate of Analysis — batch CoA against the applicable Ninth Schedule Indian Standard, or country-of-origin standards where no Indian Standard exists.
• Manufacturing licence / marketing authorisation — 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; if from a chamber of commerce, embassy-attested or apostilled.
• Non-animal-testing declaration — that the products have not been tested on animals after 12 November 2014.
• Heavy-metal and hexachlorophene declaration — test report for Pb, As, Hg and other heavy metals plus microbiological results, or an 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 fee paid under head 0210041040000-00-1.
• Duly signed Form COS-1 — original, with every detail matching the Authorisation and Second Schedule Part-I exactly.

⚗️ Composition Limits That Apply Across the Board

Regardless of product category, the finished cosmetic must respect the composition limits set out in the Cosmetics Rules, 2020:

• 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 caution "Contains hexachlorophene — not to be used on babies".
• 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.

💰 Government Fees

CDSCO cosmetic registration is priced under the Third Schedule and paid category by category, not as a single flat licence:

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 skin-care category and one hair-care category, from a single factory, with six lipstick shades and three shampoo variants, would pay 2 × USD 1,000 (categories) + USD 500 (site) + 9 × USD 50 (variants) = USD 2,950 in government fees, before professional and testing costs.

🛠️ Step-by-Step Registration Process

1. 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.
2. 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.
3. 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.
4. 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.
5. Pay the fee on BharatkoshCompute category, site and variant fees, pay online under head 0210041040000-00-1 and retain the acknowledgement receipt for upload.
6. 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.
7. Respond to CDSCO queriesQueries typically concern apostille defects, Free Sale Certificate scope mismatch, ingredient limits and label non-compliance. Reply within the stipulated period.
8. 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.

🏷️ Labelling Under Chapter VI

No cosmetic may be imported unless it is packed and labelled in conformity with the Cosmetics Rules, 2020. Where India-specific content is needed, it may be stickered onto the unit pack at a bonded warehouse before clearance. The label must carry:

• Name of the cosmetic, and the name and complete address of the manufacturing premises (or "Made in ____" where manufacture is outsourced).
• Use-before or date of expiry (month and year), and a distinctive batch or lot number.
• Net content — weight for solids, fluid measure for liquids; not required for perfume or toilet water of 60 ml or less, or solid / semi-solid cosmetics of 30 g or less.
• Adequate directions for safe use, warnings and cautions where a hazard exists, with hazardous or poisonous ingredients named on the inner label.
• Import Registration Certificate number preceded by "RC", "RC No" or "Reg. Cert. No.", with the name and address of the importer.
• Ingredient list preceded by "INGREDIENTS" — ingredients above 1% in descending order, those at or below 1% in any order; not required for packs of 60 ml (liquid) or 30 g (solid / semi-solid) or less.
• Any additional labelling required by the relevant Indian Standard for products covered by the Ninth Schedule.

⏱️ 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.

🔗 Related Approvals That Sit Alongside CDSCO

CDSCO registration rarely travels alone. Depending on the product and the importer, plan for these adjacent approvals:

• 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.
• AYUSH licence — where the product carries Ayurvedic, Siddha or Unani claims, taking it out of the CDSCO cosmetic route.
• 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.
• PESO / dangerous goods — aerosols and flammable products need storage, transport and handling approvals under the Explosives Rules and the SMPV Rules.

⚠️ Where Applications Usually Go Wrong

Across every product category, the same avoidable defects account for most query letters and rejections:

• Apostille or attestation defects — the Authorisation or FSC notarised but not apostilled, or the apostille not covering the annexed product list.
• Free Sale Certificate scope mismatch — the FSC listing fewer or differently named products than Form COS-1; the correlation chart must reconcile all three line by line.
• Category misclassification — the wrong Fourth Schedule category changes the fee and scope and can force a fresh application.
• Variants under-declared — every shade, fragrance and formulation variant is chargeable at USD 50 and must appear in the Authorisation, the FSC and Form COS-1.
• Colourants not on the Indian list — a colour permitted in the EU or US but absent from IS 4707 (Part 1) and the Tenth Schedule will not be accepted.
• Label non-compliance — missing batch number, expiry, "Made in", hazard warning, or no provision for the RC number.
• Claims that make the product a drug — anti-acne, anti-fungal, hair-growth, scar-removal and similar claims move the article out of the cosmetic definition.
• Inconsistent naming — product, brand and site names differing even slightly across the Authorisation, Second Schedule Part-I, FSC and Form COS-1.

✅ Post-Approval Obligations

The certificate is the start of an ongoing compliance duty, not the end of it. After grant, the 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, 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