Cosmetic Registration in India: CDSCO Rules & Fees

Most brands that have already been through an ASEAN launch arrive in India with the wrong mental model. Indonesia, Thailand, Malaysia and the Philippines all run notification systems: you file, you receive a number, and market surveillance happens afterwards. India does not work that way. The Central Licensing Authority grants a certificate, and until that certificate exists the goods cannot legally enter the country.

That difference changes who does the work. In a notification market the local importer carries most of the filing burden. In India a large share of the file has to be produced, signed and legally authenticated by the factory — in the country of origin, before anything reaches CDSCO. If you are manufacturing in China, that means your documentation chain is on the critical path, not your importer's paperwork.

This guide works through what the Cosmetics Rules, 2020 actually require, based on CDSCO's own guidance document for Form COS-1 submissions. Where the source is silent, we say so rather than filling the gap with an estimate.

The Schedules Do the Real Work

The Cosmetics Rules, 2020 push most of their operative detail into numbered schedules. If you cannot keep them straight, the checklist reads like an arbitrary list of attachments. Once you can, the structure of the file becomes obvious.

Schedule	What it governs
First Schedule	The format of the Authorisation from the manufacturer, referenced at rule 12(3)
Second Schedule, Part-I	Information and undertakings the manufacturer or its agent must furnish, referenced at rules 12(4), 23(2) and 23(4)
Third Schedule	The fee structure
Fourth Schedule	Product categorisation — the category you declare in Form COS-1 must come from here
Ninth Schedule	Specifications, via Bureau of Indian Standards standards
Tenth Schedule	Permitted dyes, colours and pigments

Two rules outside the schedules matter as much. Rule 39 sets the specification test: a cosmetic must comply with the Ninth Schedule specifications, and where the product is not covered by the Ninth Schedule it must instead meet the requirements of these rules plus the specifications and standards applicable to it in the country of origin. Rule 36 is the claims rule — no cosmetic may purport, claim to purport, or convey any idea that is false or misleading to the intending user.

Rule 39 is worth pausing on, because it is more generous than it first looks. For a product category the Ninth Schedule does not cover, your Chinese specification becomes the reference point rather than an obstacle. That is a very different posture from markets that insist on a locally defined specification for everything. Our note on cosmetic claims across the US, EU and China covers how differently the same claim language gets treated once you cross a border, which is the other half of rule 36.

The Fee Structure Rewards Range Depth

This is the most commercially useful thing in the entire rulebook, and it is the part brands consistently get wrong. Per the Third Schedule, as set out in CDSCO's guidance, the fees payable with a Form COS-1 application are: USD 1,000 for grant or retention of a Registration Certificate for each category of cosmetics, USD 500 for registration of each manufacturing site, USD 50 for each variant, and USD 1,000 for grant or retention of a Registration Certificate for an additional category.

Read that again with SKU count in mind. The government fee is not charged per product. It is charged per category, per site, and then only USD 50 per variant.

Scenario	Fee calculation	Government fee
One category, one site, 6 variants	1,000 + 500 + (6 × 50)	USD 1,800
One category, one site, 20 variants	1,000 + 500 + (20 × 50)	USD 2,500
Two categories, two sites, 20 variants	1,000 + 1,000 + (2 × 500) + (20 × 50)	USD 4,000

Compare that with a per-product notification market. In Indonesia the BPOM route carries a notification fee per product, and every additional SKU repeats it; our BPOM registration guide breaks that cost stack down line by line. India inverts the arithmetic. Adding your fourteenth variant to an existing category costs USD 50 in government fee. Adding your first product in a second category costs USD 1,000 before you have registered a single variant under it.

The planning consequence is concrete. In India, category breadth is expensive and range depth is cheap. A brand launching twelve skincare variants and two hair care variants is paying a full additional category fee for those two hair SKUs. Either commit to the second category properly or postpone it. The MOQ and cost guide covers the production side of the same decision, where a second category usually means a second set of minimums as well.

One mechanical detail that trips up first-time filers: since 28 February 2019 the fee must be paid through the Bharatkosh gateway only, under head of account 0210041040000-00-1 for import and registration, and the acknowledgement receipt goes into the application. A bank transfer outside Bharatkosh does not count as payment.

The Authentication Chain, Not the Fee, Is the Real Cost

The Authorisation from the manufacturer is where most China-based projects lose weeks. It is not a document you sign and scan. Under the First Schedule it must be executed and authenticated either in India before a First Class Magistrate, or in the country of origin before an equivalent authority, or attested by the Indian Embassy in that country, or apostilled if the country is a Hague Convention member.

The Authorisation names the legal or principal manufacturer with full address, the actual manufacturing sites, the authorised Indian agent, and every product with its brand name, variant name, pack sizes and the actual manufacturer and premises. It has to be conjointly signed, stamped and dated by both the authorised Indian agent and the manufacturer, with the signatory's name and designation. CDSCO's guidance is explicit that every page, including the product list, must be signed by both parties before authentication.

That sequencing is the trap. If your product list changes after the document has been apostilled — a variant added, a pack size corrected, a site name written differently from Form COS-1 — you are not editing a file, you are running the authentication chain again.

The Free Sale Certificate has its own routing logic, with three acceptable paths:

Issuer	Additional authentication required
National Regulatory Authority of the country of origin	Accepted as the primary route
Other competent association or organisation	Must be authenticated by the Indian Embassy of that country
Chamber of commerce, or notary public	Accepted where apostilled

Two further conditions attach to it. The certificate must state the country in which the applied products are freely sold or marketed, and the product list on it must be signed and stamped by the issuing authority. CDSCO also asks for a correlation chart tying each product's serial number in Form COS-1 to the Authorisation and to the Free Sale Certificate — and the covering letter is supposed to tell the reviewer which section of the checklist that chart sits in.

That correlation chart requirement tells you something about how the file is reviewed. A reviewer is checking that three separately produced documents describe the same products in the same order. Any naming drift between them is a query, and a query is a round trip.

What the Factory Has to Produce

Strip out the importer's administrative pieces and what remains is a manufacturing dossier. If you are evaluating whether a supplier can support an India launch, this is the list to put in front of them.

• Ingredient list with percentages, in standard reference nomenclature, signed and stamped by a competent authorised person at the manufacturer
• Specification and testing method for the product, each signed and stamped by the company's competent person
• Manufacturing licence, registration or marketing authorisation from the regulatory authority in the country of origin, in authenticated copy. Where the country of origin has no such provision, an undertaking from the manufacturer covers it
• Heavy metal and hexachlorophene position, either as a test report covering lead, arsenic, mercury, other heavy metals and microbiological testing where applicable, or as an undertaking that all raw materials and pigments comply with the limits in the Rules
• Non-animal testing undertaking from the manufacturer
• Original legible labels for each product and variant

Notice that CDSCO allows an undertaking in place of a test report for the heavy metals declaration. That is a real option, not a loophole, but it moves liability onto the manufacturer's signature. A factory that will sign the undertaking but cannot produce the underlying data on request is a risk you are absorbing. How to verify formulation capability sets out what to ask for at audit stage, and cosmetic stability testing covers the data package a competent supplier should already hold.

There is also a reporting obligation that survives the grant. Under the Part-I undertakings, the holder must inform the Licensing Authority of any change to the labelling, composition, testing or specifications of a registered product within thirty days, with an undertaking that the product still complies with the BIS standards referenced in the Ninth Schedule. A quiet raw material substitution at the factory is a notifiable event in India.

Composition Limits Are Written Into the Rules

India puts several numeric limits directly into the cosmetics rulebook rather than leaving them to a separate ingredient annex. These come straight from CDSCO's guidance and are the ones that decide whether an existing formula travels.

• Restricted raw materials. Materials specified in Annex A of Indian Standard IS 4707 Part 2, as amended, must not be added to the product
• Colourants. No cosmetic may be imported or manufactured containing dyes, colours or pigments other than those specified by the Bureau of Indian Standards in IS 4707 Part 1 or Part 2, as amended, and included in the Tenth Schedule
• Purity of permitted colours. Permitted synthetic and natural organic colours must not contain more than 2 ppm arsenic calculated as arsenic trioxide, 20 ppm lead, or 100 ppm of heavy metals other than lead calculated as the total of the respective metals
• Colouring compounds. The use of lead and arsenic compounds for colouring cosmetics is prohibited
• Hexachlorophene. No cosmetic containing hexachlorophene shall be manufactured. Soaps are the exception, permitted up to 1 per cent weight by weight, and then the wrapper of each soap must carry the cautionary note, printed conspicuously: Contains hexachlorophene — not to be used on babies
• Mercury. In cosmetics intended for use only in the eye area, mercury as a preservative must not exceed 70 ppm, stated in the Rules as 0.007 per cent calculated as the metal. In other finished cosmetic products, unintentional mercury must not exceed 1 ppm

The colour purity limits are the ones worth flagging to a formulation team early, because they are limits on the colourant as supplied, not on the finished product. That is a raw material specification question for your pigment supplier, and it is answered at purchase order stage or not at all. For how differently ingredient restriction is structured elsewhere, banned cosmetic ingredients in the EU shows the annex-driven alternative.

Labelling Carries Two India-Specific Requirements

Chapter VI of the Cosmetics Rules, 2020 sets the label content, and most of it will look familiar: product name, manufacturer name and complete premises address, expiry or use-before date as month and year, a distinctive batch or lot number, net content declaration, and hazard warnings with directions for safe use where a hazard exists.

Two requirements are specific to India and neither can be handled at artwork stage before you have the certificate.

The registration certificate number goes on the unit pack. For imported cosmetics marketed in India, the RC number must appear on the label of the unit pack, preceded by RC, or RC No, or Reg. Cert. No, together with the name and address of the importer. You cannot know that number until the certificate is granted, so the sequence is: register, then finalise artwork. The Rules do provide relief here — where imported cosmetics require India-specific labelling, it may be stickered onto the unit pack at a bonded warehouse.

Third-party manufacture must be disclosed. Where the product was not manufactured in a factory owned by the manufacturer named on the label, the label must carry either the name and address of the actual manufacturer or the country of manufacture as Made in followed by the country name. For a private label brand this is not optional discretion, it is a label content rule.

There are useful exemptions for small packs. If the address of the manufacturer cannot be given on a container of 30 g or less for solids and semi-solids, or 60 ml or less for liquids, the label may instead give the manufacturer's name, principal place of manufacture and pin code. The net content statement is not required for a package of perfume, toilet water or the like at 60 ml or less, or for a solid or semi-solid cosmetic at 30 g or less. The INGREDIENTS list follows the same thresholds — ingredients above 1 per cent in descending order of weight or volume as added, followed by those at or below 1 per cent in any order, and the statement need not appear for packs at or below 60 ml liquid and 30 g solid or semi-solid.

One relief matters specifically to Chinese manufacturers. The manufacturing licence number, normally required on the inner or outer label preceded by M, M. L. No or Mfg. Lic. No, may be omitted for imported products where the country of origin does not make it mandatory, subject to the other import regulations being met. Our comparison of cosmetic labelling requirements across nine markets puts these India rules next to the ASEAN and EU equivalents, which is the fastest way to see which artwork elements can be shared across a multi-market launch and which cannot.

The Animal Testing Cut-Off Is a Date, Not a Policy

Two provisions sit together here. No person shall use any animal for testing of cosmetics, and no cosmetic that has been tested on animals after the 12th day of November 2014 shall be imported into the country. An undertaking from the manufacturer that the products have not been tested on animals goes in with Form COS-1.

That fixed date is the operative part. It is not a general principle to be interpreted, it is a cut-off that applies to the product being registered. For a brand with a long ingredient history, or one importing a formula developed for a market that required animal data, this is a question to settle with the factory before the file is assembled rather than after a query arrives.

What This Guidance Document Does Not Tell You

We would rather leave gaps visible than fill them with plausible numbers, so here is what our source does not cover.

Review timeline. CDSCO's guidance for Form COS-1 sets out the mode of submission, the document set and the fee, but does not state how long the Central Licensing Authority takes to grant a Form COS-2 certificate. We are not going to estimate it. If a launch date depends on it, that is a question for a regulatory consultant with recent filing experience, or for CDSCO directly. The parts of the schedule you can plan around are the ones you control: document preparation, and the authentication or apostille chain.

Validity period. The guidance refers to grant or retention of a Registration Certificate, and lists re-registration as one of the purposes a covering letter may state, but does not state a term. One data point from CDSCO's own cosmetics page is suggestive without being authority: a published cancellation notice refers to an import registration certificate dated 29 November 2023 and valid up to 28 November 2028, which is consistent with a five-year term. Treat that as an observed example and confirm the term against the Rules before you build a renewal calendar on it.

Anything about domestic manufacture. Everything above concerns import. Cosmetics manufactured within India are licensed by State Licensing Authorities appointed by the respective State Governments, which is a separate regime with separate paperwork.

CDSCO's guidance document itself carries a note worth repeating: it exists to create public awareness and is not meant to be used for legal or professional purposes, with readers advised to refer to the statutory provisions of the Drugs and Cosmetics Act, 1940 and the Rules made under it, gazette notifications, and CDSCO guidelines and clarifications issued from time to time. The same caution applies to this article.

How This Changes an India Launch Plan

Three things follow from the structure of the Rules rather than from any single requirement.

First, decide your category count before anything else. The fee schedule prices breadth, not depth. Two categories cost USD 2,000 in category fees before variants, while twenty variants inside one category cost USD 1,000 in variant fees. If a second category is not commercially committed, it is the first thing to defer.

Second, lock the product list before authentication. Pack sizes in the Indian Metric System, variant names, category per the Fourth Schedule, and manufacturing premises have to read identically across Form COS-1, the Authorisation and the Free Sale Certificate. The authentication step is what makes late changes expensive, so the list should be frozen upstream of it.

Third, treat the factory's document capability as a selection criterion. An ingredient list with percentages under signature, a signed specification and test method, an authenticated manufacturing licence copy, and a willingness to sign the heavy metals and animal testing undertakings — a supplier either has that habit or does not. Working with a cosmetic contract manufacturer covers how that capability shows up in practice, and cosmetics technology transfer covers what happens to your documentation when a formula moves between sites — which in India also means a new site registration at USD 500.

If India is part of a wider Asia plan rather than a standalone launch, sequence it against markets whose requirements you can satisfy from the same dossier. Starting a skincare brand in Southeast Asia and the Thailand TFDA registration guide show where the overlap is: the ingredient disclosure, stability data and specification documents travel well. The authentication chain and the India-specific label elements do not.

Frequently Asked Questions

Does a foreign brand need an Indian entity to register cosmetics in India?

Not necessarily an entity of its own. CDSCO's guidance allows the application in Form COS-1 to be made by the manufacturer itself, by its authorised agent, by an importer in India, or by an Indian subsidiary authorised by the manufacturer. That said, the First Schedule Authorisation is structured around delegation to an authorised Indian agent, who must conjointly sign the document and who remains responsible for cosmetics already imported even after the power of attorney is withdrawn. In practice an Indian agent or importer is named.

What is the government fee to register a cosmetic in India?

Per the Third Schedule as set out in CDSCO's guidance: USD 1,000 for grant or retention of a Registration Certificate for each category of cosmetics, USD 500 for each manufacturing site, USD 50 for each variant, and USD 1,000 for each additional category. Payment must go through the Bharatkosh gateway under head of account 0210041040000-00-1, with the acknowledgement receipt submitted alongside the application. Consultant fees, testing, translation and document authentication are separate and are not set by the Rules.

Is the ingredient list with exact percentages really required?

Yes. The file must include the name of the cosmetic and the names of ingredients in standard reference nomenclature along with the percentage contained in the cosmetic, signed by a competent authorised person with the manufacturer's stamp. If a supplier treats full percentage disclosure as confidential, that has to be resolved before an India project starts, not during the filing.

Can we print the India label artwork before registration is granted?

Not completely. The registration certificate number has to appear on the unit pack preceded by RC, RC No or Reg. Cert. No, along with the importer's name and address, and that number does not exist until the certificate is granted. The Rules allow India-specific labelling to be stickered onto the unit pack at a bonded warehouse, which is the mechanism most importers use rather than holding back the print run.

Do cosmetics sold in India have to meet Bureau of Indian Standards specifications?

Where the product falls under the Ninth Schedule, yes — it must comply with the specifications prescribed there. Where it does not fall under the Ninth Schedule, rule 39 requires it to meet the requirements of the Rules plus the specifications and standards applicable to it in the country of origin. Products under the Ninth Schedule must also comply with any labelling requirement specified in the relevant Indian standard.

How long does CDSCO take to grant an import registration certificate?

CDSCO's guidance document for Form COS-1 submissions does not state a review timeline, and we are not going to publish an estimate we cannot source. Confirm current processing times with a regulatory consultant who has filed recently, or with CDSCO. What you can plan is the work ahead of submission: assembling the manufacturing dossier and completing the embassy attestation or apostille chain, which is the step most often underestimated.

The Short Version

India is a registration market, not a notification market, and the registration attaches to the product with its pack size, variants and manufacturing premises. The government fee structure prices category breadth heavily and range depth cheaply, which makes category count the first planning decision. The real cost and the real schedule risk sit in the authentication chain, where the Authorisation must be signed by both parties before it is apostilled or attested, and where the Form COS-1, the Authorisation and the Free Sale Certificate all have to describe the same products in the same order.

Everything above is drawn from CDSCO's own guidance document for Form COS-1 submissions and the provisions of the Cosmetics Rules, 2020 it cites. Where that source is silent — review timeline, certificate validity — we have said so rather than estimating. Verify the current position against the statutory text and current CDSCO circulars before you commit budget, and if you want the manufacturing side of the dossier reviewed against what your supplier can actually produce, that is a conversation worth having early.