Acne-care products — mattifying gels, oil-control moisturisers, spot serums, "blemish" creams — are one of the most in-demand imported skincare categories, and they sit exactly on the cosmetic-versus-drug boundary. Whether a given product is a CDSCO cosmetic or a drug depends entirely on its actives and its claims.
This guide is about staying on the cosmetic side of that line: registering acne-relief products with CDSCO under the Cosmetics Rules, 2020 where they qualify as cosmetics, and recognising when a product must go the drug route instead.
📌 Under Rule 12(1) of the Cosmetics Rules, 2020, no Acne-Relief Cosmetics may be imported into India unless the product 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 — it must be in place before the first consignment lands.
📋 Is CDSCO Registration Mandatory for Acne-Relief Cosmetics?
Yes, where the product is a cosmetic. An oil-control or blemish-care product that cleanses, mattifies or exfoliates at cosmetic levels is a Fourth Schedule cosmetic and needs CDSCO registration before import. A product that medically treats acne is a drug and needs a Form 10 import licence instead — CDSCO will not register it as a cosmetic.
The classification decision therefore comes before the filing, and it is driven by the active and the claim.
📘 The Indian Standard in Detail
Acne-care cosmetics span several formats — cleansers, toners, serums, gels and creams — and no single Ninth Schedule Indian Standard covers them. A cream base is assessed against IS 6608; the other formats are assessed against country-of-origin standards plus the Cosmetics Rules, 2020. The Certificate of Analysis is drawn against the applicable standard or the manufacturer's finished-product specification.
The critical declaration is the active: salicylic acid or a low-level exfoliating acid used for surface oil-control and gentle exfoliation is generally cosmetic, whereas benzoyl peroxide, prescription retinoids and antibiotics are drug actives. The concentration declaration is what shows the product stays within the cosmetic range.
🗂️ 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 Acne-Relief Cosmetics
On top of the core dossier above, an acne-relief cosmetic application needs:
- Certificate of Analysis against the applicable standard (IS 6608 for creams; otherwise the country-of-origin specification) — pH, appearance, active content, preservative content and microbiological limits.
- Active-ingredient declaration with the concentration of any salicylic acid or exfoliating acid, confirming it is at cosmetic level.
- Confirmation that the product contains no drug actives (benzoyl peroxide, prescription retinoids, antibiotics).
- Country-of-origin standard and specification where no Indian Standard applies.
- Preservative-system declaration and microbiological report.
- Claim-substantiation dossier framed as cosmetic oil-control / blemish-appearance care.
⚗️ 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 is everything here. Cosmetic-level salicylic acid for surface exfoliation and oil control is a cosmetic ingredient; benzoyl peroxide, prescription retinoids and topical antibiotics are drug actives that take the product off the cosmetic route entirely. Declare the acid concentration and confirm the absence of drug actives.
🏷️ Acne-Relief Cosmetics Label Requirements
In addition to the general Chapter VI requirements, acne-care cosmetic labels are checked for these product-specific points:
- Directions for use and a sun-sensitivity caution for acid-based products.
- Claims framed as cosmetic (oil-control, reduces the look of blemishes) rather than therapeutic (treats/cures acne).
- Net content by fluid measure or weight.
- Any patch-test recommendation for a higher-strength acid product.
⚖️ The Sharpest Cosmetic-versus-Drug Line
Acne-care is the textbook cosmetic-versus-drug problem. On the cosmetic side: cleansing, mattifying, oil-control and gentle cosmetic exfoliation, described in appearance terms. On the drug side: any product containing benzoyl peroxide, a prescription retinoid or an antibiotic, or any product claiming to treat, cure or clear acne as a medical condition. There is no middle registration — a product is one or the other.
The compliant approach is to fix the classification first: confirm the actives are cosmetic-level, remove any drug actives, and write the claim in cosmetic terms. A product that cannot meet those conditions belongs on the drug route under Form 10, not on COS-1.
🛠️ 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 Acne-Relief Cosmetics Applications Get Queried
Most acne-cosmetic queries are classification queries:
- A drug active (benzoyl peroxide, prescription retinoid, antibiotic) present in a product filed as a cosmetic.
- A therapeutic claim to treat or cure acne, which converts the product into a drug.
- Salicylic-acid or exfoliating-acid concentration undeclared.
- No country-of-origin specification behind the CoA for non-cream formats.
🔗 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
Can acne products be registered as cosmetics with CDSCO?
Only where they are cosmetics — cleansing, mattifying, oil-control or gentle cosmetic exfoliation with cosmetic-level actives and appearance claims. A product that medically treats acne is a drug needing a Form 10 import licence.
Is salicylic acid a cosmetic or a drug ingredient?
At low, surface-level concentrations for exfoliation and oil control it is treated as cosmetic. The concentration should be declared to show it stays within the cosmetic range.
Which acne actives make a product a drug?
Benzoyl peroxide, prescription retinoids and topical antibiotics are drug actives — a product containing them cannot be registered as a cosmetic.
Which Indian Standard applies to an acne cream?
A cream base is assessed against IS 6608; other formats (gels, toners, serums) are assessed against the country-of-origin specification plus the Cosmetics Rules.
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.
Acne-Relief Cosmetics Import Registration, Handled End to End
Global Approbation manages the complete CDSCO cosmetic registration for imported acne-relief cosmetics — classification, standard mapping, CoA and label review, dossier assembly and query response — so your first consignment clears without avoidable delay.
Talk to Our CDSCO Team Global Market Access