Hello, this is ADL Consulting.
With the recent 'K-Beauty' boom, the number of beauty companies inquiring about entering the Indian market has surged. And the very first obstacle that every one of these companies runs into is the 'licensing' issue.
"Which certification do we need in order to export our products to India officially?", "Is it true that document preparation alone takes several months?" These are the questions we hear most often in the field.
In order to export cosmetics to India, you must go through the registration procedure of the CDSCO (Central Drugs Standard Control Organisation, India's central authority for drug standards control). In this article, we will set out the seemingly complicated Indian cosmetics certification (COS-2 Registration Certificate) procedure, covering only the essentials, from A to Z.
1. What is CDSCO Cosmetic Import Registration?
Under India's Drugs and Cosmetics Act, 1940 and the Cosmetic Rules, 2020, every cosmetic product imported into India must be registered with the regulatory authority (CDSCO). Without a Registration Certificate, no cosmetic product may be imported into India. The final license obtained through this process is called 'Form COS-2', and the form used to apply for it is called 'Form COS-1'.
In other words, obtaining Form COS-2 is the most fundamental prerequisite for your products to be distributed legally in the Indian market.
2. Registration Procedure and Timeline (Step-by-Step Flow)
Many clients ask us, "Why does it take so long?" The reason is that India's licensing process is not a matter of simply filing documents – the application undergoes a strict review by each department within the relevant government authority.
The entire process takes approximately 90 to 120 working days from the date the documents are submitted.
Step 1: Document Preparation and Review
The heart of a CDSCO license is the 'integrity of the documentation'. If even a single document is missing or does not conform to the prescribed format, the application is sent back as a Query and the process can take 1.5 to 2 times longer – so preparing the documents accurately and then applying for the license is the key. The main mandatory documents are as follows.
Document Name | Key Points |
Mandatory Documents to Be Provided by the Manufacturer | |
Power of Attorney (POA) | • A legal document by which the manufacturer delegates registration authority to its local Indian representative (Authorized Agent: normally the importer or a consulting firm). • It must be drawn up on the manufacturer's letterhead and bear the company seal and the authorized signature. • Notarization and apostille are mandatory. |
Free Sale Certificate (FSC) | • A document issued by the Korea Cosmetic Association certifying that the product concerned is officially sold in Korea. • Notarization and apostille are mandatory. |
Manufacturing License | • The 'Cosmetics Manufacturing Business Registration Certificate', which proves that the cosmetics manufacturing site (factory) holds a lawful license. • Notarization (notarization of the English translation) is mandatory. |
List of Ingredients | • States the name (INCI Name) and the content (%) of every ingredient contained in the product. • It must be drawn up on the manufacturer's letterhead and bear the company seal and the authorized signature. |
Certificate of Analysis (CoA) | • Describes the physical/chemical specifications of the finished product (pH, viscosity, etc.) and the methods used to test them. • It must be drawn up on the manufacturer's letterhead and bear the company seal and the authorized signature. |
Material Safety Data Sheet (MSDS) | • A safety information sheet setting out the chemical properties of the product, precautions for handling, hazards and so on. • It must comply with the international standard GHS (16 sections) and must be written in English without exception. (Note: on the KOSHA (Korea Occupational Safety and Health Agency) MSDS website, you can search by the CAS number of each raw material to find the basic data.) |
Original & India Label | • The product label file, or the packaging (art work) file containing the label. • There is no problem in submitting a design file written in Korean, but an English label to be used for the actual export to India must also be submitted separately. |
Business Registration Certificate | • It is not submitted to CDSCO in India, but the manufacturer's business registration certificate or proof of business registration is requested during the apostille process in Korea. |
Additional Documents Required from the Manufacturer (the forms are normally provided by the consultant) | ||||||||||||||||
Non-Animal Testing Declaration | • India strictly prohibits animal testing of cosmetics, so a declaration from the manufacturer stating that the product has not been tested on animals is mandatory. • It must be drawn up on the manufacturer's letterhead and bear the company seal and the authorized signature. | |||||||||||||||
Heavy Metal & Safety Undertaking | • A document in which the manufacturer guarantees to CDSCO and to consumers that the product has been manufactured in compliance with the standards of the Bureau of Indian Standards (BIS).
• It expressly declares that hexachlorophene has not been added to the product. (Note: hexachlorophene is an ingredient that India strictly prohibits or restricts, so this wording must be included.) • The limits stated in this document are no more than a declaration; what really matters is the actual Certificate of Analysis (CoA). It is necessary to check that the actual heavy metal values on the Certificate of Analysis (CoA) fall within the limits in the table above. • It must be drawn up on the manufacturer's letterhead and bear the company seal and the authorized signature. | |||||||||||||||
Second Schedule Part-I | • A 'master data sheet' and, at the same time, a 'legal undertaking' that sets out the details of the manufacturer and the Indian agent and pledges that the cosmetic product being applied for complies with India's legal requirements (BIS, the ban on animal testing, etc.). • It must be drawn up on the manufacturer's letterhead and bear the company seal and the authorized signature. | |||||||||||||||
Mandatory Documents to Be Provided by the Importer | |
Certificate of Incorporation | • An official document issued by India's Registrar of Companies (ROC), equivalent to a certified extract of the corporate register. It proves that the importer is a company duly incorporated under Indian law. |
GST Certificate | • This is the business registration certificate proving that the company is a GST taxpayer – GST being the Indian equivalent of value added tax (VAT). It is evidence that the company genuinely exists and is currently carrying on business. |
Importer Exporter Code Certificate (IEC Certificate) | • An import-export license issued by India's Directorate General of Foreign Trade (DGFT). Without this code you cannot clear Indian customs, so any company engaged in trade must hold it. |
Authorized Signatory Details | • The identity documents of the importer's official Authorized Signatory (Aadhaar card, PAN card, passport, etc.) and their personal contact details (phone number, email) must be submitted. |
Additional Documents Required from the Importer (the forms are normally provided by the consultant) | |
Covering Letter | • A document summarizing at a glance who is applying, for which brand's products, and on what legal basis. • It must be drawn up on the importer's letterhead and bear the company seal and the authorized signature. |
Undertaking from Authorized Agent | • An official undertaking in which the local Indian importer (Authorized Agent), with respect to the Power of Attorney issued by the Korean manufacturer, agrees that it "will faithfully perform the role of legal representative in India on behalf of the manufacturer". • It must be drawn up on the importer's letterhead and bear the company seal and the authorized signature. • Notarization (notary stamping) is mandatory. |
Form COS-1 | • Generated by entering the data into the 'SUGAM' system, the online portal of India's CDSCO, this is the official import registration application form. It is not an offline form; it is the final output that is completed within the system, then printed out and signed. • The Indian importer's company seal and the authorized signatory's signature are affixed to it, and the scanned copy is uploaded. |
Step 2: Filing on the Indian Government Portal
Once all the documents are ready, they are uploaded to the online portal.
The government fees, which depend on the category (brand, number of products), are paid through the Indian government's integrated payment system.
Once the filing is complete, a unique identification number (File Number) is generated.
Step 3: Internal Review by CDSCO (Departmental Review)
This is the most important and the most time-consuming stage. Approval travels vertically upward, from the junior officers to the most senior decision-maker. If any deficiency in the documents (a Query) is found along the way, the file goes back down to a lower stage or the applicant is asked to supplement it.
Department / Officer | Key Points |
(DI) Drug Inspector
| 1st [Structural Review] Before looking at the content, they look at the 'form'. They check whether each document has been uploaded to the correct tab and section of the SUGAM portal. 2nd [Legal Review] They check whether notarization and apostille have been carried out properly and whether the documents carry a 'certified true copy of the original' attestation. In particular, they focus intensively on whether the Power of Attorney (POA) and the Free Sale Certificate (FSC) are authentic. 3rd [Technical Review] They dissect the product's composition, labels and technical documents. If there is an ingredient that does not comply with Indian regulations, or the label declaration is incorrect, a query is raised at this point. Once the file passes, it is transferred to the ADC. |
(ADC) Assistant Drugs Controller | [Re-check of Legibility and Validity] They look at whether the DI has missed anything. They check whether the attached files (POA, FSC, COI, etc.) are clearly legible on screen and whether they are still within their validity period, add their comments, and pass the file on to the DDC. |
(DDC) Deputy Drugs Controller | [In-depth Regulatory Review] They verify the test report and the list of ingredients in depth. They make a final check that the contents of the documents conform to the latest legislation, the 'Cosmetic Rules 2020', and then issue a recommendation for approval. |
(JDCI) Joint Drugs Controller | [Global Cross-Verification] This is a very important stage. To establish whether the Free Sale Certificate (FSC) submitted is genuine, they cross-verify it through the global portal of the regulatory authority of the country concerned (Korea, for example). They consolidate all the comments from the lower stages and pass the file on to the final approving authority. |
(LA) Licensing Authority (DCGI: Drugs Controller General of India) | [Final Signature] This is normally performed by the DCGI (Drugs Controller General of India). After reviewing all the review comments, the DCGI signs the final approval. Once the signature is complete, Form COS-2 (the Registration Certificate) is uploaded to the 'Issued Licenses' menu of the SUGAM portal. |
Note: If the file goes into "Query Raised" status during the review, the review clock stops. The review only restarts from the DI stage once the manufacturer submits a reply, so the time required for Step 3 depends on how quickly you respond.
Step 4: License Issuance (Issuance of Form COS-2)
Once the file has passed through the entire approval chain, the final document is issued. Only with this Registration Certificate can goods be cleared through Indian customs and legally distributed within India.
3. Government Fees
The registration cost is broadly divided into the site registration fee and the fees charged per category/product. Please refer to the government fees that are typically incurred so that you can budget accurately.
Item | Fee (USD) | Remarks |
Site Registration Fee | 500 | Registration fee per manufacturing site |
Category Registration Fee | 1,000 | Registration fee per cosmetic category (e.g. skincare, haircare, etc.) |
Additional Product Option Fee (Variant) | 50 | Fee per unit when options such as shade or fragrance are added |
4. Points to Note After the License Is Issued
1. If you do not file for 'Retention' after 5 years, you will have to apply all over again from the beginning.
The essence of the 2020 amended legislation (Cosmetics Rules 2020) is the 'perpetual validity' of the license.
Retention: If you simply pay the 'Retention Fee' before the validity period (5 years) expires, the license is automatically extended for a further 5 years without any complicated documentary review.
Warning: What happens if you miss the payment deadline by even a single day (once the grace period has passed)? The license is immediately cancelled, and you have to prepare every document and re-apply exactly as you did for the initial new registration. You must therefore be sure to file the retention application within the deadline!
2. Report Any Changes Immediately (Post-Approval Changes)
When registered information changes, the action required depends on how significant the change is.
Simple administrative changes: Changes such as a relocation of the manufacturer's or importer's address require a change application.
Material changes: What if the product's composition has changed? This may be regarded as a new product, in which case a new registration may be required. Always consult your consultant before making the change.
3. Random Sampling
Holding a license is not the end of the story. A Drug Inspector may collect products at random – at Indian customs or while they are in distribution on the market – and test them.
If the composition of the actual product at that point differs from the list of ingredients / CoA submitted at the time of registration, you may face not only refusal of customs clearance but also suspension of your license. Maintaining consistency is absolutely vital.
Frequently Asked Questions (FAQ)
Q1. Once we have the CDSCO Registration Certificate (COS-2), can we export right away?
A. No! Without 'LMPC' and 'EPR' you cannot clear customs. Cosmetic registration (CDSCO) merely proves the 'safety' of the product. To actually sell the goods, there are two more hurdles to clear.
LMPC (Legal Metrology Packaged Commodities): This is the 'legal metrology' certification. It is the procedure for checking whether the weight, the price (MRP), the consumer care information and so on shown on the product label comply with Indian requirements. Without it, the goods cannot be cleared through customs at all.
EPR (Extended Producer Responsibility): This is the 'plastic waste management' registration. Importers that use plastic as packaging material must register for EPR on the portal of the CPCB (Central Pollution Control Board). Enforcement of this requirement has been tightened considerably of late.
Q2. The information online varies enormously. Some places say to submit 'Form 43' – is that correct?
A. That is the old law! If you submit it now, it will be rejected 100% of the time. With the entry into force of the 'Cosmetics Rules 2020' in 2020, all the procedures changed.
(Former) Form 43: The old-style registration certificate form (now abolished)
(Current) Form COS-1: The official application form in use today. If there are still blogs or online communities talking about 'Form 43' or 'manual filing', that is information that has not been updated and you should disregard it. All filings are made solely through the SUGAM online portal.
Q3. When the license expires after 5 years, do we have to prepare everything from scratch again?
A. As long as you keep to the deadline, you can use it permanently simply by paying the fee. In the past, a renewal review was required every 3 years, but this has now been replaced by the 'Retention' system. If you pay the Retention Fee before the 5-year term expires, the license remains valid for a further 5 years without any separate documentary review. Caution: If you miss the payment deadline by even a single day, the license is cancelled immediately and you have to go through the registration procedure all over again from the beginning – so setting a reminder is essential!
Q4. Can we just send samples without registering them?
A. If they are samples for sale, their pack size must be registered together with the main product. India has no separate 'sample registration procedure'. If you plan to distribute or give away samples (5 ml, 10 ml, etc.) later on, then when you first register the main product (50 ml) you must, in the 'Pack Size' field of the application, also state the sample sizes. Any size that does not appear on the registration certificate will not clear customs.
Q5. I hear that, apart from Form COS-2, CDSCO has other types of registration for cosmetics – what are they?
A. Yes, registration certificates other than Form COS-2 do exist. Most of our clients wish to import and sell cosmetics manufactured overseas into India, and for that purpose the 'Form COS-2' license is what they need. However, in cases such as ▲a third party importing a product that has already been registered, ▲a product to which new ingredients or technologies have been applied, or ▲plans for direct manufacturing or OEM production within India, the type of license to be applied for varies according to the situation. This article has dealt mainly with COS-2, the license we are asked about most often, but in order to determine which license you actually need it is advisable to go through a verification process first.
The Indian beauty market is enormous, but obtaining the COS-2 license (the CDSCO license) – the key that opens its door – is a process that requires thorough preparation.
Rather than wasting months on incorrectly prepared documents, we recommend that you proceed transparently and efficiently, with accurate guidance, from the very start. If you simply share your product list and manufacturing license with us, we will carry out a preliminary assessment straight away and propose the fastest possible roadmap.
ADL Consulting will be at your side as a dependable partner for your entry into the Indian market.