Cosmetics Regulatory Services

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CDSCO

Cosmetics Regulatory Services

Central Drugs Standard Control Organisation is, known as CDSCO. Under the provision of Drugs & Cosmetics Rules it is a regulatory body for the Indian medical devices industry.

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OverView Of Cosmetics Regulatory

We are ELT Corporate Pvt Ltd specialized in providing multiple services for the registration of multiple goods. Here we are offering CDSCO license & registration consultancy services. Recently we are handling more than 500 happy clients. Our Expert team is reliable & give quick response to each client. We also help our clients in many ways such as filling application on the behalf of clients to save their precious time. We value for client time and money & make all the efforts to fulfil the need of customer on time.

Service Portfolio

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FDA / CDSCO Registrations

  1. Import Registration.
  2. Post Approval Changes.
  3. Manufacture Registration.
  4. Import of already registered products.
  5. Authorisation Attestation.
  6. FSSAI for Oral Cosmetics.
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Package and Labelling

  1. Labelling Consultancy. 
  2. Package Quality Compliance.
  3. Packaging License/Legal Metrology.
  4. EPR of Plastic Waste Packaging.
  5. Artwork Registrations.
  6. Container Design Registrations.
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Other Important Services

  1. Analysis Certificate/Lab Testing.
  2. Brand Registration
  3. ISO Registration.
  4. BIS of Companies That Make Cosmetics.
  5. Make us your Indian representative.
  6. Cosmetic Misbranding Legal Services.

How Do I Get Cosmetic Import Registration With

CDSCO?

Top FAQ’s

Every business that intends to import cosmetics into India must first register their business with the CDSCO. CDSCO Cosmetic Import Registration in India is based on the Drugs and Cosmetics Act of 1940. For Whole India the cosmetic registrations is done from the CDSCO headquarters located in Delhi.
Our office in Delhi helps you to locally coordinate the matter with the department in the fastest and effective manner.
A “cosmetic” is a product designed to maintain, enhance, or change the look of the skin, hair, nails, or teeth. Cosmetics are items used for personal grooming and aesthetics, such as makeup, perfume, skin cream, and nail polish (soap, shampoo, shaving cream, deodorant).
The following are the typical steps involved in registering a cosmetic product:
Step1: You’ll need to create a government portal that isn’t entirely digital, by registering with the CDSCo portal and then sending paper documents to the CDSCo office in Delhi.
Step2: Collect the paperwork from your overseas manufacturer and add in any additional paperwork you need to.
Our experts can assist you in navigating the complexities of the documents that you need to complete.
Step3: make a payment and upload your paperwork to the government’s online portal.
Step4: the government often sends a slew of questions via the portal after you submit. In this way, our experts can respond to these inquiries on your behalf.
Step5: Submit the Paperwork in Person Sometimes the government will ask for the physical copies of documents that have been uploaded to their website. Step6: when you’ve answered the government’s questions. The appropriate documentation (registration certificate) will be issued by the government.

This system of charging government fees by the CDSCO is depends on the following criteria:

  1. The number of manufacturing sides from which you are importing the cosmetics.
  2. The different categories of cosmetics which you are importing.For examples:- Lipsticks, Kajal, Foundation, Other face makeup products are treated as different categories under the Cosmetics act 1940.
  3. The number of variants of each category of cosmetics you are importing For example: In the categories of Lipstick you are importing different variants in the form of different shade colors of lipsticks.

For your quick note, please note the exact amount of the government fees below

  • Per cosmetics category Govt. Fee 2000 $
  • Per cosmetics variant govt. fee 50 $
  • Each Cosmetics manufacturing site 500$
  • Basic KYC: Email Id and Phone Number, Aadhar Card, GSTIN, IEC – Importer’s  For Account Opening.
  • Undertaking to be accompaniedfor Portal Creation: to be filled by the importing company’s director, Proprietor with sign and stamp.
  • Covering Letter: on  importing Company’s Letterhead detailing the application details along with the list of annexed documents.
  • Free Sale certificate to be signed and stamped from commerce chambers of respective exporting countries and Indian Embass
  • Authorisation Letter from Legal Manufacturer in the format as prescribed in First Schedule or incase of unavailability of the same, the first class magistrate in India is empowered to facilitate the same.
  • Manufacturer’s Factory License in English version to be signed and stamped from commerce chambers of respective exporting countries and Indian Embassy.
  • Certificate of Analysis from manufacturer on letter head duly sign and stamp with name and designation. 
  • List of Ingredients from manufacturer on letter head duly sign and stamp with name and designation.
  • Copy of every Product’sArtwork/Label which should be as per Drugs & Cosmetics Act,1940.
  • Duly filled & signed format of Second Schedule, as prescribed under the Cosmetics Rules,2020 from Importer.
  • Bharatkosh CDSCO challan of govt fees (system generated)
  • Specifications of the products and Testing Method.
  • Non animal Testing Declaration
  • Heavy metal undertaking/Heavy metal results in Analysis/Specifications
Under the Cosmetics regulations,  
  1. Skincare products: Facial washes, toners, shaving creams, etc.
  2. Hair Care products: Shampoos, oils, and other styling products
  3. Color Cosmetics: Includes all makeup and nail care products
  4. Fragrances: Perfumes, colognes, body splashes, etc.
  5. Personal care products: Deodorants, toothpaste, mouthwash, etc.
Approximately 80–100 categories are classified by the government, but we have mentioned the classification in the above detailed manner for easy understanding of our users. Reach out to our specialists for more info. In rare instances, categories of cosmetics may not be categorized; however, the customs authorities will still want the NOC from the CDSCO for such imports, which you will need to handle in a very strategic manner.For further information, please contact our specialists.
If your shipment becomes stuck in customs, you will undoubtedly be concerned. Generally, the customs department will request a copy of the ADC (assistant drugs controller) NOC, clearly stating that the ADC has no objections if you imported these goods without a valid cosmetic license. In such cases, it is recommended that you immediately apply for Cosmetic registration; in the meantime, you can store your goods in a customs-bonded warehouse to save the demurrages. For expert help on this, you may reach out to our specialists.
No, if Manufacturer has provided you the certificate of analysis as per the government specification then there is no requirement to separately obtain it, however sometimes the government asks for the certificate of analysis if they have any doubt about the veracity of the facts stated on the cosmetics.
  • SUBMISSIONS: Make Submission of application on behalf of clients
  • QUERY REPLIES: Make a reply to government queries.
  • GOVERNMENT OFFICE VISIT: Visit to the government authorities office on the behalf of a client.
  • STRATEGY: Strategising the application process in case of non classified cosmetics.
  • RESOURCES & NETWORK:We have in-house resources for technical support & documentation as per regulatory authority. Further we have a wide network of laboratories, Labs, Labels guidance, Dossier Preparers etc to facilitate different requirements of clients during regulatory requirements of our clients.
  • AUTHORIZEDAGENT & DISTRIBUTION: We help the foreign manufacturers by becoming their authorized representative for making successful imports in India.
  • EX-GOVERNMENT OFFICIALS: On our panel, we have ex-government officials as experts who have closely worked with the Regulators, well rewarded with the government norms and mindset of the authorities on the way of ensuring compliances and enforcements.
The government has prescribed a total timeline of 180 days to dispose of the application provided that if the government asks any question, the time spent answering such question is excluded; however, at ELT, our experts assist our clients as soon as possible and are able to complete the application in 1-2 months after successful filing.
  1. Legal Metrology: In India, the Packaged Commodity Rules, 2011 and the Legal Metrology Act, 2009 govern the laws and procedures governing labeling, packaging, and imports. In the interest of consumers, legal metrology officers evaluate the compliances of packers, importers, and manufacturers.
  2. Shelf-life data: According to BIS, a manufacturer is required to conduct a suitable shelf-life study as a protocol to ensure the quality and integrity of the product during the product’s intended shelf life through appropriate data. Such products should be tested to ensure that there are no signs of degradation, fermentation, color change, rancidity, and so on, and that the product is safe to use.
  3. Labeling requirements: According to the Drugs and Cosmetics Rules of 1945, each product must have its site of manufacture address on both the inner and outer labels. If the container is of a smaller size, the principal place of manufacture and its pin code will suffice. The ingredients used to make the product should be clearly stated on the outer label. The ‘directions for use’ must be included on the inner label, along with any other caution or warning that is required. The label should also include the names and quantities of any hazardous ingredients.
  4. Safety data: According to BIS, it is the responsibility of a manufacturer or distributor to appropriately notify customers on the labels of such items if there are any precautions that need to be taken when using the product, which has been known to indicate safety issues for a certain group of people. If such proof or research is required, the producer or distributor should have it on hand.
  5. Prohibitions: Certain cosmetic products are prohibited from being imported into India under Section 10 of the Drugs and Cosmetics Act and Rules 134A, 135,135A of the Cosmetics and Drugs Rules, 1945.
  6. EPR Plastic Waste: (EPR) EPR Plastic Waste: (EPR) Extended Producer Responsibility means that any producer of goods is responsible for channeling plastic-waste to ensure environmentally sound waste management. Extended Producer Responsibility may entail implementing a take-back system, establishing collection centers, or both, and reaching an agreement with an EPR Authorisation dismantler or recycler, either individually or collectively.
  7. Brand Trade Mark Registration: In order to sell the cosmetics online, the brand registry of the e-commerce companies asked you to verify that you are authorized to sell the brand or else they may askyou a copy of the registration certificate of the brand ownership.

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