Cosmetic registration is a complex process, and understanding the reasons for rejection in cosmetic applications can be beneficial for brands before stepping into the market. As indian regulating bodies such as CDSCO are extremely authorized by strict legislations and laws, the smallest of mistakes might end up with delays and refusals. Whether you are a manufacturer or importer, knowing these reasons in advance allows you to avoid such mistakes and make your process faster.
In this guide, you’ll find complete details about the reason for rejection and see how you can prevent your cosmetic registration application from being refused.
Top 8 Reasons For Rejection In Cosmetic Applications
If you plan to import or register cosmetic products in India, it is essential to understand why applications are often denied. Here are the most common reasons and how to avoid them:
Incomplete Or Incorrect Documentation
Incomplete documentation is one of the most significant reasons for the rejection of applications in cosmetics registration applications. CDSCO requires certain documents to accompany the application form, especially in Forms COS 1 and COS 2.
Non-Compliant Labeling
The application may also be rejected if labeling information is inaccurate or missing. It is required to state the information on the labelling under the Drugs and Cosmetics Act. CDSCO, similarly, enforces labeling considerations under Rule 39 of the Cosmetic Rules 2020.
Use Of Prohibited Or Restricted Ingredients
Use of restricted and prohibited ingredients is one of the crucial reasons for rejection in cosmetic applications by the CDSCO under the indian regulatory Act. CDSCO aligns with BIS and Schedule S of drugs and cosmetics to regulate permissible ingredients.
Improper Product Classification
Misclassification is yet another undervalued cause of rejection in cosmetic applications. Those products that promise therapeutic value are not classed as cosmetics under Indian law; instead, they might be regulated as drugs or as medical devices.
Invalid Or Expired Free Sale Certificate (FSC)
The Free Sale Certificate is one of the foundation documents in any imported product cosmetic application. It provides proof that the product is freely sold and approved in its country of origin.
Inconsistency In Submitted Information
CDSCO often rejects applications where inconsistencies are found across documents. This could involve mismatched product names, formulations, manufacturer addresses, or even differing label content.
Poor Quality Or Illegible Document Scans
If your documents are blurry, too dark, or hard to read, CDSCO may reject your cosmetic application. Even if all your paperwork is correct, poor scans can delay or stop the approval process.
Delayed Response to CDSCO Queries
CDSCO often raises queries or requests clarification during the review process. A delayed or incomplete response is one of the simplest, yet most common, reasons for application rejection.
How To Avoid Rejection In Cosmetic Applications
To avoid these reasons for rejection in cosmetic applications, it is imperative to proactively manage the typical specified issues causing regulatory delays. Below is a guide on how, via the CDSCO application process, you can avoid rejection for any of these:
Step 1: Submit Complete And Correct Documents
Gather all necessary papers before you apply, like the Free Sale Certificate (FSC), Power of Attorney (PoA), list of product ingredients, a copy of the Label, and Product Information File. Make sure all papers are complete, current, and legible. If a paper is issued from another country, get it notarized and legalized as per the rules of CDSCO. Make sure that all details, such as product name, manufacturer name, and address, are the same in every document. Use official checklists from the CDSCO to confirm nothing is missed before submission.
Step 2: Follow Labeling Guidelines
Ensure that your label contains all relevant information – Product Name, Ingredients, Net content, manufacturer, and expiration dates, etc. It should use English or Hindi on your labels as per the guidelines in India. Do not include any therapeutic or medical claims such as “treats acne”, “heals skin”, or “cures dandruff”. Make sure the information on the label is the same as the information on the application documents. The Cosmetics Rules, 2020, guidelines apply here about the related BIS (Bureau of Indian Standards) labeling standards.
Check Ingredients Against Indian Standards
Check your product’s list of ingredients & make sure everything is permitted under laws such as BIS Standards & Schedule S of Cosmetics Rules. Do not put in forbidden things like mercury or any lead compounds, and also do not use colorants. Use only approved concentration limits for restricted ingredients. Look for more recent notices or updates about CDSCO or BIS on the safety of ingredients. Add a Toxicological Risk Assessment (TRA), if necessary, to prove that the ingredients do not harm your product.
Classify Your Product Properly
You must ensure your product is described as a cosmetic, which cleans and beautifies, and not considered as a category that treats a medical illness. Do not make any claims such as “treats skin infection” or “heals acne”. If you disagree with the CDSCO because they determine that you have a drug, they will place you in a different category, not as a cosmetic. Review the CDSCO’s official list of approved cosmetic categories and ingredients. If your product lies in a grey area (such as a medicated cream or herbal product), consult a regulatory expert before applying. Match your product’s claims with its purpose and ingredients to ensure it stays within the cosmetic classification.
Provide A Valid Free Sale Certificate (FSC)
Get the FSC issued by the health authority in the country where the product is manufactured and legally sold. Make sure the FSC clearly states that the product is freely sold in the country of origin & Contains the name and address of the manufacturer. If the FSC is in a language other than English, provide an official English translation. Also, ensure the FSC is not expired and is not older than 2 years from the date of issue. Legalize or apostille the FSC if required by CDSCO, especially if it’s from a country outside of India.
Keep All Information Consistent
Use the same product name in all documents, including application form, label copy, Free Sale Certificate, Power of Attorney, and product ingredient list. Make sure the manufacturer’s name and address are the same across all documents. Check that the ingredient list and their concentrations are consistent in both the composition list and the label. The importer’s details (name, address, contact) should also match across all submissions. Review documents carefully before uploading to the SUGAM portal. Even small errors like different spellings or formatting can confuse.
Upload Clear, High-Quality Documents
Make sure all signatures, seals, and dates are easy to read. Do not crop any part of the document during scanning. Name each file clearly and correctly before uploading to the SUGAM portal. Double-check that the documents are in the correct sections of the portal before final submission.
Respond To Queries On Time
Check the SUGAM portal and your registered email regularly for notifications and questions from CDSCO. Upon receiving a query, you should review it to understand what they are asking for and then write a short answer to the query that encompasses all the points raised. You should also upload any amended or additional documents as required by these queries. It is also important to respond as early as you can and within the time specified, which is usually 30 days from the date of the query by the CDSCO. If you miss the expiry of the time specified, your application can be deemed as suspended and refused.
How ELT Can Help You Avoid Rejection in Cosmetic Applications?
Submitting a cosmetic application to CDSCO? Even minor omissions could result in a rejection of your application, such as submitting the wrong documents, banned ingredients, or incorrect labels. This is where an Expert Legal/Regulatory Team (ELT Corporate) comes into play. We can assist you with:
- Correct product classification
- Preparation of required documents
- Ingredient and label compliance
- Prompt response to CDSCO
- No mistakes that will cause delays or rejection
We can take care of the complexities so you can get approval faster and easier into the market.
FAQ’s
How Can I Avoid Reasons For Rejection In Cosmetic Applications Due To Labeling Issues?
Ensure your label follows Indian guidelines by including all required details in English or Hindi and avoid any medical or therapeutic claims like “heals” or “treats.”
Why Is Consistency In Application Details Important?
Reply promptly and thoroughly to any questions, providing complete responses within the time frame (generally 30 days) while avoiding application refusal through detailed explanations and any required additional documentation.
If CDSCO Has Any Queries Concerning My Cosmetic Application, What Should I Do?
It is important that you respond promptly and sufficiently to the queries you have received with an explanation and based on the information requested, completely and satisfactorily. Queries must be fully responded to in the required time frame specified in the letter (generally 30 days), otherwise, your application will be rejected.
