In India, hair styling products fall under the category of cosmetics, which come under the regulation and enforcement of the Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare. Suppose you manufacture, distribute, or export hair styling products. In that case, it is necessary to receive CDSCO approval before you sell to ensure that you comply with the regulations on product safety and consideration of market entry. In this Guide to CDSCO Approval for Hair Styling Products, we will cover the process for obtaining CDSCO approval from beginning to end.
What Is CDSCO Approval?
The Central Drugs Standard Control Organization (CDSCO) is the regulator that ensures drugs and cosmetics are safe, effective, and quality for sale in India. CDSCO approval is required for hair styling products to ensure that they are able to meet the safety as standards and be used safely by the consumer. CDSCO approval is a necessary step that must be taken before the product is sold in India.
Why Is CDSCO Approval For Hair Styling Products Important?
- Consumer Safety: The CDSCO authority ensures you have peace of mind about the materials found in the products you choose to use, which do not contain toxins and harmful substances.
- Legal regulatory compliance. If you did not conform to CDSCO regulations, this may very well have resulted in substantial fines, product recall, or possibly both.
- Market Credibility. When you are CDSCO accredited, consumers, suppliers, and your stakeholders have guaranteed assurance that you are reputable and supply good-quality goods to the market.
- Export potential. Also, a number of buyers internationally will only buy goods with CDSCO approval.
Types Of Hair Styling Products Covered Under CDSCO Regulations
CDSCO covers a wide range of products under its regulatory framework, including:
- Shampoos and Conditioners
- Hair Gels, Mousse, and Styling Creams
- Hair Sprays and Mists
- Hair Dyes and Colors
- Hair Serums and Oils
Step-By-Step Process To Get CDSCO Approval For Hair Styling Products
Here’s a step-by-step explanation of the CDSCO approval process for hair styling products, with each step described briefly in a paragraph:
1. Determine if the product constitutes a Cosmetic or a Drug
First, determine whether your hair styling product is a cosmetic or drug, according to Indian law. Most hair styling products (gels, sprays, waxes, etc) are cosmetics unless a therapeutic claim is being made (treats dandruff or promotes hair growth), and they would be considered drugs instead. This will determine whether or not the product requires registration as a drug.Â
2. Appoint an Authorized Indian Agent (for Imports)
As a manufacturer from abroad, you will likely need to appoint an Authorized Indian Agent to act as your representative in India. This person needs to be authorized to act as a wholesale dealer (has a valid wholesale license – Form 20B & 21B) and will gather your application and liaison with CDSCO on your behalf.
3. Apply For Product Registration (Form COS-1)
To register a product in India, you need to submit an online application that goes through the SUGAM portal. You submit an application through the SUGAM portal in Form COS-1. This form asks for product identity information, manufacturing site information, ingredient list, Safety Data, labeling information, etc. Each product variant requires registration.
4. Collect The Required Documentation
There is additional documentation amassing needed as part of the application, including a Free Sale Certificate, a copy of the manufacturer’s license, safety assessment reports, product specifications, Power of Attorney (if applicable), and labeling templates. All paperwork must satisfy Indian regulatory requirements and be notary-apostilled where required.
5. Make Required Payments
Registration and import application fees must be paid via the online Bharatkosh Portal. The fee amount is dependent on the number of products and variants being submitted. Payment receipts must be enclosed with the application.
6. Evaluation of Application and Issuance of Certificate (Form COS-2)
After submission of the application, the application will be evaluated by CDSCO, and the CDSCO may ask for clarification or raise queries as it proceeds through an evaluation phase. If all requirements are met, CDSCO will issue a Registration Certificate (Form COS-2) for the product, which gives permission to sell the registered product or import it into India.
7. Apply for Import License (Form COS-3, If Required)
Pricing products imported, after receiving a registration certificate, the authorized agent will need to apply for the Import License in the prescribed form (Form COS-3). This license will give authorization for legal importation of the registered product and must be renewed as required.
8. Compliance With Indian Labelling Rules
The label of the product must follow labelling rules as per Rule 148 of the Drugs and Cosmetics Rules, such as product name, manufacturer, batch number, expiry date, list of ingredients, safety warnings, etc. If the label does not comply with labelling rules, then the Product can be seized or rejected.
9. Ongoing Compliance
Even as an approved product, the producer must maintain the product’s quality assurance records, batch testing, customer complaints, etc. CDSCO may periodically audit you or inspect your production practices, records, etc., to assess your compliance with the approved product safety and regulatory standards.
Documents Required for CDSCO Approval of Hair Styling Products
Below is a list of the required documents that you must prepare and submit with your application:
- Covering Letter
- Form COS-1 (Online Application Form)
- Power of Attorney (POA)
- Free Sale Certificate (FSC)
- Cosmetic Manufacturer’s License/Registration Certificate
- Product Information Sheet
- Ingredient List with % Composition
- Labeling/Artwork Specimen
- Specifications and Test Reports
- Safety and Toxicology Data (if applicable)
- Declaration of Non-Animal Testing
- Undertaking by Manufacturer/Authorized Agent
- Product Sample (if requested)
- Fee Payment Receipt
How ELT Corporate Can Help?
At ELT Corporate, we are experts in Extractables and Leachables Testing to comply with the requirements of both the CDSCO and world regulatory authorities. Our team of professionals will assist you in evaluating product safety and compliance for quicker approvals of pharmaceuticals, biologics, and medical devices. Use us as a partner in your regulatory pathway to obtain reliable ELT data of the highest quality.
Conclusion
Securing CDSCO approval for your hair styling products is an important step to enhance consumer safety, build trust in your product, and comply with India’s regulation of notified cosmetics. The step-by-step guide you have received will help you progress towards securing approval and preparing your brand for success in the unsolicited and highly competitive Indian cosmetic and hair care market. Whether you are looking to expand your portfolio or enter into the Indian market in hair styling products, always consider taking professional advice and ensuring you are fulfilling your regulatory obligations. The vast rewards and opportunities associated with obtaining CDSCO approval for your business will not only enhance your confidence in health and safety but also provide reassurance to your customers.
FAQs
Do All Hair Styling Products Require CDSCO Approval?
Yes, if your product qualifies as a cosmetic under the Drugs and Cosmetics Act and is manufactured or imported for sale in India, CDSCO approval is required.
Are Imported Hair Styling Products Treated Differently From Domestic Ones?
Yes. Imported products must be registered with CDSCO and require an Authorized Indian Agent, as well as submission of additional documents like a Free Sale Certificate and Import License.
What Types Of Hair Products Fall Under CDSCO Cosmetic Regulations?
Products such as hair gels, sprays, mousses, waxes, styling creams, hair serums, and hair oils are covered, unless they make therapeutic claims, in which case they may be classified as drugs.
