The cosmetic industry is flourishing all over the world both in terms of business and frauds, therefore the requirement of Cosmetic registration in India is of utmost importance. As per the Section 3 (aaa) of the Drugs and Cosmetics Act, 1940, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetics.
Governing Authorities Of Cosmetics Registration In India
- Central Drug Standard Control Organization (CDSCO) is the regulating authority that oversees the process of cosmetic registration in India as per the provisions of the Drug & Cosmetic Act 1940 & Rules 1945.
- BIS (Bureau of Indian Standards) formulates the standards of the quality check from time to time to meet the adequate ingredients requirement of a cosmetic product.
- State License Authority (SLA) is the regulatory authority that regulates the manufacturing of cosmetics products in India.
Cosmetic Registration for Manufacturers
- A fresh application in Form COS-5 is required to be made to the authority for manufacturing cosmetics for sale or distribution in India. The license is issued in Form COS-8 to the applicant.
- To obtain a loan license for manufacturing cosmetics, an application in Form COS-6 needs to be submitted. The license is issued in Form COS-9 to the applicant.
- An application in Form COS-22 has to be made for grant or renewal of the license requiring tests on cosmetic products. The license is issued in Form COS-23 to the applicant.
Cosmetic Registration for Importers
- An Application for Registration of Cosmetic product intended to be imported into India shall be made through the online portal of the Central Government in Form COS-1.
- After examination of Documents furnished with the application under sub-rule 2 of rule 12 the Central Licensing Authority may, on being satisfied, grant cosmetic import registration certificate in Form COS-2.
Applicant Of Cosmetic Registration in India
- Manufacturer of the product who has registered office in India
- In the case of Importer – An authorized agent, Subsidiary entity or registered manufacturer can apply to CDSCO.
- Any other importer
Documents Required To Avail Cosmetics Registration To Import Cosmetics
- Regulatory Documents –
- Manufacturing license/GMP Certificate
- Government fee- Payment receipt received from Bharatkosh portal.
- An undertaking that the product doesn’t contain any prohibited items like mercury, lead and heavy metals as prescribed by BIS standards
- Technical Documents –
- Product testing Protocols and Specification sheet
- Product inserts containing a brief description of the product along with its intended use
- List of ingredients with their composition in %
- Product labels depicting the address of the manufacturer, RC No., Mfg. date, Exp. Date, Batch no.
- Legal Documents –
- Forms as prescribed along with duly affixed signatures
- COS-1 needs to be submitted by the authorized agent in India
- Part I Second Schedule in the format prescribed
- Authorization from manufacturer signed by both the manufacturer and Indian agent and apostilled or attested from Indian Embassy in country of origin.
Documents Required For Cosmetics Registration To Manufacture Cosmetics In India
- Regulatory Documents-
- Certificate of Incorporation (COI) + MOA + AOA
- No Objection Certificate from the Pollution Control Board
- No objection certificate for Fire Department
- Layout plan (Blue Print)
- Documents of Formulation chemist and analytical chemist
- Technical Documents-
- Specification sheet
- Formula & label
Timeline For Cosmetics Registration
- On submission of all the required documents, it generally takes 2-3 months to conduct the technical scrutiny by the drug inspectors of CDSCO.
- The authorities may ask for any clarification required during that period.
- If satisfied, a grant of cosmetic license is done in Form COS-2.
Application Fee For Cosmetics Registration Importers – (Import)
The fees to be paid at the time of application through online portal (Bharatkosh) is 1000 USD for each category, 500 USD for each manufacturing site and 50 USD for each variant. . There is no additional fee for the addition of a product in the approved categories
Application Fee For Cosmetics Registration Manufacturers – (Manufacturing In India)
The fees to be paid at the time of application through online portal is 10000 INR upto 10 products in each category.
Validity Of Cosmetic License In India
The manufacturing and importation license as obtained by applying on the portal is valid for 5 years.
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Conclusion
Before launching your product in the Indian market, every manufacturer or importer needs to obtain a cosmetic license from the Drug regulatory authority (CDSCO). The objective of obtaining the license is to ensure the quality, efficacy, and safety of the cosmetic products manufactured/imported in India.