Cosmetics Import License

Overview of Cosmetics Import Registration

Cosmetics Import Registration In India

The term "Cosmetic" is elucidated in section 3 (aaa) of the Drugs and Cosmetics Act, 1940 as any item meant to be gently rubbed, poured, sprinkled, sprayed onto, or inserted into, or in any other way used on the human body or any of its portions. Such use could be for any purpose including cleansing, beauty enhancement, promoting attractiveness, or modifying appearance. This definition also involves substances/elements designed to serve as constituents of cosmetics.

According to the stipulations outlined in the Drugs & Cosmetics Act of 1940, the production of cosmetics is supervised through a mechanism of assessment and authorization conducted by the State Licensing Authorities chosen by individual State Governments. Conversely, the introduction of cosmetics into the country is governed by a registration procedure managed by the Central Licensing Authority designated by the Central Government.

The Central Licensing Authority's responsibility involves the issuance and oversight of the Import Registration Certificate, along with supervising the fulfilment of post-compliance requirements outlined in the Drugs and Cosmetics Act of 1940 and its revised regulations of 2020. Moreover, the amended regulations of 2020 for the Drugs & Cosmetics Act entail the following provisions:

Any product belonging within the definition of cosmetics necessitates registration specifying details such as package dimensions, variations, and the location of manufacturing facilities which shall be determined and gained before entering into the country. Under Rule 12(1) of the Cosmetic Rules, 2020, no product shall be eligible to be imported into India unless the product has been registered in accordance with the regulations by either the Central Licensing Authority appointed by the Central Government as specified in rule 3(f), or by an individual to whom such authority may be assigned under Rule 5.

As per rule 39 of the Cosmetic Rules, 2020, any import or manufacture of cosmetics is only permitted if it adheres to the specifications laid down in the Ninth Schedule to the Act or any related standards of safety & quality. Where any item has not been listed in the Ninth Schedule, it must still satisfy the prerequisites stipulated in these rules and align with the specifications and standards that are applicable in its country of origin. Similarly, no cosmetics may either imply or claim to imply any false or misleading idea or belief to its ultimate user.

Role of CDSCO

• Reviewing various requests for NOC, No Objection Certificate or addressing inquiries concerning the importation of cosmetic goods.
• Pursuing & overseeing grievances from NGOs, the public, or consumer organizations regarding the quality of cosmetic products.
• Evaluating applications for CDSCO Cosmetic Import Registration in accordance with the mandates of the Drugs & Cosmetics Act, 1940, and its associated Rules.
• Managing & responding to public queries, hearings regarding the CDSCO Cosmetic Import Registration procedure, and furnishing appropriate guidance.
• Compiling initial responses for Right to Information, RTI applications, legal cases, inquiries related to drugs or cosmetics, or any other similar cases.

Elligibility of Cosmetic Import License?

• Any alternative importer
• Any producer of cosmetic products
• The subsidiary entity of the international manufacturer
• An authorized representative acting on behalf of the producer

Benefits Of The Cosmetics Import

1. Assurance of Safety & Quality:  When a cosmetic is certified by the CDSCO, it undergoes quality assessment at an authorized laboratory, obtains a quality certificate, and yields optimal results for patients.
2. Boosts Brand Value & Credibility: The CDSCO cosmetics Import License enhances the reputation of brands & manufacturer business entities allowing them greater consumer trust and credibility. With new regulations and guidelines in effect, each manufacturer has the opportunity to actively penetrate the market by registering their product under specific legislation.
3. Adherence to Legal Compliance: The authority conducts on-site inspections to verify that drugs are manufactured and stored in accordance with regulations. These audits help identify equipment deficiencies and contribute to mitigating potential risks that could pose harm to patients in the future.
4. Opportunities for Higher Growth & Sales: The Indian government addresses escalating demand for international manufacturers & importers by allowing overseas manufacturers to enter the Indian market, ensuring compliance with CDSCO guidelines, and maintaining a high profit margin.

Documents Required for Cosmetic Import

• Details of the Composition or Ingredients.
• Address details of the actual manufacturer along with the country of origin.
• Original label for the proposed cosmetic product or item along with their variant.
• Free Sale Certificate issued by the National Regulatory Authority,  TR-6 Challan.
• A duly notarized copy of the Power of Attorney as per CDSCO prescribed format.
• Details & undertaking required to be provided by the importer or his authorized representative.
•  Details of the manufacturing entity along with the complete address of the manufacturing unit
• Covering Letter along with product details, details of the manufacturing unit or any additional location, etc. 
• Original certified copy of Manufacturing Registration or License or Marketing Authorisation issued by the Regulatory Authority from the country of origin.

Process of Cosmetics Import Registration

Step 1: Categorization of the Cosmetics: The initial phase of importing cosmetics involves determining whether it necessitates registration according to the Drugs & Cosmetics Act 1940, and amended rules, 2020.

Step 2: Online Portal Registration: An applicant who wants to import cosmetics in India needs to create a login ID and password through the CDSCO sugam online portal https://cdscoonline.gov.in/. 

Step 3: Nomination of an Authorized Representative: When seeking a cosmetics import license, foreign manufacturers are not allowed to apply directly. Regulations dictate that the manufacturer cannot approach CDSCO themselves. Instead, they must engage an authorized licensing agent, which could be an individual or entity. The manufacturer must grant power of attorney to this agent, enabling them to apply on their behalf, communicate with the licensing authority, and submit the required information and documents.

Step 4: Fill out the form and submit: Complete Form COS-1 and provide all the necessary documents and specified fees through the CDSCO SUGAM portal by accessing the CDSCO website online and logging in to the portal.

Step 5: Grant of Cosmetics Import Registration Certificate: On receipt of the application, the Central Licensing Authority shall proceed with the assessment of the application. Upon reviewing the application, the authority may seek additional information or issue a Cosmetic Import License in the form of Form COS-2.

Terms of Cosmetics Import Registration

Assuming the application is comprehensive and no additional information is needed, the processing time from the application submission date could range from approximately 90 to 180 days. Upon approval, the import registration certificate will possess legal validity lasting for three years from the date of registration approval.

Role of Agile Regulatory

Obtaining the Cosmetics import registration could be a bit challenging due to the complex process of the documents required and the processes involved. However, with the right amount of guidance and consultation, you could easily acquire cosmetics import registration within the prescribed time. At Agile Regulatory we are committed to helping budding entrepreneurs by enabling them to acquire business licenses smoothly and carry on their business.