We believe that the key to success is collaboration. We work closely with our clients to understand their business objectives and challenges, and we partner with them to develop innovative and effective strategies to achieve their goals.

Address

D - 215, Sector-63, Noida, UP, 201301

info@agileregulatory.com

Phone

+91-8178731176

Cosmetics Import Registration | Form COS-1, COS-2

Cosmetics Import Registration (FORM COS-1, FOMM COS-2) has been issued by the Central Drugs Standard Control Organization to importers & foreign manufacturers of cosmetics items having registered offices in India. Get hassle-free support in getting cosmetics import registration from Agile Regulatory, a team of 12+ years of experienced professionals.

Overview of Cosmetics Import Registration

With growing consciousness towards beauty & well-being, India is currently experiencing massive growth in the manufacturing as well as consumption of cosmetics. Such growth not only encompasses the goods produced locally but also multi-national products promising effectiveness and better results sold in India either through physical brick-and-mortar stores but also through popular e-commerce platforms.

With evolving customer needs and preferences, there is consistent potential for fresh cosmetic items and innovative creations to enter the market. However, to ensure that such cosmetics have been prepared, tested, packaged, and distributed in a standardized and safe manner, the Government of India introduced the Cosmetics Registration Scheme in 2011 including the Cosmetics Import Registration under the central regulatory body, namely the Central Drugs Standard Control Organization (CDSCO) entrusted with the responsibility of approval & oversight under the Drugs and Cosmetics Act 1940 and Rules 1945.

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

Agile Regulatory Checklist Reviewing various requests for NOC (No Objection Certificate) or addressing inquiries concerning the importation of cosmetic goods.

Agile Regulatory Checklist Pursuing & overseeing grievances from NGOs, the public, or consumer organizations regarding the quality of cosmetic products.

Agile Regulatory Checklist Responding to official communications from the government or the Bureau of Indian Standards (BIS) as necessary.

Agile Regulatory Checklist Evaluating applications for CDSCO Cosmetic Import Registration in accordance with the mandates of the Drugs & Cosmetics Act, 1940, and its associated Rules.

Agile Regulatory Checklist Managing & responding to public queries, hearings regarding the CDSCO Cosmetic Import Registration procedure, and furnishing appropriate guidance.

Agile Regulatory Checklist Compiling initial responses for Right to Information (RTI) applications, legal cases, inquiries related to drugs or cosmetics, or any other similar cases.

Who Can Apply for Cosmetic Import Registration In India?

Agile Regulatory Checklist An authorized representative acting on behalf of the producer

Agile Regulatory Checklist The subsidiary entity of the international manufacturer

Agile Regulatory Checklist Any producer of cosmetic products.

Agile Regulatory Checklist Any alternative importer.

Benefits Of The Cosmetics Import

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.

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.

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.

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

Agile Regulatory Checklist Covering Letter along with product details, details of the manufacturing unit or any additional location, etc.

Agile Regulatory Checklist Original certified copy of Manufacturing Registration or License or Marketing Authorisation issued by the Regulatory Authority from the country of origin.

Agile Regulatory Checklist Details & undertaking required to be provided by the importer or his authorized representative.

Agile Regulatory Checklist Details of the manufacturing entity along with the complete address of the manufacturing unit.

Agile Regulatory Checklist Original label for the proposed cosmetic product or item along with their variant.

Agile Regulatory Checklist Address details of the actual manufacturer along with the country of origin.

Agile Regulatory Checklist Free Sale Certificate issued by the National Regulatory Authority, TR-6 Challan

Agile Regulatory Checklist A duly notarized copy of the Power of Attorney as per CDSCO prescribed format

Agile Regulatory Checklist Details of the Composition or Ingredients

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.

FAQ`s

All cosmetics brought into India must undergo registration with the Central Licensing Authority. This involves submitting an application via Form 42 through the SUGAM portal, and subsequently, a license in Form -43 will be granted.

Indeed, if the manufacturer remains the same entity, they can submit a singular application using Form 42 for multiple brands that are manufactured at one or multiple sites by the same manufacturer.

If the importer wishes to include more products to an already approved Registration Certificate, they need to apply for an endorsement. This application should include the necessary documents, excluding fees if the category is already registered, and as long as the extra product(s) are manufactured at the same site as before. If a new category is to be added, a fee of 250 USD per category must be paid. The validity of the endorsement granted for these supplementary products will match that of the main Registration Certificate

Any changes concerning the manufacturer (legal/actual), such as changes in constitution, name, address, etc., or any changes involving the importer or Indian Agent, like changes in constitution or name, etc require fresh registration

Changes in product composition, alterations in testing methods, minor adjustments in the manufacturing process that do not impact the final product specifications, and updates in labels and packaging with appropriate justification