An Overview of CDSCO Cosmetic Import Registration
In India, the cosmetic industry is rapidly growing, with a massive market for cosmetic and personal care products. The import of cosmetics in India should be regulated to ensure the quality, safety, and performance of cosmetics being imported into India needs CDSCO Cosmetic Import Registration Certificate from the Ministry of Health & Family Welfare as prescribed under Rule 21 of Drugs and Cosmetics Rule 1945. The certificate is required from the primary regulatory authority for CDSCO Cosmetic Import Registration in India, which is obtained from the Central Drug Standard Control Organisation (CDSCO). With this registration, import activities and sales of cosmetic items can be carried out in India without any hassle. In India, CDSCO Cosmetic Import Registration in India is governed under the Drugs and Cosmetics Act, 1940.
What is the meaning of Cosmetic?
Cosmetic means any substance which is aimed to be scrubbed, sprayed, poured, or introduced into the human body which is used for altering, cleansing, or beautifying the appearance, which also includes any article used as a part of cosmetic products.
What is the Role of CDSCO for Cosmetic Import in India?
- Amendment of the Cosmetic Rules, 2020 regarding the import and registration of cosmetic products;
- Examination of various applications for NOC (No Objection Certificate) or clarification regarding the import of cosmetic products;
- Handling of NGOs or public or Consumer forums complaints regarding the standard of cosmetic products;
- Replying to the Government correspondences or BIS as and when needed;
- Examining applications for CDSCO Cosmetic Import Registration into the nation as per the requirements of the Drugs & Cosmetics Act, 1940 and Rules;
- Handling of public inquiries or PMOPGs or hearing regarding the CDSCO Cosmetic Import Registration process & providing guidance thereto;
- Preparation of draft replies to RTI, VIP references, court cases, and Parliament questions related to cosmetics.
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Who can apply for CDSCO Cosmetic Import Registration in India?
According to the Drugs & Cosmetic Act, 1945, CDSCO has listed the applicants who are eligible to apply for CDSCO Cosmetic Import Registration in India:
- Authorised Agent: In case the manufacturer has authorised an agent on their behalf to import cosmetics.
- A subsidiary of the Manufacturer: For any foreign cosmetic manufacturer, the Indian subsidiary firm can apply on their behalf for the CDSCO Cosmetic Import Registration.
- Manufacturer: The manufacturer can also apply for the grant of CDSCO Cosmetic Import Registration in India.
- Any Other Importer: Any Indian importer willing to import cosmetics to India from a foreign manufacturer can apply for this license or registration.
CDSCO Cosmetic Import Registration
Documents required for CDSCO Cosmetic Import Registration
Following are some vital documents required at the time of CDSCO Cosmetic Import Registration:
- Covering Letter: Purpose (Fresh/Endorsement of Products or Pack Size or Manufacturing site or Additional Sourcing Location or Re-Registration) must be clearly mentioned along with the information of earlier issued Import Registration Certificate (if any) and product or product category (whether registered or not).
- Part-1 of Second Schedule: Details & undertaking required to be provided by the manufacturer or his authorised distributor or importer, or agent with the application form for Import Registration Certificate. The format should be properly filled in for each application in Form COS-1.
- List of Composition or Ingredients:
- Cosmetic name and ingredients name in the nomenclature of standard reference along with percentage contained in the Cosmetic signed by authorised person along with the stamp from the manufacturer.
- No cosmetic shall be manufactured or imported which contains Colours, Pigments, and Dyes other than the one specified by the BIS and includes the 10th schedule.
- The allowed synthetic organic colours and natural organic colours used in the Cosmetic shall not contain more than:
- 20 parts/million of lead calculated as lead;
- 2 parts/million of Arsenic calculated as Arsenic Trioxide;
- 100 parts/million of Heavy Metals other than lead are calculated as the total of the respective metals.
- Raw material stated in ANNEX A of the IS: 4707 Part 2, as amended from time to time, shall not be added to the cosmetic product.
- No cosmetic containing Hexachlorophene shall be manufactured. In the case of soaps, Hexachlorophene may be used in concentrations not exceeding 1% weight by weight with a cautionary note be shown & shall appear in a conspicuous manner on the wrapper of a package of each soap.
- Cosmetics manufactured or imported into the country shall contain mercury in the following proportions:
- In cosmetics aimed for use only in the area of the eye, the level of mercury not exceeding 70 parts per million (0,007 per cent) of mercury, calculated as the metal, as a preservative;
- In other finished cosmetic products, unplanned mercury shall not exceed one part/million (1 ppm).
- The use of arsenic & lead compounds for the purpose of colouring cosmetics is prohibited.
- Labels of Proposed Products: Original label for the proposed cosmetic product or item along with their variant (if any) as per the Chapter VI of the Cosmetics Rules, 2020, which comprised the following:
- Cosmetic name;
- Manufacturer name and complete address of the manufacturer's premises where the Cosmetic has been manufactured. If the product hasn’t been manufactured in a factory owned by the manufacturer, the name & address of the manufacturer or the country name where it has actually been manufactured as “Made in (Country Name)” should be there on the label;
- Date of expiry or use before or use by or expiry XX months from manufactured date or date of manufacturing;
- A unique Lot Number or Batch Number;
- Manufacturing License Number, the number is preceded by the letter M or M.L. No or Mfg. Lic. No. shall carry on outer/inner labels;
- A declaration of the net contents stated in terms of weight for solids, fluid measure/weight for semi-solids, fluid measure for liquids, combined with numerical count if the content is sub-divided;
- In the case of cosmetics, where a hazard exists; every inner label must clearly indicate enough directors for safe use, caution or any special direction required to be observed by the customer;
- In the instance of imported cosmetics to be marketed in India, the CDSCO Cosmetic Import Registration number shall be cited in the unit pack label preceded by the letter RC or Reg. Cert. No. or RC No, along with the address & name of the importer;
- If a cosmetic package has only one label, such label must contain all the details required to be displayed on both the inner and the other outer labels under the prescribed rules;
- In all instances, the ingredients list, present in a concentration of more than 1% must be listed in the descending order of volume or weight during they are added, followed by those in a concentration of equal/less than 1%, in any order and preceded by the words "INGREDIENTS”;
- The Cosmetic must comply with all the labelling requirements, if any, specified in the relevant Indian standard as set by BIS for the cosmetics covered under the 9th Schedule;
- No Cosmetic shall be imported unless it is packed & labelled in conformity with these rules & label of imported cosmetics shall bear the Registration Certificate Number of the product & name and address of the owner of the CDSCO Cosmetic Import Registration for marketing the concerned product in India.
- Specification & Testing Methods: The specification of document is required from the manufacturer's end. The protocol for testing of cosmetics & specifications are as per the standards specified in the Cosmetics Rules, 2020 for the applied product.
- Pack Insert (If any).
- Manufacturing Licenses: Original certified copy of Manufacturing Registration or License or Marketing Authorisation regarding applied products issued by the Regulatory Authority from the country of origin or undertaking.
- Free Sale Certificate: This certificate is issued by the National Regulatory Authority of the country for the applied products or from the Indian Embassy of the country of origin. List of products of Free Sale Certificate should be signed & stamped by issuing authority. A Free Sale Certificate (FSC) should contain the statement that in which nation the applied product is freely sold.
- Declaration of Non-Animal Testing.
- Declaration for Heavy Metal & Hexachlorophene.
- Application COS-I Form.
- TR-6 Challan (In Original).
Note: All the documents are in the English language.
Procedure for CDSCO Cosmetic Import Registration in India
Following is the step by step procedure for CDSCO Cosmetic Import Registration in India:
Step 1: Determination of Cosmetics Classification: When a manufacturer decides to register their products in India, then the manufacturer must check the Gazette Notification of CDSCO prior to making a final determination of a device’s regulatory status & classification.
Step 2: Appointment of an Indian Agent: The manufacturer should appoint an authorised Indian agent to interact with the CDSCO. The agent will be granted a Power of Attorney to assist in cosmetic approvals and manage registration & importation in India.
Step 3: Fill out the Application Form for CDSCO Cosmetic Import Registration: After appointing an agent, the importer or manufacturer of cosmetics shall be required to submit the Registration Form along with all the documents and prescribed fee on the CDSCO website to the Drug Controller General of India (DGCI) by simply logging on to the online website of CDSCO and signing into the website.
Step 4: Issuance of CDSCO Cosmetic Import Registration Certificate: Once the application form along with documents & fee is submitted on the website of CDSCO, the DGCI Registration Authority may send a query via an inquiry letter to the manufacturer or from the certified representative of the importer. Once the authority is fully satisfied with the application, then they may issue a Cosmetic Import License.
How will Corpbiz help you?
Corpbiz assists in applying CDSCO Cosmetic Import Registration Certificate. The applicant may find it difficult to comply with documentation and requirements, as we mentioned above. So in such a case, it is recommendable to contact Corpbiz, who will definitely guide you on each step of the procedure.
Frequently Asked Questions
It means any substance which is aimed to be scrubbed, sprayed, poured, or introduced into the human body which is used for altering, cleansing, or beautifying the appearance this also includes any article used as a part of cosmetic products.
Import of cosmetics should be regulated in India to ensure the safety & quality of cosmetics being imported in India.
DGCI, CDSCO, Directorate General of Health Services, Ministry of Health & Family Welfare. Government of India.
The authorised agent of the manufacturer, the manufacturer, the subsidiary of the manufacturer, and any other importer.
Then you need to apply for re-registration within 6 months before the expiry of the said certificate; then, the existing Registration Certificate shall be considered to continue to remain in force.
It can be issued by the National Regulatory Authority, which in original or authenticated from the country of origin is to be submitted.
No. In this case, a Registration Certificate is not required.
No, cosmetics that are tested on any animals are not allowed for import in India.
A Cosmetic Manufacturing License is issued by the respective State Licensing Authorities appointed by the State Government.