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💄 Cosmetics Import Registration 📑 Frequently Asked Questions 🥇 Consultant in New Delhi India

A: As per 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 cosmetic.
A: Yes, import of cosmetic is regulated in India under the provisions of the Drugs & Cosmetic Act, 1940 & the Cosmetics Rules, 2020.
A: The copy of the Cosmetics Rules, 2020 is available under Cosmetics Section on CDSCO website (Gazette notification G.S.R 763 (E)).
A: Import of cosmetics in India needs to be regulated to ensure safety, quality and performance of cosmetics being imported into India.
A: The copy of the Drugs &Cosmetics Act, 1940 & the Cosmetics Rules, 2020 is available on CDSCO website.
A: The manufacturer himself/the Authorized Agent of the Manufacturer/the authorized subsidiary of the manufacturer in India/any other importer in India can be an applicant for grant of Import Registration Certificate for import of cosmetics products into India.
A: Import registration certificate” means a certificate issued under rule 13 of New Cosmetics Rules, 2020 by the Central Licensing Authority for registration of cosmetics manufactured for import into and use in India
A: The Drugs Controller General (India), Central Drugs Standard Control Organization(CDSCO)HQ, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India , FDA Bhawan, ITO, Kotla Road, New Delhi -110002.
A: Cosmetics Division, Central Drugs Standard Control Organization (CDSCO) HQ,
A: For import of Cosmetics products into India, the cosmetic products and manufacturing site are to be registered with Central Drugs Standards Control Organization by submitting an application in Form COS-1 to obtain a Registration Certificate in Form COS-2.
A: Form COS-1 is an application for grant of a Registration Certificate for Import of cosmetics into India under the Cosmetics Rules, 2020.
A: Form COS-2 is an Import Registration Certificate to be issued for import of cosmetics into India under the Cosmetics Rules, 2020.
A: A detailed procedure to obtain “Import Registration Certificate” in Form COS-2 is available under Cosmetics Section on CDSCO website
A: Documents required for issuance of Import Registration Certificate in Form COS-2 are available under Cosmetics Section on CDSCO website. (Detailed information is available under the Guidance Document on CDSCO website.
A: As per the Third Schedule of Cosmetics Rules, 2020, a fee of One Thousand US dollars or its equivalent in Indian Rupees for grant or retention of Registration Certificate for each category of cosmetics, a fee of Five Hundred US dollars for registration of each manufacturing site, a fee of Fifty US dollars for each variant and a fee of One Thousand US dollars for grant or retention of Registration Certificate for additional category of Cosmetic shall be paid along with the application in Form COS-1.
As per the circular no. CDSCO/IT/2018-(37) dated 09.01.2019 of this directorate, from 15.02.2019 the fees shall be paid through Bharatkosh only. The fee shall be paid through Bharatkosh gateway under Head of Account “0210041040000-00-1” Import and Registration and the acknowledgement receipt shall be submitted along with the application for registration of cosmetics.
A: Cosmetics are categorized as per Fourth Schedule of the Cosmetics Rules, 2020 while applying for Registration Certificate for import into India.
A: Different colour/shade or flavour of a product can be considered as a variant for the purpose of registration for import of cosmetics into the country.
A: “Use before” or “date of expiry” means the date recorded on the container, label or wrapper as the date up to which the cosmetic shall retain its characteristics as per standard at proposed storage condition stated on the label.
A: Actual manufacturer in relation to import of cosmetics, means a person who manufactures cosmetics at his own manufacturing site in a country other than India approved by National Regulatory Authority or any authorized competent authority in that country for that purpose, by whatever name called.
A: Legal manufacturer or brand owner in relation to import of cosmetics, means a person, who auhorises the other manufacturer from India or overseas countries for the manufacture of cosmetics, by way of an authorization referred under Rule 12 of the Cosmetics Rules, 2020.
A: A cosmetic manufactured at a foreign site and already registered under Rule13 for import and sale in India, may be imported by any person or entity by making an online application in Form COS-4 for grant of Import Registration Number in Form COS-4A in SUGAM Portal with an undertaking as specified in Sixth Schedule.
A: An Import Registration Number granted in Form COS-4A shall remain valid for a period of three years from the date of its issue, unless it is suspended or cancelled.
A: The applications for grant of Import Registration Number for import of cosmetic which is already registered for import into India shall be submitted to the Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO)HQ, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhawan, ITO, Kotla Road, New Delhi -110002.
A: As per Rule 13 of the Cosmetics Rules, 2020, if the application is complete in all respects and information and documents specified in Part I of Second Schedule is in order, the Central Licensing Authority may, on being satisfied, grant Import Registration Certificate or may reject such application for which reasons shall be recorded in writing with in a period of six months from the date an application. However, CDSCO’s targeted timeline for processing of applications is 90 days as per Circular dated 30.05.2014.
A: A Registration Certificate in Form COS-2 shall remain valid in perpetuity, subject to payment of registration certificate retention fee specified in the Third Schedule before completion of the period of Five Years from the date of its issue, unless it is suspended, or cancelled by the Central Licensing Authority. If the licensee fails to pay the required registration certificate retention fee on or before the due date, the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within one hundred and eighty days and in the event of non-payment of such fee during that period, the registration certificate shall be deemed to have been cancelled.
A: Importer has to apply for endorsement to the existing valid Registration Certificate along with the requisite documents except fees if the category is already registered and provided that the additional product(s) are being manufactured at the same manufacturing site. If additional category needs to be added, a fees of USD 1000 for each additional category needs to be paid. If an additional manufacturing site has to be added in the endorsement then a fee of USD 500 needs to be paid for registration of each additional manufacturing site.
A: Duration/validity of endorsement will be same as of the Registration Certificate (Form COS-2) under which endorsement has been issued.
A: A valid manufacturing license for finished formulation of cosmetic ready to fill in finished form from the State Licensing Authority and details of registered brand owner of the finished product in India need to be submitted along with application in Form COS-1. However, in case of trader or other importer who do not have their own manufacturing site but they only supply to the manufacturer having valid manufacturing license. Such applicant needs to submit a notarized agreement with the manufacturer along with copy of valid manufacturing license of that manufacturer. The details of registered brand owner of the finished product in India also need to be submitted.
A: A cosmetic which contain novel ingredient which has not been used anywhere in the world or is not recognised for use in cosmetics in any National and International literature.
A: Yes. Prior permission from the Central Licensing Authority is required for import or manufacture of New Cosmetics in India.
A: The applicant shall obtain a prior permission in Form COS-3, by making an application (in offline mode) in Form COS-12 along with requisite fee and documents as provided in Chapter V of the Cosmetics Rules, 2020, from Central Licensing Authority before registration of import of new cosmetic in India.
A: An application for import and manufacture under Chapter III and under Chapter IV respectively, of the Cosmetics Rules, 2020 shall be made to the Central Licensing Authority or the State Licensing Authority, as the case may be, along with the prior permission obtained in Form COS-3 from the Central Licensing Authority.
A: Yes
A: Free sale certificate can be issued by the National Regulatory Authority which in Original or authenticated (notarized/apostilled/attested by Indian Embassy) from Country of origin is required to be submitted. In case if it is not issued by National Regulatory Authority from the country of origin then from other competent Associations/ organizations duly authenticated from the Indian embassy of country of origin need to be submitted or in case if free sale certificate is authenticated either from chamber of commerce and apostilled or from notary public and apostilled, then it may be accepted.
A: Yes. Free sale certificate for all variants needs to be submitted.
A: Yes, an authorization by the manufacturer to his agent in India shall be duly authenticated either in India before a First Class Magistrate or by Indian Embassy in the country of origin or by an equivalent authority through apostile.
A: The following changes require a fresh registration –Any change in constitution of a registration holder or overseas manufacturer. An application shall me made under Rule 12 for grant of fresh Registration with in a period of 180 days from the date of such change in constitution.
A: For any changes in product labelling or composition or testing of registered cosmetic product or its specification, the Central Licensing Authority shall be informed within 15 days along with an undertaking that registered cosmetic products comply with BIS as referred in the Ninth schedule. Any change in name or address of Registration Certificate (RC) holder or Overseas Manufacturer, an application for amendment shall be made in online portal for prior approval of Central Licensing Authority (CLA) for the said changes in registration certificate with in a period of 60 days from the date of such changes.
A: Yes, as per condition nos. 3, 4& 5 of the Form COS-2.
A: Yes and Indian agent/ Importer shall inform the licensing authority immediately in writing and shall submit fresh application as per as per condition 4 of Form COS-2.
A: If a manufacturer or authorized agent, as the case may be has reason to believe that a cosmetics, which has been imported, manufactured, sold or distributed, is likely to pose risk to health of a user and therefore may be unsafe, such manufacturer or authorized agent shall immediately initiate procedures to withdraw the said product from the market under intimation to concerned SLA or CLA, as the case may be, of the details relating thereto.
A: While original labels are required, however applicants may submit copy of original label incorporating all details as per chapter VI of Cosmetics Rules, 2020.
A: Label should be in conformity with Rule 34 read with Chapter VI of the Cosmetics Rules, 2020.
A: Yes, importers of registered Cosmetic products are currently allowed to incorporate India specific requirements like name and address of importer, import Registration Certificate Number on imported Cosmetic products post landing in India at the bonded warehouses.
A: No. The applicant has to submit the Fresh application excluding fee.
A: There is no time limit for submission of Query Response as per the provision of Drugs and Cosmetics Act and Cosmetics Rules, 2020; however, it should be reasonable and justifiable.
A: No. either applicant or his authorized Regular employee may ask the status of their application if it is beyond the time limit prescribed under Drugs and Cosmetics Act and the Cosmetics Rules, 2020.
A: Only authorised Subject Expert or Technical Person of the firm/company, who is competent to make technical presentation.
A: No, Registration Certificate is not required.
A: Concerned Port offices of CDSCO are required to be approached for the above mentioned purposes.
A: No, Registration Certificate is not required. In such cases the importer has to obtain necessary permission from CDSCO, HQ New Delhi. Importer must give a written undertaking stating that these products are not released for domestic sale.
A: At the time of clearance of the consignment at the port office, an undertaking issued from the manufacturer stating that the cosmetic has not been tested on animals on 12.11.2014 or after the date is required to be submitted to the concerned port office.
A: No. Cosmetic and Drug are defined separately under Section 3 of the Drugs and Cosmetics Act. Products having drug claim do not come under the definition of cosmetic as per the Act and therefore cannot be considered for registration as cosmetic. Further, No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user. [As per rule 36 of the Cosmetic Rules, 2020]
A: No, cosmetics that are tested on animals are not allowed for import in India.
A: No cosmetic shall be imported unless it complies with the standards prescribed under Ninth Schedule of the Cosmetics Rules, 2020or any other standards of quality and safety, applicable to it, and other provisions under the Rules. In case the cosmetic is not included under Ninth Schedule, it shall meet with specifications under the rules and standards applicable to it in the country of origin.
A: No, it is not necessary. However, manufacturer may submit this document in place of product specification.
A: Yes, as per clause 3(a) of Part 1 of Cosmetics Rules, 2020, name(s) of ingredients in the nomenclature of standard references, along with percentage contained in the cosmetics is required to be submitted.
A: No, CDSCO does not grant license to manufacture cosmetics in India.
A: Manufacturing license for cosmetics are issued by respective State Licensing Authorities appointed by State Governments.
A: As per Chapter VI, Rule 34 if the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or name of the country where it has actually been manufactured as “Made in.......( Name of country)” should be there on the label. Further, for very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.
A: As per IS 4707 (Part 2):2017, the presence of the substance must be indicated in the list of ingredients when its concentration exceeds.- a) 0.001% in leave on products b)0.01% in rinse off products. Besides that some fragrance ingredients are mentioned in ANNEX-A (list of substances which must not form part of the composition of the cosmetic products) However, firm may submit undertaking from the manufacturer stating that the perfume/parfum/fragrance compositions are free from banned fragrance ingredients and complying to IS 4707 (Part 2):2017.
A: Firm can apply online on SUGAM portal of CDSCO w.r.t. the post approval change in their already issued/valid Registration Certificate.
A: Firm can apply online for the below mentioned post approval changes in their already issued Registration Certificate:-
i. Change of the Indian Agent in Registration Certificate (without constitution change)
ii. Change of Name of legal/principal manufacturer in Registration Certificate (without constitution change)
iii. Change of address of legal/principal manufacturer in Registration Certificate (Location Change)
iv. Change of address of legal/principal manufacturer in Registration Certificate (No Location Change)
A: Different colour/shade or flavour of a product can be considered as a variant for the purpose of registration for import of cosmetics into the country.
A: No. As per the Form COS-1 and Part 1 of Second Schedule, it is required to mention the name of cosmetics along with their brand name, category, pack size and variants to be registered and meant for import into and use in India. Similarly, under Registration Certificate in Form COS-2, it is also required to mention the pack size and variant separately. Therefore, different pack size(s) of a product are not covered under the definition of variant.
A: The following categories of cosmetics can be imported without import registration certificate subject to condition that the cosmetics shall not be used for domestic sale:-
(i) Cosmetics in bulk for repackaging for 100% export to other countries.
(ii) Cosmetics for research and development purposes like packaging trials, consumer studies, shelf life studies and transport studies.
(iii) Cosmetics for sale to overseas passengers in duty free shops situated within international airports.
(iv) Cosmetics in amenity kits for exclusive use of International passengers on complimentary basis if not be used for domestic sale.
(v) Cosmetics imported for use in hotels exclusively for their captive consumption and after providing notarized undertaking to this effect.
(vi) Hair Fixers, namely mucilaginous preparations containing gums, used by men for fixing beard.
A: No. Cosmetics imported in the form of a Kit to be marketed in India as such, wherein all individual products of the Kit are already registered for import into India under Cosmetics Rules, 2020, such Kit is exempted from registration. However, if the applicant opted for registration certificate for kit, the same may be granted without any fees.
A: Yes. Only such cosmetics imported in the form of Kit(s) to be marketed in India as such are exempted from registrations which are already registered for import into India under the Cosmetics Rules, 2020.
A: No. After commencement of the Cosmetics Rules, 2020 i.e. after 15.12.2020, the firm need to apply for a fresh Registration Certificate for import of cosmetics into India under the provisions of the Cosmetics Rules, 2020. However, the old Registration Certificate (Form 43) granted under the Drugs and Cosmetics Rules, 1945 is valid for import of cosmetics registered in that Registration Certificate till its expiry or for a period of eighteen months from the date on these rules are notified, whichever is later.
A: The applications for grant of registration certificate which are applied before 15.12.2020 under the Drugs and Cosmetics Rules, 1945, but are still in process/query reply not submitted and not granted the Registration Certificate, such applications will be processed as per the Drugs and Cosmetics Rules, 1945.
A: As per rule 72 (i), the approvals or licences or permissions or certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules, 1945 in respect of cosmetics prior to commencement of these rules, shall be deemed to be valid for all purposes still its expiry or for a period of eighteen months from the date these rules are notified, whichever is later, under the corresponding provisions of these rules.
A: No. The Registration Certificate granted in Form COS-2 under the Cosmetics Rules, 2020 shall remain valid in perpetuity subject to the payment of registration certificate retention fee.
A: No. A cosmetic manufactured at a foreign site and already registered under Rule13 (Form COS-2) for import and sale in India, may be imported by any person or entity by making an online application in Form COS-4 for grant of Import Registration Number in Form COS-4A in SUGAM with an undertaking as specified in Sixth Schedule.
A: No, as specified in proviso of rule 34(10) of the Cosmetics Rules, 2020, that where a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the State Licensing Authority.
A: No. As per rule 18(2) of the Cosmetics Rules, 2020, “No cosmetics shall be imported unless the “Use Before or use by” date shown on the label, wrapper or container of the cosmetic is later than six months from the date of import”.
A: No. There is no change in checklist for application for import registration of cosmetics on SUGAM. However, the forms/legal documents have been modified as per the Cosmetics Rules, 2020.
A: Yes. If a unit pack (Kit, Palettes etc.) containing different colors, shades, flavours, fragrances or other inherent characteristics apart from the base formulation, which is sold as a single unit pack in retail, then it will be considered as a single variant.
A: No. The firm need to apply for a fresh Registration Certificate under the Cosmetics Rules, 2020 with changed name or address of the firm.
A: No. As per rule 20(3) of the Cosmetics Rules, 2020, “If the suspected contravention of the provisions of the Act or the rules is such as may have to be determined by test, the officer shall send the sample to the Laboratory established for the purpose for performing such tests and the consignment of the said cosmetic shall be detained till such time, the test report on that sample is received from the Director of the said Laboratory or any other officer of the Laboratory empowered by him in this behalf”.
A: Yes. As per rule 72 (i), the approvals or licences or permissions or certificate, issued under the provisions of the Act and the Drugs and Cosmetics Rules, 1945 in respect of cosmetics prior to commencement of these rules, shall be deemed to be valid for all purposes still its expiry or for a period of eighteen months from the date these rules are notified, whichever is later, under the corresponding provisions of these rules.
A: Yes. The firm shall make an application in Form COS-5 and Form COS-6 for grant of license and loan license, respectively for manufacturing cosmetics in India, to the concerned State Licensing Authorities under the Cosmetics Rules, 2020.
A: As per rule 30 of the Cosmetics Rules, 2020, a licence or loan licence issued in Form COS- 8 or Form COS- 9 shall remain valid in perpetuity, subject to payment of licence or loan licence retention fee as specified in the Third Schedule before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the state Licensing Authority.
A: Yes. Prior permission from the Central Licensing Authority i.e. the Drugs Controller General (I) is required for manufacture of New Cosmetics in India.
A: The applicant who want to manufacture new cosmetics in India, need to obtain a prior permission in Form COS-3 from the Central Licensing Authority by making an application (in offline mode) in Form COS-12 along with requisite fee and documents as provided in Chapter V of the Cosmetics Rules, 2020.
A: Label of cosmetics either manufactured in India or imported shall comply with the provisions specified in rule 34 of the Cosmetics Rules, 2020.
A: No cosmetic shall be manufactured unless it complies with the standards prescribed under Ninth Schedule of the Cosmetics Rules, 2020 or any other standards of quality and safety, applicable to it, and other provisions under the Rules.
A: No. As per rule 39(7), no person shall use any animal for testing of cosmetics.
A: An application in Form COS-5 or Form COS-6 along with information and undertaking as specified in Part-II of Second Schedule of the Cosmetics Rules, 2020 and requisite fee as specified in Third Schedule need to be submitted to the concerned State Licensing Authorities for grant of license or loan license for manufacturing cosmetics in India.
A: Yes. As per rule 72(2), any things done or any action taken or purported to have been done or taken, including any rule, notification, inspection, order or notice made or issued or any appointment or declaration made or any operation undertaken or any direction given or any proceedings taken or any penalty, punishment, forfeiture or fine imposed under the Drugs and Cosmetics Rules, 1945 shall, be deemed to have been done or taken under the corresponding provisions of these rules and shall always remain valid for all purposes.

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