India Cosmetics Regulation QA
Email: bom4ww@evershinecpa.com
A-16, 1st Floor, Aruna Asaf Ali Marg, Qutub Institutional Area, New Delhi, 110067, India
Manager Punit Singh Negi , speak in Indian and English.
Skype: cspunitnegi
HLF-TW-10
What are the categories of cosmetics in India? What is its official name? What is the intensity of management of different categories? What is the governmental authority of cosmetics? Website?
Evershine RD：
In India, cosmetics are regulated by the Headquarters of the Central Drug Standards Control Organization – Department of Health and Family Welfare (CDSCO). The production of cosmetics is subject to the inspection and licensing system of the state licensing agencies designated by the state governments, while the import of cosmetics is subject to the registration system of the central licensing agency designated by the central government.
Cosmetics is defined as any article intended to be used as a cosmetic ingredient, rubbed, poured, sprayed, introduced or otherwise applied to the human body or any part thereof, for the purpose of cleaning, beautifying, enhancing attractiveness or altering the appearance.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-20
If a foreign company wants to sell cosmetics in India, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration? If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
無須申請營業許可證。
No business license is required.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-25
假如需要辦理，請問印度有專業服務公司可以協助辦理化妝品公司營業許可證？
Evershine RD：
無須申請營業許可證。
HLF-TW-30
If a foreign company wants to sell cosmetics in India, can it assign an India company to act as a business agent? What are the requests for acting as a business agent? What are the required documents and application procedures? What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
Yes. Cosmetic products need to be registered by a local company in India, which can be the manufacturer/authorized agent of the manufacturer/subsidiary/importer of the manufacturer or a third party as the product holder.
Registration:
1. First register with CDSCO through the website: http://cdscoonline.gov.in
2. Sign up and create your login credentials.
3. Submit all details and complete the registration process using a valid email ID and mobile number. (Users have to upload the necessary documents such as identification details, power of attorney, company address, etc. These documents should be prepared in PDF format before the registration process.)
4. After successful registration, log in to the portal.
5. In the Form Submission section, select the department and select the form type: New Application, Proxy.
6. Upload the relevant files.
7. Pay.
8. Submit for review.
The product license holder shall be responsible for the safety, quality of cosmetics, and handling of adverse events, and report to the competent authority.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-35
假如需要辦理指派印度公司擔任營業代理人，請問印度有專業服務公司可以協助？
Evershine RD：
ARGUS
PHARMACOS
HLF-TW-40
Do foreign companies need to apply for an approval before importing cosmetics sold to India? If yes, which authority is in charge?
What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
Cosmetic products need to be registered by a local company in India, which can be the manufacturer/authorized agent of the manufacturer/subsidiary/importer of the manufacturer or a third party as the product holder.
Registration:
1. First register with CDSCO through the website: http://cdscoonline.gov.in
2. Sign up and create your login credentials.
3. Submit all details and complete the registration process using a valid email ID and mobile number. (Users have to upload the necessary documents such as identification details, power of attorney, company address, etc. These documents should be prepared in PDF format before the registration process.)
4. After successful registration, log in to the portal.
5. In the Form Submission section, select the department and select the form type: New Application, Proxy.
6. Upload the relevant files.
7. Pay.
8. Submit for review.
Document
1. Application
． Manufacturer and manufacturing site details: name, address and phone number, fax number and e-mail address of the manufacturing site to be registered, name and address of the partner/director.
． The name and address of the authorised importer/distributor/agent in India who is responsible for the manufacturer’s business including the name and address of its partners/directors.
． A brief overview of the manufacturer’s business activities in the domestic and global markets.
． Cosmetics name and its brand name, category, pack size and variants for registration and for import into and use in India.
2. Manufacturer’s Authorization (Formal Certification)
3. Chemical information of cosmetic products
． The name of the ingredient in the standard reference nomenclature, and the percentage contained in the cosmetic.
． Cosmetic testing specifications and test methods.
． Product labeling
． Package leaflet, inserts (if any).
4. Statement of Commitment
． Declare compliance with all conditions on the Cosmetics Import Registration Certificate under the Cosmetics Rules 2020.
． Declare that every cosmetic product imported into India complies with the standards set by the Bureau of Indian Standards.
． Non-animal testing statement.
． A statement that the licensing authority shall be notified of any changes in the labelling, composition, or testing of the registered product or its specifications, and a commitment that the product complies with the standards set by the Bureau of Indian Standards.
． Statement to report from time to time any administrative action taken due to adverse reactions, market withdrawal/regulatory restrictions on any cosmetic product in relation to the registration certificate, or deauthorization and/or quality reporting by any regulatory authority in any country/region where the cosmetic product is sold or distributed In the event of non-compliance, the shipment and sale of cosmetic products shall be stopped and the authorities notified immediately.
． The statement will comply with further requirements made by the Government of India under the Act and Rules.
． If the licensing authority deems it necessary, the authority or anyone else authorised to take a cosmetic sample for testing will be allowed.
． Heavy metal and hexachlorophenol content declaration, test report including lead, arsenic, mercury, other heavy metal and microbiological test results (if applicable) or manufacturer’s commitment to declare all raw materials/pigments used, heavy metals (with specified limits) and The content of hexachlorophenol in the applied products meets the specified standards.
． Declare that the documents submitted above are true.
5. Details of the manufacturing license/product license/marketing authorization/certificate of free sale (if any) for the manufacture of cosmetic products in the country of origin and a copy issued by the country’s regulatory authority or any other competent authority/association.
6. Product Specifications and Testing Protocols
7. List of countries that have obtained marketing authorization or import authorization for the cosmetic product.
8. Copies of brand, product and manufacturer information
9. If other documents (if any) are in a foreign language, the applicant should provide English translations of any other foreign language documents provided by a qualified translator.
10. Fees: Original electronic receipt for payment of fees
11. If there is no licence to manufacture the cosmetic product in the country of origin, the importer shall provide a statement on the affidavit.
12. Cosmetics imported into India in bulk for repackaging for 100% export to other countries do not require a registration certificate, but importers must obtain the necessary licenses from CDSCO headquarters. Importers must undertake in writing that these products will not be sold domestically.
13. The import of cosmetic products for R&D purposes, such as packaging testing, consumer research, shelf life research and shipping research, does not require a registration certificate, but the importer must obtain the necessary licenses from CDSCO headquarters. Importers must guarantee in writing that these products will not be sold domestically
14. The validity period of the license is 3 years.
Label
1. Cosmetics name.
2. Manufacturer’s name, full address of manufacturer’s premises.
． If the product is not manufactured in a factory owned by the manufacturer, the actual manufacturer’s name, address or country of manufacture should be indicated on the label.
． If the cosmetic is packed in a very small container, the cosmetic is solid or semi-solid under 30 grams and liquid under 60 ml, and the manufacturer’s address cannot be given, the manufacturer’s name and the main place of manufacture should be marked together.
3. Expiration Date.
4. Unique Lot Number
5. The production license number, preceded by the letters M or L. No or Mfg.,
． For imported products, if this provision is not mandatory in the country of origin, such cosmetics may be permitted without a production license number, subject to other import regulations.
6. Volumes are expressed as net content by solid weight, liquid measure or semi-solid weight, combined with digital counts if the content is subdivided. No labelling is required if the packaging does not exceed 60ml net content of perfume, toilet water, etc. or any solid or semi-solid cosmetic product with a net content of not more than 30g.
7. In the case of cosmetics; in the event of a hazard, each internal label should clearly identify adequate instructions for safe use, any warnings, cautions or special instructions that consumers need to follow, and a description of the name and name of the hazardous or toxic ingredient. Quantity statement.
8. Imported cosmetics sold in India should be marked with the import registration certificate number on the unit package label, with the letters RC/RC No/Reg. certificate, and the name and address of the importer.
9. If the cosmetic packaging has only one label, the label shall contain all the information required to be displayed on the inner and outer labels as specified in this rule.
10. The list of ingredients with a concentration of more than 1% shall be listed in descending order of weight or volume at the time of addition, followed by the ingredients with a concentration of less than or equal to 1%, preceded by the word ingredient. This declaration is not required for packages of less than or equal to 60ml of liquid and 30g of solid and semi-solid.
11. The label of imported cosmetic products should indicate the registration number of the product and the name and address of the holder of the registration certificate for sale in India. If India specific labelling is required for imported cosmetic products, the same label should be allowed to be affixed to the unit package in bonded warehouse.
12. The specifications on the labels of all cosmetic products manufactured/imported and sold in India must be stated in English, or in Indian regional languages.
Notice
1. No person shall alter, apply or deface any inscription or marking made or recorded by the manufacturer on any cosmetic container, label or packaging.
2. No cosmetic product shall claim, purport to or communicate any idea that is false or misleading to the intended user.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-45
請問在印度有哪些專業服務機構，可以協助辦理化妝品產品許可證？
Evershine RD：
Morulaa
CliniExperts
HLF-TW-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do cosmetics packaging and labeling require prior approval? Which languages are allowed?? Website?
Evershine RD：
Cosmetic products need to be registered by a local company in India, which can be the manufacturer/authorized agent of the manufacturer/subsidiary/importer of the manufacturer or a third party as the product holder.
way to register
1. First register with CDSCO through the website: http://cdscoonline.gov.in
2. Sign up and create your login credentials.
3. Submit all details and complete the registration process using a valid email ID and mobile number. (Users have to upload the necessary documents such as identification details, power of attorney, company address, etc. These documents should be prepared in PDF format before the registration process.)
4. After successful registration, log in to the portal.
5. In the Form Submission section, select the department and select the form type: New Application, Proxy.
6. Upload the relevant files.
7. Pay.
8. Submit for review.
Document
1. Application
． Manufacturer and manufacturing site details: name, address and phone number, fax number and e-mail address of the manufacturing site to be registered, name and address of the partner/director.
． The name and address of the authorised importer/distributor/agent in India who is responsible for the manufacturer’s business including the name and address of its partners/directors.
． A brief overview of the manufacturer’s business activities in the domestic and global markets.
． Cosmetics name and its brand name, category, pack size and variants for registration and for import into and use in India.
2. Manufacturer’s Authorization (Formal Certification)
3. Chemical information of cosmetic products
． The name of the ingredient in the standard reference nomenclature, and the percentage contained in the cosmetic.
． Cosmetic testing specifications and test methods.
． Product labeling
． Package leaflet, inserts (if any).
4. Statement of Commitment
． Declare compliance with all conditions on the Cosmetics Import Registration Certificate under the Cosmetics Rules 2020.
． Declare that every cosmetic product imported into India complies with the standards set by the Bureau of Indian Standards.
． Non-animal testing statement.
． A statement that the licensing authority shall be notified of any changes in the labelling, composition, or testing of the registered product or its specifications, and a commitment that the product complies with the standards set by the Bureau of Indian Standards.
． Statement to report from time to time any administrative action taken due to adverse reactions, market withdrawal/regulatory restrictions on any cosmetic product in relation to the registration certificate, or deauthorization and/or quality reporting by any regulatory authority in any country/region where the cosmetic product is sold or distributed In the event of non-compliance, the shipment and sale of cosmetic products shall be stopped and the authorities notified immediately.
． The statement will comply with further requirements made by the Government of India under the Act and Rules.
． If the licensing authority deems it necessary, the authority or anyone else authorised to take a cosmetic sample for testing will be allowed.
． Heavy metal and hexachlorophenol content declaration, test report including lead, arsenic, mercury, other heavy metal and microbiological test results (if applicable) or manufacturer’s commitment to declare all raw materials/pigments used, heavy metals (with specified limits) and The content of hexachlorophenol in the applied products meets the specified standards.
． Declare that the documents submitted above are true.
5. Details of the manufacturing license/product license/marketing authorization/certificate of free sale (if any) for the manufacture of cosmetic products in the country of origin and a copy issued by the country’s regulatory authority or any other competent authority/association.
6. Product Specifications and Testing Protocols
7. List of countries that have obtained marketing authorization or import authorization for the cosmetic product.
8. Copies of brand, product and manufacturer information
9. If other documents (if any) are in a foreign language, the applicant should provide English translations of any other foreign language documents provided by a qualified translator.
10. Fees: Original electronic receipt for payment of fees
11. If there is no licence to manufacture the cosmetic product in the country of origin, the importer shall provide a statement on the affidavit.
12. Cosmetics imported into India in bulk for repackaging for 100% export to other countries do not require a registration certificate, but importers must obtain the necessary licenses from CDSCO headquarters. Importers must undertake in writing that these products will not be sold domestically.
13. The import of cosmetic products for R&D purposes, such as packaging testing, consumer research, shelf life research and shipping research, does not require a registration certificate, but the importer must obtain the necessary licenses from CDSCO headquarters. Importers must guarantee in writing that these products will not be sold domestically
14. The validity period of the license is 3 years.
Label
1. Cosmetics name.
2. Manufacturer’s name, full address of manufacturer’s premises.
． If the product is not manufactured in a factory owned by the manufacturer, the actual manufacturer’s name, address or country of manufacture should be indicated on the label.
． If the cosmetic is packed in a very small container, the cosmetic is solid or semi-solid under 30 grams and liquid under 60 ml, and the manufacturer’s address cannot be given, the manufacturer’s name and the main place of manufacture should be marked together.
3. Expiration Date.
4. Unique Lot Number
5. The production license number, preceded by the letters M or L. No or Mfg.,
． For imported products, if this provision is not mandatory in the country of origin, such cosmetics may be permitted without a production license number, subject to other import regulations.
6. Volumes are expressed as net content by solid weight, liquid measure or semi-solid weight, combined with digital counts if the content is subdivided. No labelling is required if the packaging does not exceed 60ml net content of perfume, toilet water, etc. or any solid or semi-solid cosmetic product with a net content of not more than 30g.
7. In the case of cosmetics; in the event of a hazard, each internal label should clearly identify adequate instructions for safe use, any warnings, cautions or special instructions that consumers need to follow, and a description of the name and name of the hazardous or toxic ingredient. Quantity statement.
8. Imported cosmetics sold in India should be marked with the import registration certificate number on the unit package label, with the letters RC/RC No/Reg. certificate, and the name and address of the importer.
9. If the cosmetic packaging has only one label, the label shall contain all the information required to be displayed on the inner and outer labels as specified in this rule.
10. The list of ingredients with a concentration of more than 1% shall be listed in descending order of weight or volume at the time of addition, followed by the ingredients with a concentration of less than or equal to 1%, preceded by the word ingredient. This declaration is not required for packages of less than or equal to 60ml of liquid and 30g of solid and semi-solid.
11. The label of imported cosmetic products should indicate the registration number of the product and the name and address of the holder of the registration certificate for sale in India. If India specific labelling is required for imported cosmetic products, the same label should be allowed to be affixed to the unit package in bonded warehouse.
12. The specifications on the labels of all cosmetic products manufactured/imported and sold in India must be stated in English, or in Indian regional languages.
Notice
1. No person shall alter, apply or deface any inscription or marking made or recorded by the manufacturer on any cosmetic container, label or packaging.
2. No cosmetic product shall claim, purport to or communicate any idea that is false or misleading to the intended user.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-55
請問在印度有哪些專業服務機構，可以協助以外國公司名義辦理化妝品產品許可證？
Evershine RD：
Morulaa
Vyomusconsulting
HLF-TW-60
What documents are required when importing approved cosmetics into India? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
Customs declarations are required.
Import/Export Code (IEC)
A prerequisite for importing cosmetic products, an Import and Export Code (IEC) is required to be able to import and export commercially in India. The IEC number is a 10-digit code issued to Indian companies by the Director General of Foreign Trade. Every person or entity engaged in importing or exporting business must obtain IEC. It has a lifetime validity and takes about 15 days to issue.
1. Web registration: https://www.dgft.gov.in/CP/
．The nature of the company that obtains the IEC can be any of the following: Sole Proprietorship, Partnership, LLP, Limited Company, Trust, HU”. With the introduction of GST, the IEC number will be the same as the company’s PAN. The IEC will be issued separately by the DGFT.
2. Sign the statement.
3. Pay the IEC fee.
4. Issue the IEC code.
Customs procedure
1. Register as a member in India Customs Electronic Gateway (ICEGATE)The Indian Customs Electronic Gateway (ICEGATE) is the national gateway to the Central Indirect Tax and Customs Board (CBIC) of Customs of India, providing electronic declaration services to trades, freight carriers and other trading partners electronically.
URL: https://www.icegate.gov.in/index.html
． Applicant
． Company Name
． Address
． City
． Password
． Telephone, fax number, e-mail
． Category: Importer/Exporter etc.
． Customs clearance location
2. Import declaration
． Contents, place of origin, place of receipt
． Details of cargo, cargo registration
． Commercial invoice
． Contract
． B/L
． Component analysis report (translation document required)
． Label sample (translation file required)
． Wood packaging fumigation certificate (wooden packaging needs to be provided)
． Filling date
． Cosmetic Product License
． Receiving company IEC Code
． Photocopy of the consignee’s personal certificate (PAN: Permanent Account Number/TAN: Tax and Tax Reduction Account Number/ID Card/Passport)
3. Payment via electronic cash ledger and electronic tax credit sorting.
【參考連結】
https://www.icegate.gov.in/index.html
HLF-TW-70
印度化妝品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
The Bureau of Indian Standards (BIS) regulates that cosmetics need to undergo laboratory testing and meet the standards for imported cosmetics registration, including:
1. Chemical analysis of raw materials and active components
2. Safety testing to evaluate heavy metal content in cosmetics, banned pigments and chemicals
3. Microbiological quality inspection to ensure no microbial counts and pathogens
4. Qualitative and quantitative estimation of active ingredients
5. Physical test, including parameters such as viscosity, spreading ability, scratch test, and pay-off test
6. Estimate SPF
7. Skin irritation and sensitivity studies
8. Stability test, shelf life determination, etc.
9. Bacterial aerobic counts, fungal aerobic plate counts
10. Preservative testing
11. Non-animal safety/toxicity testing
12. Customized tests, etc.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-75
印度化妝品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
SGS
BV
https://www.bureauveritas.co.in/
TÜV
HLF-TW-77
請問在印度有哪些化妝品檢驗機構可以提供化妝品檢驗服務？網頁？
Evershine RD：
Auriga
Sigma Test & Research Center
SAL
http://www.testinglaboratoryindia.com/
HLF-TW-80
After a foreign subsidiary imports cosmetics and entrusts a distributor in India to sell it, does the distributor need a cosmetics business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
No business license is required. The product license holder shall be responsible for the safety, quality of cosmetics, and handling of adverse events, and report to the competent authority.
【參考連結】
https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
HLF-TW-85
請問在印度有哪些專精於化妝品銷售與消費權益相關法律服務的業者？
Evershine RD：
AMBIENT ALLIANCE
TMT
Lawayz
Contact Us
Email: bom4ww@evershinecpa.com
A-16, 1st Floor, Aruna Asaf Ali Marg, Qutub Institutional Area, New Delhi, 110067, India
Manager Punit Singh Negi , speak in Indian and English.
Skype: cspunitnegi
or
For investment structure relevant to multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4bom@evershinecpa.com
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Email address:dalechen@evershinecpa.com
Linkedin address:Dale Chen
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