CSDCO COSMATIC
At the federal government level, all notified medical products are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The responsibility lies with the Drugs Controller General of India (DCGI) under the CDSCO (can be referred to Indian FDA) for license or product approval. The CDSCO is responsible for approval and regulation of New Drugs and Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
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Cosmetic Import Registration
For the import of cosmetics into India, the cosmetic products need to be registered with the
licensing authority as defined under Rule 21 of Drugs & Cosmetic Rules. The regulatory
application needs to be submitted in Form 42 along with Soft copies of the information
about the brands, products and manufacturer, product specification and testing protocol to
receive the cosmetics registration certificate in Form 43.
A list of documents including Schedule D III, shall be submitted to CDSCO. The full list of
documents required for submission and the labeling requirements for importing cosmetics
into India is explained in Step by Step process of Cosmetic Registration. The Cosmetics that
are supposed to be imported are categorized into Brands. These brands are divided into 4
main category namely Skin products, Hair and scalp products, nail and cuticle products and
Oral hygiene products.
Cosmetic Manufacturing Approval - cosmetic manufacturers helping them obtain the manufacturing license and test their
products from certified labs in India. The following licenses are required for cosmetic
product manufacturing & market in India according to D & C Act, 1940.
: License in form 32 is issued for manufacturing cosmetics for sale or for distribution.
(Application is filed in Form 31)
: License in form 32-A is issued for loan license for manufacturing cosmetics for sale or for
distribution. (Application is filed in Form 31-A)
: License on Form 37 is issued for grant or renewal of approval for carrying out tests on
drugs/cosmetics or raw material used in the manufacture thereof on behalf of licenses for
manufacture for sale of drugs/cosmetics. (Application is filed in Form 36).
Who can apply for Registration of Import of Cosmetics / who can be an importer:
- The Manufacturer himself having registered office in India.
- The Authorised Agent of the Manufacturer
- The Subsidiary of the Manufacturer
- Any other importer
What is the validity of CDSCO Cosmetic license ?
After filling the inquiry form you will get a verification call shortly from our business advisor he will guide you on which ISO certification is best according to your business. After Verify from your side then we need some documents to complete the process. Such as Business registration proof, Letter Head or Visiting card, Sale Purchase Invoice or Certification in India GST registration, and scope of business. After submitting all the documents you will get your ISO certificate within a week.
CDSCO COSMATIC: FAQ
Ans: 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, ortherwise 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.
Ans: Yes, import of cosmetic is regulated in India under the provisions of the Drugs & Cosmetic Act, 1940 & the Cosmetics Rules, 2020.
Ans: The copy of the Cosmetics Rules, 2020 is available under Cosmetics Section onCDSCO website (Gazette notification G.S.R 763 (E)).
Ans: Import of cosmetics in India needs to be regulated to ensure safety, quality and performance of cosmetics being imported into India.
Ans: The copy of the Drugs &Cosmetics Act, 1940 & the Cosmetics Rules, 2020 is available on CDSCO website.
Ans: 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.
Ans: 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.
Ans: 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 Phone: 91-11- 23236965 / 23236975, Fax: 91-11-23236973, E-mail:- dci@nic.in.Central Drugs Standard Control Organization Directorate General of Health Services Ministry of Health and Family Welfare, Government of India
Ans. Cosmetics Division, Central Drugs Standard Control Organization (CDSCO) HQ,
Ans: 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.
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