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Cosmetics License

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PHARMA - Cosmetic License

Leading the way in Cosmetic Regulations

Drugs and Cosmetics Act 1940 and Cosmetics Rules 2020 regulate the import, manufacture, distribution and sale of drugs and cosmetics in India. Cosmetics are regulated by Central Drugs Standard Control Organization (CDSCO) in the office of the Drug Controller General of India (DCGI).
All manufacturers and importers who intend to market cosmetic products in India need cosmetic registration and approval. It requires planning and review of the ingredients and labelling for registration. The application process is different for manufacturers and importers.

Issue of Import licenses for cosmetic items is regulated by the Central Drugs Standard Control Organisation (CDSCO) in India.

State Licensing Authorities is a regulatory body governing cosmetic manufacturing license and loan license in India.

NOVEL

COSMETICS

A cosmetic which contains a novel ingredient which has not been used anywhere in the world or is not recognised for use in cosmetics in any National or International literature.

The Cosmetic Rules, 2020 states that if a cosmetic product contains a novel ingredient, approval for import or manufacture is required.

For registering a new cosmetic in India, the applicant needs to apply to CDSCO in Form COS-12 and approval is granted in Form COS- 3.

How
Mind Sync
Can Help?

At Mind Sync we provide a range of regulatory services for the cosmetics industry, customized to suit the requirements of large enterprises, small to medium-sized businesses, and micro-enterprises. Our team of Regulatory Experts has a proven track record in assisting applicants with expert guidance for thorough reviews of cosmetic formulations, labelling evaluations, claims analysis, and registration processes in India. We ensure precise documentation that complies with Indian cosmetics regulations, offering comprehensive support for various process-related services.

Import & Manufacture of Existing Cosmetic Products

Cosmetic Import License

  • Granted by CDSCO.
  • Application made in Form COS-1.
  • Issue of Import Registration Certificate in Form COS-2.

Cosmetics Manufacturing / Loan License

  • Granted by State Licensing Authorities.
  • Manufacturing license: Application made in Form COS-5, Issue of Registration Certificate in Form COS-8.
  • Loan license: Application made in Form COS-6, Issue of Registration Certificate in Form COS-9.
  • Grant or renewal of approval for carrying out tests on cosmetics or raw material used in the manufacture thereof on behalf of licenses for the manufacture for sale of cosmetics: Application made in Form COS-22, Issue of Registration Certificate in Form COS-23.

QUICK ANSWERS

  • A manufacturer having a factory premises located in a Notified Industrial area and not in a residential area, home, unofficial industrial area;
  • Good Manufacturing Practices (GMP) requirements to be followed. The factory premise should comply with all the requirements and conditions specified in the Seventh schedule;
  • Cosmetic manufacturer should have at least one technical person who is a full-time employee, having a Bachelor in Pharmacy/ Diploma in Pharmacy/ holds a Bachelor Degree in Cosmetic Technology from a recognised university.
  • Submit Form COS 5 or COS 6 application through SLA portal;
  • SLAs approve the grant or loan license in Form COS-8 or COS- 9 for manufacturing cosmetics in India;
  • The timeline to obtain the grant of license is 45 days from the date of application;
  • A fee of Rs. 10,000 is charged for the grant of License in Form COS-8 for manufacturing cosmetics for sale and distribution of 10 items of each category of cosmetics. An additional fee of Rs. 500 is charged for each additional item in the cosmetic category;
  • The validity of the Cosmetic Manufacturing License (COS-8/COS-9) is 5 years.
  • The Manufacturer himself having registered office in India.
  • The Authorized Agent of the Manufacturer- Authorized Agent is a person or entity in India authorized by the manufacturer. The authorized agent will be responsible for the business activities of the manufacturer in India, including compliance with the provisions of Drug and Cosmetic Act in all respects.
  • The Subsidiary in India authorised by the Manufacturer
  • Importer in India- Any person or entity purporting to import cosmetic products other than the manufacturer, its authorized agent and its subsidiary
  • Cosmetic product classification
  • Appointment of Authorised Indian Agent- Foreign manufacturers are required to appoint an authorised agent in India who will act as a point of contact for registration process, assist in product approvals, post compliances;
  • Register on SUGAM online portal;
  • Draft an application and upload all essential documents;
  • Generate Form COS-1 and include details about the premises of manufacturing, description of cosmetic products, pack size, brand names etc;
  • Upload signed and stamped COS-1 form;
  • Pay the fees and upload the challan;
  • The application will be approved by the CDSCO within 180 days as per the new Cosmetic Rules, 2020;
  • On approval, the registration certificate or COS-2 will be produced by the authorised importer, distributer, or Indian authorised agent;
  • Validity of Import license is 5 years;
  • A fee of 500 USD per manufacturing site to obtain an import registration certificate for the import and market of cosmetic products in India.

Central Drugs Standard Control Organization (CDSCO)
State Licensing Authority (SLA)

  • Face care products other than face mask
  • Face Mask
  • Eye contour products
  • Lip care products
  • Hand care products
  • Foot care products
  • Body care products
  • External intimate care products
  • Chemical exfoliation products
  • Mechanical exfoliation products
  • Skin lightening products
  • Other skin care products
  • Soap products
  • Bath / shower products
  • Make-up remover products
  • External Intimate hygiene products
  • Other skin cleansing products
  • Chemical depilatories
  • Physical epilation products
  • Other body hair removal products
  • Bleach for body hair
  • Products with antiperspirant activity
  • Products without antiperspirant activity
  • Shaving products
  • Pre- / after-shaving products
  • Other shaving and pre- / after- shaving products
  • Foundation
  • Concealer
  • Other face make-up products
  • Mascara
  • Eye shadow
  • Eye pencil
  • Eye liner
  • Other eye make-up products
  • Lip stick
  • Lipstick sealer
  • Other lip make-up products
  • Body or face paint , including "carneval make-up"
  • Other make-up products
  • Hydro alcoholic perfumes
  • Non hydro alcoholic perfumes
  • Before and after sun products Sun protection products
  • Self-tanning products
  • Other sun and self-tanning products
  • Other skin products
  • Hair conditioner
  • Scalp and hair roots care products
  • Anti hair loss products
  • Other hair and scalp care and cleansing products
  • Antidandruff products
  • Oxidative hair colour products
  • Non-oxidative hair colour products
  • Hair bleaching and dye remover products
  • Other hair colouring products
  • Products for temporary hair
  • Styling Permanent wave products
  • Hair relaxer / straightener products
  • Other hair styling products
  • Hair sun protection products
  • Other hair and scalp products
  • Nail varnish / Nail make-up
  • Nail varnish remover
  • Nail varnish thinner
  • Nail bleach
  • Other nail varnish and remover products
  • Nail care products
  • Nail hardener
  • Other nail care / nail hardener products
  • Nail glue remover
  • Cuticle remover / softener
  • Nail sculpting products
  • Other nail and cuticle products
  • Toothpaste
  • Tooth cleansing powder / salt
  • Other tooth care products
  • Mouth wash
  • Breath spray
  • Other mouth wash / breath spray products
  • Tooth whiteners
  • Other oral hygiene products

Do you have any queries?

This information is in summary form and is therefore intended for general guidance only. It is not intended to be a substitute for detailed research or the exercise of professional judgment. Mind Sync does not accept any responsibility for loss occasioned to any person acting or refraining from action as a result of any information provided herein. On any specific matter, reference should be made to the appropriate advisor.

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