With a sizable market for cosmetic and personal care products, India's cosmetic business is expanding quickly. To ensure the quality, safety, and effectiveness of cosmetics being imported into India, there should be regulations in place. According to Rule 21 of the Drugs and Cosmetics Rule 1945, the Ministry of Health & Family Welfare must issue a CDSCO Cosmetic Important License Registration Certificate. For CDSCO Cosmetic Import License India, the certificate is necessary from the major regulatory body, which is received from the Central Drug Standard Control Organization (CDSCO). With this registration, selling and importing cosmetics can be done without difficulty in India. But why it is needed?

Cosmetic products are quite "chemically enhanced" in nature by their very nature. Additionally, a lot of it is based on materials and chemicals that are dangerous to people. Additionally, there has always been a problem with animal testing.

Despite this, the majority of nations still rely on FDA cosmetic registration. However, as time has gone on and the desire for foreign cosmetics has increased, various concerns about the morality of how these goods are made have surfaced.

Since we have established the importance of getting the cosmetic import licensed. Let's get down to its how, which is eligibility, document and process of cosmetic import license.

India's Eligibility Requirements for CDSCO Cosmetic Import License

The following parties are qualified to get cosmetic license registration for importation or a CDSCO registration certificate under CDSCO regulations:

  1. A factory with a local operating office that is registered (India).
  2. Any representative that the manufacturer has authorized.
  3. An affiliate of that manufacturer.
  4. Anyone else who wants to engage in the business of bringing in cosmetics from other nations.

All of the aforementioned must be registered with CDSCO.

Documents Needed To Register For Cosmetic Imports with CDSCO

The following are some important documentation needed when registering for a CDSCO cosmetic import license:

Covering Letter: Include information about any previously granted import registration certificates (if any), the product or product category, and the purpose (fresh/endorsement of products, pack size, additional sourcing location, manufacturing site, or re-registration) (whether registered or not).

Second Schedule, Part 1: The manufacturer, his authorized distributor, importer, or agent must include certain information and an undertaking with the application for an import registration certificate. Each application on Form COS-1 must be properly filled out in the format.

List of Ingredients or Composition:

  1. Cosmetic name, ingredients listed in nomenclature of standard reference, percentage of ingredients in Cosmetic, signed by authorized individual, and manufacturer's stamp.
  2. Cosmetics must only contain the colors, pigments, and dyes listed in the BIS's schedule 10, and they cannot be made or imported.
  3. The permitted synthetic organic colors and natural organic colors used in cosmetics may not contain more than

i) 20 ppm (parts/million) of lead calculated as lead,

ii) 2 ppm (parts/million) of arsenic calculated as arsenic trioxide, and

iii) 100 ppm (parts/million) of other heavy metals calculated as the sum of the individual elements.

  1. The cosmetic product shall not contain any of the raw materials listed in ANNEX A of IS: 4707 Part 2, as updated from time to time.
  2. No hexachlorophene-containing cosmetics may be produced. Hexachlorophene may be used in soaps in concentrations that do not exceed 1% weight by weight with a warning label that must be clearly visible on the package of every soap.
  3. Cosmetics produced or imported into the nation must have the following amounts of mercury in them:
    1. mercury levels in cosmetics intended for use just around the eyes should not be higher than 70 parts per million (0,007%) of mercury, measured as the metal, as a preservative;
    2. Unplanned mercury levels in other final cosmetic goods are limited to one part per million (1 ppm).
    3. It is forbidden to color cosmetics with substances containing arsenic and lead.

All of the documents should be written in English.

Guidelines on Registration of Import of Cosmetics

The steps for CDSCO cosmetic import registration in India are as follows:

Step 1: Determining Cosmetics Classification: Before deciding on a device's regulatory status and classification, a manufacturer must first review the CDSCO's Gazette Notification when deciding to register their products in India.

Step 2: Appointment of an Indian Representative: To communicate with the CDSCO, the manufacturer must appoint an authorized Indian agent. A Power of Attorney will be provided to the agent to oversee registration and importing in India and aid with cosmetic permits.

Step 3: Complete the CDSCO Cosmetic Import Registration Application Form. After appointing an agent, the importer or manufacturer of cosmetics must submit the Registration Form to the Drug Controller General of India (DGCI) by simply logging on to the CDSCO website, signing in, and attaching all required supporting documentation.

Step 4: Issuance Of CDSCO Cosmetic Import Registration Certificate: After the application form, documentation, and fee are submitted on the CDSCO website, the DGCI Registration Authority may contact the manufacturer or the authorized importer agent with a question via an inquiry letter. The authorities may provide a decision whenever they are completely satisfied with the application of a cosmetic import license.

Why Choose Regalguru for Cosmetic Import License?

We at Regalguru view your need for cosmetics import registration with a critical eye. Regalguru helps with all aspects of CDSCO license registration, from writing your cover letter to making sure you have all the necessary paperwork on hand, from submitting your application to conducting a careful follow-up to address any problems that may arise. We are the best option for the import license for cosmetics.