Introduction

According to Section 3(aaa) of the Drugs and Cosmetics Act 1940 and Rules 1945, the term "Cosmetic" is defined as any article that is intended to be rubbed, poured, sprinkled, sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof. The purpose of such articles is for cleansing, beautifying, promoting attractiveness, or altering the appearance. Additionally, this definition encompasses any article that is intended for use as a component of a cosmetic product.

The CDSCO is a central based drugs control authority under the aegis of the Central Government regulated by the Drugs & Cosmetics Act. The said legislation was enacted to govern the import, manufacture, & distribution of medications across India ensuring the drugs are safe to consume, effective & adheres to the quality standards prescribed further the said Act has categorized drugs in schedules of the Act and which further provides basic requirements & guidelines for storage, sale, display, & prescription of each category.

Objectives of Drugs & Cosmetics Act 1945

  1. Regulation of import, manufacture & distribution of drugs
  2. Ensuring that counterfeit medications are not imported in the country
  3. Forbids the manufacturing and distribution of forfeited or Counterfeited drugs
  4. Ensuring that Sale & Distribution of pharmaceuticals are conducted by trained professionals only.
  5. Appointed Drug Inspectors for inspecting registered premises regularly
  6. Specifying the Standards for pharmaceuticals & cosmetics

Functions of CDSCO

The CDSCO is responsible for approval of drugs, conducting clinical trials, specifying the drugs standards, coordination with State Drug Control Organizations by providing advice for achieving uniformity with respect to the drugs.

Who is eligible to apply for CDSCO Cosmetic Import Registration in India?

  • According to the Drugs & Cosmetic Act, 1945, the following applicants are eligible to apply for CDSCO Cosmetic Import Registration in India:
  • Authorised Agent: If a manufacturer has appointed an authorized agent to import cosmetics on their behalf, the authorized agent can apply for CDSCO Cosmetic Import Registration.
  • Subsidiary of the Manufacturer: If a foreign cosmetic manufacturer has an Indian subsidiary firm, the subsidiary can apply for CDSCO Cosmetic Import Registration on behalf of the manufacturer.
  • Manufacturer: The manufacturer of the cosmetics itself can directly apply for the grant of CDSCO Cosmetic Import Registration in India.
  • Any Other Importer: Any Indian importer who intends to import cosmetics from a foreign manufacturer can also apply for this license or registration with CDSCO.

Documents required for Importing Cosmetics

  1. Cover Letter
  2. Authorization from the Producer
  3. Import registration Certificate authenticated by the First-Class Magistrate
  4. Particulars of the Manufacturers as per Form COS-1
  5. Particulars of Indian Agent as per Form COS-1
  6. Name of the Cosmetics, Address where it is manufactured
  7. Duly conjointly signed, stamped, and dated with name & designation of the signatory by both authorised Indian agent & the manufacturer
  8. List of Ingredients/composition
  9. Labels of Proposed Products
  10. Testing Method used for Cosmetics
  11. Manufacturing License
  12. Free Sale Certificate
  13. Non Animal Testing Declaration
  14. Declaration for heavy metal or Hexachlorophene content
  15. Other Documents as maybe demanded

Procedure for registration

Step 1 - Visit the CDSCO e-portal

Step 2 - Application is to be made in Form COS-1, which is to be authorized by the Indian Agent

Step 3 - Fill up the necessary details such as Particulars of cosmetics, Particulars of Authorized Agent, Particulars of the Producer

Step 4 - Payment of Fees through Bharatkosh portal

Step 5 - Issue of registration

 Article by 

Farhan Hashmi a legal intern at Corpzo

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