CDSCO

What is FORM-42 and FORM-43?

calendar03 Aug, 2022
timeReading Time: 5 Minutes
FORM-42 and FORM-43

The term “cosmetic” is defined in section 3(aaa) of the Drugs and Cosmetics Act of 1940[1]. It states that “cosmetic” includes any item intended to be used as a cosmetic ingredient as well as any object meant to be rubbed, poured, sprinkled, sprayed, applied to the human body or any part for cleansing, beautifying, promoting beauty, or altering the appearance. Anyone or any organization wishing to import cosmetics into India must register with the CDSCO first. Form-42 and Form-43 are used in the registration process; Form 42 is an application for the issuance of a Registration Certificate for the Import of Cosmetics into India under the Drugs and Cosmetics Rules of 1945, and Form 43 is a Registration Certificate to be issued for the Import of Cosmetics into India under the Drugs and Cosmetics Rules of 1945.

Types of Cosmetic Registration in India

There are two types of registration of cosmetic products in India-

  • Manufacturing License:  When planning to manufacture cosmetics, you must have a manufacturing licence. Therefore, in order to manufacture and market cosmetic products in India, the following licence is required by the D & C Act, 1940:

1.       A request is made in Form-31 and a licence in Form-32 is issued for the manufacturing of cosmetics for sale or distribution.

2.       Application is submitted in Form No. 31-A, and License in Form 32-A is issued for Loan License for Manufacturing Cosmetics for Sale and Distribution.

3.       On behalf of the licence for manufacture for sale of drugs and cosmetics, the licence on Form 37 is issued for the grant or renewal of approval for conducting tests on drugs, cosmetics, or raw materials used in their manufacturing.

  • Importing licence: When an organization imports and resells cosmetics in India but does not manufacture them, they need a licence as a cosmetic importer. The importing license is obtained through form-42 and form-43; to get the licence for the import of cosmetics, importers must submit Form 42 to the central licencing authority, which is an application for the issue of registration certificate for the import of cosmetics into India. According to the Rules, Form 43 is used to issue registration certificates for importing cosmetics into India from other countries.

CDSCO’s Function in Cosmetic Imports

• Modifying the Cosmetic Rules, 2020 regarding the import and registration of cosmetic products;

•Amendment of the Cosmetic Rules, 2020 considering the import and registration of cosmetic products;

•Analysing various requests for NOCs (No Objection Certificates) or clarifications relating to the import of cosmetics;

•Handling complaints from NGOs, the general public, or consumer forums about the quality of cosmetic products;

•Responding as necessary to correspondence from the government or BIS;

•Analysing applications for CDSCO Cosmetic Import Registration by the rules and requirements of the 1940 Drugs and Cosmetics Act;

•Responding to public questions, PMOPGs, or hearings about the CDSCO Cosmetic Import Registration process and offering assistance therein;

•Creating draught responses to questions from the Parliament about cosmetics and RTI, VIP references, legal cases, and court cases.

Information Required for Application of Cosmetic Registration – Form-42 and Form-43

• Information about the producer and the location of the factory.

• Evidence of registration fee payment.

• Information on cosmetics.

• Product Details.

Documents Required for Cosmetic Registration

• Covering letter: The application’s goal must be stated in detail. The importer provides this document.

• Form 42: This is made online after the importer pays the government fee. The importer must give a stamped and signed copy of the same form.

• Challan: A document containing information about the applicant as well as the payment made for the application in Indian rupees.

• Power of Attorney by the Manufacturer: This document outlines the contractual arrangement between the Manufacturer and the importer and lists the goods to be imported, along with the categories for which they are being registered and the pack sizes.

• Schedule D (III): Provides information on the manufacturer and manufacturing facilities

• A product label that is either original or a copy.

• For each variant, a Free Sale Certificate (FSC), a letter of marketing authorization, and a manufacturing licence must be submitted: lists the goods and states that they can be bought and sold without restriction in the nation of origin.

• Product testing procedures and product specifications.

• A list of the nations to which import authorization, registration, or market authorization has been granted.

• Product inserts in packages.

• Digital copies of information on product manufacturers, brands, and products.

Documents Required for Re-Registration of Cosmetic Products

Central Drugs Standard Control Organization (CDSCO) introduced a new set of clarifications along with the current regulations on October 15, 2015, emphasising the import and registration of cosmetic products. A list of additional documents needed to renew the registration certificate is also included. The group of papers consists of:

  • An original power of attorney;
  • Required fees;
  • Form 42- properly completed and signed, along with the list of items that need to be renewed;
  • A letter of marketing authorization, a manufacturing licence, or a certificate of free sale, as applicable;
  • Copies of earlier-issued original RC and endorsement certificates; and
  • An undertaking or self-declaration stating the information previously shared regarding the product’s details.

Cosmetic Registration and Approval (FORM-42 and Form-43)

The following individuals or entities may submit Form-42 and Form-43 requests for Registration of Import of Cosmetics: 

  • The Manufacturer having registered office in India 
  • The Manufacturer’s authorized representative 
  • The Manufacturer’s Affiliate 
  • Any additional importer 

Drugs Controller General (I), CDSCO, New Delhi, receives the registration application (Form-42) and the necessary paperwork. This application is submitted with the required fee, as well as the data and commitment listed in Schedule D-III. Form-42 and Form-43 are required to register the import of cosmetics. For any number of brands produced at one or more locations by a single manufacturer, a single application in Form 42 must be submitted. The registration is valid for 3 years, the Registration Certificate (Form 43) can be obtained in roughly three months. 

Validity

The authority must issue a certificate of registration within six months of receiving a complete application, as stated in Rule 129C of the Drugs and Cosmetics Rules, 1945. Still, in some exceptional cases, the certificate may be issued three months after the authority has recorded the reasons for it in writing. This is in line with the time frame that the CDSCO aims for, which is 90 days.

After being issued as Form-42 and Form-43, the certificate for import of cosmetics is valid for three years from the date of issuance.

Conclusion:

With a sizable economy for cosmetic and personal care products, Today’s cosmetic industry is expanding quickly. To ensure the safety, quality of cosmetics imported into India, regulations should be in place. According to Rule 21 of the Drugs and Cosmetics Rule 1945, the Ministry of Health & Family Welfare must issue a CDSCO Cosmetic Import Registration Certificate via Form-42 and Form-43. For CDSCO Cosmetic Import Registration in India, the certificate is necessary from the primary regulatory body, which is collected from the Central Drug Standard Control Organization (CDSCO). With this registration, selling and importing cosmetics can be done without difficulty in India. The 1940 Drugs and Cosmetics Act governs CDSCO Cosmetic Import Registration in India.

Read our Article:Cosmetic Product Manufacturer License in India

Snehita Shukla

Snehita has her qualifications in B.Com LLB and LLM, and holds a specialization in Corporate & Financial Laws and Policy. She is hardworking, dedicated and sincere. She has a great command in english and has great problem solving, critical thinking and writing skills which makes her stand out of the crowd. She has a keen interest in legal research work and content writing, she also has a hold in legal research methodology. She loves to take challenges and to explore new topics to research on. She aims to improve her knowledge and skills through her experience.

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