Laws and Legal Compliances applicable upon Foreign Companies for Selling Beauty Products and Cosmetics in India: Lawyers Advice

The Central Drugs Standard Control Organization (CDSCO) regulated the cosmetics in India. The Indian Parliament passed the Drug and Cosmetic Act 1940 and Rules 1945 to regulate the import, manufacture, distribution and sale of drugs and cosmetics.

Rules Governing Cosmetics and Beauty Products
As per Section 3 (aaa) of the Drugs and Cosmetics Act, 1940, “cosmetic” means any item designed to be poured, sprinkled, rubbed or sprayed on or otherwise applied on the human body or any part of the human body, for beautifying, cleansing, altering the appearance or promoting attractiveness and also consists of any item designed for use as a component of the cosmetic.

Before March 31, 2013, registration of the cosmetic product was not necessary to import them in India. Registration became compulsory from April 1, 2013 for every cosmetic imported in the country. After the amendment in Rule 21 of Drugs and Cosmetics Rules, 1945, all cosmetic and beauty products that are imported for selling in India have to be registered with the licensing authority.
In the Supreme Court case of Commissioner of Central Excise vs. Sharma Chemical Works (Appeal (Civil) 7610 of 1999), it was held that whether a product falls under the definition of ‘cosmetic’ does not depend on its physical attributes like fragrance, any product meant for external application intended to beautify is to be considered a ‘cosmetic’.
One needs to be compliant with the Indian regulations and legislations in order to legally register, import and sell cosmetic products in India.

Cosmetics Registration
The Registration application for import of Cosmetics can be submitted by: –
• The one manufacturing, having a registered office in India
• The authorized agent of the one manufacturing
• The subsidiary of the one manufacturing
• Any other importer

The submission of the registration application (Form – 42) along with all the essential documents is made to the Drugs Controller General, CDSCO, New Delhi. This application for registration is accompanied by any fee specified along with undertaking in Schedule D-III. A single application is made by a single manufacturer in Form 42 for one or more brands manufactured at one or more places.
While the Registration (Form 43) may be attained in about three months, the registration validity is for three years.
In the case of Gopilal Agarwal vs State of Orissa And Anr. (AIR 1973 Ori 15), it was held that registration and licensing of the product in question, which was manufactured for cleansing of teeth, cannot be affected by it having a narcotic effect or if fails to simultaneously whiten the teeth as well.

Government of India Amendment
The Central Government had issued a gazetted notification G.S.R. 426(E) on 19th May 2010 making registration of all imported cosmetics compulsory. This amendment of Rule 129 of Drugs and Cosmetics Rules was notified in the gazette and the amendment and its provisions came into effect from 1st April, 2012.

Fresh Registration: –
The following changes require a fresh registration, after obtaining a Cosmetic Registration Certificate, –
• Any changes in relation to manufacturer like a change in constitution, a change in name, change in address, etc. Any change in relation to Indian Agent or importer like a change in constitution or a change in name, etc.
• The licensing authority should be informed as soon as possible by the manufacturer or his authorized agent in India, if any change in the address of the registered office/factory premises and/or the constitution of the firm functioning under this Registration Certificate.
• In such cases, the Registration Certificate currently issues shall be valid for a three-month period unless, in the meantime, the licensing authority has given a new Registration Certificate for the firm that now has a changed address for their registered office or factory premises and/or has changed the constitution of the firm.
• The licensing authority has to be informed immediately in writing by the importer/ Indian Agent, in case of merger or acquisition of one company by another company, and a fresh application has to be submitted as per Rules, since acquisition/merger of one company is believed to be a change in constitution of company.

Changes not requiring fresh registration: –
Following changes only require notification or amendment and do not require a new/fresh registration: –
• Composition changes
• Changes to the method of testing
• Small changes in the process of manufacturing, that will not affect the final product specifications
• Updates to packaging and labelling, with proper justification

Important Points to Remember: –
• A legal Indian Authorized Representative or Agent has to be officially appointed if a company does not have a physical and registered office in India with legal personnel and necessary licenses.
• Such an appointed Authorized Representative would also be responsible for pre-certification and post-market investigation examinations. A single Indian Authorized Representative office will suffice for operations of the whole country.
• The brand owner or manufacturer of cosmetic products has to give a one-time self-declaration that their products have not been tested on animals, before registering their cosmetic to the related department along with specifics of import registration and an acknowledgment copy by CDSCO.
• The usual duration for reply to a change in notification is approximately 90 working days. If brand owner has submitted an application for a Registration Certificate that is yet to be issued and during that time, a change has happened in constitution of either the Manufacturer or Indian Agent or, the address of manufacturer, then submission of a fresh application has to be done, including the fees.

In conclusion, the registration as well as re-registration of cosmetic products is mandatory to ensure its efficacy, safety and quality but it brings along a complicated process of paper work that has to be completed to obtain the registration of a cosmetic product under a brand. With cosmetics considered a drug, it becomes increasingly important to ensure its licensing so that the customer is not duped.
Authored By: Adv. Anant Sharma & Parinay Gupta