Permission And License Required To Make Cosmetics In India

Make Cosmetics In India

In India, the cosmetics market is growing at an accelerating rate. In the past few years, the demand for different cosmetics products has augmented, especially in the urban areas. There are several factors that contribute to the increase in the increased purchasing power, the influence of the western culture, desire to look attractive and beautiful etc.

At present, in the market, there is an exhaustive range of the different cosmetic products accessible. While using the cosmetic products of the top brand’s many people do not assume to ask the question, how safe is to use the cosmetic product. Well, every cosmetic product contains different chemicals and for the government of the country, it is imperative to look after the interest of the end consumers and ensure providing the quality and safe cosmetic products.

In the past few years, there have been many top brands whose cosmetic and beauty products skin-whitening creams, lipsticks, anti-aging creams etc. were reported to have excessive levels of several hazardous chemicals like mercury. Also, in many beauty cosmetic products, there was the use of the animal fat and other animal derivatives. Also, these cosmetic ingredients and products were tested on the animals before introducing in the market because of which the animals sometimes get harmed and disables as a result.

Earlier there were no such strict regulations regarding the cosmetic products. But with the increasing awareness of the harmful effects of the chemicals and to embrace no cruelty policy for animals today the government of the different countries in formulating policies and regulations. The statutory authority of the country must ensure to take stringent steps related to make sure the cosmetic products are safe for the use. In India, the Central Drugs Standard Control Organisation (CDSCO) has issued various clarifications with regard to the import and registration of cosmetics.

Import and registration of cosmetics in addition to existing guidelines

  • Undertaking regarding the cosmetic products not tested on animals: The Manufacturer either legal or actual / Indian subsidiaries/ brand owner of the products can submit a one-time self-declaration that the cosmetics products have not been tested on animals along with the import registration detail to CDSCO. The acknowledgment copy for submission of the undertaking as received by the applicants from CDSCO can be produced at the port offices in future for clearing the future consignments.
  • Free sale certificate from the responsible person instead of the actual manufacturer: Free sale certificate issued by National Regulatory Authority or other competent organizations from the country of the legal manufacturer in addition, to the actual manufacturer from the country of origin can be considered.
  • Letter of Authorization (LOA)in the case of Third party manufacturing outside India: In the cases where the brand owner is located in India and gets its products manufactured from places located outside India an LOA can be considered in place of Power of Attorney (POA).The overseas manufacturer has to give acceptance of LOA and conditions on an apostilled copy.
  • Import of Bulk Cosmetics– Requirement of a Certificate of Free Sale (CFS): Applicants can obtain Free Sale Certificate (FSC) either from the country of origin or any other major market where the same product is freely sold. Alternatively, bulk importers could get the bulk cosmetics tested in India at a Government laboratory to obtain the customs clearance.

For renewal of Registration Certificate following documents will be required: 

  1. Power of Attorney in original
  2. Necessary fees
  3. Duly filled and signed Form 42 with the list of products to be renewed
  4. Certificate of free sale/Marketing Authorization letter/Manufacturing License, if any
  5. Copies of original RC and endorsement certificates that were granted earlier
  6. Undertaking/ Self-declaration stating that there are no changes in earlier shared information with respect to product details (like the composition, test methods, specifications, label ( complying Rule 148 of D&C Rules 1945) etc., the constitution of the firm and sourcing location/site of the products.

The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act, 1940.

  • The License on form 32 is issued for manufacture or sale distribute of cosmetics.
  • The License on form 32-A is issued for loan license for manufacture or sale distribute of cosmetics.
  • License on form 37 is issued for the grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in the manufacturing

All the cosmetic products that are imported in India for sale need to be registered with the licensing authority as defined under Rule (21) of Drugs & Cosmetics Rules, 1945.

The application for the Registration of Import of the different Cosmetics products can be made by-

  • The Authorized Agent of the Manufacturer
  • The Manufacturer himself having registered office in India
  • The Subsidiary of the Manufacturer
  • Any other importer

Every cosmetic product got manufactured by the manufacturer for the import under the Registration Certificate into India must conform to the specifications and guidelines that are defined in the Drugs & Cosmetics Rules, 1945 as amended from time to time. The registration provided to the manufacturer is valid for a period of three years.

Additionally, the manufacturer of the cosmetic product must inform the statutory authority about any changes or variants in the category or change in manufacturing location. The manufacturer must also fulfill the labeling requirements as specified in the act. The product labels must display the address of the manufacturer, manufacturer and expiry date, importer name and address, import license no, cautions (if any), the list of ingredients used in the product, etc.

Moreover, the authority also orders a time to time inspection under the act, of the whole premises, where the different operations are to be carried out before granting or rejecting the application for acquiring the cosmetic license in India. Every manufacturer must ensure to follow the rules as defined under the Drugs & Cosmetics Rules, 1945 strictly so as to acquire the license for selling the cosmetics products in India and also providing the highest quality and safe cosmetic products for the use of end consumers.

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