About Regulatory History

Cosmetics-Registration-in-India.com

We, COSMETICS REGISTRATION (INDIA) are a consultancy subsidiary of ARHAM CONSULTANTS (INDIA) PTY, New Delhi and are focused on the regulatory compliance of Cosmetics Imports Registration in India.

About Regulatory History
Imported Cosmetics:
History of Registration Regulations in India

In India, the import of cosmetics was not regulated till as recently as the year 2011 and so, till then it was not mandatory for the foreign manufactured cosmetics to be registered before import into India. In the absence of any regulatory framework, spurious and sub-standard cosmetics, worth millions of dollars, were being sold in India. The new requirements of ‘Cosmetics Registration in India’ were thus an outcome of the dumping practices of many foreign companies wherein a large volume of beauty & personal care brands, the quality of which was a health hazard, were being sold illegally in India.

In line with international practices, in 2011 India introduced a new regulatory system that made compulsory a prior registration of foreign manufactured cosmetic products before they are exported to India. The new system made it mandatory to register every item that comes under the purview of imported cosmetics and specified the administrative process, the documentary requirements and the time frame for the issuance of the Cosmetics Import Registration Certificate in India. It was a regulatory effort that was planned to prevent the selling of inferior quality & spurious cosmetics in India and also to bring consistency to the import policy for such products.

Regulatory Guidelines:
They are still under evolution

With the new regulatory system in place from 1st October 2011, every cosmetic product being imported in India has to be duly registered at the office of the Licensing Authority i.e. the DCGI - Drug Controller General of India, New Delhi - or any of its nominees. The office of the Drug Controller works under the Indian Drugs and Cosmetics Act of 1940 which administers the manufacturing, sales, clinical research and import / export of drugs and cosmetics in India.

The new regulations give an exemption of the Cosmetics Registration requirement for those cosmetic products which are being imported for 100% re-export from India and/or are being imported in bulk raw-material form for reprocessing and repackaging in India. However, registration is mandatory for the cosmetic products which are to be imported in finished form for a direct as-it-is sale in the Indian markets.

Registration is required for all the Indian importers who can be an Authorized Agent or a Manufacturer or a Distributor of the cosmetics products being imported. The foreign manufacturer through a duly appointed Authorized Representative / or through its own Indian Companies Act registered and Indian Drugs Act licensed subsidiary in India can make an application to the Licensing Authority for registration of the cosmetic products for Imports into India.

The Registration Fee for each Brand* of cosmetics is US $250 that includes all the pack sizes and variants of that Brand. In case the importer wishes to import two or more brands then each brand would require a registration fee of US $250, separately. Also, the importer would be liable to pay the testing fees for securing quality approvals by the Government of India for analysis and examination of the cosmetic brand, if such orders are passed on the application.

* Under the Cosmetics Registration guidelines, a Brand is defined not as the marketing name of the cosmetics but as the product category as per the Annexure List issued by the Licensing Authority for such purpose.

Although the registration fees is currently fixed at an introductory low amount of US $250 only for an entire brand category of cosmetics, the applicant has to fulfill an exhaustive cosmetics dossier / documents requirement for each and every type , pack size and variant of the applied cosmetic brand. On submission of complete and accurate information documents and the application form, the Registration Certificate would be issued within a period of 6 months from such submission. Once issued, the registration certificate will remain valid for 3 years unless it gets cancelled or suspended in-between for any reasons, to be informed in writing by the Licensing Authority.

After the Registration Certificate has been granted, the label on the cosmetic products should show the Registration Number, Name and Address of the firm or person who holds the Registration Certificate or is importing the cosmetics into India. Except for the purpose of testing, analysis and examination, no cosmetic product can be imported if it falls on the list of products prohibited for sale, distribution and manufacturing in the country of its origin. The Licensing Authority holds the right to review the existing products which are already present in the Indian market and approve registration on a case to case basis on a fast-track course.

Procedure of Registration:
Registration of cosmetics being imported in India

The issuance of a Registration Certificate for a cosmetic brand planned to be imported in India needs to undergo a specified application process:

  • . The application form for granting registration certificate should be made on the prescribed Form-42 format along with a Covering Letter, in both electronic and hard copy, to the Licensing Authority of the Office of the Drugs Controller General of India at the Indian Ministry of Health & Family Welfare, New Delhi. The Manufacturer, its Subsidiary or its Authorized Representative / Importer / Distributor / Agent in India can submit the Application Form alongwith the prescribed fee of US $250 or the equivalent value in Indian currency for each brand of imported cosmetics.
  • . The Covering Letter for the Registration Application should be provided on the official letterhead of the Authorized Representative or the Importer, duly signed and stamped by that company’s Authorized Signatory. Also, the manufacturer is required to provide his Indian Authorized Representative an Authorization Letter duly authenticated before a magistrate in India or an equivalent authority in the country of origin.
  • . Upon receiving the application, the office of the Drugs Controller General of India will provide an acknowledgement on the copy of the Covering Letter by putting its official stamp and a mention of the acknowledgment number, receipt date and other details for future reference
  • . The Registration Fee needs to be submitted at any of the branches of the Bank of Baroda in US $ or in Indian currency in the Treasury Receipt format as provided by the Licensing Authority. In case the foreign manufacturer wants to make the payment directly, then an EFT ‘Electronic Fund Transfer’ can be made from the country of origin to Bank of Baroda, Kasturba Gandhi Marg, New Delhi. Later on, the proof of fund transfer must be taken from the bank and provided to the Licensing Authority along with the receipt of any difference in the remittance amount and the application form for registration.
  • . Once the Licensing Authority of the Drugs Controller General of India has made an assessment and review of the application file, the Registration Certificate would be issued within 6 month’s time of submission of the application and shall have a validity period of 3 years.
  • . While applying for registration, one single application can be made by the manufacturer for one or more than one cosmetic brands that include the different pack sizes, variants and the manufacturing locations. One single application form, in the prescribed format, can therefore correspond to different cosmetic brands by the same manufacturer at different manufacturing locations. However, to avoid confusion and expedite the processing of application, it is advisable to make separate applications for each brand as the fees in any case has to be deposited for the number of brands and there is not going to be any cost saving by any clubbing of brands in a single application.
  • . In case the cosmetic brand is already registered and now the importer wants to import the same brand in bulk raw material form, then the new application form for the bulk product will get endorsed on the same registration number.
Documents List:
Cosmetics Registration Application submission

Every application form needs to be provided with documents that pertain to the registration process of the cosmetic brand. An indicative list of such document is as under -

  • 1. Documents should be provided about the name and complete address of the manufacturer, manufacturing sites and the details on contact number, addresses, emails and the profile of the manufacturer with a brief note on the present and past business activities in the domestic and global market.
  • 2. Document showing the proof of deposit of the full amount of Registration Fee at the bank of the Licensing Authority.
  • 3. Documents pertaining to the cosmetic brand such as the brand name, chemical composition, pack sizes, category and the variants to be imported to India for sale
  • 4. Documents pertaining to the registration, manufacturing licenses, marketing licenses issued by the regulatory bodies for manufacturing and marketing at the country of origin
  • 5. Documents pertaining to import permission at different countries (if any) for marketing the cosmetic brand
  • 6. Documents pertaining to the chemical composition of the cosmetic brand, ingredients and the scientific nomenclature as per the international standards along with the percentage for every ingredient in the cosmetic brand, testing values, methods and lab specifications / results for each product
  • 7. Document copies of the package insert, labels and user information if any.
  • 8. Documents pertaining to information on the cosmetics availability in the Indian market, if the brand is already present and being sold in the country
  • 9. Physical samples of the Cosmetic products as mentioned in the Application.
International Brand Cosmetics:
Market Entry in India

The key factor to a successful entry into the competitive Indian cosmetics market is a careful analysis and research in order to understand the consumer preferences and the assortment of the sales channels. Such strategic imperatives help the foreign companies in determining the product mix, pricing structure and the brand positioning. This includes an in-depth search for the key partners who have the required knowledge about the local market, procedural understanding, marketing infrastructure, logistic resources, business acumen, sound planning and a consistent follow-up. The business partners need to make sure that the network of distributors is reliable and credible enough to manage the market with commitment and patience.

We, COSMETICS REGISTRATION (INDIA), make sure that customized solutions are provided for the business to make the right impact and succeed into the Indian market. The foreign companies can utilize our Indian Partner Search Service for identifying potential distributors or agents in India. Foreign companies can also utilize our Commercial Services for conducting a background check of the probable potential business associates in India. For a prompt provision of such services, we have a very resourceful presence at New Delhi, the capital of India.

India is one country where the market is very price sensitive and this calls for developing pricing strategies which are both innovative and competitive. Evidently, the Indian consumer is willing to avail world class services but the price has to be reasonable. It is therefore of critical importance that the Indian consumer is appropriately satisfied for its aspirations, preferences and the attitude. For instance, a lot of cosmetic and toiletries companies in India have come up with small pack sizes in order to keep the price-conscious customer interested; price sensitivity and affordability are two key issues in this market. Small pack sizes are strategically right as they make sure that the product remains affordable to the average Indian consumer and the low purchase cost throws an opportunity for the consumer to try new products.

India being a big market requires an equally big marketing support and sales infrastructure. This makes it imperative for the business firms to acquire more than one importer and distributor at any given territory for a much better geographic coverage. It is also very important that the Indian color and the skin types are properly understood for the introduction of appropriate cosmetic products.

Favorable Import Tariffs:
Assess to Indian markets is easy now

In the last few years the import tariffs on cosmetics in the Indian market have been curtailed significantly. Currently, the total customs duty under the HS Code 3303-3307 for Cosmetics and Beauty Products is 26.84%. It has reduced considerably from 56% (2005-2006) to 31.7% during the last year. One of the bigger components of this custom duty is the 10% CIF value i.e. Cost Insurance Freight, being applied on the value of the goods. This is further made heavier by the countervailing duty popularly known as CVD of 10.30% and an additional CVD of 4%. The later represents the value added tax, sales tax and the sundry levies which are applicable to domestic goods in India. CVD i.e. countervailing duty can also be compared to the local Excise Tax being applied on domestic goods being manufactured within the country.

Labeling Information:
Compliance to Packaging Norms

The Indian government has, since January 2001, made it mandatory for the pre-packaged goods, which are being imported into India for direct retail sales, to carry some mandatory details on the product labels. Likewise, the import consignments of Cosmetics must also clear some specific labeling compliance before they reach the customs office. However, the labeling requirements don’t include commodities that have to undergo further processing such as bulk imports and the raw materials.

A cosmetic product should carry the following information on the outer and the inner label:

  • 1) Brand name and the generic name / use category of the cosmetic product
  • 2) Manufacturers’ / Importers’ name, address and location of the manufacturing site with the the number of manufacturing license mentioned after the letter ‘M’. [Note: if the brand comes in the container of a very small size and the manufacturer’s details cannot be placed on that, then it is essential that the manufacturer’s name, the principle site of manufacturing and the zip code is mentioned]
  • 3) a description of the composition of the different ingredients / contents in terms of fluid measure for liquids and weight for semi-solids and solids [Note: it is not essential to mention the contents in case the net content is not more than 30gms (for a semi-solid or solid product like toilet soap) or 60ml (for a liquid product like perfume)].
  • 4) description of each ingredient in order of % composition, volume measurement and the batch number details starting with ‘B’ [Note: cosmetic products are exempted where the liquid volume is less than 25ml and the solid or semi-solid weight is less than 10gms]. For cosmetic products like soap, the label should carry the month and year of manufacturing and not the batch number.
  • adequate and appropriate directions must be mentioned in the package insert for preventing any hazard / accident, safe use, caution, warning, contraindications and special direction in specific conditions
  • 6) the MRP [Maximum Retail Price] at which the product would be sold to the end consumer in the packaged form. The MRP would include freight and transport charges, taxes, dealer commission and all the other charges.
  • 7) the date of Manufacturing & Import into India and the Best before date.
  • 8) any other information deemed relevant to the Licensing Authority.
Cosmetics Registration not granted:
Items that are banned from import

Import of cosmetic products in India is completely banned where such cosmetics contain excess than the specified limits of lead, hexachlorophene, mercury or arsenic compounds; these contents must not exceed:

  • . 2 PPM ‘Parts per Million’ of Arsenic compounded as Arsenic Trioxide
  • . 20 PPM ‘Parts per Million’ of Lead
  • . 100 PPM ‘Parts per Million’ of the heavy metals [calculated as total for each metal but excluding Lead]

The Government of India empowers the custom officers who have all the rights to take samples out of the imported consignments and conduct quality tests, if required.

Disclaimer:

All the information on various aspects of Cosmetics Registration process and regulations in India is the personal interpretation of the author as gathered from various online & offline source materials. None of the information on this site, in part or whole, is claimed to be an authoritative opinion or summary extract of any law or regulations ; readers are requested to validate the information from their own informed sources and act so on their own wise decision.

Resources:

The Drug & Cosmetics Act, 1940

Drug Controller of India, Ministry of Health, Government of India

Ministry of Finance, Government of India

Reserve Bank of India