The Ministry of Health and Family Welfare (“MoHFW”), via notification dated December 15,2020, had notified the Cosmetic Rules, 2020 (“Rules”) under the provisions of Drugs and Cosmetics Act, 1940. The Rules have been framed after due consultation with Drugs Technical Advisory Board and have come into effect from date of publication of the rules i.e., December 15, 2020. The Rules codify the regime pertaining to import, labelling, manufacturing and distribution of cosmetics.
The Rules had earlier been released by the MoHFW in the form of draft rules for inviting comments and suggestions and now the final Rules have been released. The Rules are applicable to ‘Cosmetics’ which have been defined under the Drugs and Cosmetics Act, 1940 as- “any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic”
The Rules contain provisions with respect to procedure of sampling for test or analysis, seizure report, manner of certifying copies, approval of laboratory for carrying out tests on cosmetics and their raw materials, voluntary recall of cosmetics, provisions for digitalisation of forms etc. The existing approvals/permissions or licenses have been allowed to be valid for a time period of 18 months from date of issue of these Rules or till the time of their expiry.
Key Highlights
Prior approvals or permissions or licenses or certificates issued - The Rules provide that Prior approvals or permissions or licenses or certificates which have been issued in accordance to the rules which were applicable prior to the commencement of these Rules shall continue to be valid till its expiry or for a period of eighteen months from the date on these rules are notified, whichever is later.
Concept of ‘New Cosmetic’- The Rules have introduced the concept of New Cosmetic by defining it as a cosmetic which contains a novel ingredient that has not been used anywhere in the world or is not recognised for use in cosmetics in any National or International literature. It has been prescribed that before registration of import of new cosmetic into India, the applicant shall obtain prior permission in Form COS- 3 from the Central Licensing Authority. Such permission shall be required even for grant of license or loan license to manufacture new cosmetics for sale or for distribution and no licence to manufacture any cosmetic shall be granted by the State Licensing Authority without such permission.
Voluntary Recall of Cosmetics- The Rules have introduced the concept of voluntary recall of cosmetics which enables a manufacturer or an authorised agent to withdraw the cosmetics in question from the market if he/she believes that a cosmetic, which has been imported, manufactured, sold or distributed, is likely to pose risk to the health of a user during its use and therefore may be unsafe. The manufacturer will have to inform and co-operate with the state licensing authority in case there are reasons to believe that the cosmetic which has been placed in the market is unsafe for users.
Digitalisation- The Rules provide that the Forms which have been prescribed under these rules may be suitably modified by the Central Drugs Standard Control Organisation for the purpose of digitalisation and the conversion of digital forms shall be legally valid for all purposes.
Import of Cosmetics – The Rules do not change most of the processes of registration and import of cosmetics but have reduced the statutory fees. For grant of import registration certificate, the importer is required to make a single application and seek a single certificate for the same in case of import of one or more cosmetics manufactured by the same manufacturer.
For import or manufacture of New Cosmetics in India, the applicant will have to make an application under chapter III or chapter IV of the Rules. Prior to this, the applicant is supposed to obtain permission in Form COS-3 for seeking permission for import or manufacture of new cosmetic.
The manufacturer himself/the authorized agent of the manufacturer/the authorized subsidiary of the manufacturer in India/any other importer in India can be an applicant for grant of Import Registration Certificate for import of cosmetics products into India.
The Rules have defined manufacturer to include both the Actual Manufacturer as well as the Legal Manufacturer. Actual Manufacturer in relation to import of cosmetics means a person who manufactures cosmetics at his own manufacturing site in a country other than India and is approved by the concerned authorised competent authority. Legal manufacturer in relation to import of cosmetics means a person who authorises the other manufacturer from India or overseas to manufacture cosmetics.
Further, there has been imposed a prohibition on the import of certain cosmetics. The import has been prohibited in the following cases-
- Cosmetics whose manufacture, sale or distribution is prohibited in the country of origin
- Where the ‘Use Before’ or ‘use by’ date, as shown on the label/wrapper, is later than six months from the date of import.
- Where the cosmetic contains hexachlorophene
- Where the cosmetic has been tested on animals after the 12th day of November 2014.
With respect to the validity of the import registration certificate, the Rules state that the import registration certificate shall remain valid in perpetuity subject to payment of registration certificate retention fee before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by the Licensing Authority. In case the licensee fails to pay the required registration certificate retention fee on or before the due date, then the registration certificate holder shall be liable to pay a late fee at 2 percent interest and in case he/she fails to pay it during the period of 180 days then the registration certificate shall be deemed to be cancelled.
Exemptions from Import Registration Certificate –
The following categories of cosmetics can be imported without import registration certificate condition, it is imperative for availing this exemption that the cosmetics shall not be used for domestic sale-
(i) Cosmetics in bulk for repackaging for 100% export to other countries. (ii) Cosmetics for research and development purposes like packaging trials, consumer studies, shelf-life studies and transport studies. (iii) Cosmetics for sale to overseas passengers in duty free shops situated within international airports. (iv) Cosmetics in amenity kits for exclusive use of International passengers on complimentary basis if not be used for domestic sale. (v) Cosmetics imported for use in hotels exclusively for their captive consumption and after providing notarized undertaking to this effect. (vi) Hair Fixers, namely mucilaginous preparations containing gums, used by men for fixing beard.
Grant of license for manufacture of cosmetics for sale or for distribution-
While the process for obtaining registration remains mostly similar to the erstwhile regime prescribed under the Drugs and Cosmetic Rules, 1945, new forms and a reduction in statutory fee has been prescribed under the new Rules. A new addition is declaration of adoption of good manufacturing practices, requirements of premises, plants and equipment for manufacture of cosmetics and other requirements prescribed under the Rules. With respect to the validity of the license for manufacture of cosmetics for sale or for distribution certificate, the Rules state that the import registration certificate shall remain valid in perpetuity subject to payment of registration certificate retention fee before completion of the period of five years from the date of its issue.
Labelling, Packing and Standards for sale or distribution of cosmetics
The Rules specify that no Indian origin cosmetic shall be sold or distributed unless the same has been manufactured and labelled and packed in accordance with these Rules. The Rules prescribe the manner of labelling and specify how the inner and outer labels of the cosmetic shall be labelled. The Rules also specify that no cosmetic shall purport or claim any false or misleading idea.
List of ingredients- As per the Rules, it is mandatory for the cosmetic’s packaging’s outer as well as inner label to display the list of ingredients listed in the descending order of weight or volume where the concentration is more than one percent. The ingredients whose concentrating is equal to one percent or less than one percent shall follow the list and may be displayed in any order.
Fee Requirement for registration of cosmetics for Import into India-
As per the Third Schedule of Cosmetics Rules, 2020, a fee of One Thousand US dollars or its equivalent in Indian Rupees for grant or retention of Registration Certificate for each category of cosmetics, a fee of Five Hundred US dollars for registration of each manufacturing site, a fee of Fifty US dollars for each variant and a fee of One Thousand US dollars for grant or retention of Registration Certificate for additional category of Cosmetic shall be paid along with the application for issue of registration certificate for import of cosmetics into India as per form COS-1.
Our Thoughts
The Rules seek to streamline the regulatory requirements for the import, manufacture and distribution of cosmetics. The transition has been made easier by providing validity to the already granted permissions, licenses or certificates and gives ample time to get them renewed. Accountability of the importer and manufactures has been increased by including provisions pertaining to quality and giving of self-declaration for adopting good manufacturing practices. At the same time, reduction of statutory fee and requirement of importer to make a single application for seeking a certificate in case of import of one or more cosmetics manufactured by the same manufacturer, are seen as easing up the process and making it more efficient for both the manufacturers as well as the importers.