SJES 031015 Dated 07th October 2015
The Ensuing Regulatory Environment of Cosmetics Import in India
The emergence of a young urban elite population with increasing disposable income in cities, including an increase in the number of working women increasingly looking for lifestyle-oriented and luxury products is the main driver of demand for imported cosmetics products. Indian consumers tend to look towards international brands as lifestyle enhancement products.
The total size of the Indian retail beauty and cosmetics market is currently estimated at $950 million. The overall beauty and wellness market, which includes beauty services, is $2.68 billion. The cosmetics market in India is growing at 15-20% annually, twice as fast as that of the United States and European market (these figures have been reported in specialized studies pertaining to the Indian cosmetics market). Premium global brands are gaining sales as Indian consumers gain exposure to the global media and move from functional items to advance and specialized cosmetic products. Hence, it is extremely imperative for anyone desirous of entering the Indian cosmetics market or desirous of increasing their market share in the burgeoning cosmetics market of India, to be familiar with the regulatory landscape encompassing import of cosmetics.
2. Present Regulatory Environment:
Import of Cosmetics is governed by Section 9C to 15 of The Drugs and Cosmetics Act,1940. These Sections essentially empowers the Government to formulate rules specifying the operational conditionalities of cosmetics import. Pursuant to the Act, Part XIII of the Drugs and Cosmetics Rules, 1945, along with Rule 43A(which specifies the place of importation of cosmetics),Rule 144(which prohibits the import of cosmetics under specific circumstances) and part XV of the Drugs and Cosmetics Rules(which specifies the labeling and packaging requirements of imported cosmetics);in essence spells out in details the legal requirements to be fulfilled for importing cosmetics into India or exporting cosmetics to India. The defining feature of import at the moment is obtaining shipment by shipment no objection certificate from the authorities specified in the Drugs and Cosmetics Act. Theses regulations while retaining the standards, quality and packaging relating requirements is slated for a significant change with effect from 01.04.2011.(the date has now been advanced to 1st october,2012)
3. The Ensuing Regulatory Changes w.e.f: 01.04.2013
Govt. of India has issued a gazette notification G.S.R. 426(E) dated 19th May 2010 making it mandatory to register all imported cosmetics. This amendment to Drugs & Cosmetics Rules was notified in the gazette amending Rule 129 of Drugs & Cosmetics Rules. The above amendment and the provisions as in the amendment has come into force from 1st day of April, 2013.
3.1. Salient features of the amendment:
-In the Drugs and Cosmetics Rules, 1945, in Part XIII, for the heading “IMPORT OF COSMETICS”, the heading “IMPORT AND REGISTRATION OF COSMETICS” shall be substituted.
–In the said rules, for Rule 129, the following rules shall be substituted, namely:-
129- Registration of cosmetic products imported into the country.- No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.
129A– Form and manner of application for Registration Certificate–
(1) An application for issue of a Registration Certification for cosmetics intended to be imported into India shall be made in form 42 either by the manufacturer himself or by the subsidiary in India authorized by the manufacturer and shall be accompanied by a fee of two hundred and fifty US dollars or its equivalent to Indian rupees for each brand of cosmetic. The application shall be accompanied by a treasury challan as specified in sub-rule (3) along with the information and undertaking as specified in Schedule D(III) duly signed by or on behalf of the manufacturer or by his authorized agent or importer in India or by the subsidiary in India authorised by the manufacturer.
(2) An authorization by the manufacturer to his agent in India shall be duly authenticated either in India before a first Class magistrate or in the country of origin before such an equivalent authority.
(3) The fees shall be paid through a challan in the designated branches of Bank of Baroda either in US dollars or in equivalent Indian rupees under Head of Account “0210- MEDICAL AND PUBLIC HEALTH, 04 PUBLIC HEALTH, 104-FESS AND FINES” and the original copy of the treasury challan shall be submitted alongwith the application for product registration.
Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the electronic Code of the bank in the Head of Account “0210- MEDICAL AND PUBLIC HEALTH, 04 PUBLIC HEALTH, 104-FESS AND FINES” and the original receipt of the said transfer shall be treated as an equivalent to the bank challan subject to the approval by the Bank of Baroda that they have received the payment.
(4) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government, as may be, required for examination, tests and analysis of cosmetics.
(5) A fee of one hundred US dollars or its equivalent shall be paid for a duplicate copy of the registration Certificate, if the original is defaced, damaged or lost.
129.B –Registration Certificate for the import of cosmetics manufactured by one manufacturer. – A single application may be made and a single Registration Certificate in Form 43 may be issued in respect of import of one or more than one cosmetics manufactured by the same manufacturer ; Provided that the cosmetics are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit.
129C- Grant of registration Certificate.- (1) On receipt of an application for Registration Certificate in the form and manner specified in rule 129A, the licensing authority shall, if satisfied, issue a Registration Certificate in form 43 subject to the conditions of the registration certificates in form 43;Provided that if the application is complete in all respects and information specified in Schedule D III is in order, the licensing authority shall, within six months from the date of receipt of an application, issue such registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit.
129D- Duration of registration Certificate. – A registration Certificate, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue: Provided that if application for a fresh Registration Certificate is made within six months before the expiry of the said certificate, the existing registration Certificate shall be deemed to continue to remain in force until orders are passed on the application.
129F- Prohibition of import of certain cosmetics.- No cosmetic, the manufacture, sale or distribution on which is prohibited in the county of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.
129G – Standard for imported Cosmetics. – No cosmetic shall be imported unless it complies with the specifications prescribed under Schedule S and Schedule Q or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case the cosmetic is not included under Schedule S, it shall meet with specifications under the rules and standards applicable to it in the country of origin.
129H – Labeling and Packing of Cosmetics. – No cosmetic shall be imported unless it is packed and labeled in conformity with the rules in Parts XV.Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India”.
4. Checklist of information required for completing the application form as well as the undertaking.
PARTICULARS OF THE MANUFACTURER AND MANUFACTURING PREMISES:-
(a) Name and address of the manufacturer and manufacturing premises to be registered along with telephone numbers, Fax numbers and e-mail address.
(b) Name (s) and address of the Partners / Directors.
(c) Name and address of the authorized importer distributor agent in India, responsible for the business of the manufacturer.
(d) A brief profile of the manufacturer’s business activity, in domestic as well as global market.
PARTICULARS OF THE COSMETICS TO BE REGISTERED:-
(a) Names of cosmetics along with their brands name, category, pack sizes and variants to be registered and meant for import into and use in India.
(b) Particulars of the manufacturing licenses/ registration/ marketing authorizations (if any) under which the cosmetics are being manufactured in the country of origin along with the copy of the licenses / marketing authorization/ registration issued by the Regulatory authority of that country.
(c) List of countries where marketing authorization or import permission for the said cosmetic has been granted.
CHEMICAL INFORMATION OF COSMETICS:-
(a) Name(s) of ingredients in the nomenclature of standard references, along with percentages contained in the cosmetic.
(b) Specification and testing method for testing of the cosmetic(s).
(c) Manner of labeling as per Drugs and Cosmetics Rules, 1945.
(d) Package insert (if any)
5. In addition the office of Drug Controller of India/CDSO has issued clarification that Import of cosmetics for R & D purposes [like packaging trails, consumer studies, shelf life and transport studies, etc] or for non commercial use are out of scope of import registration.
The firm have to give information about the cosmetics product(s), quantities to be imported along with justification for the quantity to be imported, and reason for importing, brief protocol of the studies to be conducted, needs to be submitted to the registration authority. In such cases no fees is to be paid. The registration authority may issue a NOC for the same, which need to be shown to such authorities to get goods cleared. Such material should be clearly mentioned “Not for Sale, for R & D Studies only” OR “Not for Sale, for consumer Studies only” The applicant will also give an undertaking that such cosmetics will not be sold, offered for sale distributed or displayed. Industry / importer /and Manufactures are responsible to ensure the same. CDSCO may take necessary actions if cosmetics packs are found not complying to this requirements as per provisions of Drugs & Cosmetics Act and Rules as applicable, including any penalty if found not complying this NOC issued.
The amended provisions itself envisages grant of the registration certificate within a period of six months from the filing of the registration application in the prescribed manner. Given the serious human resources constraints being faced by the CDSCO(Central Drug Standardisation Organisation) which has been mandated to process and issue the registration certificate; the existing players as well as those interested in entering the Indian Cosmetics Market should kick start the registration process at the earliest possible.
GOVERNMENT OF INDIA, MINISTRY OF HEALTH & FAMILY WELFARE
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