Dated 07th April 2011
The Ensuing Regulatory Environment of Cosmetics Import in India
1. Introduction:
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<strong>.(the date has now been advanced to 1st october,2012)
3. The Ensuing Regulatory Changes w.e.f: 01.04.2011
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 will come into force from 1st day of April, 2011.
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.
5.1. Clarification:
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.
6. Conclusion:
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 CDSO(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.
Disclaimer: The views expressed by the author have been given in his personal capacity. For initiating any business decision on the issue of import of cosmetics; the readers are strongly recommended to refer to the official publication in this regard.
GOVERNMENT OF INDIA, MINISTRY OF FINANCE
I have read your article on Import Registration rules. Thank you for providing latest information. We are Ahmadabad based cosmetic company and importing products from Korea and USA. We need some help in Import Registration process. Can we contact you?
— Nishant
nishant@dolphinskinsolutions.com
yes !!
Dear Darshita,
We are a company importing beaty products & need help in registration, Is there some guidance available or can you help us provide registeration on turn key basis. If yes please do contact v_devgun@hotmail.com or you may call me on 09818009007
hi nishant
i think you got the maximum information , if u need more help contact me at 09319345628
t
Dear Mr. Nishant,
Hope your query still stands. In case you are interested, please write to us on kngconsultant@gmail.com. We can provide you with range of services within regulatory framework of India.
Thanks,
Shweta Kumar.
Great information, thanks! Wanted to get some info on the Import duties structure on Cosmetics in India. Might you be able to help? How can I speak with you?
Hi ,
We are a mumbai based import firm .We have recently ventured in the imports for the cosmetic industry .We found your article very helpful. we may need an consultant to work with us for products of such nature .If you can please contact us at the earliest via phone,else we await your reply here.thank you for the information provided here.
Sukalp c Bagde
Marketing Manager India
Wig O Mania
Tel – 9822203542/9967648138 (Maha – India )
we licese of Impor of cosmetic in india
Hi
We are a safety supplies company from Bangalore.We want to import and market a perticular type of handwash cream from Italy. This is used by industrial workers to clean their hands from heavy dirty,grease etc.
I want to know if this comes under cosmetics, and need your help in getting the regulatory process done.
Please guide as to how to go about it.
Thanks
Ravi Narayan.
the question is not complete,send it on neeraj001@gmail.com.
Hi, Thanks for the information read your article on Import Registration rules. Thank you for providing latest information.
Sir, for one of our new venture we request you to guide us on the following issue.
We are in the process of launching a new product of external use related to Skin and Beauty
(Non medical, Not listed under “Cosmetic use” as per the Manufacturer)
The said product will be manufactured either in S-KOREA, TAIWAN and or in CHINA. (OEM)
We plan to market, promote and trade for the product in India under our own Brand Name.
Pl. guide if
1. We need to register the product / range of product in India
2. If yes where and with which authority
3. Can we get the Product approved from Authorities like FDA Etc, for quality assurance in India. if yes what are the agencies etc)
hope to hear from you soon,
In conclusion thank you for your valuable time
regards
Dr. Shinde M R
kitindia1@yahoo.com
Dear Sir,
We want to import cosmetic items from Europe,we need the procedures for the registration of our products in India so that at the time of import we may submit the NOC from ADC.
Kindly Advise.
rgds
Rajesh Maithani
I am planning to import a full line of skin care products from the USA. Would like to seek your help in guiding us through the registration process and obtaining the import licence.
Can you please contact me for further details?
thanks
Hello, We are planning to import top branded cosmetics like lipsticks, face products, eye care and nail care products from USA/Europe to India. As these are already branded items being sold in India, do I need to go thru the process of cosmetic registration? Wouldn’t the brand manufacturers already done that? Highly appreciate your guidance with this matter.
Hello, We are planning to import top branded cosmetics like lip color, nail care, skin care, eye care products from USA to India. These brands are already available in India and are being sold. Do I have to go thru this registration process? Highly appreciate your guidance to this matter.
Thanks,
Muru
HI,
I READ THE INFORMATION ON IMPORITING REGULATIONS,
WE ARE JAKARTA BASED COMPANY AND INTERESTED IN IMPORTING SKINCARE PRODUCTS IN INDIA , CAN WE CONTACT YOU,
THANKYOU
i am forwarding your query to a consultant whom i happen to know.they might be contacting you with their business proposal,which you may like to consider.
Dear Harry,
Hope your query still stands. In case you are interested, please write to us on kngconsultant@gmail.com. We can provide you with range of services within regulatory framework of India.
Thanks,
Shweta Kumar.
I want your contact information. I want cosmetic import license
mail us at info@taxandregulatoryaffairs.com
Its like you read my thoughts! You appear to know a lot approximately this, like you wrote the e-book in it or something. I think that you simply could do with a few percent to force the message home a bit, however other than that, this is magnificent blog. An excellent read. I’ll certainly be back.
Hi,
I am based in UK and looking into exporting perfumes to India. These will be 100% genuine brands, my question is what are the import/ duty costs related to such items and what import registration will be required? I hope you can help in dealing with this question.
Kind Regards
Chan
i am forwarding your requirement to a consultant for an appropriate response.
Dear Chan,
Hope your query still stands. In case you are interested, please write to us on kngconsultant@gmail.com. We can provide you with range of services within regulatory framework of India.
Thanks,
Shweta Kumar.
HI,
I read the information on Import regulations., interest in import cosmetic product to india., so i need guide lines .,and refer any consultant regarding my cosmetic imports
kind regards.
viveganand
i have forwarded your mail to a consultant who would contact you.
Dear Mr. Vivekanand,
Hope your query still stands. In case you are interested, please write to us on kngconsultant@gmail.com. We can provide you with range of services within regulatory framework of India.
Thanks,
Shweta Kumar.
Hello, i am Sudhir Dhavan from Mumbai, India. We deal in Services of International Exhibitions In India, we need to know the rules and regulations of Import of Beauty Products with its restrictions if any in to India in dept. Also if there are any special facilties being offered by the Govt. to promote the trade if any.
WE WOULD LIKE TO IMPORT COSMETICS IN INDIA FROM EUROPE. YOUR ARTICLE WAS GREAT HELP. KINDLY SUGGEST A CONSULTANT.
Dear Gaurav,
With reference to your query on our blog, If you are still interested, please contact our consultants Mr. Ravi or Mr. Manoj on following number 09953006168.
Regards.
Shweta.
We are a cosmetic company in india & would be importing eye products in india. Can you please guide us in minimum statutory requiremets for labelling on the pack?
Dear Anand,
With reference to your query on our blog, If you are still interested, please contact our consultants Mr. Ravi or Mr. Manoj on following number 09953006168.
Regards.
Shweta.
Hi…my company is interested to start / import our own line of cosmetics. Could you please send my query to a suitable consultant. Thanks!
Dear Gaurav,
With reference to your query on our blog, If you are still interested, please contact our consultants Mr. Ravi or Mr. Manoj on following number 09953006168.
Regards.
Shweta.
Hi Mr. Neeraj Prasad
Hope you are doing fine,
I seek your help in understing the requirements for import of sanitary napkins in india.
I am Sachin Bansal from BNM Healthcare Pvt Ltd, the company wants to import and sell Sanitary Napkins and Baby Diapers in india.
Request you to please advise us on the licencing and testing requirements.
Regards
Sachin Bansal
BNM Healthcare
We are also interested for the same.can u help us if u received already licencing and testing method and laws governing import of sanitary napkin and diaper
Ravi
Hi,
I am planning to export nail polish from usa to india.what are the formalities to be completed from the usa side and from the indian counterpart.
Thanks
Goldy
hi
i want to get contract manufacturing done from usa and import my already registered brand names in india.
kindly advise
Hello Mr. Neeraj Prasad,
We are a speciality Chemical company and seek you advise on whether the import registrations are also required for cosmetic ingredients?
Thanks & Regards!
Padma
Dear Padma,
Thanks for your enquiry. However we can assist you after an MoU is signed between us. The fee for consultancy shall be derived based on the extent of your requirements. Kindly provide us all the relevant details pertaining to the ingredients that you plan to import for cosmetics along with the complete ITC (HS) code details. Accordingly we shall offer our consultancy on your enquiry. I have also send an e-mail so kindly check and revert.
Thanks & Regards,
Ravi S Jha.
hello Shweta
Can you tells us the process for adding any further new brand or product to be imported, in any existing valid registration certificate.
do we need file separate application if yes kindly suport me with pre checklist of the documents
KetanSharma1313@ymail.com
its urgent kidly reply ASAP….KetanSharma1313@ymail.com
Dear Mr. Ketan Sharma,
We have received your inquiry post on our blog taxandregulatoryaffairs.wordpress.com, addressed to Mr. Shweta Kumar. Please be noted that in case you wish to add another brand to your existing portfolio of brands you need to obtain a separate registration certificate for the same. A fresh application needs to be made for this purpose. Hope this info helps you in your endeavor. Please feel free to contact us for the registration assistance.
Thanks & Regards,
Ravi S Jha.
International Trade Consultant
Kashyap & Gaur Consultants Pvt Ltd,
A-3,R.V. Aptt., Z-111/9,Near MCD Boys School,
Kishangarh, Vasant Kunj, New Delhi
PIN: 110 070, India
Tel No: +91-11-2612 5098 FAX: +91-11-2612 5097
Skype: jha.sravi MSN: jha.sravi@hotmail.com
Twitter: @jhasravi
Website: http://www.kngtrade.com
Blog : http://www.taxandregulatoryaffairs.wordpress.com
Mob: +91-9953006168 (New Delhi)
+91-9830008858 (Kolkata)
WE can provide/work on FOLLOWING PRODUCT FORMULAE —–
THE LIST —
1-SUN CARE CREAM
2-FAIRNESS LOTION
3.FAIRNESS CREAM
4–HAND AND NAIL CREAM WITH REVITALISING AGENTS
5-MEN MOISTURISING FAIRNESS LOTION
6–NOURISHING HAND CREAM FOR DRY HANDS
7–INTENSE HAND PROTECTION CONCETRATE
8-DAILY HAND CREAM
9-SOOTHING/FOOT CREAM
10–HAND AND NAIL CREAM WITH NOURISHING AGENTS
11-OVERNIGHT MOISTURISING FOOT CREAM
12–ANTI PERSPIRANT FOOT CREAM
13–BEAUTY HAND CREAM
14–FOOT SALVATION CREAM
15–ANTI-WRINKLE NIGHT CREAM
16–WHITENING ANTI WRINKLE DAY CREAM
17–BEAUTY BODY CREAM
18–8 HRS NIGHT CREM
19–FEMININE SOOTHING INTIMATE CREAM
20–2 IN 1 PROTECTING HAND AND NIGHT CREAM
21–SPA NIGHT RENEWAL HAND CREAM
22-PRO-YOUTH HAND CREAM
23–EXTRA COMFORT CREAM
24–NOURISHING NIGHT CREAM
25–HER BODY CREAM
26–DIVINE BODY CREAM
27–ENIGMA BODY CREAM
28–ELIXIR BODY CREAM
29–CHIFFON BODY CREAM
30–NUTRI CALM DAY CREAM
31–NUTRI CALM NIGHT CREAM
32–OXYGEN BOOST CREAM
33—CALMING FACE CREAM
34–MEN TOTAL AGE CONTROLE CREAM
35—BIO-MAXIMUM DAY CREAM
36–BIO-MAXIMUM NIGHT CREAM
37–WOMEN BODY CREAM
38–GENERAL BODY CREAM
39–SENSUAL BODY CREAM
40–DANCING LADY BODY CREAM
41–RADIANT LIGHT BODY CREAM
42–SENSUAL BODY CREAM
43–DELIGHTING BODY CREAM
44–SOOTHING FACE CREAM
45–REVITALIZING FACE CREAM
46–BALANCING FACE CREAM
47–INTENSE HYDRATION YOUTH PRESERVE DAY CREAM
48–EVERY DAY PROTECTOR CREAM
49–TENSE DEEP NIGHT REFORMER CREAM
50–MULTI BENEFITS EYE CREAM
51—SOOTHING HERBAL FACE CREAM
52—GENTLE PEELING CREAM
53–YOUTH PRESERVE NIGHT CREAM
54—DAY GEL CREAM
55–TOUCH NIGHT GEL CREAM
56—WHITE NIGHT CREAM
57—MOISTURISING DAY CREAM
58–ANTI-AGING CREAM
59—RESTORING DAY CREAM
60–RESTORING NIGHT CREAM
61—EVEN OUT DAY CREAM
62–FAIRNESS CREAM
63—NOURISHING HAND AND BODY CREAM
64—BOOST SHAMPOO
65—ANTI DANDRUFF SHAMPOO
66—COCONUT PROTECT SHAMPOO
67—REPAIR THERAPY SHAMPOO
68—ANTI AGING SHAMPOO
69—DAILY CARE SHAMPOO
70–FRIZZ FREE SHAMPOO
71–SPA SHOWER GEL
72—TROPICAL RAIN FOREST SHOWER GEL
73—MEN ANTI DANDRUFF SHAMPOO
74—PURE BALANCE SHAMPOO
75—COCO HAIR OIL
76–SUN CARE LOTION
77–CALM FACE MASK
78—OXYGEN BOOST FACE MASK
79–MOISTURIZING GEL MASK
80—PURIFYING CLAY MASK
81—SPA PURIFYING FACE MASK
82—ANTI PERSPIRANT 24 HRS DE-ODORANT
83—24 HRS ANTIPERSPIRANT DEODORANT
84—ROLL-ON DEODORANT FOR MEN
85—SKIN GLOW LIGHT
86–SKIN GLOW DARK
87—INCREDI BALM-PINK
88—MATT CONTROLE FOUNDATION SERIES
89—LIP GLOSS SERIES
89—WHITENING LIQUID FOUNDATION
90—MINERAL THERAPY FOUNDATION SERIES
91—OXYGEN BOOST FOUNDATION SERIES
92—MINERAL THERAPY CONCEALER SERIES
93—WHITENING LIQUID FOUNDATION SERIES
94—LASH MASCARA-BLACK
95—LASH FASCHINATION MASCARA-BLACK/BROWN
96—LASH EXPLOSION MASKARA-BLACK
97—ENDLESS LASH MASCARA–BLACK/GREEN
98—FAT LASH MASCARA–BLACK
99—WATER PROOF MASCARA–BLACK
100—INTENSE BLACK MASCARA
101—FX MASCARA BLACK
102—ANTI WRINKLE EYE CARE
103—SPA BEAUTY WONDER OIL
104—MEN NORMAL SKIN SHOURING GEL
thanks
S CHANDRA
NEO-TECH
INDIA
hey, i hv to import cosmetics for trade in india. what is the formalities to get import license..can u send me a paper requirement for the same. i m neither a manufacturer nor an authorized agent.
kindly sent paper requirement on my id rohit913@yahoo.com
Dear Rohit, we will certainly help you in this. Please be noted that now it is mandatory to register the cosmetic product categories with CDSCO before importing to India. Please drop us an email @ info@taxandregulatoryaffairs.com and ravi.shekhar@taxandregulatoryaffairs.com with complete details and we will certainly reply back to you. Best Regards
Dear Ravi,
We understand that for registration of each brand category a fee of USD 250 is payable. Can you please clarify if brand category is as per column 3 of the annexure in CDSCO guidelines, which means for each category mentioned in column 3, a separate fee of USD 250 is payable?
Thank you very much for your detailed informations about registration of imported cosmetics in India. But I am so late to read your commends. Already applied for registration through another party for one manufacture’s 8 products in 2 section and paid 500 USD as fee for the same . But registration certificate received only 4 products of one section . What’s the next step for obtaining rest of 4 products registration.
Best regards,
ANIL