The demand of the Cosmetics products has been on rise in the Global market, there has been a significant and many fold increase of the Beauty products in Indian market as well.
With Boom in the Indian market and increase of E commerce in the last decade there are plenty of brands which have reached the Tier 2 and Tier 3 cities as well in the country.Launch and exponential Growth of Indian Startups such as Nykaa, Purplle has rocketed the Growth of Beauty Industry in India with simultaneously launching of Home Grown Beauty brands by indian startup such as Nykaa, Sugar, Miss Claire, PAC,and many more with tech induced ideas and technology driven methods. Growth has been seen across product segments such as Skin care, hair care, oral care, color cosmetics etc. In order to regulate the cosmetic products being sold to the Indian consumer, there are clear guidelines and procedures that have been set in Drugs & Cosmetics Act and Bureau of Indian Standards that need to be followed.
As per Section 3(aaa) of Drugs and Cosmetics Act, 1940 “Cosmetic” means “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.”
Regulation of Cosmetics in India by CDSCO
Import and Manufacture of Cosmetics in india is Regulated by Central Drugs Standard Control Organisation (CDSCO) under Drugs and Cosmetics Act 1940 and as per IS 4707-2: Classification for cosmetic raw materials and adjuncts, Part 2: List of raw materials generally not recognized as safe for use in cosmetics by Bureau of Indian standards (BIS).
Regulatory pathway for Imported Cosmetics- Mandatory Cosmetic Registration
Cosmetics Imported into India are regulated by CDSCO New Delhi, India under the Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India. CDSCO is the National Regulatory Authority (NRA) of India.
Product Formulation & Specification
For a cosmetic product to be approved in India, whether manufactured in India or Imported in India, it has to follow standards , limits, acceptable limits laid in Drugs & Cosmetics Act, & Bureau of Indian Standards
Gazette Notification G.S.R 426(E) issued by Government of India has made registration of imported cosmetics with CDSCO mandatory.
The Government mandated that from 1 April 2013, all imported Cosmetics shall be Subject to Registration with the CDSCO Office, FDA Bhawan, Ministry of Health and Family welfare, India
Under the RULE 21 of Drugs & Cosmetics Rules 1945, All cosmetic products that are imported for sale in India need to be registered with the licensing authority.
License issued by CDSCO under the Drugs & Cosmetics Act 1940 for cosmetic imported in India
Form 43: Application for request of Registration Certificate for import of cosmetics in India is submitted under Form 42
Applicants can apply in an application (FORM 42) on the online portal of CDSCO i.e. SUGAM by submitting the requisite documents and fees to the office of Drugs Controller General India CDSCO.
Okay, but why are the rules made?
To check the sale of sub-standard products being sold to the Indian comsumer as well as having a same quality benchmark set for imported cosmetics in line with the products manufactured in India. By clear enforcement , traders – companies and brands are being made accountable to the Indian consumer in case the products do not meet the safety requirements and/or pose any health risk.
The rules that matter.
RULE 129 A
Form and manner of application for Registration Certificate. Products Imported into the country.
rule 129 b
Registration certificate for the import of cosmetics
rule 129 c
Grant of Registration Certificate
rule 129 d
Duration of Registration Certificate
rule 129
Registration of Cosmetic Products Imported into the country.
rule 129 e
Suspension and Cancellation of Registration Certificate.
rule 129 f
Prohibition of import of certain cosmetics.
rule 129 g
Standard for imported cosmetics.
rule 129 h
Registration of Cosmetic Products Imported into the country.
Before going deep into the application process, the documentation and the requisite government fee, it is important to know the framework of the rules which have been laid out for the industry to follow.
Applicable Rules for Imported Cosmetics As per Drugs and Cosmetics Act 1940
Rule 129: Registration of Cosmetic Products Imported into the country
Registration of Cosmetic Products Imported into the country.
Rule 129 A: Form and manner of application for Registration Certificate.
An application for issuance of Registration certificate in Form 43 must be submitted on SUGAM Portal online in Form 42. The Checklist of all documents must be followed as per Guidance document issued by CDSCO along with the Fees of USD 2000 per category and USD 50 per variant of a product. Government fees of USD 2000 per category are defined as per Guidance document Page 3-4, column 3. Category fees of USD 2000 per category are as per Column 3 only.
DOWNLOAD GUIDELINES ON REGISTRATION OF IMPORT OF COSMETICS
Rule 129 B: Registration certificate for the import of cosmetics
Single application or registration certificate in form 43 may be issued in respect of import of one or more cosmetics manufactured by the same manufacturer. Provided that the cosmetics are manufactured at one factory or more than one factory functioning co jointly as a single manufacturing unit.
Rule 129 C: Grant of RegistrationCertificate
Once the application is submitted on SUGAM in Form 42 and if licensing authority is satisfied according to rule 129 A and with respect to Schedule D III then it may issue registration certificate in form 43 within 6 months from date of receipt of an application. If an applicant does not receive a registration certificate within the expected period may appeal to the Central Government.
Rule 129 D: Duration of Registration Certificate
Validity of Registration certificate in Form 43 is 3 Years from the issue date. Applications need to apply 6 months before expiry for renewal.
Rule 129 E: Suspension and Cancellation of Registration Certificate.
Registration certificate once Issues lists the Conditions mentioned in the Certificate which must be followed. If the manufacturer or his authorized agent fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the cosmetics to which it relates: Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the said appellant an opportunity of being heard pass orders as it thinks fit.
Rule 129 F: Prohibition of import of certain cosmetics.
No cosmetic, the manufacture, sale or distribution of which is prohibited in the country of origin,shall be imported under the same name or any other name except for the purpose of examination, test or analysis
Rule 129 G :Standard for imported cosmetics
Cosmetic Products have to comply with the specifications prescribed under Schedule S and Schedule Q or any other standard of quality and safety of CDSCO & BIS from time to time . 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.
Schedule S
Finished products specific standards as per Bureau of Indian Standards. The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by BIS (+30) Skin Powders. / Skin Powder for infants./ Tooth Powder./ Toothpaste./ Skin Creams. / Hair Oils. /Shampoo, Soap-based. / Shampoo, Synthetic-Detergent based. / Hair Creams. / Oxidation hair dyes, Liquid. / Cologne./ Nail Polish (Nail Enamel). / After Shave Lotion. / Pomades and Brilliantines. / Depilatories Chemical. / Shaving Creams. / Cosmetic Pencils. / Lipstick. / Toilet Soap. / Liquid Toilet Soap./ Baby Toilet Soap. / Shaving Soap. / Transparent Toilet Soap./ Lipsalve / Powder Hair Dye / Bindi (Liquid). / Kum Kum Powder / Henna Powder …etc.
Schedule Q
Contains a list of permitted dyes and pigments in soap and cosmetics as below:
IS 4707 (Part 1) Ingredients Generally recognized as Safe (GRAS) given in dyes, colors and pigments
IS 4707 (Part 2) Ingredients Generally not recognized as safe (GNRAS)
a) Annex A – List of substance which must not form part of the composition of cosmetic products.
b)Annex B – List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down.
c) Annex C – List of preservatives which cosmetic products may contain.
d) Annex D – List of U.V. filters which cosmetic sunscreen products may contain.
RULE 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 and as per RULE 148 , RULE 148 A , RULE 148 B and RULE 149, rule 149 A.
RULE 133: Import through points of entry
No cosmetic shall be imported into India except through the points of entry specified in rule 43A by CDSCO.
RULE 134: Cosmetic to contain Dyes, Colours and Pigments
No Cosmetic shall contain Dyes, Colours and Pigments other than those specified by the Bureau of Indian Standards (IS:4707 Part 1 and Part 2 as amended) and Schedule Q. The permitted Synthetic Organic Colours and Natural Organic Colours used in the Cosmetic shall not contain more than:
(i) 2 parts per million of arsenic calculated as arsenic trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii) 100 parts per million
RULE 134-A: Prohibition of import of cosmetic containing Hexachlorophene
CDSCO Mandates that No cosmetic containing hexachlorophene shall be imported in India and a Declaration for the same must be submitted to CDSCO along with Application in Form 42 for the same as well.
RULE 135. Import of cosmetic containing Lead or Arsenic compound prohibited
The approved Limits as per BIS and CDSCO for lead is less than 2p ppm and Arsenic is less than 2 ppm
RULE 135-A: Import of cosmetics containing mercury
Cosmetics imported into India shall contain mercury in the following proportion, namely;
(a) in cosmetics intended for use only in the area of eye, the level of mercury not exceeding seventy parts per million (0.007 per cent.) of mercury, calculated as the metal, as a preservative;
(b) in other finished cosmetic products, unintentional mercury shall not exceed one part per million (1 ppm) RULE 135-B: Prohibition of import of cosmetics tested on animals
No cosmetic that has been tested on animals must be imported in india. CDSCO expects us to submit a undertaking along with our application in Form42 issued from the Legal or Actual manufacturer stating that the cosmetics products intended to be imported in India has not been tested on animals on or after the date 12.11.2014 as per circular, file no. 18- 12/2013-DC/part file dated 03.02.2015
At NKG, Our Knowledge is up-to-date and is based on the provisions of the LAW. We do not beat around the bush and tell our clients what they need to know.Founded in 2004 , NKG team has more than 70 years of cumulative regulatory experience amongst the core team members. We immediately act as Asset and let our clients focus on their CORE activities and leave the Regulatory Compliance and approvals to us.
in numbers from
regulatory track record
5000+
INTERNATIONAL BRANDSRegistered
100k+
Products Registered
100%
transparency & trust
proudly SUPPORTING
trade commiSsions
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
member of
indian beauty & hygience association
our renowned
associates
contact nkg
we help you meet your compliance needs
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.