Cosmetic regulations in India are new and evolving from time to time. Various factors such as advances in science and global manufacturing practices, new technologies, formulations, newer raw materials, further accurate testing, the effect on wildlife as well as climate keep pushing for evolving regulatory norms around the world.  When such changes happen globally as well as in India, it leads to changes in regulatory expectations. Something which was right till yesterday could be not so right today.

At the same time, you are looking to launch your brand in India. You are hiring PR agencies, personel, Marketing initiatives, retail spaces, trainers, etc. Basically you are going all out to grab your rightful share in the Indian market. In the midst of all this entrepreneurial rush, Such evolving regulatory changes or expectations can disrupt business plans greatly.

This is where NKG experts comes in the picture.

NKG team brings method in this madness. We try to identify the variables and keep working with our clients and helping formulate the best regulatory strategy as changes keep happening.

In the  last decade, through thousands of cosmetics  regulatory submissions and approvals, , working with global regulatory teams and offices and hand holding the biggest , the best the most respectable and the most glamourous brands in the beauty business, NKG team has established a tried and tested , yet simple way of preparing the cosmetic regulatory dossier for product registration in India.

A) Basics to note before diving deep:

There are two broad types of documents that we will ultimately prepare for seeking  regulatory approval or registration certificate of an imported cosmetic product in India.

B) NKG Insight::

Cosmetic Registration  Procedure For Imported cosmetics in India is both

Meaning, it is important to freeze in the companies involved in the regulatory dossier as well as prepare an exhaustive product listing with regards to what needs to imported in India. A miss here, can lead to a minor, major, or even altogether new submission of regulatory dossier.

The key is to note that it is important to make a Framework of the regulatory dossier before actually starting to prepare documents. Quite similar to visualizing a work  of Art in the mind , before actually creating one on the canvas.

In the excitement of launching in India, many companies push the accelerator pedal without taking into account

Any mistake small or big can take a project back by many months and thousands of dollars. 

So what can we do?

The founding members of NKG have personally developed a Robust,  Exhaustive, Globally executable, Time-efficient and most importantly SIMPLE formula to prepare a cosmetic regulatory dossier. Whether it is the regulatory team of the biggest beauty group in Paris, New York, Japan, Singapore, or retail house in crowded streets of Mumbai & Delhi we have got our clients covered.

Step by Step – Regulatory dossier preparation

1. Name and address of the Brand holder for all products.

NKG Insight: Cosmetic registration in India is ENTITY DRIVEN. This is important to investigate correctly as the application for registration of cosmetics will be made in the name of this ENTITY. A mistake here due to incorrect or incomplete name and/or address can mean RE-DOING  the entire regulatory submission and paying the fees again.

2. In case, the  Exporter of products to India is a separate entity/different from Brand Holder,  Name and address of the Exporting Company

NKG Insight: It is important to ascertain if the final export to the Indian Importing entity will be done by the Brand Hodler company or some other company. A confusion here can lead to supply chain challenges and roadblocks in custom clearances in India even after a successful grant of registration certificate for imported cosmetics.

3. A copy of the Manufacturing License or GMP Certificate or ISO certificate or Hygiene License in English version of all actual Manufacturing sites of the products

NKG Insight: Cosmetic registration in India is ENTITY DRIVEN. It is important to pull out the names and addresses of the ACTUAL manufacturers of the products being imported in India from the manufacturing licenses issued to such manufacturers by the regulatory authorities in their respective countries. Missing out on a manufacturing site or using an incorrect or incomplete detail of an actual manufacturing site in the application for registration is considered a MAJOR regulatory change.

4. The final list of products and pack sizes intended to be registered in below format in an excel sheet

a) The Product list must include all sample sizes, testers, variants, shades, Flavors, and colors that are planned to be exported in India. 

b) Please also include any different presentation of the products such as Kits, Combos, Travel set, Trial set, and Collection sets. 

c) Kindly note each different presentation or size of the product must be registered in order to Import hence all the said sizes must be included in the above sheet for Registration.

NKG Insight: Cosmetic registration in India is PRODUCT Driven. It is important to prepare an exhaustive list of products intended to be imported in India. Making a mistake or missing out on an SKU can be considered as MINOR or MAJOR regulatory change with corresponding regulatory actions required.

Case of Missing product: Considered a new product, Major regulatory change
Case of Incorrect or incomplete Name: Considered a new product, Major regulatory change
Case of New shade in the registered product: Considered a new product, Major regulatory change
Case of New Sizes in a registered product: Minor Regulatory change

Therefore as you can see, It is important to set in motion a practice of regulatory forecasting so that regulatory submissions made to CDSCO for seeking approval can be for an updated list of SKUS as desired by the business owners.

5. Artworks of all products as per the above list in PDF Files.

NKG action: Once our team receives the artworks from the client,  we go through the label claims and intended uses of each product/SKU in order to correctly categorize the product as per the categories made available by CDSCO for registration. Correct categorization as per product families will help us estimate the applicable government registration fee which needs to be deposited to CDSCO before submission of application.

Once NKG  team has answers to the above 5 questions, we set in motion an “ ENTITY & SKU Framework” that basically freezes the boundaries of THAT respective regulatory dossier. This is important to be done immediately as mistakes here can lead to minor-major or complete regulatory re-submission which can be financially expensive and time spending exercise.

1. Power Of Attorney 

An overseas Brand holder/ Manufacturer has to issue a Power of Attorney to an Indian Entity as per the format prescribed under the Drugs & Cosmetics Act 1940. Team NKG will use the information received in Step no 1 to prepare the first draft version of the Power of Attorney format and share it with the client for its approval.

NKG Insight:
– Power of attorney has to be issued by Legal Manufacturer on its letter head signed and stamped
– Should list an exhaustive  product list as per categorization explained above 
– Complete correlation in product names – descriptions – pack sizes in ml or gms as per Artworks of products
– Should be Co-Jointly signed by Both Indian importer and Overseas  Legal Manufacturer
– Validity of Power of attorney should be mentioned as 3 years minimum,  since registration is valid for 3 Years

Common Mistake that can be avoided: 
– The name of the Brand is not mentioned in the product list.
– Attestation done by the overseas Brand holder is not as per CDSCO guidelines as below.

The Power of attorney can be attested in ANY ONE of the below 3 ways:

– In the country of origin – Apostille
– In the country of origin- Indian Embassy Attestation
– In India – Attested by First class magistrate in India

2. Certificate of Free Sale 

An overseas Brand holder/ Manufacturer has to procure a Certificate of Free Sale for the products that are expected to be imported into India.Since Certificates of  Free Sale are issued by different bodies in different countries of the world therefore there is NO set format for the same. Accordingly, to ensure accuracy, Team NKG shares a final product list framework that needs to be used to apply for the Free Sale Certificate. 

Team NKG will use the information received in Step no 1 to prepare the first product list version that has to be used to procure a Certificate of Free Sale by the overseas Brand Holder or Manufacturer, duly Apostilled/attested by Indian Embassy issued by either the Health Ministry of the said country or Chamber of commerce.

NKG Insight:
– FSC can be procured EITHER by the Legal Manufacturer OR the Actual manufacture in their respective countries. 
– FSC can be issued by either the Chamber of Commerce or Ministry of Health.
– FSC can  be duly apostilled or attested by the Indian embassy.
– Product names on POA/FSC Must be identical and request you to use enclosed FSC List for the issuance of FSC.
– FSC must mention that products are FREELY SOLD In the country of Origin

Common Mistake that can be avoided: 

– FSC uses the word “can be exported” and not “Freely sold”
-Brand name of the products are missing from the product list section
– In case of FSC issued in a language other than English, there is no English translation either attached or attested.

3. Manufacturing License

An overseas manufacturer has to produce a copy of the Manufacturing License or GMP Certificate or ISO certificate or Hygiene License issued to its manufacturing premises by the regulatory authority of its country respectively.

Team NKG will use the information received in Step no 1 and check the validity of these documents shared by clients and suggest the next steps.

NKG insights:
– The document needs to be either issued by the Regulatory Authority of manufacturer or
– In the case of an actual manufacturer, where no such license is granted by a regulatory authority in its country, a self-declaration conforming to GMP will be sufficient.
– Can be either notarized or apostilled or attested by Indian Embassy
– Make sure the GMP is issued or translated to the English Language.- Once the document is issued then the same needs to be attested.

Common Mistake that can be avoided: 
– The license being used is either expired before submission of the application or getting expired after submission but before the grant of approval of registration certificate.

1. Ingredient List 

The cosmetic division of CDSCO expects a Qualitative & Quantitative breakdown of the Ingredient List of all products to be submitted in order to check the safety of products before granting product approval.

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 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.

NKG insights:
– Needs to be Qualitative & Quantitative Ingredient List with the exact composition of ingredients totaling up to 100%
– CDSCO will check the maximum and Minimum Permissible Limits of each ingredient as per IS 4707:2017 of Bureau of Indian standards
– Chemical Abstracts Services No (CAS No.) should be mentioned so that CDSCO can refer to the same.
– Functions of ingredients should be listed for each ingredient.
– List of Ingredients mentioned on the Composition Sheet Must correlate with List of Ingredients on Artworks

Common Mistake that can be avoided: 
– The product name on this document must be exactly the same as per POA and Free sale certificate
– The document must be issued on Letterhead of Legal or Actual Manufacturer duly signed and stamped stating the name and designation of the person who has signed the document.

2. Certificate of Analysis

The Certificate of Analysis of all products have to be submitted to the Cosmetic division of CDSCO as part of regulatory dossier accompanying application for registration of 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.

NKG insights:
– Product name on Certificate of analysis must be identical to name on Power of attorney and Free sale certificate.
– Certificate of analysis must mention the columns such as Specification, Test methods and Results for each Parameter which is Being tested.
– Bureau of Indian Standards has issued Relevant Indian Standards that need to be followed.
– The mentioned methods for each category is listed by CDSCO and manufacturer must use the applicable test in the analysis document to showcase the results
– The document must be issued on Letter head of Legal or Actual Manufacturer duly signed and stamped stating the name and designation of the person who has signed the document.

3. Test Methods & Specifications

A Brief write up of Test Methods & descriptions of Specifications used to perform the tests listed in Certificate of Analysis needs to be submitted to CDSCO. Common tests are such as pH, Viscosity  Heavy Metal tests or any other internal methods. These should be duly signed & stamped by the authorized personnel of the manufacturer.

4. Heavy Metals in Cosmetics

The Bureau of Indian Standards has laid our clear verdict on how much heavy metals are allowed in India.

All cosmetic products being placed in the Indian Markets need to follow the below specifications for heavy metals.

Test Items	BIS Limits	Test Methods
Arsenic (As)	< 2 ppm	ICP/MS*
Lead (Pb)	< 20 ppm	ICP/MS*
Mercury (HG) Eye-Area Products Such As Eyeliners And Mascara	< 70 ppm	ICP/MS*
Other Finished Cosmetic Products	< 1 ppm	ICP/MS*
Other Heavy Metals (Cd, Cr, Ni)	< 100 ppm	ICP/MS*

*Inductively Coupled Plasma Mass Spectroscopy

NKG Insights:
– A  Declaration stating that the products are free from Hexachlorophene content needs to be submitted.
– The overseas manufacturer can also submit a declaration confirming that the products being exported to India follow the above guidelines of BIS with regards to Heavy metals.
– No cosmetics shall be imported in India on which lead or arsenic compound has been used for the purpose of coloring.
– The above reports or undertaking needs to be signed and stamped by the authorized personnel of the manufacturer.

5. Non Animal Test Declaration

Animal testing on cosmetics is Banned in India. The manufacturer should submit s self declaration undertaking that the products being imported in India have NOT been tested on animals on or after 12.11.2014.

• This undertaking needs to be signed and stamped by the authorised personnel of the manufacturer.

6. Declaration on Non Human Ingredient/cells/tissues usage

Ingredients derived from Human cells or tissues are banned from use in Cosmetics in India. Therefore, CDSCO expects manufacturers to declare and undertake that 

“none of the ingredients are derived from any  human cells or tissues and all ingredients are safe to be used in cosmetics”

• This undertaking needs to be signed and stamped by the authorised personnel of the manufacturer.

7. Declaration for Use of Microbeads

CDSCO India has banned the use of non-biodegradable Microbeads in cosmetic products the size of which is less than or equal 5mm. Therefore a declaration from the manufacturer to this effect needs to be submitted.

• This undertaking needs to be signed and stamped by the authorised personnel of the manufacturer.

8. Brief write up of the Brand, List of Partners/Directors & Export countries

CDSCO expects us to submit a brief write up on information of Brand covering information on topics such as Company History Brief about company activities and products,  Directors Names and address , Export activities and authorisations, or  if any Certifications or awards received etc.

9. Petrolatum

Various subjective declarations such as Information regarding refining history of petrolatum if petrolatums is used as an ingredient in any of the product.

10. Sodium Hyluronate/ Hyluronic Acid

In case product contains Ingredients such as Sodium Hyluronate/ Hyluronic Acid , then a declaration is required stating that the products do not contain any ingredient from human cells or tissues and a state- ment declaring sources of the ingredient is required

11. Labels of all products

The labels or regulatory artworks of the products are required to be submitted to CDSCO as part of documents for processing of application for grant of approval.

Under the Drugs & Cosmetics Act, strict and clear guidelines are laid out for overseas brands and importers to follow on the product packaging. 

12. Checklist of Labels: 

Description	Outer Label	Inner Label	To be done from Country of Origin	Allowed in India Through a Sticker	Comment or Exception
Brand name along with product name	✓	✓	✓
Pack size such as 50ml or 100gm etc	✓	✓	✓
Name and address of Legal Manufacturer	✓	✓	✓
Name and address of Actual Manufacturer or Manufacturing Country	✓	✓	✓
List of Ingredients as per submitted Composition sheet. Ingredients are mandatory to be listed for sizes more than 60 ml or 30 gms	Ingredients are mandatory to be listed for sizes more than 60 ml or 30 gms	Ingredients are mandatory to be listed for sizes more than 60 ml or 30 gms	✓		The list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume at the time they are added, followed by those in concentration of less than or equal to one percent, in any order, and preceded by the words ‘INGREDIENTS‘. Provided that this statement need not appear for packs of less than 60 ml of liquid and30 gm of solid and semi-solids
Caution if any and Instructions to use		✓	✓		On Inner Label (a) adequate direction for safe use, (b) any warning, caution or special direction required to be observed by the consumer, (c) a statement of the names and quantities of the ingredients that are hazardous or poisonous.
Batch No to be prefixed by “B”	✓	✓	✓		this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state, and 25 millilitres or less if the cosmetic is in a liquid state: 2 [Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.
Manufactured on	✓	✓	✓
Use before date	✓	✓	✓
Name and address of Registered Indian importer/Responsible Person/License Holder	✓	✓		✓
Registration certificate number[will be received post approval granted by CDSCO]	✓	✓		✓
Customer care number and email address of Indian importer	✓	✓		✓
Month and year of Import[mm/yy]	✓	✓		✓
Product name and pack size as per registration certificate [if space allows, but preferable]	✓	✓		✓
MRP, inclusive of taxes	✓	✓		✓

NKG Insights:
In Addition to the above, Cosmetic products are Packaged Commodities, therefore they are also regulated under the Legal Metrology (PACKAGED COMMODITIES) Rules 2011. Various aspects of India specific labelling & mandatory declarations need to be followed on the product labels before the products are placed on the Indian Markets. Cosmetic Products have to follow the mandatory declarations on label requirements as per both the Drugs & Cosmetics Act as well as the Legal Metrology (PACKAGED COMMODITIES) Rules 2011. 

For a detailed understanding of labeling requirements as per Drugs & Cosmetics Act, please read this link.

Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or brand owner , one is already engrossed in various business aspects prior to launch of a brand in India. If a mistake is made, it can lead to complete delay in business plan, overheads, financial planning issues  as well as supply chain disruption. 

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, At,  NKG we make a head start by following our unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.