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In a major blow to ecommerce in India, both Amazon and Flipkart have received notices regarding fake cosmetics being sold via
their platform.
In case they fail to reply within 10 days, 'strict action' will be taken against them.
Considering that India's largest festive sales is currently going on for these two mega-portals, this is a major concern.
Who has issued the notice? And what actually happened here?
Keep reading to find out more.
Fake Cosmetics Found On Amazon, Flipkart
Drug Controller General of India (DCGI) had raided various warehouses and shipping hubs of Amazon and Flipkart, between
October 5th and 6th, right before the festive season sale started.
Drug Controller General of India operates under Central Drugs Standard Control Organization, and "is responsible for approval of
licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India."
During the raids, officials from DCGI recovered fake cosmetic products, including "spurious and adulterated" imported cosmetics.
In the notice sent to these ecommerce portals, DCGI S Eswara Reddy said, "In case, you fail to submit the reply within the stipulate
period, it will be presumed that you have no reply to offer and appropriate action as deemed fit will be initiated against you,"
Which Rules Were Broken?
To start with, several cosmetic products didn't have any valid manufacturing license on them, without which they cannot be sold
anywhere in India.
Besides the ingredients used for manufacturing these cosmetics were imported from foreign locations, and no registration
certificates were found. Infact, some of the ingredients were under "negative list" of the BIS (Bureau of Indian Standards), and
cannot be used in India.
As per Drug and Cosmetics Act, all imported cosmetic products should have a registration certificate, and all cosmetic products
manufactured in India should have a valid license.
The cosmetics sold should adhere to the standards as laid down by Bureau of Indian Standards, and no ingredients under the
'negative list' can be used.
Amazon Responds; Flipkart Is Silent
Amazon has said that they are a marketplace, and strict action will be taken against the sellers who tried to sell fake cosmetics.
In a statement, Amazon India spokesperson said , "[Link] has a very high bar of customer experience and does take strict
action against sellers who are selling illegal or fake [Link] accordance with the due process of law, as and when such
incidents are reported to us,"
Flipkart hasn't responded yet. A similar notice was also sent to IndiaMart, one of the largest B2B platform in India.
As per a report, 25% of all fake luxury products are sold via online platforms, almost 30% of all online buyers receive a fake
product .
The issue of fake products sold via online portals is a serious issue, and we demand that Flipkart, Amazon, IndiaMart and other
ecommerce majors take appropriate action against this menace.
Have you received any fake product while shopping online? Do let us know by commenting right here.

Cosmetics market in India is growing at a rapid pace. The demand for cosmetics products has been growing, particularly in urban
centres owing to several factors such as greater purchasing power because of higher incomes, increasing influence of western
culture, desire to look better and more attractive etc. Cosmetics is also a sector that needs to be strictly regulated. Presently the
governing legislation in case of cosmetics in India is the Drugs & Cosmetics Act, 1940 which defines a ‘cosmetic’ as “any article
intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, 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.”

How to apply for license to manufacture cosmetics?

The procedure to be followed in order to manufacture cosmetics in India has been laid down under the Drugs and Cosmetics
Rules, 1945. Schedule M-II classifies cosmetics into 11 broad product categories: 1) Powders, 2) Creams, lotions, emulsions,
pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams, hairoils etc., 3) Nail Polishes and Nail Lacquers, 4)
Lipsticks & Lip Gloss etc., 5) Depilatories, 6) Preparations used for eyes, 7) Aerosol, 8) Alcoholic Fragrance Solutions (Cologne), 9)
Hair Dyes, 10) Tooth Powders and Tooth Pastes etc., 11) Toilet Soaps. To manufacture any of these products, a license has to be
obtained from a Licensing Authority appointed by the State Government. The application has to be submitted in Form 31
alongwith a license fee of Rs. 2500 and an inspection fee of Rs. 1000. The manufacturer has to ensure that the production is done
in the presence of a competent and qualified technical staff and at least one of the staff persons should possess the following
educational requirements:

 Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
 Is registered under the Pharmacy Act, 1948; or
 Has passed the intermediate examination with Chemistry as one of the subjects or any other examination as
recognized by the Licensing Authority as equivalent to it.
Before granting or refusing the license, the Licensing Authority is required to order inspection of the whole premises where the
operations are to be carried out. The inspectors are appointed under the Act. They are then required to submit a detailed report
to the Licensing Authority which can then decide whether to grant the license or not.

What are the requirements for factory premises?

The factory premises needs to comply with certain conditions as laid down under Schedule M-II. Some of the general
requirements are as follows:

 Location and Surroundings: It is required that the area in which the factory/manufacturing facility is located and the
vicinity are hygienic with proper sanitary conditions. No operations should take place within or around a residential
locality.
 Building: The building in which the operations are to be carried out must be free from rodents, insects etc. The
rooms of the building should be at least 6 feet from the floor in height. It should also be smooth, waterproof and
capable of being kept clean. With respect to floors the same should be smooth, washable, even and dust-free.
 Disposal of used water: Suitable arrangements should be made for careful and proper discharge or disposal of
waste water.
 Staff: The appointed staff persons should not be suffering from any communicable or infectious disease. It is also
important that they are provided with the necessary tools such as hand gloves, masks, uniforms etc. as and when
required. First aid facility should also be available inside the factory premises.

What are the requirements pertaining to labelling of products?

Following are some of the labelling requirements as laid down under the Drugs and Cosmetics Rules, 1945:

 Name of the product along with the manufacturing address must be mentioned on both the inner and the outer
labels. If the container is small in size then the principal place of manufacturing and the pin code are enough.
 The outer label should clearly specify the net contents of the ingredients used in the manufacture of the product.
 The inner label should contain the ‘directions for use’ along with any warning or caution that may be necessary. It
should also contain names and quantities of ingredients which are hazardous in nature.
 A distinctive batch number preceded by letter ‘B’ alongwith manufacturing license number preceded by letter ‘M’
must be mentioned on the label.

Quality standards in case of the aforementioned categories of products must conform to the Indian standards laid down and
revised by the Bureau of Indian Standards (BIS) from time to time.

What may happen if the rules are not complied with?

The Drugs and Cosmetics Act, 1940 is a punitive Act. If any of the provisions or rules under the Act with respect to Cosmetics
is/are not complied with, imprisonment upto one year or fine upto Rs. 1000 or both can be imposed on first conviction and on
subsequent convictions, imprisonment can be extended to two years and fine to Rs. 2000.

 Cosmetic Manufacturing License

We offer one stop solutions for cosmetic manufacturers helping them obtain the manufacturing license and test their products
from certified labs in India. The following licenses are required for cosmetic product manufacturing & market in India according to
D & C Act, 1940.

1. License in form 32 is issued for manufacturing cosmetics for sale or for distribution. (Application is filed in Form 31)
2. License in form 32-A is issued for loan license for manufacturing cosmetics for sale or for distribution. (Application is
filed in Form 31-A)
3. License on Form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material
used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Application is filed
in Form 36).
 1. Prescreening Checklist: TR-6 Challan 3. Fee: TR-6 Challan (in Original) 3.1 Fees paid (250 USD equivalent Indian rupees
for each Brand proposed viz. each category of cosmetics as mentioned in Column 3 of the guidelines of cosmetics 3.2
Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines) adjustable to PAO, DGHS, New
Delhi 3.3 Total categories of cosmetics … TR6 No … USD … INR … 3.4 TR6 Challan Number, date of challan and
Realization Stamp Note:- The categories of applied products and manufacturer’s name shall be mentioned in TR-6
Challan
2. Prescreening Checklist: Power of Attorney 4. Power Of Attorney (in Original) • 4.1 Executed & authenticated either in
India before a First class Magistrate, or in the country of origin before such an equivalent Authority or attested by the
Indian Embassy of the said country or Apostilled from Hague convention member countries as per proforma attached •
4.2 Name and full address of the manufacturer & its manufacturing site as per Form-42 • 4.3 Name and full address of
the Indian Agent • 4.4 Name of the Cosmetic product, variants (if any) along with actual manufacturer of the product to
be registered. The categorization of the product should be as per Column 3 of guidelines of cosmetics • 4.5 Duly
conjointly signed, stamped, and dated with name & designation of the signatory by both Indian agent & the
manufacturer • Note:-All the pages of power of attorney including product list duly apostilled/notarized and
authenticated from the country of origin or It should be tamper proof seal • 4.6 Time period for which POA is valid must
be mentioned in power of attorney
3. Prescreening Checklist: Schedule D III & Label 5. Duly filled, signed and sealed Schedule D III by manufacturer or Indian
agent along with undertaking 6. Labels of proposed products: 6.1 Legible label of the products circulated in the country
of origin 6.2 Legible Original label for proposed products along with their variants (if any) as per Drugs and Cosmetics
Rules, 1945 which includes following:-  Name of Cosmetics  Name of Manufacturer and Complete address of premises
where the cosmetic is manufactured.  Use Before  Direction for safe use/Caution  Batch number  Manufacturing
License number  Registration Number and Importer name and address  Other Information (if any)  List of ingredients
4. Prescreening Checklist: Ingredient List & Regulatory Certificates • With details of concentration of each ingredient used
in the product composition duly signed by competent QC person from the manufacturer 7. List of Ingredients • 8.1
Authenticated copy of manufacturing licenses/registration/marketing authorization in respect of applied products
issued by regulatory Authority from country of origin • 8.2 Original Free Sale Certificate issued by National Regulatory
Authority of Country of origin for the applied products • 8.3 In case if it is not issued by National Regulatory Authority
from the country of origin then from other competent Associations/ organizations duly authenticated from the Indian
embassy of country of origin need to be submitted 8. Regulatory Certificates
5. Prescreening Checklist: Chemical Info, Pack Insert, Soft Copies 9. Chemical Information of cosmetics • 9.1 Test protocol
for testing of cosmetics • 9.2 Specification (BIS 14648:2011) • 9.3 Test report including result of Pb, As, Hg and
microbiological test. (Wherever applicable) • Note:-Testing protocol, Specification and Test Report duly signed by
competent QC person from the manufacturer 10. Pack insert, (if any) 11. Soft copies of the information (MS Word & MS
Excel) about product name along with category, pack size and actual manufacturing site

COSMETIC MANUFACTURING LICENSE

CliniExperts offers one stop solution for cosmetic license application & registration in India. We assist cosmetic companies to help
them to overcome the challenges within the provisions under Drug and Cosmetics Act, 1945.

Our team of experts is extremely skilled to get your company Cosmetic license and registration in India. We have the expertise to
help you get the cosmetic registration certificates which were proposed from 1st April, 2011 as per modified Rules of Drugs
& Cosmetics Act, 1945.

The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act,
1940 –

1. License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31)
2. License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A)
3. License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material
used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Form no. 36)
The following are the requirement of documents for the grant of cosmetic licence in India for sale of drugs and cosmetics-

1. Application forms
2. Challan of fee deposited
3. Declaration form
4. Key plan (Blue print)
5. Site plan (Blue print)
6. Basis of possession of the premises
7. Proof of ownership of the premises, if rented
8. Proof of constitution of the firm (Certified copy)
9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940
10. Certified copy of Registration Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered
Pharmacist/Competent person and qualification certificates
11. Bio-data form
12. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary
 13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person
The licensing authority appointed by the State Government gives the license to manufacture any cosmeticproducts. The
manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least
one of the staff persons should possess the following educational requirements:

1. Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
2. Is registered under the Pharmacy Act, 1948; or
3. Has passed the intermediate examination with one of the subjects as Chemistry or any other examination which is
recognized by the Licensing Authority as equivalent to it.

The Licensing Authority also orders an inspection by the inspectors appointed under the act, of the whole premises, where the
operations are to be carried out before granting or refusing the cosmetic license in India. A detailed report is submitted to the
Licensing Authority which then decides whether to grant the cosmetic license in India and or not.
All the above mentioned procedures for Cosmetic License Application & Registration in India are carried out by our expert team at
CliniExperts.

[12:07 PM, 1/6/2019] Devanshu: the drugs and cosmetics act 1940 and rules 1945 were passed by the Indian parliament to regulate
the import manufacture distribution and sale of drugs and cosmetics in India the cosmetics are regulated by the central drugs
standard control organisation drugs controller general was established dgci is the head of drug standard control organisation who
regulates cosmetics devices and drugs in India

[12:09 PM, 1/6/2019] Devanshu: Drugs and cosmetics amendment rules 2010

[12:10 PM, 1/6/2019] Devanshu: 129c

[12:10 PM, 1/6/2019] Devanshu: 129h

All cosmetics products that are imported for sale in India need to be registered with the licensing authority as defined under Rule
21 of Drugs & Cosmetics Rules, 1945. For the import of Cosmetics in India, the imported cosmetics products are required to be
registered with Central Drugs Standards Control Organization (CDSCO) by giving application in Form 42 to obtain Registration
Certificate in Form 43.
Important Terminologies

Brand

 A “Brand” for the purpose of these rules will mean each category of cosmetics product as mentioned in Column 3 of the list
enclosed at Annexure 1.
 A “Brand” will include all variants of a product e.g. colour, shades, pack sizes, etc.
 A “Brand” will not mean the trade name of any product of a manufacturer or the manufacturer himself / itself.
Manufacturer

 “Manufacturer” means a person or entity in a Country other than India who owns the trade name of the brand of the cosmetics
product for which registration has been applied for and who / which manufactures such product at his / its own manufacturing
site or at a site owned by another manufacturer in the trade name of his / its brand.
Authorized Agent

An “Authorized Agent” means a person or entity in India authorized by the manufacturer. The Indian Authorized Agent will be
responsible for the business activities of the manufacturer in India including compliance to the provisions of the Act in all respects.
Time Line

Time period for Grant of Registration Certificate in Form 43

As per Rule 129C provided that if the application is complete in all respects and the 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. However CDSCO targeted timeline for
processing of application is 90 days as per circular dated 30.05.2014. Check this table – The Timelines of CDSCO for further
understanding the CDSCO timelines for different categories.
Duration/Validity of “Registration certificate” in Form-43 for Cosmetics in India

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.
 Cosmetic Industry is a blooming industry in India with a huge market for cosmetic and personal care products. Especially, with the
start of online marketing cosmetic industry went through a paradigm shift. India is an attractive place for global brands
making/planning an entry an entry.

Cosmetics Regulation in India protects consumers and makes sure that all cosmetic products on the Indian market are
safe. Importing of cosmetic products in India requires registration certificate from Ministry of Health and Family Welfare as defined
under Rule 21 of Drugs and cosmetics rule, 1945.
To obtain necessary clearances for selling Cosmetics in India, Registration Certificate is required from the Central Drugs Standard
Control Organization (CDSCO). Using this license, import activities can be performed. Morulaa Health Tech provides assistance in
applying Cosmetic Registration Certificate, Master importer (Customs Clearance, Supply Chain and Logistics), analysis and testing of
cosmetics. In addition, we also assist manufacturers in setting up e-commerce portal for the sales of cosmetic product in India.
Procedure for Issue of Cosmetic Registration Certificate:
1. The manufacturer or by his authorized channel in India or by the subsidiary in India authorized by the manufacturer.
2. The application form must be submitted to the office of the DCGI under Indian Ministry of Health and Family Welfare,
New Delhi (Both as a hard Copy and Soft Copy)
3. The application must be submitted
 Form – 42
 along with a cover letter
 Challan
 Power of Attorney
 Schedule DIII
 Original or copy of a label
 FSC/Marketing Authorization letter/Manufacturing License (if any)
 Product specification and testing protocol
 List of countries where Market Authorization or Import Permission or Registration has been granted
 Pack insert ( if any)
 Soft copies of the information about the brands, products and manufacturer.
4. Receipt of the application form
 The Drug Controller General office will issue an acknowledgement i.e. copy of duly stamped cover letter.
5. Registration fee
 USD250 or equivalent per imported product
 Fee is to be deposited in designated branches of the Bank of Baroda
6. Waiting period before issue of registration certificate
 Drug Controller General’s office would issue a registration certificate within six months from the date of submission of
application.
7. Validity period of the registration certificate
 The registration certificate would be valid for three years.
8. A single application and a registration certificate in Form 43 may be issued for import of one or more than one cosmetics
manufactured by the same manufacturer only if the cosmetics are manufactured at one factory or more than one factory
functioning combined as a single manufacturing unit.
9. A Registration Certificate is sooner suspended or cancelled shall be valid for 3 years from the date of its issue only if
application for a new Registration Certificate is made within 6 months before the expiry of the said certificate, the existing
Registration Certificate shall continue to remain until orders are passed on the application.
10. No cosmetic shall be imported with the specifications mentioned in schedule S and schedule Q or any other standards of
quality, safety and other provisions under the rules. If cosmetic is not included under schedule S then it shall meet with
specifications under the rules and standards applicable to it in the country of origin.
11. Registration certificate is not required for Import of cosmetics for Research and development (R&D) purposes like packaging
trials, consumer studies, shelf life and transport studies. In such cases the importer has to get necessary permission from
CDSCO(HEAD QUARTERS). Importer must give written statement that these products are not released for domestic sale.

At present, in the market, there is an exhaustive range of the different cosmetic products accessible. While using the cosmetic
products of the top brand’s many people do not assume to ask the question, how safe is to use the cosmetic product. Well, every
cosmetic product contains different chemicals and for the government of the country, it is imperative to look after the interest of
the end consumers and ensure providing the quality and safe cosmetic products.

In the past few years, there have been many top brands whose cosmetic and beauty products skin-whitening creams, lipsticks,
anti-aging creams etc. were reported to have excessive levels of several hazardous chemicals like mercury. Also, in many beauty
cosmetic products, there was the use of the animal fat and other animal derivatives. Also, these cosmetic ingredients and
products were tested on the animals before introducing in the market because of which the animals sometimes get harmed and
disables as a result.

Earlier there were no such strict regulations regarding the cosmetic products. But with the increasing awareness of the harmful
effects of the chemicals and to embrace no cruelty policy for animals today the government of the different countries in
formulating policies and regulations. The statutory authority of the country must ensure to take stringent steps related to make
sure the cosmetic products are safe for the use. In India, the Central Drugs Standard Control Organisation (CDSCO) has issued
various clarifications with regard to the import and registration of cosmetics.

Import and registration of cosmetics in addition to existing guidelines

 Undertaking regarding the cosmetic products not tested on animals: The Manufacturer either legal or actual / Indian
subsidiaries/ brand owner of the products can submit a one-time self-declaration that the cosmetics products have not been
tested on animals along with the import registration detail to CDSCO. The acknowledgment copy for submission of the
 undertaking as received by the applicants from CDSCO can be produced at the port offices in future for clearing the future
consignments.
 Free sale certificate from the responsible person instead of the actual manufacturer: Free sale certificate issued by National
Regulatory Authority or other competent organizations from the country of the legal manufacturer in addition, to the actual
manufacturer from the country of origin can be considered.
 Letter of Authorization (LOA)in the case of Third party manufacturing outside India: In the cases where the brand owner is
located in India and gets its products manufactured from places located outside India an LOA can be considered in place of
Power of Attorney (POA).The overseas manufacturer has to give acceptance of LOA and conditions on an apostilled copy.
 Import of Bulk Cosmetics– Requirement of a Certificate of Free Sale (CFS): Applicants can obtain Free Sale Certificate (FSC)
either from the country of origin or any other major market where the same product is freely sold. Alternatively, bulk
importers could get the bulk cosmetics tested in India at a Government laboratory to obtain the customs clearance.

For renewal of Registration Certificate following documents will be required:

1. Power of Attorney in original

2. Necessary fees
3. Duly filled and signed Form 42 with the list of products to be renewed
4. Certificate of free sale/Marketing Authorization letter/Manufacturing License, if any
5. Copies of original RC and endorsement certificates that were granted earlier
6. Undertaking/ Self-declaration stating that there are no changes in earlier shared information with respect to product details
(like the composition, test methods, specifications, label ( complying Rule 148 of D&C Rules 1945) etc., the constitution of the
firm and sourcing location/site of the products.

The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act,
1940.

 The License on form 32 is issued for manufacture or sale distribute of cosmetics.

 The License on form 32-A is issued for loan license for manufacture or sale distribute of cosmetics.
 License on form 37 is issued for the grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material
used in the manufacturing

All the cosmetic products that are imported in India for sale need to be registered with the licensing authority as defined under
Rule (21) of Drugs & Cosmetics Rules, 1945.

MANUFACTURING LICENSE

[Link]
license/?highlight=%E2%80%A2%09Cosmetic%20Manufacturing%20License

RE-REGISTRATION OF COSMETIC PRODUCTS

In response to better lifestyle approach, high purchasing capacity and self care, the demand for cosmeticproducts in India has
risen expeditiously. To protect and maintain the worth of cosmetics in India, the cosmetic products are regulated under the
provisions of the Drugs & Cosmetic Act 1940 & Rules 1945 vide Gazette notification G.S.R 426(E). A registration certificate of
a cosmetic product is valid for a period of three years from the date of its issue. It required to be renewed after the given validity.
However, it can be suspended or cancelled, in case of violence of rules. The registration as well as re-registration
of cosmeticproducts is required to ensure its quality, efficacy and safety, but, it brings along a tedious paper work that has to be
accomplished to maintain the registration of a cosmetic product under a Brand. CliniExperts bestows an easy- hassle free
approach to resolve technical as well as non technical challenges associated with the renewal of registration
of Cosmetic products. We own the expertise and skills required to achieve goals in stringent timelines, that too in a smooth and
tranquil way. Our regulatory specialists are striving all day to make the process of re-registration smooth to avoid unwanted
frictions and anomalies, so as to accomplish the task well in time.

Documents required for re- registration of cosmetic products

A new set of clarifications has been issued by the Central Drugs Standard Control Organization (CDSCO) on 15th of October, 2015
along with the existing guidelines, focusing on the import and registration of cosmetics. In addition to this, a string of documents
required to renew the registration certificate are also enlisted. The string of documents includes:

1. Power of attorney in original;

 2. Necessary fees;
3. Duly filled and signed Form 42 along with the list of products to be renewed;
4. Certificate of free sale or manufacturing license or marketing authorization letter if any;
5. Copies of original RC and endorsement certificates that were granted earlier; and
6. Undertaking/ self-declaration stating that there are no changes in information that was shared earlier as regards
product details (like composition, test methods, specifications, label (in compliance with Rule 148 of D&C Rules 1945)
etc., constitution of the firm and sourcing location / site of the products.

CliniExperts: A one step solution

1. We offer unconditional support for renewal of cosmetic registration in India by assisting cosmeticcompanies to
overcome the challenges within the provisions under Drug and Cosmetics Act, 1945.
2. We help the client to fill Form 42. This is a very important component of the renewal procedure.
3. We also prepare a self declaration form which has just to be read, understood and duly signed by the client.
4. We have a team of experienced regulatory professionals who cater the requirements of regulatory authorities, market
authorization as well as simplify the process of getting the Re-registration Certificate.
5. We respect and obey the stringency of the regulatory authorities by submitting all the duly filled and signed documents.
Besides, we also take care of the client by assisting in swift and flawless delivery of documents with an aim to bring the
renewal certificate in the hands of the client well in time.
6. Our commitment to client is our motto which is attained by providing complete client satisfaction by assisting him in any
post changes, that too at any level.
7. We help the client in saving their time by eliminating challenges such as waiting in queues, absenteeism of officers,
submission delays, etc.

Our team of experts is extremely skilled to get your company Cosmetic license and registration in India. We have the expertise to
help you get the cosmetic registration certificates which were proposed from 1st April, 2011 as per modified Rules of Drugs &
Cosmetics Act, 1945.

The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act,
1940.

1. License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31)

2. License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A)

3. License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in
the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Form no. 36)

The following are the requirement of documents for the grant of cosmetic licence in India for sale of drugs and cosmetics-

1. Application forms.

2. Challan of fee deposited.

3. Declaration form.

4. Key plan (Blue print)

5. Site plan (Blue print)

6. Basis of possession of the premises.

7. Proof of ownership of the premises, if rented.

8. Proof of constitution of the firm (Certified copy)

9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940.

10. Certified copy of Regn. Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered Pharmacist/Competent
person and qualification certificates.

11. Bio-data form.

12. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary.

13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person.

The licensing authority appointed by the State Government gives the license to manufacture any cosmetic products. The
manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at least
one of the staff persons should possess the following educational requirements:
1. Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or

2. Is registered under the Pharmacy Act, 1948; or

3. Has passed the intermediate examination with one of the subjects as Chemistry or any other examination which is recognized
by the Licensing Authority as equivalent to it.

The Licensing Authority also orders an inspection by the inspectors appointed under the act, of the whole premises, where the
operations are to be carried out before granting or refusing the cosmetic license in India. A detailed report is submitted to the
Licensing Authority which then decides whether to grant the cosmetic license in India and or not.

All the above mentioned procedures for Cosmetic License Application & Registration in India are carried out by our expert team
at Cliniexpert.

Our team of experts is extremely skilled to get your company Cosmetic license and registration in India. We have the expertise to
help you get the cosmetic registration certificates which were proposed from 1st April, 2011 as per modified Rules of Drugs &
Cosmetics Act, 1945.

The following licenses are required for cosmetic product manufacturing & market in India according to Drug and Cosmetics Act,
1940 –

1. License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31)
2. License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A)
3. License on form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw
material used in the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Form
no. 36)
The following are the requirement of documents for the grant of cosmetic licence in India for sale of drugs and cosmetics –

1. Application forms
2. Challan of fee deposited
3. Declaration form
4. Key plan (Blue print)
5. Site plan (Blue print)
6. Basis of possession of the premises
7. Proof of ownership of the premises, if rented
8. Proof of constitution of the firm (Certified copy)
9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940
10. Certified copy of Registration Certificate of Delhi Pharmacy Council/Experience Certificate of the Registered
Pharmacist/Competent person and qualification certificates
11. Bio-data form
12. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by
Notary
13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person
The licensing authority appointed by the State Government gives the license to manufacture any cosmetic products. The
manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff and at
least one of the staff persons should possess the following educational requirements:

1. Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
2. Is registered under the Pharmacy Act, 1948; or
3. Has passed the intermediate examination with one of the subjects as Chemistry or any other examination which is
recognized by the Licensing Authority as equivalent to it.
The Licensing Authority also orders an inspection by the inspectors appointed under the act, of the whole premises, where the
operations are to be carried out before granting or refusing the cosmetic license in India. A detailed report is submitted to the
Licensing Authority which then decides whether to grant the cosmetic license in India and or not.

The following are required

1. Manufacturing licence: Manufacturing licence is to be obtained from a licencing officer to start a manufacturing
activity.
2. Patents: Patent refers to the exclusive rights that are granted for a new invention. Patent must be obtained
according to the innovations in the manufacturing or in the product.
3. Registered trademark: A trademark, that is a distinctive symbol (or sign) for the product confirming it's originality
must be registered.
To manufacture any of the cosmetics, a license has to be obtained from a licensing Authority appointed by the State Government.
The application has to be submitted in Form 31 along with a license fee of ₹2500 and an inspection fee of ₹1000. The
manufacturer has to ensure that the production is done in a presence of a competent and qualified technical staff and at least one
of the staff persons should possess the following educational requirements:
  Holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948; or
 Is registered under the Pharmacy Act,1948; or
 Has passed intermediate examination with Chemistry as one of the subjects or any other examination as recognized
by the Licensing Authority as equivalent to it.

How to Get Cosmetic Registration in India?

Cosmetic Market in India is expanding its arms everywhere from starting their first look in the television advertisement to making
money from a social media platform nowadays. Hundreds and thousands of people are advertising and filing their pocket with the
cosmetic market as the market has the magic of never going into recession.

People from all over the world use the cosmetic whether they fall into male section or female section. Yes, you heard me right the
male section also, these days the male society has been witnessed rubbing their hands with the lotion or whitening cream. The
cosmetic industry does not discriminate between male or female.

But as we all know power comes with responsibility, hence the cosmetic industry also become the star of eyes of government due
to its popularity and amount of fraud that can be eventually occur in this market. Currently, the Drugs & Cosmetics Act, 1940
governs the cosmetic registration in India which exclusively defines the word “Cosmetic” as an “article that intends to be, poured,
sprinkled rubbed or sprayed on or introduced into or otherwise applied to any human body or any part thereof for cleansing,
beautifying, promoting attractiveness or altering the appearance and also includes an article intended to use as a component of
cosmetic”.

Types of Cosmetic License in India

The very first question that arises here is what kind of License you need for your business because the license purely depends
upon the nature of your business. Hence, the following are two kinds of cosmetic license in India–

 For manufacturer
 For importers

The manufacturing license for cosmetics is required when you intend to manufacture the cosmetics. Hence, Following is the
license that is required for cosmetic product manufacturing and market in India according to D & C Act, 1940-

 License in Form no 32 that is issued for manufacturing cosmetics for sale or for distribution and the supplication is filed in Form no
31.
 License in Form 32-A that is issued for loan license for manufacturing cosmetics for sale for distribution and the application is filed
in form no 31-A
 The license on Form 37 is issued for grant or renewal of approval for carrying out tests on drugs or cosmetic or raw material used
in the manufacturing thereof on behalf of license for manufacture for sale of drugs and cosmetics.

The Importer License for cosmetic is required when we do not manufacture the cosmetic but import and resale it in India and for
that we need an importer cosmetic registration in India.

Guidelines for Manufacturing or Importer of Cosmetics in India

An Undertaking specifying that the product is not tested in animals

It is clearly stated that any manufacturer or importer of cosmetic products before registering their cosmetic registration should
give an undertaking detailing that the products have not been tested on the animals and along with that the details of import
registration and received acknowledgment copy by CDSCO to the applicants which can be used for future consignments.

Letter of Authorization in case of third party manufacturing outside India

In case when the brand owner of the product is outside India then the manufacturer needs to sign a letter of authorization to
brand owner and authorize him to do an act on behalf of the owner which authorize the importer to do an act in the behalf of the
manufacturer sitting outside India and this letter is considered as Power of Attorney.
 Import Bulk Cosmetics

The applicant can also obtain a certificate of free sale and bulk importer for sale of the same products and can obtain customs
clearance approval after the testing of Cosmetic business license.

Cosmetic Regulations in India for Cosmetic license

Under the Drugs and Cosmetic Rules, 1945, Schedule M-II classifies cosmetics into 11 broad products categories-

 Powders
 Creams, lotions, cleansing, milk, shampoos, pomade, shaving creams, hair oils etc.
 Nail polishes and Nail lacquers
 Lipsticks and Lipgloss
 Depilatories
 Preparations used for eyes
 Aerosol
 Alcoholic Fragrance Solutions
 Hair Dyes
 Tooth powder and toothpaste
 Toilet soaps

To manufacture any item from the above-discussed list, a license is required that has been obtained from a licensing authority
appointed by the State Government. The application has to be submitted in Form 31 along with a license fee of Rs. 2500 and with
an inspection fee of Rs 1000. Furthermore, the manufacturer needs to keep a check that the production is done in the presence of
a skilled and competent technical staff and at least one of the staff people should possess the following educational
requirements-

 Holds a diploma in pharmacy by the Pharmacy Council of India under the Pharmacy Act, 1948 or
 Is registered under the Pharmacy Act, 1948 or
 Has passed the intermediate examination with the chemistry as one of the subjects or any education as the Licensing Authority
may deem fit

Now before granting or refusing the license, the Licensing Authority is required to inspect the whole premises where the
operation is to be carried out and also the inspector is to appointed according to the act. The Inspection officer needs to submit
the complete report to the Licensing Authority which will decide whether to grant the license or not.

Regulation for Manufacturer pertaining to labeling of the products

Following are the labeling requirements as laid down under the Drugs and Cosmetic Rules, 1945:

 The name of the product should be clearly mentioned on both the inner and the outer labels and in case the container is small in
size then the principal place and the pin code are fine.
 The outer label should clearly display the ingredients that are used in the manufacturer of the products.
 The inner label must contain the direction for use along with the warning or cautions that may be necessary
 A separate batch number preceded by letter “B” and manufacturing batch with “M” must be stated on the label.

The Bureau of Indian Standards (BIS) checks the quality of the product for time to time and also revised the Indian standard.

Documents Required for Cosmetic Registration in India

 Original copy of Power of Attorney in case of Importer

 Certificate of free sale, marketing authorization letter
 Form 42 duly signed and filed and the list of products to be renewed
 Fees as mentioned
 A self-declaration that there are no changes in earlier shred information
 NOC from Pollution Control Board
 Plan the layout of the premises
 Rent agreement in case of rented premises
 list of laboratory equipment
 Affidavit of Applicant
 list of machines installed for manufacturing

The Importer needs to apply for cosmetic registration products by

 An authorized agent of the manufacturer

 A Subsidiary of the manufacturer
 A manufacturer having registered premises in India
 Any other importer

Each and every product that is manufactured or import should conform with the Drugs and Cosmetics Rules, 1945and the
registration is valid for the period of three years.

The penalty imposed for not complying with Drugs and Cosmetic Act, 1940

The Drugs and Cosmetics Act, 1940 is a penalty act in which it is clearly stated that if any provision or rules under the Act with
respect to Cosmetics is not complied with, imprisonment up to one year or more and fine up to Rs 1000 or both can be imposed
on first conviction and in the subsequent conviction imprisonment can be extended to two years and fine to Rs 2000.

To start a business of cosmetics in India, it will need a high end and meticulous planning as a lot of permissions and licenses are
required to start this venture.

There are two options. One can either Import cosmetics and the other is manufacturing. Lets have a look at them one by one.

=> For a manufacturer First the cosmetic registration needs to be done. Then he needs to acquire the following licenses:

# License in form 32 is issued for manufacturing cosmetics for sale or for distribution. (Application is filed in Form 31)

# License in form 32-A is issued for loan license for manufacturing cosmetics for sale or for distribution. (Application is filed in
Form 31-A)

# License on Form 37 is issued for grant or renewal of approval for carrying out tests on drugs/cosmetics or raw material used in
the manufacture thereof on behalf of licenses for manufacture for sale of drugs/cosmetics. (Application is filed in Form 36).

After acquiring these licenses he needs to make his labels and get them approved and then finally the sample testing will be done.

=>The importers have to get their things done through an authorized agent.

# Cosmetic Registration Approval

# Amendment in Cosmetic Registration certificate

# Re-registration of cosmetic product

# Labelling

# Sample testing

Read more on [Link] - [Link]

Manufacturing of hand soap under Drugs and cosmetics Act and Rule

As defined under the Drugs and Cosmetics Act manufacturing includes many stages like the process of making, altering,
ornamenting, finishing, packing, labelling and breaking up or treating or adopting any drug or cosmetic with view of its sale or
distribution. But the manufacturing process does not include the compounding or dispensing in ordinary course of retail
business. But the foremost thing which is required for manufacturing hand made soap is to get a manufacturing licence, for which
the procedure and the grounds for acquiring a licence has been mentioned in part XIV of Drugs and Cosmetics Rule. After acquiring
a licence the other thing which has to be determined is the area or place where the manufacturing process should be done.
How to get a manufacturing licence for hand made soaps?

As per the Drugs and Cosmetics Act and Rule, the Central Government and the State Government makes rule regarding issuance of
licence to a person for manufacturing cosmetics. Basically it is the State Drug Authorities of respective States, who are authorized
to issue manufacturing licenses.

 Firstly, a person applying for a manufacturing licence for hand made soap needs to fill the application form 31 along
with it; the person is required to pay an amount of Rs 3,500 and Rs 2,500 as a government and inspection fee of 2500
respectively.
 Secondly, the cosmetics for which the licence is being acquired should be specified into classes of cosmetics, as has
been mentioned under Schedule M-II, where the cosmetics have been classified into 10 categories.
 A person applying for the license of manufacturing hand made soap or any other cosmetics should have passed
intermediate exam with Chemistry as one of its subject or any examination which is recognised by the Licensing
authority.
 Apart from it to get a license it is required to hold a diploma in Pharmacy which should be certified and approved
either under the Pharmacy Council of India under the Pharmacy Act, 1948 or under the Pharmacy Act, 1948
 At the time of applying for the licence it is required to mention other information like the lists of equipment,
manufacturing facility details with minimum area required for manufacturing, Technical Competent personnel details,
etc.
 Apart from those details the licencing authority also considers before approving the licence that whether the cosmetic
is misbranded or is a spurious cosmetic.
 For renewal also the manufacturer is required to categorise the cosmetics as per Schedule M-II, apart from it Rs. 1000
has to be paid as a charge for every inspection for renewal

It is mandatory for the Licensing Authority to direct an inspection of the area where manufacturing will take place, before approving
or rejecting the application of license. After the inspection a report is send to the Licensing Authority on the basis of which they
either approve the licence application or reject it.

Place of Manufacturing

While determining the place for manufacturing the hand made soaps it has to be seen that the manufacturing house should work
in a manner it benefits the public at the same time it should not affect the environment adversely. Also there has been rule laid
down relating to the factory premises which have been mentioned in the Schedule M-II of the Drugs and Cosmetics Act and Rule.
The manufacturer has to comply with those requirements and conditions.

 Location and surroundings– The production house or factory should not be established near residential areas. Also it
should have measures to avoid risk of contamination from the external environment including open sewage, drain,
and public lavatory.
 Building and premises– ventilation openings and similar lines shall be designed Apart from it the factory should have
proper sanitation facilities, hygiene should be maintain in the manufacturing building, for that it has to be ensured
that the workers are provided and are using hand gloves and masks. They shall also conform to the conditions laid
down in the factories Act, 1948. They should design, construct and maintain to prevent the entry of insects, pests,
birds and rodents.
 Waste disposal– Proper arrangement should be made for disposal of solid waste as well as liquid waste. All bio-
medical waste shall be destroyed as per the provisions of the Bio-Medical Waste Rule, 1996. Apart from it provision
should be made for proper and safe storage of waste material waiting for disposal.
 Health, clothing and sanitation of workers- prior to employment all personnel shall undergo medical examination
including eye examination. It should be ensured that any of the working staff is not suffering from any communicable
diseases. Also all the employ should be required to report about their illness or abnormal health condition to their
immediate supervisor.

Drugs Controller General is appointed by the Central Government as a head of the Central Drug Standard Control Organization who
is authorised to regulate the cosmetics and drugs in India.

Action which can be taken when the manufacturing of hand made soap is against the provisions of Drugs and Cosmetics Acts and
Rules

The act provides provisions for penalising the manufacturer who does not comply with the Act, which has been dealt under Sec.26
to Sec.29 of the Act, by manufacturing cosmetics which are prohibited by the Act, or is not disclosing the name of manufacturer,
place of manufacturing, any other records or documents prescribed by the legitimate authority. The person may either be
imprisoned or may be fined or both. The fine may exceed upto Rs. 5000. Also a person is penalised if uses any report of a test or
analysis which the Central Drugs Laboratory or Government Analyst has given.

Import and export of the hand made soaps

For a manufacturer to import hand made soap has to fill form 10. As per the new amendment 2010, it is required to have prior
registration before importation of any cosmetic to India, which includes hand made soap. The Central Government has the power
to prohibit the import of cosmetics in public interest only. If the Central Government is satisfied that the use would harm the public
then it can prohibit the import of the cosmetics.
The Central Drug Standard Control Organization also controls the import of cosmetics and drugs at the same time regulate the
approval of new drugs. The basic requirement for the import and export of the hand soap are Manufacturing license, good
Manufacturing Practice (GMP), Free sale Certificates, labelling of a cosmetic is required for bot importing and exporting of a
cosmetic. Labelling should be done as per the methods prescribed under Rule 148 of the Drug and Cosmetic Act, the product should
not contain prohibited items as prescribed by the Act and the hand soap should either comply with the Bureau of Indian Standards
or of the International Cosmetics Standards.

Conclusion

Increase in manufacturing house for hand made soaps on one hand fulfils the demand of the public and on the other hand it also
generates employment opportunities. The Act not only deals with the licencing process but also deals with import and export of the
hand soap; it also looks into the working of the manufacturing department. The Act gives power to the Central and State
Government to check the working these manufacturing companies after they get licence. Hence, the Central government
establishes different committees under this Act like Drug Technical Advisory Board who advises the Central Government as well as
the State Government on matters arising out of the Administration of the Act. A Central Drugs Laboratory is also established by the
Central Government in order to determine the working of the manufacturing company that they comply with the Act or not.

Trade license is also required.

[Link] necessary laws are Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

here is 28% GST applicable for cosmetics whether it is company made or hand made.

The Government of India has implemented the National Programme for Organic Production (NPOP). The national programme
involves the accreditation programme for Certification Bodies, standards for organic production, promotion of organic farming
etc.

India Organic is a certification mark for organically farmed food products manufactured in India. The certification mark certifies
that an organic food product conforms to the National Standards for Organic Products established in 2000.

Those standards ensures that the product or the raw materials used in the product were grown through organic farming, without
the use of chemical fertilizers, pesticides, or induced hormones. The certification is issued by testing centres accredited by the
Agricultural and Processed Food Products Export Development Authority (APEDA) under the National Program for Organic
Production of the Government of India.

Re: Application for the grant/renewal of a license to sell, stock or exhibit for sale, or offer for sale or distribute drugs by retail dealers (Form 19/19A/19B) in the Drugs Control Dept, Govt of Delhi

 apply for cosmetic & Manufacturing License to sell our products online & offline

 Sevencias Private Ltd.

 official place at IGNOU road, Neb Sarai
 area of 1700 Sq ft. (158 sq mt)

 trade mark Ancient Flower for which we have received an objection on the word "Ancient"
 register new trade mark
Following documents will be required for your Fresh Application of Retail/Wholesale license

1. Suitable User id
2. Siutable Password (one letter capital, one special character, one digit, minimum 8 letters)
3. Site plan of the premises
4. key plan of the premises
5. Constitution of the firm viz: Memorandum and articles of association
6. Copy of resolution Passed (in case of company)
7. Partnership deed (in case of partner-ship firm)
8. Trust deed( in case of trust / society)
9. Photo ID proof of proprietor /
10. Photo ID proof of partner / director
11. Affidavit regarding non-conviction of Prop./Partner/Director
12. Affidavit regarding compliance of MPD 2021
13. Registration / Conversion charge /
14. Parking charge receipt issued by MCD
15. Relevant documents in support of commercial use as per MPD 2021 (document indicating the Name of notified commercial / mixed use road/street)
16. Affidavit from the Regd. pharmacist/competent person /Experience Certificate/Appointment Letter and Bio-data/Affidavit by Competent Person
17. For Retail Sale Registered Pharmacist: a) Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets. b) Registration of Delhi Pharmacy Council, c) Appointment Letter and Bio-data
18. For Wholesale Licence Competent person: a) Proof of qualification i.e. final degree certificate / provisional certificate with mark sheets b) Experience Certificate, c) Appointment Letter and Bio-data.
19. Premises :
a) If Owned: either Regd. Sale Deed / Regd. GPA / Conveyance Deed in the name of owner, or Un regd. Sale Deed / un regd. GPA supported with Electricity Bill / Water Bill / property tax receipt.
b) If Rented: Rent Receipt and either Regd. Rent Agreement, or Un registered Rent Agreement along with ownership documents of landlord, as stated above.

Also, please answer these questions -

1. If there is any change in constitution in your firm after you have registered it. (Y/N)
2. If using any imported item in the product manufactured. (Y/N)
3. Which category your product will falls - Allopathic /Homoeopathic Medicines
4. Which category your product will falls - Retail/ wholesale

Note:
1. please send all documents in back and white scanned copy, self-attested by the applicant/authorized person
2. No drug license is granted in a premises situated on a DDA alloted residential plot/land or flat unless it meets with the requirements of MPD-2021.
3. Minimum height need to be height of 2.75 m
4. valid for a period of five years on and from the date on which it is granted or renewed:
5. renewal of the license after its expiry.
6. All the original documents are necessary to be showed to the inspector at the time of inspection.
The documents necessary for drug manufacturing license under De lhi Drug License are as follows ( For Sales License: Licensing Authority of the concerned Zone/For Manufacturing: Assistant Drugs Controller of the concerned Zone)

 Application in the prescribed form

 Declaration form

 Key plan and site plan in blue print / ammonia print.

 Proof of Possession: A) Rented: rent receipt & rent agreement. (Notary Attested) B) Self-occupied

 Proof of constitution of firm in case of partnership / private limited/ trust.

 Copy of Resolution passed by Board of Directors.

 Proof of Ownership : Copy of registered GPA / sale deed / property tax receipt

 Affidavit of Non Conviction as per format given in Guide Line Booklet.

 List of Equipment And Machineries Provided For Manufacturing.

 List of equipment provided for testing.

 List of technical staff for manufacturing along with their self certified photocopies, certificates of education qualification, experience certificate, biodata on proforma, appointment letter, three photographs.

 List of technical staff for testing along with their self certified photocopies w.r.t. certificates of education qualification, experience certificate, biodata on proforma, appointment letter, three photographs.

 Affidavit from employer and or technical staff for full time working with the firm as per format given in Guide Line Booklet.

 List of Formulations to be permitted along with product information separately for each drug and affidavit about owner / user of the trade name applied for.

 Consent of approved testing laboratory for sophisticated testing.

 All industries seeking licenses for manufacturing of Drugs should obtain a No Objection Certificate from Delhi Pollution Control Committee.

 Drugs Manufacturers Units applying licenses where the drugs involve the use of alcohol and other inflammable material in the processing should acquire a No Objection Certificate from Delhi Fire Services.