REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETIC. Minimum requirement of space, equipment and machinery for manufacturing of cosmetic have been prescribed under M II to the Drugs and Cosmetics Rule,1945

1. REGULATORY PROVISION RELATING TO
MANUFACTURING OF COSMETIC
Presented
By
SOURAV MOHANTO
Department Of Pharmaceutics, Himalayan Pharmacy Institute
Under The Guidance Of
DR. SHUBHRAJITMANTRY
MR. SUDIPDAS
Department Of Pharmaceutics, Himalayan Pharmacy Institute
Majhitar, East Sikkim

2. 1. INTRODUCTION
2. CONDITION FOR OBTAINING LISCENCE
3. PRIHIBITION OF MANUFACTURINGAND SALE OF COSMETICS
4. LOAN LISCENCE
5. OFFENCESAND PENALTIES

3. WHAT IS
COSMETICS?
MISBRANDED
DRUG?
ADULTERATED
DRUG?
SPURIOUS
DRUG?

4. 1.Cosmetics: The word cosmetic arises from a Greck word Kosmeticos which means to “adorn”. Since that
time any material used for beautification or improvement of appearance is known as cosmetic.
According to the Drugs and Cosmetics act and rule 1940 and 1945 “any article intended to be rubbed, poured,
sprinkled or sprayed on or introduced into or otherwise applied to the human body or over other parts thereof
for cleansing, beautifying, promoting, attractiveness or good appearance.
2. MisbrandedDrugs: A drug is termed as misbranded-
 If its so colored, coated, powderedor polished that damage or if it is made to appearof betteror greater
therapeuticvalue than it really ease.
 If it is not labelled in a propermanner.
 If its labelledor containeror anything accompanying the drug of any statement, design and device which
makes any false claim for the drug or for which is false or misleading in any particular.

5. 3. Adulterated drugs: A drug is termed as adulteratedwhen-
 If it consist in whole or in part of any filthy or decomposed substances.
 If it has been prepared, packed or stored under in sanitary condition whereby it may have been
contaminatedwith filthy or whereby it may have been render injurious to health.
 If it’s container composed in whole or in part of any poisonous substances which may render the content
injurious to health.
 If it contain any harmful or toxic substances which may render injurious to health.
4. Spurious drug: A drug termed as spurious-
If it is imported under a name which belongs to another drug.
If the labelled or container contain the name of an individual or company to be the manufacturer of the drug,
which individual or company does not exist.
If it has been substitutedwhole or in part by another drug or substances.

6. 1.INTRODUCTION
 Cosmetics are regulated under Drugs and Cosmetics Act and Rule, 1940 and 1945 and the labelling
declared by BIS.
 Bureau of Indian Standard sets the standard for cosmetic productslisted under the ScheduleS of the
Drugs and Cosmetics rule, 1945.

7. 2.CONDITIONS FOR OBTAINING LISCENCE
 Minimum requirement of space, equipment and machinery for manufacturing of cosmetic have
been prescribed under M II to the Drugs and Cosmetics Rule,1945.
 ScheduleM II Classifies cosmetic into 11 brand productcategories such as-
 Powder
 Cream, lotion, emulsion,paste,cleansingmilk, shampoo etc.
 Nail polish and nail remover
 Lipstick
 Depilatories
 Preparation of cosmetics for Eye
 Aerosol
 Alcoholicfragrance solution
 Hair dyes
 Tooth paste and powder
 Toilet soap

8. Licensing authorityappointedby state govt
Application has to be submitted(Formno-
31) along with license fees RS 2500/-and
Inspection Fees RS 1000/-
Qualified Staff
Qualified person/ staff should posses following educationalrequirements-
 Holds Diploma in Pharmacy.
 Person should register underpharmacy act 1948.
 He / She has passed the intermediate examination with chemistry as one the subject or any other
examination as recognized by the licensing authorityas equivalent to it.

9. REQUIRMENT OF THE FACTORY PREMISES FOR MANUFACTURING OF
COSMETICS
GENERAL
REQUIRMENTS
PLANT
EQUIPMENT
Location and
surrounding
Building Water
supply
Disposal
of Water
Sanitary
For Tablet For
Capsules
For Analysis The
Final Product

10.  Manufacturershall have to continueto provide and maintain the premises and equipment at
the time of grant of license.
 Manufacturershouldtest each batch of raw material.
 Manufacturershouldtest each batch of finished products.
 Manufacturershouldhave to maintain records of raw materials.

11. PARTICULARSIN
MANUFACTURING
RECORD
Serial No Product name Batch Size Batch No
Ingredient name
and quantityuse
Packaging
material
Signature of
the expert staff

12. FOR MANUFACTURING:
 Drugs not a standard qualityor misbranded, adulterated,spurious.
 Patent or proprietarymedicine.
 Drugs in ScheduleJ risk to human being or animal.
 Drugs without therapeuticvalue.
FOR SALE OF COSMETICS:
 Cosmetics containingany ingredient which may render its unsafe for use.
 Cosmetic containingcoal tar color other than one mention in Schedule.
 Cosmetic intended for use on eye-borrowor eye lashes which contain coal tar dye coloror
intermediateor a base.
 Cosmetics containingHexachlorophene.

13. 4.LOAN LISCENCE
Application form
no 31A
Fees 3500/-
State regulatory
authority
 A person not having his own manufacturing facility can get cosmetic manufacturer from a license
cosmetic manufacture under loan license system.
 Application for loan license is prescribed form no 31A along with the fees of 3500/- together with other
documentsshould be submitted to the state regulatory authority.
 A qualified person can make sure use of approved facility of manufacturing provided by any other
person obtain a loan license for manufacture of drugs other than C, C1, and X.

14. 5.OFFENCESAND PENALTIES
 For spurious, adulterated cosmetic imprisonment up to 3 years and fine.
 For not keeping records for cosmetic properly imprisonment up to 3years and fine up
to 5000/- for manufacturer and wholesaler.

15. CONTRAVENTIONIN BRIEF PENALTY
Import of spurious cosmetic or cosmetic
containing any ingredient which harmful for
Use.
Imprisonment for term of 3 years which may
extends to 5 years with fine of five thousand
rupees
Import of cosmetic whose import is prohibited under
section 10-A
Imprisonment for term of 3 years which may
extends to 5 years with fine of five thousand
Rupees.
Repeated offence of above two. Imprisonment for term of 5 years and fine which may
extend to 10 thousand rupees.
Sale/manufacture of cosmetic which is not of
standard or misbranded cosmetic
Imprisonment for term of 3 years which may
extends to 5 years with fine of five thousand
Rupees.

16. REFERENCES
 Sharma P.P; Cosmetic formulation manufacturing and qualitycontrol;3rd Edition; Nirali Prakashan;
chapter-1;P.13-33
 http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1888
 http://www.pharmatutor.org/articles/review-regulatory-provisions-regarding-cosmetics-inindia
 http://blog.ipleaders.in/cosmetics-regulation-in-india-the-law-you-need-to-know-beforegetting-into-
cosmetics-manufacturing-business/
 URL:http://www.cdsco.nic.in/writereaddata/G_S_R_%20 69(E).pdf.
 http://www.authorstream.com/Presentation/shashi4883-906961-regulatoryprovisionsrelated
cosmetics/
 https://www.slideshare.net/JankiPatel10/regulatory-of-cosmetic-in-india?from_action=save