Labelling Regulatory aspects of artwork management @ LM

2. DEFINITION
Drug Cosmetic
All the medicines for internal or external use of human
beings or animal and all substances indented to be used
for or in the diagnosis , treatment , mitigation or
prevention of any disease or disorder in human beings or
animals , including preparations applied on human body
for the purpose of repelling insects like mosquitoes
Any article indented to be rubbed , poured , sprinkled or
sprayed on , or introduced into , or otherwise applied to
the human body or any part of these of for cleaning ,
beautifying , promoting attractiveness or altering the
appearance and include any article intended for use as a
component of cosmetic
Regulatory aspects of Artwork Management
Reference :- Drug & Cosmetic Act 1940 , Rule 1945

3. Regulatory aspects of Artwork Management
The Drugs and Cosmetics Act 1940 , Rule 1945
– Name of the cosmetic.
– Name of the manufacturer and complete address of manufacturer with pin code.
– Net quantity in terms of standard unit of weights and measures
– Adequate direction for Sale use - adequate directions for safe use, warning, caution or special direction required to
be observed by the consumer, statement of the names and quantities of the ingredients that are hazardous or
poisonous.
 Batch number preceded by the letter “B”(Can be exempted if pack size is less than 10 g / 25 ml
 Manufacturing license number preceded by the letter “M.”
– The names of ingredients in the order of percentage of content. ( Exempted for 30 g in case to case ).
– Labelling requirement if any specified in relevant Indian Standard laid by BIS cover under schedule S.
 Month and year of packing in which the commodity is manufactured or packed or imported (MM/YYYY).
 Maximum retail sales price (MRP) at which the commodity in packaged form may be sold to the end consumer.
 Prohibition against false or misleading claims.

4. Regulatory aspects of Artwork Management
Bureau of Indian Standards of Cosmetic Products & BIS 4707 :2015 , State Regulatory
Bodies(FDA).
- Name of Material
- Manufacturer’s Name and Recognized Trade Mark
- Net Content
- Batch No.
- Manufacturing date
- Expiry / Best use before date
- Storage Condition ( If required )
- List of Ingredients
- Name & Content of Denaturant – Cologne
- Caution :- HARMFUL IF TAKEN INTERNALLY , FOR EXTERNAL USE ONLY Total Fatty Matter , Dye Content & statement
with reference to ingredients hazards as per BIS .
- Other Caution sign / information required by salutatory authorities.Caution sign , Cautions / Instruction display

5. Regulatory aspects of Artwork Management
The Legal Metrology Act 2009 rule 2011
• The Legal Metrology Act 2009 rule 2011 (Pre-Packed Commodity)
• Applicability of the Law for Package for below 25 kg and excepted for pack less than 10 g ( Case basis).
• No pre-packing Transported from manufacturer premises done without MRP.
• Specific commodities should packed and sold in standard pack as per schedule -2
• All mandate information should be on Principle Display panel , text & Images size .
• When two pack grouped together and packed for sale then individual pack should complies with Norms.

6. Regulatory aspects of Artwork Management
The Legal Metrology Act 2009 rule 2011
• Declaration to be Legible and prominent.
• Numerals of the Retail sale price and net quantity declaration , Mfg. , Use before ( Printed )shall be printed , painted
or inscribed on the package in a colour that contrast conspicuously with the background of the label .
• No system of units other than the international system of units shall be used in furnishing the net quantity of the
package .
- Common / Generic Name of Commodity .
- Manufacturer’s / Packer’s Name ( Manufactured by ) / Marketed By
- Net Content ( “When packed” – Soaps , Lotions , Cream and camphor )
- Manufacturing or Packing Date ( MM/YYYY) – D&C Apply .
- Best Before / Use By Date (MM/YYYY)
- Retail sale price (MRP )- Exempted for Bindi, LPG or Govt. regulated commodity ( MRP ₹ ….. Inclusive of all taxes.

7. Regulatory aspects of Artwork Management
- Name , address , Telephone no. e mail address for Consumer complaints .
- Cosmetics & Toiletries shall bear the top of its principle display panel a Red / Brown dot – Non vegetarian origin ,
green for vegetarian origin.
- In case of package having a capacity of five cubic cm or less , the principle display panel may be a card or tape
affixed firmly to the package so can not detached without opening the pack.
- Optional Logo :- Barcode or GTIN or QR Code , E code (Central government ) , Logos of Government scheme
(Swatch bharat mission etc. )
- E- Commerce entity shall confirm to all requirement .
Label :- Means any written , marked , stamped , printed or graphic matter affixed to , or appearing upon any pre-
package commodity

8. Regulatory aspects of Artwork Management
Principle Display Panel :- in relation to a package means the total surface area of package where the information
required under these rules are to be given in the following manner :
- All the information could be grouped together and given at one place .
- The pre-printed information could be grouped together and given in one place and on line information grouped
together in other place.
- Declaration to be made on principle display panel and Quantity declaration shall be free from printed information.
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- Above and below by space equal to at least the height of the numeral in the declaration
- To the left and right by space at least twice the height of numeral in declaration.
- The width of the letter or numeral shall not be less than one third of its height , except in the case of numeral “I”
and letter (i) , (I) .

9. The area not including the top, bottom, flange at top and bottom of cans, and shoulders and neck of bottle and jars
shall be determined in the following manner, namely:-
(a) in the case of a rectangular package, where one entire side can properly be considered to be the principal display
panel side, the product of the height multiplied by the width of that side;
(b) in case of a cylindrical or nearly cylindrical package, 40 per cent. of the product of the height of the package
multiplied by the circumference; excluding top , bottom and flanges .
(c) in case of any other shaped package , 40 per cent. of the total surface of the package, or an area considered to be a
principal display panel of the package.
Regulatory aspects of Artwork Management

10. Regulatory aspects of Artwork Management
Implication of Violation of Regulations
– Imprisonment for 3-5 Years or more.
– Financial Penalty ( 2000- 50000/- INR ).
– Financial Losses due to Recall , destruction, Redevelopment.
– Financial Losses in terms of fine or remuneration paid to applicant.
– Black listing of Brand/ Company.

11. Thanks….By VICKY SHARMA