Cosmetics Regulation in India: Laws, Labelling Requirements, and Industry Compliance

his presentation explains the regulatory framework under the Drugs and Cosmetics Act, 1940, and Rules, 1945, with emphasis on Rules 148, 149, and 149A. It explores the history of cosmetics, Indian regulatory requirements for labelling and import, misbranded and spurious cosmetics, and BIS standards. Special attention is given to consumer safety provisions, hair dye regulations, and fluoride content in toothpaste. Pharmacy students interested in regulatory affairs and cosmetic science will find this presentation a practical guide to Indian compliance.
This presentation provides a detailed overview of cosmetics regulation under the Drugs & Cosmetics Act, 1940 and Rules, 1945. Topics include the historical use of cosmetics in India, definition of cosmetics, regulatory requirements, labeling provisions, and BIS standards. Special emphasis is given to Rules 148, 149, and 149A regarding labeling of cosmetics, hair dyes, and fluoride-containing toothpaste. The slides also cover regulatory provisions for import, licensing, spurious and misbranded cosmetics, and consumer protection under the Consumer Protection Act, 1986. This is a valuable reference for students, industry professionals, and researchers interested in cosmetic formulation, labeling, and compliance with Indian and international standards.

1. COSMETICS REGULATION Presented by Ayushi P Jain M.Pharm 1

2. CONTENTS Introduction History of cosmetics History of cosmetics in India Definition of cosmetics as per Indian regulation Indian regulatory requirements for labelling of cosmetics Rule 148 Rule 149 Rule 149A Regulatory provisions relating to import of cosmetics Misbranded cosmetics Spurious cosmetics Restrictions 2

3. INTRODUCTION The word COSMETICS arises from a Greek word ‘kosmeticos’ which means to adorn ( more attractive ). According to USFDA Cosmetics defined as the substance which are intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance without affecting body’s function. 3

4. HISTORY The beginning of cosmetics First it was found in Ancient Egypt in year 4000 B.C. Ancient Greeks, Romans & Egyptians used mercury, white lead, frankincense & myrrh. Bright green paste of copper – face – colour. Sheep’s fat, lead & soot – eyebrows. Flowers used in China for decorative purpose. Red iron laced with clay to make lipstick in Greece 1000 B.C. Barley flour & butter on pimples in Rome 100A.D. 1950s modern Era of cosmetics. 4

5. India Henna was used around 4 th & 5 th century as hair dye & mehendi. Women in India did not used soap instead used gram flour mixed with turmeric & milk. The use of kohl or kajal has used long in the Hindu culture. Ubtan in festive occasions, special bathing are used even today. India is famous in the earlier days for using attar /ittar similar to modern scents. It is estimated that the Indian beauty market is worth more than US$ 950 million ( approx. ) and is raising at 20% a year, twice as fast as the US and Europe markets. 5

6. DEFINITION OF COSMETIC PRODUCTS AS PER INDIAN REGULATION Import, manufacture, sale or distribution of cosmetics were not being regulated in India prior to year 1962. In early sixties, it is being regulate import, manufacture & sale distribution of cosmetics due to prevalence of misbranded and/or spurious cosmetics. Cosmetics was brought within the purview of the Drugs Act & the name of the Act was changed to the Drugs and Cosmetics Act, 1940 ( here in after referred to as the Act ) by act 21 of 1962. however, the implementation of these provisions came into effect only in mid sixties when rules relating to import & manufacture of cosmetics were framed by the Government of India in 1964. thereafter, rules have been amended time to time to achieve the intended purpose. 6

7. Under the Act, Cosmetics has been defined as, Cosmetics means “ any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic .” Earlier, soap was excluded from this definition by adding words “but does not include soap” to the definition. But, in 1982 these words were omitted & since then, toilet soaps have been covered under the definition of cosmetics. 7

8. INDIAN REGULATORY REQUIREMENTS FOR LABELLING OF COSMETICS D & C Act divided in different parts :- Part 13 – import of cosmetics. Part 14 – manufacturing of cosmetics. Part 15 – labelling, packaging, standard of cosmetics. Part 16 – an approval of institute for analysis of drug, cosmetics & raw materials. 8

9. Labelling involves providing verbal information about the product & the seller. Labelling has become very significant as it being as a marketing tool to attract consumers. There are possibilities that sellers try to deceive & mislead the consumers through labelling. In order to prevent the exploitation of consumers & to standardize the base minimum material information government has enacted the Consumer Protection Act, 1986. Right to Information & Right to Consumer Education are major rights which the sellers to keep in mind while labelling the cosmetics. 9

10. General requirement for labelling :- Trade name Common name Net weight List of ingredients Name and address of manufacturer Lot number / batch number Any special storage condition / instructions Any consumer warnings / directions Expiry date / best before use MRP of the product 10

11. Content of label If targeted for export :- Regulation of the importing country shall be adhered to and shall contain name & address of the manufacturer ( code number – if requested by the consignee ). If targeted for sale or consumption in India :- Shall be manufactured by a licensed manufacturer. Shall be labelled as prescribed. Shall not contain misleading / false claim. 11

12. LAWS APPLICABLE The key focus is cosmetics hence the relevant applicable laws are the Drugs and Cosmetics Rule 1945 passed under section 12 & 33 off the D & C Act 1940 and supplementary labelling guidelines requirement as provided under relevant BIS. The BIS is national standards authority of India which formulate, recognize or promote the Indian Standards. 12

13. Cosmetics whether imported or manufactured in India must be labelled in accordance laid down under rule 148 of Drugs & Cosmetics Rules. Special provisions related to labelling hair dye containing coal tar colours & tooth paste containing fluoride are given under Rules 149 & 149A. These Rules are reproduced here fore the convenience of the readers. Labelling declaration : Name and address of the importer. Generic or common name of the commodity packed. Net quality in terms of standard unit of weights & measures. Month & year of packing in which the commodity is manufactured or packed or imported and Maximum retail sales price ( MRP ) at which the commodity in packaged form may be sold to the end consumer. 13

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15. 148 1. On both the inner & outer labels :- The name of the cosmetics. The name of manufacturer & complete address of the premises of the manufacturer where the cosmetic has been manufactured. Provided that if the cosmetic is contained in a very small size container where the address of the manufacturer can not be given, the name of the manufacturer & his principal place of manufacture shall be given along with pin code. 15

16. 2. On the outer label :- A declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi-solids, combined with numerical count if the content is sub-divided : Provided that this statement need not appear in case of a package of perfume, toilet water or like, the net content of which does not exceed 60ml or any package of solid or semi-solid cosmetic the net content of which does not exceed 30grams. Adequate direction of use, warning, caution or special precaution/directions, name & quantities of hazardous or poisonous substances. 16

17. 3. On the inner label, where a hazard exists :- Adequate direction for safe use. Any warning, caution or special direction required to be observed by the consumer. A statement of the names & quantities of the ingredients that are hazardous or poisonous. 17

18. 4. A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded & are available for inspection, the figures representing the batch number being preceded by the letter “ B ”. Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state & 25 millilitres or less if the cosmetic is in a liquid state. Provided further that in the case of soaps, instead of the batch number, the month & year of manufacture of soap shall be given on the label. 18

19. 5. Manufacturing license number, the number being preceded by the letter “ M ”. 6. Where a package of a cosmetic has only one label such label shall contain all the information required to be shown on both the inner & the outer labels, under these rules. 19

20. Categories Manner of labelling example Common or Generic Name of the cosmetic product Name of cosmetics on both inner & outer labels If package has more than 1 product, name & number of quantity of each quantity to be mentioned on package Yardley London Body Spray for Men Name & A ddress of Manufacturer On both inner & outer labels Manufactured by … or packed by …. Name of the manufacturer Complete address of the premises where the product was manufactured Name & address of the packer or/& importer in relevant cases If the size of container is small name + place +pin code of manufacturer Cinthol Deo Spray – Manufacturing & Marketing Address Manufacture Date Date of manufacture or packed or import of commodity Rubber stamp can be used but without overwriting On both inner & outer label Fogg Body Spray 20

21. Expiry Date “Use Before” … ( months & year ) has to be labelled Or expiry date On both outer label & inner label Ayur Cleansing Milk Net Quantity Standard unit of weight or measure On outer label Weight of wrappers / containers – excluded “net quantity” if the commodity is not likely to vary on account of environmental conditions If likely to vary – “when packed” If package capacity is less than 10cubic cm or less – quantity declaration to be made on tag, card, tape etc No declaration required – if the net content of the package of perfume, toilet water or like is less than 60ml or 30gm Area surrounding the quantity declaration should be free from printed information. (Rule 8(1) of LM (packaging rules, 2011) The maximum permissible error, in excess or in deficiency should be as per Schedule one of L.M.(Packaging) Rules 2011. In case of wholesale packages, the total number/ net quantity of retail package contained. Axe Deodorant Body Spray Pears bathing bar 21

22. Retail Sale Price Of the package. Packages’ containing alcoholic beverages or spirituous liquor – State Excise laws applies. For reducing MRP, a sticker with revised MRP may be affixed inclusive of all taxes. But such sticker should not cover the MRP declaration by manufacturer or packer on the package. Fiama Di Wills Gel Bar Axe Deodorant Body Spray Batch Number Batch number not required- If cosmetic is of 10 grams or 25 milliliters or less. Soaps- instead of batch number, the month and year of manufacture may be given. Santoor Body Deodorant Warning or Caution if Hazard Exists On the inner label. Directions for sale use A statement of names and quantities of the hazardous or poisonous ingredients Dettol Liquid Hand Wash 22

23. Manufacturing License Number Preceded by letter “M”. Santoor Hand Wash Ingredients Precede d by the word “ingredients” Ingredients present in concentration of more than 1% listed in the descending order of weight / volume Followed by those in concentration of less than or equal to 1 % in any order Not required to appear for the packs of less than 60ml or 30gm Ingredients of Deodorant Bottle in Descending Order of its Volume Registration Certificate Number (RCN) On the label of imported cosmetics should bear RCN of the product The name & address of RCN holder for marketing the said cosmetic product in India Nivea Men Deodorant 23

24. Consumer Care Details Name, address, telephone number, E-mail address Of the person who can be contacted in case of consumer complaints Santoor Hand Wash Using Stickers Not permissible for altering or making declaration Except in the case of reducing MRP but same should not cover the MRP declaration made by the manufacturer or packer ( Bar Code of Individual Packs are Stickered ) Lifebuoy Hand Wash Pouch – offer buy 2 @ Rs 69 /- Brown/Red or Green Dot For the package of soap, shampoos, tooth pastes & other cosmetics & toiletries Non-vegetarian origin – brown dot Vegetarian origin – green dot Roop Mantra – Neem & Tulsi Soap 24

25. ‘Not a Standard Pack Size under Legal Metrology (Packaged C ommodities) Rules, 2011’ Specific cosmetics should be packed in the standard quantities mentioned in the second schedule of the said rule. If packed in size other than that prescribed in schedule, then it should be prominently labelled in the said manner. Value based packages can be sold without complying with the second schedule. Trigunieze Eats – Rasa Vada 25

26. 149 Labelling of hair dyes containing coal tar colours :- Hair dyes such as p- phenylenediamine or other coal tar dye will be labelled in English and local languages and these shall appear on both the inner & the outer labels. “caution – this product contains ingredients which may cause skin irritation in certain cases & so a preliminary test according to the accompanying directions should first be made. This product should not be used for dyeing the eyelashes or eyebrows as such a use may cause blindness.” 26

27. 149 A Special provision relating to toothpaste containing fluoride :- Fluoride content should not be more than 100ppm & the content of fluoride in terms of ppm shall be mentioned on the tube & carton. Date of expiry should be mentioned on the tube & carton. License of the manufacturer can be suspended or cancelled by the licensing authority if he is found not complying with the conditions of the licenses mentioned above or if he is found contravening any other provisions of the act or rules made thereunder. 27

28. REGULATORY PROVSIONS RELATING TO IMPORT OF COSMETICS Chapter 3 of the D & C Act deals with the import of drugs & cosmetics. Import of certain cosmetics is prohibited under section 10 of the act & rules 134A, 135, 135A of the D & C Act 1945. These are : Any cosmetic which is not of standard quality. Any misbranded or spurious cosmetics. Any cosmetic for the import of which a license is prescribed. Any cosmetic containing any ingredient which may render it un safe or harmful for use under the directions indicated or recommended. Any cosmetic the import of which is prohibited by rule. Any cosmetic containing hexachlorophene. Any cosmetic in which lead or arsenic compound has been used for coloring purpose. Any cosmetic which contains mercury compounds. 28

29. However small quantities of cosmetics can be imported which are subjected to two conditions : Cosmetics should form a part of passengers baggage & should be the property of & be intended for the bonafide use of passenger. Cosmetics should declared to the custom authorities, if they so direct. 29

30. In Feb 2007, the Government of India ministry of family welfare has notified draft rules for amending the D & C Rules, 1945 to provide for Registration of cosmetics products imported into India. It is being provided that no cosmetic shall be imported into the country unless the product is registered under rule 129D by the licensing authority appointed by the Central Government under rule 21. Usually Drugs Controller General ( India ) is the licensing authority . 30

31. Cosmetics can be imported into India only through ports of entry prescribed under rule 43A and are :- Firozepur cantonment & Amritsar railway stations ( through Pakistan border). Ranaghat, Bongaon & Mohiassan railway stations ( through Bangladesh border ). Raxaul ( by road/railway lines connecting Raxaul in India & Birganj in Nepal ). Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva & kandla ( by sea route ). Ahmedabad, Chennai, Delhi, Hyderabad, Kolkata & Mumbai ( by air ). 31

32. 28 cosmetics have been placed under schedule S to the rules & are required to comply with Indian standards & these are :- 1. Skin powders 15. Depilatories , chemicals 2. Skin powders for infants 16. Shaving creams 3. Tooth powders 17. Cosmetic pencils 4. Tooth pastes 18. lipsticks 5. Skin creams 19. Toilet soap 6. Hair oils 20. Liquid toilet soap 7. shampoo, soap based 21. Baby toilet soap 8. shampoo, synthetic detergent based 22. Transparent toilet soap 9. Hair creams 23. Shaving soap 10. Oxidation hair dyes, liquid 24. lip salve 11. cologne 25. Powder hair dye 12. Nail polish ( nail enamel ) 26. Bindi ( liquid ) 13. After shave lotion 27. Kumkum powder 14. Pomades & brilliantine's 28. Henna powder 32

33. All the consignments which have to be imported should be accompanied by an invoice or statement showing the name & quantities of cosmetics included. Name & address of manufacturer. Declaration by the Authorised person to the collector of custom. The officer appointed by the Government of India on port may take sample for examination & advice the collector of custom for the action. The consignment received is on hold until report is received from the officer. The importer shall have to return the consignment to the collector of custom within 10 days of notice. If the report is contravening any provisions then the consignment is returned & send back. The importer may go against the report & shall forward the fresh sample to the officer & obtain the report. 33

34. 9-C MISBRANDED COSMETICS They are the cosmetics that are labelled falsely or misleading. A cosmetic shall be deemed to be misbranded :- If it contains a colour which is not prescribed ; or If it is not labelled in the prescribed manner ; or If the label or container or anything accompanying the cosmetic bears any statement which is false or misleading in any particular. 34

35. 9-D SPURIOUS COSMETICS A cosmetic shall be deemed to be spurious If it is imported under a name which belongs to another cosmetics ; or If it is a imitation of, or is a substitute for, another cosmetic or resembles the label or container, or the name of another cosmetic ; or Its lack of identity with another cosmetic ; or If the label or container bears the name of an individual or a company purporting to be the manufacturer of the cosmetic which individual or company is fictitious or does not exist ; or If it purports to be the product of a manufacturer of whom it is not truly a product. 35

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37. RESTRICTIONS :- Rule 134 of the rules stipulates that no cosmetic shall be imported which contains a coal tar colour other than the one prescribed in schedule Q & indian standard ( IS: 4707 Part 1 ) to the said rules & coal tar colour used in cosmetic shall not contain more than – 2ppm of arsenic calculated as arsenic trioxide. 20ppm of lead calculated as lead 100ppm of heavy metals other than lead calculated as the total of the respective metals. 37

38. THANKYOU 38

39. REFERENCES Cosmetics – formulation, manufacture & quality control, pp sharma , 4 th edition. Handbook of cosmetic science & technology A.O.Barel , M.Paye & H.I.Maibach . 3 rd edition. http://www.cdsco.nic.in http://www.pharmatutor.org/articles/review-regarding cosmetics in india . http://www.slideshare.com /presentation/ basant shah/related to cosmetic regulations. 39