The document defines cosmetics and cosmeceuticals under Indian laws. It states that cosmetics are defined under Section 3(AAA) of the Drugs and Cosmetics Act, 1940 as any article intended to be applied to the human body for cleansing, beautifying or altering appearance. The regulatory bodies for manufacturing and importing cosmetics in India are discussed. Quasi-drugs and their examples are also mentioned along with the ideal characteristics of cosmetic excipients and functions of skin.

1. PREPARED BY
MR. SHAILENDRA SINGH BHADAURIA
(ASSISTANT PROFESSOR)
RAMA UNIVERSITY

2. COSMETIC IS DEFINED UNDER
SECTION 3(AAA)
• COSMETIC IS DEFINED UNDER SECTION 3(AAA) OF THE DRUGS AND
COSMETICS ACT, 1940 AS, 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.

3. REGULATORY BODIES FOR
MANUFACTURING AND IMPORT IN INDIA
UNDER D&C ACT
• UNDER THE PROVISIONS OF DRUGS AND COSMETICS ACT, 1940 AND RULES MADE THERE
UNDER, THE MANUFACTURE OF COSMETICS IS REGULATED UNDER A SYSTEM OF
INSPECTION AND LICENSING BY THE STATE LICENSING AUTHORITIES APPOINTED BY THE
RESPECTIVE STATE GOVERNMENTS, WHILE THE IMPORT OF COSMETICS IS REGULATED
UNDER A SYSTEM OF REGISTRATION BY THE CENTRAL LICENSING AUTHORITY APPOINTED BY
THE CENTRAL GOVERNMENT.
• THE DRUGS CONTROLLER GENERAL (INDIA) FUNCTIONS AS THE CENTRAL LICENSING
AUTHORITY WHO GRANTS THE IMPORT REGISTRATION CERTIFICATE AND REGULATES THE
IMPORT OF COSMETICS INTO INDIA VIDE GAZETTE NOTIFICATION G.S.R 763(E) UNDER THE
PROVISIONS OF DRUGS AND COSMETICS ACT, 1940.

4. • NO COSMETIC SHALL BE IMPORTED INTO INDIA UNLESS THE PRODUCT IS REGISTERED UNDER THE
RULES BY THE CENTRAL LICENSING AUTHORITY APPOINTED BY THE CENTRAL GOVERNMENT
UNDER RULE 3(F) OR BY ANY PERSON TO WHOM SUCH POWERS MAY BE DELEGATED UNDER RULE
5. [AS PER RULE 12(1) OF THE COSMETIC RULES, 2020]
• NO COSMETIC SHALL BE IMPORTED OR MANUFACTURED UNLESS IT COMPLIES WITH THE
SPECIFICATIONS PRESCRIBED UNDER THE NINTH SCHEDULE OR ANY OTHER STANDARDS OF
QUALITY AND SAFETY, APPLICABLE TO IT, AND OTHER PROVISIONS UNDER THE RULES.
• IN CASE, THE COSMETIC IS NOT INCLUDED UNDER THE NINTH SCHEDULE, IT SHALL MEET THE
REQUIREMENTS UNDER THESE RULES AND SPECIFICATIONS AND STANDARDS APPLICABLE TO IT IN
THE COUNTRY OF ORIGIN. [AS PER RULE 39 OF THE COSMETIC RULES, 2020]
• NO COSMETIC MAY PURPORT OR CLAIM TO PURPORT OR CONVEY ANY IDEA WHICH IS FALSE OR
MISLEADING TO THE INTENDING USER. [AS PER RULE 36 OF THE COSMETIC RULES, 2020]

5. DEFINITION OF COSMECEUTICAL
• COSMECEUTICALS MEANS COMBINATION OF COSMETICS AND
PHARMACEUTICALS.
• COSMECEUTICALS ARE COSMETIC PRODUCTS WITH BIOLOGICALLY ACTIVE
INGREDIENTS PURPORTING TO HAVE MEDICAL OR DRUG-LIKE BENEFITS.
• COSMECEUTICALS ARE USED TO IMPROVE AND NOURISH THE SKIN
APPEARANCE AND KNOWN TO TREAT DIFFERENT DERMATOLOGIC
CONDITIONS. LIKE COSMETICS,
• COSMECEUTICALS ARE ALSO APPLIED TOPICALLY HAVING INGREDIENTS THAT
INFLUENCE THE SKIN‘S BIOLOGICAL FUNCTION

6. WHAT IS QUASI-DRUGS
QUASI-DRUGS ARE ONE OF THE PRIMARY CATEGORIES OF BEAUTY PRODUCTS
IN SOUTH KOREA. THE OTHER CATEGORY OF BEAUTY PRODUCTS IS
COSMETICS. THERE IS A THIN LINE BETWEEN DRUGS AND COSMETICS, WHICH
CAN BE CONSIDERED AS QUASI-DRUGS. SINCE THEIR BENEFITS ARE NOT AS
SUITABLE AS DRUGS: SOUTH KOREA’S HEALTH AUTHORITY (HA) AND THE
MINISTRY OF FOOD AND DRUG SAFETY (MFDS) HAS CATEGORIZED THEM UNDER
SKINCARE PRODUCTS LIKE ACNE FOR SKIN DULLNESS.

7. WHAT ARE THE EXAMPLES OF
QUASI-DRUGS?
• QUASI-DRUGS INCLUDE OXIDATIVE HAIR DYEING PRODUCTS,
• HAIR WAVING OR STRAIGHTENING PRODUCTS,
• DEPILATORIES
• BREATH FRESHENERS,
• DEODORANT PRODUCTS
• TALCUM POWDER
• ANTI-DANDRUFF PRODUCTS,
• PRODUCTS TO PREVENT MELANIN SPOTS AND FRECKLES

8. WHAT ARE THE TYPES OF QUASI-
DRUGS?
QUASI-DRUGS ARE GENERALLY CLASSIFIED INTO TWO TYPES:
TYPE I
• ITEMS USED FOR SANITARY PURPOSES SUCH AS SANITARY PADS, TAMPONS AND MENSTRUAL PADS
• THE TEXTILES USED FOR MANUFACTURING MASKS SUCH AS DUST AND SURGICAL MASKS.
• WET WIPES FOR ORAL HYGIENE.
• SANITARY PRODUCTS USED FOR PROTECTION, PRESERVATIVES, AND TREATMENT OF AFFECTED AREAS
INCLUDE DIFFERENT KINDS OF BANDAGES, PLASTIC BANDAGES.

9. TYPE II
• ODOUR INHIBITORS LIKE TOOTHPASTE, ANTIPERSPIRANTS AND BATH PRODUCTS.
PRODUCTS.
• HAIRCARE PRODUCTS THAT ARE ONLY MEANT FOR EXTERNAL USAGE.
• PRODUCTS THAT DON’T CONTAIN NICOTINE FOR THOSE WHO SMOKE.
• OINTMENTS AND ANTI-INFLAMMATORY PRODUCTS FOR EXTERNAL USE

10. OTC DRUG
OVER-THE-COUNTER MEDICINE IS ALSO KNOWN AS OTC OR NONPRESCRIPTION
MEDICINE.
ALL THESE TERMS REFER TO MEDICINE THAT YOU CAN BUY WITHOUT A
PRESCRIPTION.
THEY ARE SAFE AND EFFECTIVE WHEN YOU FOLLOW THE DIRECTIONS ON THE
LABEL AND AS DIRECTED BY YOUR HEALTH CARE PROFESSIONAL

11. EXCIPENT
• EXCIPIENTS ARE PHARMACOLOGICALLY INERT INGREDIENTS ADDED
INTENTIONALLY TO A DRUG PRODUCT (DP) FOR VARIOUS FUNCTIONAL ROLES,
SUCH AS TO ENHANCE DOSAGE FORM VOLUME OR SIZE, DISINTEGRATION OF
SOLID DOSAGE FORMS, BINDING OF PARTICULATES, LUBRICATION DURING
PROCESSING, TASTE MASKING, OR MODIFYING DRUG RELEASE.

12. IDEAL CHARACTERISTIC OF COSMETIC
• AN EXCIPIENT IS PHARMACOLOGICALLY INACTIVE
• NON-TOXIC
• DOES NOT INTERACT WITH THE ACTIVE INGREDIENTS OR OTHER EXCIPIENTS

13. • Active ingredient (Anti-
Acne , Anti- Dandruff,
Antiperspirant)
• Antioxidant (L-
Ascorbic acid, Arbutin)
• Buffering agent
(Potassium acetate,
Sodium phosphate,
Maltobionic acid
• Preservative ( Boric
acid, Cetrimide,
Isobutyl paraben,
Methylparaben)
Surfactant (Sodium
Lauryl Sulfoacetate,
Propylene Glycol
Monolaurate
• Sweeteners
• Thickeners
• Flavoring agent
• Fragrance agent
• Moisturizes
Cosmetic
agent

14. SKIN

15. FUNCTION OF SKIN
• THE SKIN IS THE BODY’S LARGEST ORGAN. IT SERVES MANY IMPORTANT
FUNCTIONS, INCLUDING
• PROTECTING THE BODY AGAINST TRAUMA
• REGULATING BODY TEMPERATURE
• MAINTAINING WATER AND ELECTROLYTE BALANCE
• SENSING PAINFUL AND PLEASANT STIMULI
• PARTICIPATING IN VIT D SYNTHESIS