This document discusses cosmetovigilance and adverse reactions to cosmetics. It begins with a case study of a 42-year-old woman who developed contact dermatitis from hair dye use. Upon stopping the hair dye, her dermatitis resolved. Necessary actions include reporting the adverse event to authorities and promoting further vigilance. The document then defines cosmetics and cosmetovigilance, discusses differing regulations for drugs and cosmetics, prohibited ingredients, and the need for monitoring cosmetic safety. It also covers Indian laws, causality assessment methods, and the present status of cosmetovigilance globally and in India.

1. Dr.Arun.S
First year PG
Department of Pharmacology
GMC, Ananthapuramu

2. • Mrs. Lakshmi
• 42/Female
• House wife
• Regularily uses hair
dye
• Developed Contact
dermatitis
• On stoppage of
Hair dye, contact
dermatitis settled

3. What necessary actions can be taken to prevent or monitor the ADRs due to cosmetics?
CASE STUDY

4. SPECIFIC LEARNING OBJECTIVES
At the end of the seminar, the learner will be able to
describe
1. What is a cosmetic?
2. What is cosmetovigilance?
3. Drug vs cosmetics - The Grey zone
4. Differing laws and regulations to drugs and cosmetics
5. Adverse reactions to Cosmetics
6. Prohibited or restricted ingredients by FDA
7. Need for Cosmetovigilance
8. Indian Laws for Cosmetics
9. Causality assessment methods in Cosmetovigilance
10. Present status of Cosmetovigilance in India and globally
11. Vigilance activities in Cosmetovigilance

5. WHAT IS A COSMETIC
• Any article intended to be rubbed, poured, sprinkled or sprayed on, or
introduced into, or otherwise applied to, the human body or any part there
of for cleansing, beautifying, promoting attractiveness, or altering the
appearance.

6. SUBSTANCES WHICH COME UNDER COSMETICS
Skin moisturizers
Perfumes
Lipsticks
Nail polishes
Eye and facial makeups
Cleansing shampoos
Permanent waves
Hair colors
Deodrants
COSMETICS

7. RELATIONSHIP BETWEEN PHARMACEUTICAL, COSMECEUTICAL
AND NUTRACEUTICAL

8. WHAT IS COSMETOVIGILANCE
Collection
Evaluation
Monitoring
Undesirable
events observed
during or after
normal or
reasonably
forseeable use of
a cosmetic
product

9. DRUGS VS COSMETICS - THE GREY ZONE
• The distinction between drugs and cosmetics is sometimes not clear.
• Examples where drugs are used as cosmetics:
Aminophylline (used for Rx of asthma) is present in many thigh cream products for
cellulite.
Tretinoin and other acne medicines are used for wrinkle reduction.
Botulinum toxin (used to treat torsion dystonias & other involuntary movements) is used
for soothing facial lines and wrinkles.
Corticosteroids used as depigmenting agents are very common.

10. DRUGS VS COSMETICS - THE GREY ZONE
• Some products meet the definition of both drug and a cosmetic,
Anti-dandruff shampoo - cosmetic + drug
Toothpastes that contain fluoride
Deodrants that are also anti-perspirants
Moisturizers and makeup marketed with sun protection claims

11. DIFFERING LAWS & REGULATIONS FOR DRUGS & COSMETICS

12. ADVERSE REACTIONS TO COSMETICS
• Intolerance to cosmetics - irritation, burning sensation, erythema, itching
• Preservatives, fragrances & hairdyes - allergic dermatitis
• Kumkum, kajal, sticker bindi - contact dermatitis
• Systemic reactions - rhinoconjuctivitis, headache, asthma
• Underarm cosmetics - cause of Breast cancer
• Hair dyes - Bladder cancer and Non-hodgkins lymphoma
• Hair technicians - prone to asthma
• Female hair technicians - prone to fertility problems
• Status cosmeticus - Intolerance to all cosmetics due to the patient having pre-existing
dermatosis - rosacea, seborrhoeic and atopic dermatitis

13. RESTRICTED INGREDIENTS BY FDA
• Bithionol - photocontact sensitization
• Chloroform, Methylene chloride - causes cancer in animals
• Halogenated salicylanilides - serious skin disorders
• Hexachlorophene - not to be used in lips and mucous membranes
• Mercury compounds - skin irritation, neurotoxic
• Vinyl chloride - causes cancer and other health problems
• Zirconium containing compounds -
Animals - toxic lung effects; humans - skin granulomas.

14. NEED FOR COSMETOVIGILANCE
• Increasing Adverse Cosmetic Events (ACEs) - due to incorrect use / abuse of
cosmetics, cosmetic intolerance.
• Underreporting by patients and physicians
• Easy availability of misbranded and spurious cosmetics in India - may contain
prohibited / high level of restricted ingredients
• The efficacy and safety of cosmetic products are not reviewed or approved by
national authorities before they are sold to the public
• Responsibility of manufacturers plays a crucial role in identifying the products and
ingredients that are harmful before they are marketed.

15. INDIAN LAWS FOR COSMETICS
• Cosmetics are regulated as per Drugs and Cosmetics Act 1940 and Rules 1945
• Part XIII - Regulates import and registration of cosmetics
• Part XIV - Manufacture of cosmetic for sale or for distribution
• Part XV - Regulates labelling, packing and standards of cosmetics
• Rule 145 and 135 - Prohibits the use and import of arsenic and lead containing
compounds.
• Rule 135A and 145D - Cosmetics containing mercury are prohibited
• Rule 134A - prohibits the import of hexachlorophene containing cosmetic
• Rule 134 - specifies that cosmetic products should contain color, dye, or pigment as
specified by schedule Q and Bureau of Indian Standards.

16. CAUSALITY ASSESSMENT METHOD IN COSMETOVIGILANCE
• The causality assessment is strictly aimed at analyzing individual cases. It does not
claim to study the potential of the suspected product to cause harm in a given population.
• Causality assessment is based on following principles:
1
• Adequate quantity of information should be obtained - in terms of suspected product and
description of symptoms
2
• The method must be applied irrespective of the cosmetic product under consideration and
the nature of effect observed
3
• This method combines the collection of information, about a series of mandatory criteria,
resulting in a reliability score - allows a classification into different level of causality.

17. COLIPA METHOD OF CAUSALITY ASSESSMENT
• COLIPA - The European Cosmetic, toiletry and Perfumery association - provides
guidelines for causality assessment of undesirable effects on human health - this is a
validated method.
• Level of causal relationship is expressed as
Very Likely
Likely
Questionable
Unlikely

18. COLIPA - ANALYSIS OF MAIN THREE QUESTIONS
Time sequence of events (chronology)
in relation to product use
Re-exposure to the product
Evocativeness / Likelihood of
symptoms

20. PRESENT STATUS OF COSMETICS IN INDIA
• Indian Cosmetics industry at a glance...
• Average - 15-20%
• Skin care products - 7-15%
Current growth rate
• 6.27 billion US dollars
Market size
• Western India - 28% of market share
Largest market in
India

22. PRESENT STATUS OF COSMETOVIGILANCE IN INDIA

23. GLOBAL STATUS OF COSMETOVIGILANCE IN 2022

24. SAFETY MONITORING / COSMETOVIGILANCE ACTIVITIES
• Establish point of contacts
• Adverse effect report forms
Adverse effect
reporting
• Signal detection & Evidence evaluation
• Causality / frequency / severity
• Validation
Assessment of
reports
• Risk / benefit assessment
• Changes to product information
• Monitoring
Risk management

25. CONCLUSION
• Cosmetovigilance is a new concept of safety monitoring of cosmetic products. It may be
considered as an important component of public health activities.
• As postmarketing surveillance of cosmetics become widespread globally, problems
related to these products can be identified and solved, and thus safety can be achieved.
• Family medicine physicians and primary care practitioners have an essential role to
recognize ADRs induced by cosmetic products, and thus encourage patients for ADR
reporting.
• Increasing awareness on this new concept will be a valuable remark on global public
health.

26. • Mrs. Lakshmi
• 42/Female
• House wife
• Regularily uses hair
dye
• Developed Contact
dermatitis
• On stoppage of
Hair dye, contact
dermatitis settled

27. • The necessary action to be taken in this case is to stop the usage of the cosmetic and
report the adverse cosmetic event to National authority so that the information of
cosmetics will be updated and further vigilance will be promoted
CASE STUDY

28. REFERENCES
• Zweers PG, Gilmour NJ, Hepburn PA, Gerritsen RF, van Puijenbroek EP. Causality
methods in cosmetovigilance: Comparison of Colipa and PLM versus global introspection.
Regul Toxicol Pharmacol. 2012;63:409–17
• Vigan M, Castelain F. Cosmetovigilance: Definition, regulation and use “in practice” Eur J
Dermatol. 2014;24:643–9
• Toklu HZ, Antigua A, Lewis V, Reynolds M, Jones J. Cosmetovigilance: A review of the
current literature. J Family Med Prim Care. 2019 May;8(5):1540-1545. doi:
10.4103/jfmpc.jfmpc_447_18. PMID: 31198710; PMCID: PMC6559068.
• Post Graduate Pharmacology by Rituparna Maiti - 3rd edition; chapter - 36, pg:254-258.