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Good Morning and Welcome to the

Enigmatic and Indispensable World of Cosmetics

Paradigm Shift of the

Cosmetic Industry in India

A Glimpse

Sanju Nanda M.Pharm., Ph. D (IITD), LLB. (Hons)

Department of Pharm. Sciences M.D.University, Rohtak (India)

sn_mdu@rediffmail.com

A Presentation By

Department of Pharmaceutical Sciences

Highlights of the Presentation

Cosmetics are now not just used as luxury articles. They have become an integral part of our grooming.

They are now being used by people of all ages and gender.

Cosmetic products are also being used as Topical (therapeutic) formulations.

Intervention of innovative technologies like Herbal, Nanotechnology, Biotechnology and Packaging Technology in Cosmetics is promotional for this industry.

This presentation is made with two major objectives in mind

1. To share the existing developments taking in the field of Cosmetics in India

2. My research interests in Cosmetics

Beauty in Indian context ...

• Fair complexion

• Long black hairs

• Youthful face

• Good health and height

• “Solah Shringar”

• Beauty of inner self

Beauty in the changing paradigms

• Fairer complexion

• Size zero

• Colouring and styling of hairs

• Anti aging treatments - Botox, facials, herbal and other anti aging creams

• Concern for health in a holistic way

• Beauty with Brains

• Women of substance

India A Land of ... • Aryan lineage

• Forests, rivers and mountains

• Rich source of flora and fauna

• Heritage of knowledge -Traditional system of medicine like Ayurveda

• Patronage by regal beauties like Noorjahan, Padmavati

• Beauty Queens like Sushmita Sen, Lara Dutta , Aishwarya Rai

Attars – The Indian Perfumes

Attar is the traditional Indian fragrant perfume oil that is pure and lasting. Non-alcoholic and natural, attars are produced from flower petals distilled in water. Some include herbs, wood, spice and resin extracts. Attars use sandalwood oil fragrance as the base. Popular attars are Zafran, Majmuha, Chameli, Nargis, Jantey, Firdos, Kasturi, Sandalwood, etc.

India :

Unity in Diversity

• Varied Ethnic groups, skin and hair types

• Different Socio -Economic status

• Highest number of young population -65% (median age 25)

• Consumer base lies between 16-75 yrs

Per capita expenditure on Cosmetics (in US $)

Hong Kong Malaysia Japan China India

40 10 12 1.5 0.68

The Indian Cosmetic industry is estimated to grow at a CAGR of around 22% -- RNCOS Analysis

Pre GLP and Post GLP Scenario

• GLP – Globalization, Liberalization and Privatization

Paradigm shift – from stems to stem cells

• Fairness creams

• Antiaging creams

• Herbal cosmetics

• Sunscreens

• Deodorants

• Perfumes

• Cosmetics for Men

• Cosmetics for Children

Cosmetic Industry is growing…

The current size of

Cosmetics and

Toiletries market is

about Rs 4600 crores

and is expected to touch

a figure of Rs. 20,000 cr.

By 2014

It is expected to reach

US $ 20.23 bn by 2017

-- ASSOCHAM

The demand is growing due to ..

• Higher disposable incomes

• Cosmetics are now being used by persons in all age groups and genders

• Robust media promotion

• More global travel and exposure to global trends

• Fashion and Film industry is also progressing and influencing the beauty industry

• Premium Herbal products available

And also by creating new set of customers

• Boys

• Village and semi – urban female population

Ref.: “Beauty Segment Unleashed”, by Retailers Association of India, March 22,2013, http://rai.net.in (accessed on 19.05.13)

Cosmetics in India

• Education - The Pharmacy Act 1948 (PCI) and AICTE

• Industry – Ministry for Chemicals and Fertilizers

• Formulation and enforcement of Regulation

- MH&FW

- CDSCO

- State Drug Control Departments

• CDSCO

• Schedule ‘S’, ‘Q’, ‘M II’

• BIS

• AYUSH

• Ministry For Consumer Affairs

Indian Regulators

Cosmetics in India: The regulatory perspective

• Defined under the D&C Act 1940

• Added only in 1964

• Under Schedule “S” of the Act

• Enlists 28 cosmetics, many of them for Indian users

• Responsibility of BIS to make standards for cosmetics

As per the D&C Act, Cosmetics include

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.

List of Cosmetics- Schedule ‘S’

• Skin powders

• Skin powders for infants

• Tooth powder toothpaste skin creams

• Hairoils

• Shampoo –soapbased

• Shampoo synthetic detergent based

• Hair creamst

• Toilet soap,liquid toilet soap and baby toilet soap

• Cologne

• Oxidation – hair dyes, liquid

• Nail polish (Nail enamel)

• Pomades and brilliantines

• Depilatories chemicals

• Shaving creams and after shave lotion

• Cosmetic pencils

• Lipstics and lipsalves

• Powder hair dyes, henna and kum kum powder

The Drug and Cosmetics Act 1940 and Rules 1945

• Manufacture of Cosmetics for Sale or for Distribution

• Labelling, Packing and Standards of Cosmetics (through BIS)

• Import of Cosmetics in India

• Testing Cosmetics by its Referral Lab Central Drugs laboratory (MH&FW)

Safety /Toxicity Testing

• Safety Testing of cosmetics to be conducted according to the Standards IS 4011:1997

• This is only for circumstances where a new raw material, ( i.e. materials other than the ones mentioned in the aforementioned documents) in an old formulation or an entirely new formulation is used

• This forms the crux of ongoing safety testing on cosmetics in India (GRAS and GNRAS)

Pro Consumer Efforts

• Consumer Protection Act 1986,( amended 2002)

• Consumer Commissions and Forums became functional (PPD in henna, dantmajans,VOICE)

• Consumer Redressal mechanisms were made pro consumer and faster (90 days)

• Consumer awareness workshops and awareness campaigns were sponsored by the newly created Ministry of Consumer Affairs

Brands that built the

image in India and Overseas …

• Shahnaz

• Dabur Samara

• Zydus Cadila

• Ayur

• Biotique

• Lotus

• Himalaya

• Dabur – Uveda

• Blossom Kochhar

• Other Potential Indian Brands

• Ponds

• Lakme

• Emami

• Godrej

• Marico

• Revlon

• Lux

Direct selling cosmetic companies

• Oriflame

• Amway

• Modicare

• Avon

International Brands in India

• L’Oreal

• Head and Shoulders

• Garnier

• Pantene

• Nivea

• Rexona

• Colgate

• Unilever

Cosmetic Pushers

• Colors

• Herbals & Naturals

• Anti aging

• Fairness

• For Children

• For Men

• New Technologies

The Technologies in Vogue …..

Herbal Technology

Nano Technology

Bio Technology

Packaging Technology

Herbal Technology

GREEN IS IN ……

Global Organic and Natural Market

2007 --- $ 07 bn.

2010 --- $ 10 bn.

2012 --- $ 14 bn.

INCREASE IN USE OF HERBAL COSMETICS:

POSITIVE CONSUMER

ATTITUDE TOWARDS

NATURALS

NATURAL

PRODUCTS

TREATED AS

HARMLESS, INERT

AND SAFE .

CONSUMERS

TIRED OF

SIDE

EFFECTS OF

CHEMICALS

HERBS HAVE

BEEN A PART OF

HOME MADE

RECIPES AND

TRADITIONAL

SYSTEM OF

MEDICINE AND

FOLKLORE

THEY INCLUDE …………

• CRUDE PLANT MATERIALS LIKE LEAVES, FLOWERS, SEEDS, FRUITS, STEMS, WOOD, ROOTS, RHIZOMES OR OTHER PLANT PARTS WHICH MAY BE ENTIRE, FRAGMENTED OR POWDERED.

• NATURAL MATERIALS IN ADDITION TO THE ABOVE

• FRESH JUICES

• GUMS,

• FIXED OILS, ESSENTIAL OILS, RESINS, etc.

Herbs used in Cosmetics

Herbal Cosmetic Market: Getting Dynamic (about 1200 crore)

• Dabur India Ltd - launching a new series – Anmol

• J R Herbal Care- Ear marked 10 crore for the manufacturing of its product “Joves” at Noida. Looking forward to position its product in EU including UK

• Others are Shahnaz Hussain, Vinita Jain,Ozone,F&L, Lotus, Vicco

Changing Frontiers for Herbal Cosmetics

• Biotechnology interfacing Herbal Cosmetics

• Novel Drug Delivery Systems in Natural and Herbal Cosmetics

• Nanotechnology interfacing Herbal Cosmetics

Concerns…

Increased Use of Botanicals and other

Naturals in Cosmetics

Are they really effective ? Are they really required ? Are they stable ? Are they economical ?

•Amla in Shampoos •Ad Oil in Shampoos •Egg in Shampoos

Problems •Standardisation •Inconsistent Quality •Preservation

Herbal Cosmetics: BIS General Guidelines

• Standard No. IS 15753: 2006

• Purpose: To provide assurance to the consumers that the products labeled as “Herbal Cosmetics” are actually delivering the benefit claims, are safe and of standard quality.

BIS on Herbal Cosmetics

• Cosmetics claimed and labelled as ‘Herbal’ could be those products which are formulated using standard, approved cosmetic base into which herbs are added for providing the claimed product benefits

• No stipulations have been made in these guidelines regarding the composition of the herbal cosmetics

No Tug of War ….

• Formulators/Marketers of Herbal cosmetics need to comply with the general guidelines for Herbal Cosmetics.

• If they are using herbs/herbal ingredients, for example, to create variants, in which case the cosmetic formulation shall be governed by the current regulations under the Drugs and Cosmetics Act and Rules as may be applicable, and this general guideline for Herbal Cosmetics shall not be applicable to such products

• Cosmetics are meant only for topical use and the purpose is either cleansing, beautifying, nourishing and altering appearance

• If a cosmetic product is sold with a claim which indicates a therapeutic benefit or interferes with the physiology of skin (antiperspirant, fairness, etc), then it needs to be substantiated with clinical data and approval sought as a drug.

• IS 11377: 2001 - Guidelines for hygienic manufacture of cosmetics

• IS 14648: 2005 – Methods of test for microbiological examination of cosmetics and cosmetic raw materials

• IS 3958:1984 – Methods of sampling cosmetics

BIS also guides on

• Selection of Herbal ingredients

• Quantity/Proportions of Herbs used

• Herbal cosmetics Benefits claims

• Quality Assurance

• Shelf – life data

• Safety data

Ayurveda: Science of Life

• Ayu – age/life

• Veda – Knowledge/Science

• Holistic way of living

• Maintains the health of the healthy

• Cures the sick

Living a Balanced Life

Every individual is made up of five elements

• Air

• Water

• Earth

• Fire

• Ether

• Imbalances leads to Doshas – Vatta, Kapha and Vayu

• Similar to the Yin Yang theory of Chinese Medicine , and

• Four Humours of Hippocratic Theory

Beauty Management Through Ayurveda

• Diet and Nutrition

• Mode of life

• Through social behaviour

• Rasayans

• Skin care

• Hair care

• Foot care

• Eye care

• Natural Deodorants

• Natural Hair Colorants

• Cosmetic corrections of scar tissue

• Sandhana vidhi – Cosmetic Surgical corrections

Ayurvedic Cosmetic market is growing

• Vicco

• Shahnaz

• Charak

• Himalaya

• Biotique Spas,

Massages

Naturopathy,

Aromatherapy

Recent developments in the Country

• L’Oreal opens new Research And Innovation Centre in Mumbai

• Unilever to build deodorant facility in India

• Women Colleges opening new departments and courses in the area of Cosmetology – Dev Samaj College for Women, Ferozpur

L’Oreal in India • L’ Oreal launched its first Research & Innovations

Centre in India which is the 6th in the world.

• It plans to invest Rs 1000 crore over the next three years to research and innovate on Indian Hair and skin care

• Centres at Mumbai and Bangalore

• Acc. to Jean Paul Agon, Chairman and CEO L’ Oreal Paris, at the launch said “The Indian beauty market is the fastest growing globally and will be the 6th largest in the world by 2020 by which time L’Oreal hopes to reach 150 million Indian Consumers”.

Unilever to build Deodorant facility in India

• British PM David Cameron visited HUL in Mumbai early this year

• This global personal care giant is set to open its first Aerosol manufacturing plant in Asia , in Khargaon , Mumbai

• Investment of Euro 50 mn (USD 66 mn) proposed

• This plant shall be one of the 30 new factories being built by 2015

• Meant to cater to India and across South East Asia

• Will use superior technology to maximize energy efficiency and reduce waste water to zero

Regulatory Developments

• Import Registration of Cosmetics have become mandatory from 1st April 2013

• No cosmetic in India shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Govt under Rule 22 of D&C Act

• An application for the registration in Form 42 along with all requisite documents shall be submitted to Drugs Controller General (I), New Delhi, CDSCO.

How ever, No licence, after

permission from CDSCO , in case of ... • Bulk Cosmetics - for repackaging for 100%

export to other companies will not require registration certificate but with an undertaking that it shall not be released for sale in India

• For R& D purposes - like packaging trials, consumer studies, shelf life studies, transport studies – not to be released for domestic sale

Alternatives to Animal Testing

DCGI may reconsider ban on animal testing on animals due to pressure from animal welfare groups

India contributing to ISO on Natural and Herbal Cosmetics

• In 2010, International Organization for standardization(ISO) took up a new project and constituted a working group namely ISO/TC217/WG4.

• This working group is preparing an International Standard for “Definition, Terminologies and Criteria for Natural and Organic Chemists “

• Herbals are a subset of Naturals

Indian inputs ………. • The Working Group is preparing two

documents

• Initial Document was prepared by Colipa (the European Cosmetic Association)

• Indian Inputs: ISTMA (Indian Soap and Toiletry Manufacturers Association) and members of the Cosmetics Sectional Committee-PCD 19

• Dr. D B Anantha Narayana represents India through BIS in the meetings of ISO

1) BIS Product Certification Scheme:

• Provides Third Party Guarantee of quality, safety and reliability of products to the ultimate customer

• ISI mark is issued under this scheme

2) ECOMARK:

• Launched in the eco-labeling scheme `Ecomark' in 1991

• For easy identification of environment-friendly products.

Indian Certification Schemes for

Food, Drugs and Cosmetics

Voluntary Certification

Scheme for AYUSH

Products • Department of AYUSH- the Scheme owner

• Quality Council of India -responsible for managing the scheme

• Two certification criteria:

Ayush Standard Mark-Based on compliance to the domestic regulatory requirements

Ayush Premium Mark-Based on two options:

a) Compliance to GMP Requirements based on WHO Guidelines

b) Compliance to regulatory requirements of any importing country provided they are more stringent than Option A above.

Halal

Certification

• Quranic term meaning ‘permitted, allowed or lawful’.

• The opposite is Haram- prohibited activity

• Pork, alcohol, blood, carcasses of dead animals is explicitly forbidden

• Halal logo is an authoritative, independent and reliable testimony to support Halal claims

Conferences being held in the area of Cosmetics

• PICASA 2013 – Annual Scientific Seminar of ISSC held in January KET’s V G Vaze Collge Mumbai ,on the theme “Emerging trends in Cosmetic Science”

• “New frontiers in Herbal Cosmetics and Nutraceuticals”, International Symposium at Dehradun in February

• Shoolini University, 21st June, 2013

Proposed Workshops from ISCC

• Perfumery workshop – April 2013

• Sensory Evaluation workshop – May 2013

• Photo stabilization of sunscreens and actives – July 2013

• Workshop on Herbal Cosmetics – September 2013

• Workshop on Hair Science – November 2013

• Workshop on Skin Science - January 2014

Conclusion

Indian Cosmetic Industry

A SWOC ANALYSIS

A SWOC ANALYSIS

• Strengths

• Weakness

• Opportunities

• Challenges

Strengths

• Abundance of Natural Resources

• No Dearth of Scientists and Skilled Manpower

• Increase in Demand

Weakness

• Consumption of cosmetics less in India

• Standards should be more elaborate

• GMP compliant manufacturing facilities should be ensured

• Lesser consumer awareness.

• Safety studies of new technologies

Opportunities

• Increase in the user class

• MNCs showing interest

• Harmonization of regulations

• Certification Schemes

Challenges

• Standards to be made comparable with the world

• Regulatory control tightened • Stopping the misuse of

traditional systems • Check needed on misleading

claims • Short term and long term

stability studies as well as toxicology studies should be performed for new technologies

• Cost effective • Check on Advertisements

• Disclosure of ingredients on the product label

• Strengthen Consumer redressal

Need of the Hour

Researchers, Regulators and Manufacturers should come together to adopt a scientific approach so as to produce safe products for common use and help in passing on the benefits of new technologies to consumers in a cost effective manner

Areas of my Interest

• Skin : Structure, enzymes, kinetics, reconstruction of artificial membrane

• TDDS

• Development of novel cosmetic formulations for Indian skin type and dermal problems.

• Regulatory affairs

• Cosmetic Education and Consumer awareness

• Alternatives to animal testing

Present Area of Work..

IP - MICROSPONGE /NANOSPONGES DRUG DELIVERY SYSTEMS

(Using indigenous herbs)

• MDDS of Minoxidil for Alopecia (Gel)- Arti

• MDDS of Acyclovir for Herpes labilis and H. Simplex (Gel and Lip Balm) - Pooja

• MDDS of Safranal for Sunprotection (Cream) - Kumud

Highly cross-linked, porous, polymeric microspheres, consists of micro porous beads of size ranges from 5-300µm.

Can entrap wide range of actives and then release them onto the skin over a time mode and also in response to trigger.

Unique technology for the controlled release of topical agents.

Used in prescription Drugs, Cosmetics, Over The Counter (OTC) drugs and Skin care products.

Release Mechanism of Drug from Micro sponge Drug Delivery

System

Drug in entrapped form in vehicle

applied to the skin

Drug that is already in vehicle will be absorbed

in skin

Vehicle become unsaturated and

equilibrium disturbed

Flow of drug from microsponge

particle to vehicle

Flow of drug from vehicle into the

skin

Release can also be controlled

through diffusion pressure,

temperature etc.

Herpes Labialis

Herpes Keratitis

Need for Herbal Formulation(s): A number of herbs are found to cure or help in the cure of Herpes. These are : Aloe Vera • Polysaccharides in Aloe stimulate white blood cell activity and increase

the number of T-helper cells • An Anthroquinine called Emodin in Aloe Vera disables the functioning of

herpes simplex virus type 1 and 2 • Also it keeps the skin hydrated and reduces irritation in herpes

Peppermint Oil • Stops reproduction of herpes virus Rose Oil • Decreases irritation and hydrates skin

Prepared Lip Balm

Drug Loaded Microsponges Test for Grittiness

Saffron Flower and its

Stigma for Sunprotection

The final formulation is expected to have:

• Considerable good SPF value

• Broad spectrum of UV protection.

• Restricted to the epidermal layers of the skin.

• Better performance on Indian skin type.

• Good stability.

• Additional benefits like anti aging and moisturizing.

DRA – Drug Regulatory Affairs

• Alternatives to Animal Testing for Drugs and Cosmetics - Kavita

• Certification Schemes and Marks for Food, Drug and Cosmetics - Bakul

• Regulatory guidelines for Stability Testing of Cosmetics across the Globe – Mayank

• Naturals in Cosmetics - Anil

My Personal Opinion about Cosmetics

Beauty lies in the eyes of the

Beholder

• Accept and Respect your body

• Cleanse, nourish and protect your Skin, Hairs, Nails, etc

Cosmetics definitely plays a positive role in the well being of people but it is also important that it should be judiciously and cautiously used

After all they are made up

of Chemicals

Eat Nutraceuticals for Cosmeceutical Benefits

• Vegetarian: Vegetables, Fruits, Cereals, colored food, soy, salads,

• Non Vegetarian: Fish, Eggs,Poultry

• Adequate Liquids: Juices, Water, Green Tea, Milk, Butter milk, Herbal drinks

Exercise and Think Positive

Use freshly prepared ‘Lepas’, ‘Ubtons’, ‘Rinses’ for holistic benefits

Prayer

Thank You God

For the beauty of Self

The precious innate Self.

The only thing

That cannot be taken from us

The only thing we really own. Marjorie Holmes

Stay Healthy and look Beautiful

Acknowledgements • Prof. Chang Seo Park and NCR for

the invitation and hospitality

• Vice Chancellor, M D University, Rohtak for the permission

• Volunteers of this Symposium for everything

The Audience For The Patient Listening

ANY QUESTIONS