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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 A Presentation By Sanju Nanda M.Pharm., Ph. D (IITD), LLB. (Hons) Department of Pharm. Sciences M.D.University, Rohtak (India) [email protected] 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 Indian Regulators • • • • • CDSCO Schedule ‘S’, ‘Q’, ‘M II’ BIS AYUSH Ministry For Consumer Affairs 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: NATURAL PRODUCTS TREATED AS HARMLESS, INERT AND SAFE . POSITIVE CONSUMER ATTITUDE TOWARDS NATURALS 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 Increased Use of Botanicals and other Naturals in Cosmetics Concerns… Are Are Are Are they they they they really effective ? really required ? stable ? 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 Indian Certification Schemes for Food, Drugs and Cosmetics 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. 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 5300µm. 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 Release can also be controlled through diffusion pressure, temperature etc. Drug that is already in vehicle will be absorbed in skin Vehicle become unsaturated and equilibrium disturbed Flow of drug from vehicle into the skin Flow of drug from microsponge particle to vehicle 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