Anurag Agarwal Chief Operating Officer Natural Remedies Pvt Ltd. Bangalore

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I ndian Herbals Global opportunities Anurag Agarwal Chief Operating Officer Natural Remedies Pvt Ltd. Bangalore Time : Date : 28 th June, 2007 16.00 pm to 17.30 pm Venue: Hotel Marriot, Hyderabad

WORLD HERBAL MARKET *Global herbal market - 62 billion USD/year The Planning Commission of India targets that export of medicinal plant based products to be Rs. 2.5 billion by 2010 Ref: *Gautam V, et al, Exporting Indian healthcare, (2002), Export-Import Bank of India. ^Times of India September 30, 2002

Herbal Dietary supplements Herbal Cosmetics F&B with herbal contents Vitamins and micronutrients 12.53% 5.37% 6.12% 75.98% Ref: National Herbal products Survey, U.S.A., 1997

U.S.A Japan Australia Selected parts of Europe Rest of the world 60% 10% 10% 10% 10% The scenario is changing with emerging markets like Latin America

Strong traditional support- mainly from Ayurveda Plants used for centuries safety margin very high Availability of herbs for variety of indications like sugar/ weight management, cholesterol/ lipid lowering, Energy boosters etc.. Rich Indian biodiversity Positive government policies towards herbal sector Herbal Industry in India is increasingly becoming research based

GLOBAL RECOGNITION FOR INDIAN PLANTS Scientific publications on many Indian plants are on a upward trend Researchers in the west are now working on Indian plants Nutraceutical segment is growing worldwide and people are looking for newer options everyday. Monographs on Indian herbs are being published in the west Eg: Monograph on Withania somnifera by American Herbal Pharmacopoeia Knowledge of Ayurveda is being spread due to globalization

As crude drugs/raw herbs As standardized extracts As finished formulations (generally polyherbal) As phytochemicals / pure isolates

Herbal extracts containing known amounts of active / markers constituents Expected to ensure consistency in biological activity Considered as ready raw materials for incorporation in herbal products (nutraceuticals( nutraceuticals,, medicine, cosmetics ), food/ beverages etc. Lower incorporation as compared to crude herbs Comply to safety tests like pesticides, solvent residues, microbial ial burden etc. as per international requirements Supplied in bulk quantities Ideal for Nutraceutical segment

Standardized herbal extracts- A view point Present strenghts Manufacturing facilities (GMP compliant) Safety related QC Microbial counts Aflatoxins Pesticide residues Opportunities Linking bioactivity of herbs to its constituents (Bitter gourd : active constituents unknown) Clinical trials - RCTs Animal efficacy studiesincreasing evidence (Bitter gourd : > 25 publications) Thorn in the flesh : Regulatory requirements vary from country to country

Case studies : Knowledge of Active constituents 3 Categories Typical Example Main use(s) Bio-active constituent(s) Remarks 1 Andrographis paniculata (Kalmeg) Hepatoprotective Andrographolid e Well known & accepted 2 Bacopa monnieri (Brahmi) Learning & Memory Bacoside A Confusion in chemical identification & hence in QC NRPL - Original work 3. Tribulus terrestris (Gokhru) Aphrodisiac... Antiurolithiatic... Anti-inflammatory... inflammatory... Expectorant... Anthelmintic.....?..?..?..? Tribulosin Bioactive constituents unknown NRPL- Bioactivity guided fractionation

Development of a branded standardised extract of Bacopa monnieri Ambiguities in bacoside A structure in the literature At NRPL bacoside A was found to be a mixture of four saponins Efficient HPLC method developed. Geographic variations studied Unique extraction method for consistent composition.

HPLC of Bacoside A Saponins in Bacopa monnieri Example of geographic variation Bacoside A saponins NRPL Bacopa extract Bacoside A standard

Efficacy studies Journal of Natural Remedies, 7(1), 166-173 173 Journal of Science and Healing (Submitted, under review) Safety studies Phytomedicine,, 14, 301-308 308 Food and Chemical Toxicology (In Press). Biomedical and Environmental Sciences (In Press) Chemistry / Analytical studies Phytomedicine, 11, 264-268 (2004) Phytochemical analysis, 16(1), 24-29 (2005) Overall, more than 20 research articles have been published by NRPL on various aspects related to Bacopa monnieri.

Backed with original work done on Chemistry and quality control Efficacy studies in animals and humans Safety studies in animals and humans Mechanism studies in vitro Patent pending We are able to create a distinction between BacoMind and other unbranded extracts of Bacopa in the market

Opportunities created for BacoMind Nutraceuticals Tea Herbal medicine Food use GRAS status being explored

GLOBAL OPPORTUNITIES FOR INDIAN HERBALS Animal Healthcare segment In India, herbal animal healthcare market is growing at a faster rate Herbal products are preferred in many areas due to safety and cost reasons NRPL is one of the market leaders Important segments Poultry Cattle Piggery

SOME ESTABLISHED HERBAL PRODUCTS FOR ANIMAL HEALTHCARE POULTRY : Product Name Zigbir Natchol NaturaLiv Zist Gout-Ease Main use Natural Performance Enhancer Natural Alternative to synthetic choline chloride Liver tonic and productivity booster Complete stress manager Complete solution for prevention and treatment of gout

SOME ESTABLISHED HERBAL PRODUCTS FOR ANIMAL HEALTHCARE CATTLE : Product Name BucoFert Bucomin- E Topicure Spray Involon Main use Oestrus inducer with power of Phytoestrogens Source of trace minerals- enriched with Vitamin E To treat deep seated and maggotted wounds Uterine tonic and ecbolic

SOME ESTABLISHED HERBAL PRODUCTS FOR ANIMAL HEALTHCARE PIGGERY : Product Name Hygestin Main use Growth promoter Piggelo Prevents weaning diarrhea Topicure Total topical cure Zist For pregnant sows

What more can be done to augment growth of Indian herbal products Every country generally has a positive list of plants which can be used. Many important Indian plants are not listed in the positive lists Thus path for entry is blocked.

Other constraints for exporting Indian herbal products Need for sufficient scientific information on many plants (Scientific efforts are required) Need for RCTs (Clinical trials should be encouraged) Need for standardization and quality control protocols (Knowledge of active constituents is required) Patent hurdles (Commodities will get into difficulty) Need for understanding of regulatory requirements of different countries (Government help is needed)

Global opportunities for Indian Herbals are on the rise Generation of scientific information can help in increasing global opportunities Indian companies are investing more in research to en-cash on the global opportunities Indian Government to play active part to get Indian medicinal plants approved in various countries