Herbals in pharma industry

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A brief college level seminar for Herbals in pharma industry... Short n Sweet... Regards...Swapnil M. Sanghavi

Transcript of Herbals in pharma industry

  • 1.HERBALS In Pharmaceutical industry 1/26

2. CONTENTS:-

  • Why we should include herbs in pharmaceuticals?
  • Points to be look over precisely before introducing herbs in pharmaceuticals.
  • WHO GUIDELINE Assessment for modern herbal medicines - A brief outline.
  • Regulatory status of herbs OR herbal medicines in US & UK.
  • Importance of herbs in pharma industries- Asian perspectives.
  • Some herbal preparations - Traditional and modern available in market.

/26 2 3. Why we should include herbs in pharmaceuticals? 3 4. 1. HERBS ARE IMPORTANT SOURCE OF LEAD GENERATION:- 4 DRUG DRUG OF CHOICE IN ORIGINAL SOURCE DIGOXIN CCF FLOXGLOVE COLCHICINE GOUT COLCHICUM SEEDS QUININE MALARIA CINCHONA CROMOGLYCATE SODIUM ASTHMA IN CHILDRENAMI MAJUS. 5. 2 NDREASON:-

  • Today,Weare living in the era of allopathic
  • butunfortunately not successfulso much yet
  • thatwe can develop safer new molecules for d iseases like cancer, AIDS, diabetes etc .

5 6. Plant name/familyDrugsTreatmentCathranthus rosesusL. (Apocynaceae)Vinblastine and vincristine Hodgkins, Lymphosarcomas and children leukemia.Podophyllum emodiWall. (Beriberidaceae)Podophyllotaxin,Testicular cancer, small cell lung cancer and lymphomas.Taxus brevifolius(Taxaceae)Paciltaxel, taxotereOvarian cancer, lung cancer and malignant melanoma.Mappia foetidaMiers.Comptothecin, lrenoteccan and topotecanLung, ovarian and cervical cancer.Comptotheca acuminataQuinoline and comptothecin alkaloidsused in Japan for the treatment of cervical cancerJuniperus communisL. (Cupressaceae)Teniposide and etoposieLung cancer 7. 3 rdreason:- Market potential of phytomedicine 7 CountryYearsDrugs sales in US $ (billion)1EuropeGermanyFranceItalyOthers2006 63.01.60.60.82Europe2006 10.03USA2006 4.04India2006 1.05Other countries2006 5.06All countries2006 30.0 - 60.0 8.

  • Points to be look over precisely
  • before introducing
  • herbs
  • in
  • pharmaceuticals.

8 9.

  • standardization of herbs
  • Procurement from the correct source
  • Identity of Common Adulterants by microscopy or other techniques
  • Quality of the herb
  • Toxicity studies
  • Herbal and Drug Interaction

/26 9 10. WHO GUIDELINE Assessment for modern herbal medicines - A brief outline.

  • Guideline available on following topics:-
  • Pharmaceutical assessment
  • Crude plant material
  • Plant preparations
  • Finished product
  • Stability assessment and shelf life
  • Activity
  • Evidence required to support indication

10 11. These guidelines describe

  • Quality control of crude drugsmaterial, plant preparations and finished products.
  • Stability assessmentand shelf life.
  • Safety assessment ; documentation of safety based on experience ortoxicological studies .
  • Assessment of efficacy bymedical information andbiological activity evaluations.

11 12. Last amendments in guidelines:-

  • Following new points are included:-
  • 1.Limits of pesticides
  • Mainly pesticides likeDDT, BHC, toxaphene, and aldrincause serious side-effects in human beings if the crude drugs are mixed with these agents.
  • 2. Limits of microbial contamination
  • 3. Radioactive contamination

12 13.

  • REGULATORY STATUS OF HERBS AND HERBAL PRODUCTS
  • A LOOPHOLE IN US AND EUROPE GUIDELINE..???

13 14.

  • Manufacturers have to provide scientific evidence of safety and efficacy of their products.
  • In early 60s,
  • in Europe and US someAsian medicine producersbegan marketing their products as nutritional supplementsusinga legistative loophole which allowed the products with no proven efficacy to be marketed as long as no claims of efficacy on the label.
  • For example:
  • Asian medicine producers made claim that
  • St.johns wart enhances the mood
  • Instead of claiming that st.johns wart treats dipression.
  • By using this loophole in claiming and labeling a new dimension of herbal products that is known as the NUTRACEUTICALS has come out.
  • Based on this facts no. of asian producers are enjoying profits by getting marketing authorization of their products in foreign market.

15.

  • Importance of herbs in pharma industries
  • - Asian perspective.

15 16.

  • 2 major players :-
  • China and India
  • Share in global herbal and herbal product market :-
  • Total global market:- 60 billion US$
  • India sharing:- only 1% of it
  • China sharing :- 30 % of it.

16 17. Why china is ahead of India in global herbal market?

  • Reasons:-
  • Most of the Chinese medicines are standardized.
  • which increase its authenticity in global market.
  • 2. China has created the data base of its encient knowledge of herbs with modern flavor.

17 18. CDB example: CNPD- China Natural Products Database 18 19. What we (Indian companies) have achieved ?

  • No of Indian companies have patented their products in india as well as abroad.
  • Examples:
  • Himalaya Drug Company (HDC), Emami, Aswini, Ayur, Dabur.

19 20. HDC patented its Herbal Laxativepreparation for treatment of constipation inFebruary 2001 in the US .HDCs 5 products have been endorsed by more than 250,000 doctors worldwide, and thecompany exports its products to more than 60 countries .Today, HDC is theonly phytopharmaceutical company whose ayurvedic products are registeredas apharmaceutical specialty inSwitzerland. Dabur, which owns 29 patents in the US, is amongst the leaders in healthcare. It became one of the only two companies in the world to introduce an anti-cancer drug, Intaxel (Paclitaxel). 20 21. Some herbal preparations:- traditional preparations:

  • Asva/Arista- drug is soaked in solution of jaggery and allowed to ferment.
  • Avaleha/Pak - kalka (decoction) of drug is repeatedly boiled and condensed with jaggery
  • Bhasma- prepared by heating (oxidation) of drug
  • Churna- a form of powder.
  • Gutika/vati/Pill- pulverized drug admixed with honey and made up into Gutika or vati or Pill.

/26 21 22. Modern concept of dosage form:

  • Tablet (plain or sugar coated or film coated)
  • lozenges
  • capsule (hard or soft)
  • liquid orals (suspension or emulsion or syrup)
  • external application (cream or ointment)

22 23.

  • Available herbal formulation with modern touch:
  • Mexican Wild Yam 60 Capsules
  • Beetroot Complex 90 Capsules
  • Concentrated Cranberry Powder 40G
  • Ginkgo Plus 90 Capsules
  • Garlic Plus 30 Capsules
  • Ginseng 60 Capsules
  • Milk Thistle Plus Tea

23 24. REFERENCES:-

  • 1. Figures as quoted by Asia-Pacific Traditional Medicine and Herbal Technology Network:APTMNET.COM
  • 2. India: Herbal Revolution Waiting to Happen,www.apctt-tm. net, 25 May 2005.
  • 3. US relaxes its guidelines on herbal supplements
  • BMJ2000;320:208
  • 4.Current status of herbal and their future perspectives
  • R. Perumal Samy, and P. Gopalakrishnakone*Council of Scientific and Industrial Research ,New Delhi
  • 5.WHAT IS INDIAN PHARMAS NEXT MOVE?
  • iPrexsolutions.com
  • 6. Herbal drugindustry ; chaudhary R.D. 8 thedition .1999

25 25. THANKS [email_address]