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R OLE OF VALIDATED AND
S TANDARDIZED H ERBAL
P RODUCTS -
A SCIENTIFIC APPROACH
Dr Capt Tanweer Alam
Head( AHP ) International Marketing
G ROWING I MPORTANCE

   Out of 252 drugs considered basic and essential
    by WHO , 11% are exclusively from plant origin
    and 28% are of synthetic origin but obtained
    from natural precursors
   Eighty Five percent (85%) people in developing
    countries still rely on traditional medicines as
    first choice for human health care (WHO).
T HE     COMPARISON OF SCOPE !




 Total world population
 Poultry : 19 Billion         Total world population
 Cattle : 1.5 billion         Human: 6.88 Billion
 Sheep and goat : 1.6 billion




              Source: FAOSTAT website
H ERBAL M ARKET:                                      A COMPARISON



                                                          Total Animal Health

                                                          Herbal Market

   Total Global Herbal Market
   100 Billion USD                             1.5
                                            Billion USD




                  Source: FAOSTAT website
                  & CLFMA REPORT 2009
H ERBAL U SAGE T RANSITION




Fr om          to   Shout
H ERBAL U SAGE T RANSITION



Don’t Ask ;   Usage with
Don’t Tell    reasoning
P OSITIVE T REND :
A CROSS THE S EGMENT AND S PECIES


               Digestive



 Respiratory                   Dermal




    Nutrient replacer
                           Stress care
G ROWING C REDENTIALS : T HE   REASONS
G ROWING C REDENTIALS : S TANDARDIZATION &
               B ETTER A NALYTICAL METHODS
G ROWING C REDENTIALS : S TANDARISATION &
              B ETTER A NALYTICAL METHODS




   A. paniculata   Bacopa monnieri   Zingiber officinale
G ROWING C REDENTIALS :
            AVAILABLE T ECHNICAL B ACK - UPS

Total number of research papers listed on PubMed
     containing the word "phytoconstituents."
G ROWING C REDENTIALS :
       A RRAY   OF H ERBAL M ONOGRAPHS



Publication and availability of authoritative
monographs by various organizations, improving
the scientific credibility of herbs.
G ROWING C REDENTIALS :
        A RRAY        OF H ERBAL M ONOGRAPHS

                           United States
                          Pharmacopoeia
                              ( USP )      Europe Scientific
                                              Cooperative
     Indian Herbal                                on
    Pharmacopoeia                            Phytotherapy
                                              (ESCOP)

                           Confluence of
                               Herbal
                           Pharmacopoeia        Chinese Herbal
 British Herbal                                 Pharmacopoeia
Pharmacopoeia


             English Translation
                      of           American Herbal
                  German            Pharmacopoeia
               Commissions             ( AHP )
               E monographs
INDIA

   2,50,000 flowering plants world wide
   India – 8th largest country in natural plants
   One of the largest flora bio diversity
   75% of the medicinal plants grow naturally
    in India.
   Scientific approch of herbal product development
4 cardinal
                focus points

Genuineness   Safety     Efficacy   Consistency
G ENUINENESS


 Test for Foreign Matter
                                              Contaminated
(i) Foreign organs: matter coming from
   the source plant but not defined as the
   drug.
(ii) Foreign elements: matter not coming
   from the source plant and of either
   vegetable or mineral origin. (viz,.         Free from
                                             contamination
   Moulds, insects and other animal
   contamination.)
G ENUINENESS


Organoleptic analysis

•   Colour
                                                 Coleus forskohlii Root
•   Shape                                        (Dried)
•   Odour
•   Taste



                        Coleus forskohlii
                        Root (Fresh)
G ENUINENESS


  HPTLC Finger print

Phytochemical profile checked by
Chromotographic techniques.
The samples are chromotographed reference standards
of marker constituents.
E FFICACY

Quantification of Markers / Actives
using HPLC




            High Performance liquid chromatography
E FFICACY




Estimation of Forskolin
using HPLC & TLC
E FFICACY

   LC/MS DETECTION:
   Powerful Tool for Organic Compound Analysis




Its application is oriented towards the specific detection and potential
entification of phytomarkers in the presence of other phytochemical
S AFETY

•   Physico-chemical [ Moisture, Ash, Acid insoluble ash,,Silica (Sand)]
•   Heavy metal residues (Pb, Cd, As, Hg)
•   Mycotoxin residues
•   Pesticide residues (organochloro pesticides and organophosphorous
    pesticides).
•   Organic volatile impurities (solvent residues-wherever applicable)
•   Naturally occuring toxins (like pyrrolizidine, alkaloids, beta asarone,
    cynogenic glycosides etc.)
•   Microbial Analysis for specific pathogens
CONSISTENCY

                    Batch to batch consistency




S – STANDARD MIX
T1- TEST SAMPLE (BATCH NO. AP/07, 24 MONTHS OLD SAMPLE)
T2- TEST SAMPLE (BATCH NO. AP/01005, 18 MONTHS OLD SAMPLE)
T3- TEST SAMPLE (BATCH NO. AP/02001, 12 MONTHS OLD SAMPLE)
T4- TEST SAMPLE (BATCH NO. AP/02006, 6 MONTHS OLD SAMPLE)

T5- TEST SAMPLE (BATCH NO. AP/02010, 1 MONTH OLD SAMPLE)
A BRIEF
   India’s No 1 Herbal Veterinary company for
    the last 60 years
   Pioneers in phyto-pharmaceuticals
   State-of-the-Art R&D with more than 100
    qualified scientists
O UR A CCREDITATIONS
O UR A CCREDITATIONS
C ORPORATE S OCIAL
                                                       RESPONSIBILITY




   Quarterly journal called “Journal of Natural Remedies” dedicated to
    Medicinal Plant research across the globe.




   A monthly magazine “Pashudhan”, dedicated to animal healthcare
    since 35 years and




   Launched a web portal “vetsjobsindia.com”, developed exclusively for
    communicating employment opportunities to vets.
tanweer@naturalremedy.com

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Role Of Validated And Standardized Herbal Products

  • 1. R OLE OF VALIDATED AND S TANDARDIZED H ERBAL P RODUCTS - A SCIENTIFIC APPROACH Dr Capt Tanweer Alam Head( AHP ) International Marketing
  • 2. G ROWING I MPORTANCE  Out of 252 drugs considered basic and essential by WHO , 11% are exclusively from plant origin and 28% are of synthetic origin but obtained from natural precursors  Eighty Five percent (85%) people in developing countries still rely on traditional medicines as first choice for human health care (WHO).
  • 3. T HE COMPARISON OF SCOPE ! Total world population Poultry : 19 Billion Total world population Cattle : 1.5 billion Human: 6.88 Billion Sheep and goat : 1.6 billion Source: FAOSTAT website
  • 4. H ERBAL M ARKET: A COMPARISON Total Animal Health Herbal Market Total Global Herbal Market 100 Billion USD 1.5 Billion USD Source: FAOSTAT website & CLFMA REPORT 2009
  • 5. H ERBAL U SAGE T RANSITION Fr om to Shout
  • 6. H ERBAL U SAGE T RANSITION Don’t Ask ; Usage with Don’t Tell reasoning
  • 7. P OSITIVE T REND : A CROSS THE S EGMENT AND S PECIES Digestive Respiratory Dermal Nutrient replacer Stress care
  • 8. G ROWING C REDENTIALS : T HE REASONS
  • 9. G ROWING C REDENTIALS : S TANDARDIZATION & B ETTER A NALYTICAL METHODS
  • 10. G ROWING C REDENTIALS : S TANDARISATION & B ETTER A NALYTICAL METHODS A. paniculata Bacopa monnieri Zingiber officinale
  • 11. G ROWING C REDENTIALS : AVAILABLE T ECHNICAL B ACK - UPS Total number of research papers listed on PubMed containing the word "phytoconstituents."
  • 12. G ROWING C REDENTIALS : A RRAY OF H ERBAL M ONOGRAPHS Publication and availability of authoritative monographs by various organizations, improving the scientific credibility of herbs.
  • 13. G ROWING C REDENTIALS : A RRAY OF H ERBAL M ONOGRAPHS United States Pharmacopoeia ( USP ) Europe Scientific Cooperative Indian Herbal on Pharmacopoeia Phytotherapy (ESCOP) Confluence of Herbal Pharmacopoeia Chinese Herbal British Herbal Pharmacopoeia Pharmacopoeia English Translation of American Herbal German Pharmacopoeia Commissions ( AHP ) E monographs
  • 14. INDIA  2,50,000 flowering plants world wide  India – 8th largest country in natural plants  One of the largest flora bio diversity  75% of the medicinal plants grow naturally in India.
  • 15. Scientific approch of herbal product development
  • 16. 4 cardinal focus points Genuineness Safety Efficacy Consistency
  • 17. G ENUINENESS Test for Foreign Matter Contaminated (i) Foreign organs: matter coming from the source plant but not defined as the drug. (ii) Foreign elements: matter not coming from the source plant and of either vegetable or mineral origin. (viz,. Free from contamination Moulds, insects and other animal contamination.)
  • 18. G ENUINENESS Organoleptic analysis • Colour Coleus forskohlii Root • Shape (Dried) • Odour • Taste Coleus forskohlii Root (Fresh)
  • 19. G ENUINENESS HPTLC Finger print Phytochemical profile checked by Chromotographic techniques. The samples are chromotographed reference standards of marker constituents.
  • 20. E FFICACY Quantification of Markers / Actives using HPLC High Performance liquid chromatography
  • 21. E FFICACY Estimation of Forskolin using HPLC & TLC
  • 22. E FFICACY LC/MS DETECTION: Powerful Tool for Organic Compound Analysis Its application is oriented towards the specific detection and potential entification of phytomarkers in the presence of other phytochemical
  • 23. S AFETY • Physico-chemical [ Moisture, Ash, Acid insoluble ash,,Silica (Sand)] • Heavy metal residues (Pb, Cd, As, Hg) • Mycotoxin residues • Pesticide residues (organochloro pesticides and organophosphorous pesticides). • Organic volatile impurities (solvent residues-wherever applicable) • Naturally occuring toxins (like pyrrolizidine, alkaloids, beta asarone, cynogenic glycosides etc.) • Microbial Analysis for specific pathogens
  • 24. CONSISTENCY Batch to batch consistency S – STANDARD MIX T1- TEST SAMPLE (BATCH NO. AP/07, 24 MONTHS OLD SAMPLE) T2- TEST SAMPLE (BATCH NO. AP/01005, 18 MONTHS OLD SAMPLE) T3- TEST SAMPLE (BATCH NO. AP/02001, 12 MONTHS OLD SAMPLE) T4- TEST SAMPLE (BATCH NO. AP/02006, 6 MONTHS OLD SAMPLE) T5- TEST SAMPLE (BATCH NO. AP/02010, 1 MONTH OLD SAMPLE)
  • 25. A BRIEF  India’s No 1 Herbal Veterinary company for the last 60 years  Pioneers in phyto-pharmaceuticals  State-of-the-Art R&D with more than 100 qualified scientists
  • 26. O UR A CCREDITATIONS
  • 27. O UR A CCREDITATIONS
  • 28. C ORPORATE S OCIAL RESPONSIBILITY  Quarterly journal called “Journal of Natural Remedies” dedicated to Medicinal Plant research across the globe.  A monthly magazine “Pashudhan”, dedicated to animal healthcare since 35 years and  Launched a web portal “vetsjobsindia.com”, developed exclusively for communicating employment opportunities to vets.

Editor's Notes

  1. The market is increasing on all fronts. This includes consumer purchases from health food stores, drugstores, grocery stores as well as mass market outlets. Increased demand is reflected in the growth of multilevel marketers; Amway is now selling herbs! So is Shaklee and many others.It is no longer correct to say that they are going mainstream - they are mainstream!When you take aspirin for a headache, you are essentially practicing herbalism in a sense. Why? Aspirin comes from the inner bark of the Willow tree. Obviously, it does not come in the form of a tablet, but there is no denying the relief you obtain from taking it is from the plant derivative of that bark
  2. Liquid chromatography–mass spectrometry (LC-MS) is an analytical chemistry technique that combines the physical separation capabilities of liquid chromatography (or HPLC) with the mass analysis capabilities of mass spectrometry. LC-MS is a powerful technique used for many applications which has very high sensitivity and selectivity. Its application is oriented towards the specific detection and potential identification of phytomarkers in the presence of other phytochemical (in a complex mixture). LC/MS adds additional confidence to quantification enabling to obtain limits of detection which can be up to 1000 times greater than UV detection. Sensitivity and specificity both prevail in high abundance with this detector, which decrease costs and increases confidence.