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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




25th Oct 2011
Sun Moon Lake, Nantau, Taiwan
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 ; A scientific approach

  • 1. R OLE OF VALIDATED AND S TANDARDIZED H ERBAL P RODUCTS - A SCIENTIFIC APPROACH Dr Capt Tanweer Alam Head( AHP ) International Marketing 25th Oct 2011 Sun Moon Lake, Nantau, Taiwan
  • 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.