Role of validated and standardized herbal products ; A scientific approach

Post on 25-May-2015

362 views 2 download

Tags:

transcript

Dr Capt Tanweer AlamHead( AHP ) International Marketing

ROLE OF VALIDATED AND STANDARDIZED HERBAL PRODUCTS-A SCIENTIFIC APPROACH

25th Oct 2011Sun Moon Lake, Nantau, Taiwan

GROWING IMPORTANCE

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).

THE COMPARISON OF SCOPE!

Source: FAOSTAT website

Total world population Poultry : 19 BillionCattle : 1.5 billionSheep and goat : 1.6 billion

Total world population Human: 6.88 Billion

HERBAL MARKET: A COMPARISON

Source: FAOSTAT website & CLFMA REPORT 2009

1.5 Billion USD

Total Global Herbal Market 100 Billion USD

Total Animal Health

Herbal Market

HERBAL USAGE TRANSITION

Shhh… Shout!!!!From to

HERBAL USAGE TRANSITION

Don’t Ask ; Don’t Tell Usage with reasoning

POSITIVE TREND: ACROSS THE SEGMENT AND SPECIES

Digestive

Respiratory Dermal

Nutrient replacerStress care

GROWING CREDENTIALS : THE REASONS

GROWING CREDENTIALS : STANDARDIZATION & BETTER

ANALYTICAL METHODS

Standardization is the process by which one or more active ingredients of an herb are identified, and all batches of the herb produced by a single manufacturer contain the same amount of active

Standardisation and better analytical methods

TLC ProfilesA. paniculata Bacopa monnieri Zingiber officinale

GROWING CREDENTIALS : STANDARISATION & BETTER ANALYTICAL METHODS

GROWING CREDENTIALS:AVAILABLE TECHNICAL BACK-

UPS

Total number of research papers listed on PubMed containing the word "phytoconstituents."

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.

INDIA

Scientific approch of herbal product development

Ethnomedical information

Selection and standardization of in vitro

assays

Screening Program

(Selection of plants, parts,

solvent)

Bioactivity guided

fractionation

Standardization and

Chemical fingerprinting

Development of prototype/ formulation (Based on

compatibility studies)

Validation of safety and

efficacy using in vivo models

Field trials

Commercial production

4 cardinal focus points

Genuineness Safety Efficacy Consisten

cy

(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,.

Moulds, insects and other animal

contamination.)

Free from contamination

Test for Foreign Matter

Contaminated

GENUINENESS

Coleus forskohlii Root (Dried)

Coleus forskohlii Root (Fresh)

Organoleptic analysis

• Colour

• Shape

• Odour

• Taste

GENUINENESS

Phytochemical profile checked by

Chromotographic techniques.

The samples are chromotographed reference standards

of marker constituents.

HPTLC Finger print

GENUINENESS

EFFICACY

Quantification of Markers / Actives using HPLC

High Performance liquid chromatography

Estimation of Forskolin using HPLC & TLC

EFFICACY

EFFICACY

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

SAFETY

• 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

OUR ACCREDITATIONS

OUR ACCREDITATIONS

CORPORATE SOCIAL 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