challenges , their reasons , outcomes, solutions to overcome and initiatives taken ...

1. -JASMINE KAUR
M.PHARM (IST YEAR)

2. INTRODUCTION
 Medicinal plants have been major sources of drugs for
thousands of years, even popular today.
 Unani and Ayurvedic system of medicines are classic and oldest
examples.
 Around 80% of population in developing countries is dependent
upon the plants for their primary health care.
 In developed countries also one-fourth of population prefer
herbal medicines.
 Herbal drugs have know been found to be effective against
chronic ailments such as metabolic and degenerative disorders.

3. Estimated that about 25,000 licensed pharmacy of Indian systems of
medicine (ISM).
Presently, about 1,000 single drugs and about 3,000 compound
formulations are registered.
A Herbal industry in India uses about 8,000 medicinal plants.
However, none of the Pharma has standardized herbal medicines
using active compounds as markers linked with confirmation of
bioactivity of herbal drugs in experimental animal models.
From about 8,000 drug manufactures in India, there are however not
more than 25 manufactures that can be classified as large-scale
manufactures.
The annual turnover of Indian herbal industry was estimated around
US$ 300 million in Ayurvedic, and Unani medicine was about US$
27.7 million.

4. 1. Ansar Drug Laboratories, Surat
2. Acis Laboratories, Kanpur
3. Amil Pharmaceutical, New Delhi
4. Allen Laboratories, Kolkata
5. Bharti Rasanagar, Kolkata
6. Dabur India Ltd., Ghaziabad (www.dabur.com)
7. Dattatraya Krishan Sandu Bros., Mumbai
8. Herbals Pvt. Ltd., Patna
9. Herbo-med (P) Ltd., Kolkata
10. The Himalaya Drug Co., Bangalore (www.himalayawellness.com)
11. Indian Herb and Research Supply Co., Saharanpur
12. J & J Dechane Laboratories Pvt. Ltd., Hyderabad
13. Madona Pharmaceutical Reaearch Pvt. Ltd., Kolkata
14. Kruzer Herbals, New Delhi
15. Shilpachem, Indore
16. Hamdard (Wakf) Laboratories, Delhi (www.hamdard.in)
17. Zandu Pharmaceutical Works Ltd., Mumbai (www.zanduayurveda.com)
18. Baidyanath Ayurveda Bhavan, Jhansi (www.baidyanath.com)
19. Charak Pharmaceuticals, Mumbai
20. Natural Remedies Pvt. Ltd., Banglore (www.naturalremedy.com)
21. Sami Labs Limited, Banglore (www.samilabs.com)
22. Patanjali Ayurved Ltd.

5. Herbal Medicines
Includes herbs, herbal materials, herbal preparations and
finished herbal products, that contain as active ingredients parts
of plants, or other plant materials or combinations.
Herbal Formulation
A dosage form consisting of one or more herbs or processed
herb(s) in specified quantities to provide specific nutritional,
cosmetic benefits, and/or other benefits meant for use to
diagnose, treat, mitigate diseases of human beings or animals
and/or to alter the structure or physiology of human beings or
animals.

6.  Herbal preparations are obtained by subjecting herbal substances to
treatments such as extraction, distillation, expression, fractionation,
purification, concentration or fermentation.
 Herbal preparations includes powdered substances, tinctures,
extracts, essential oils, expressed juices and processed exudates.
 Ayurvedic herbal formulations-
• Solid dosage forms- Gutika and Churna
• Semisolid – Avaleha and Ghrita
• Liquid – Asava, Arishta, Taila
Other herbal formulations includes Tablets, Capsules, Gels, Herbal
creams, lotions, pastes, shampoos, conditioners, Herbal Tea etc.
Novel formulations like- polymeric nanoparticles, nanocapsules,
liposomes, phytosomes, nanoemulsions, transferosomes, microsphere
and ethosomes etc.

7.  Global market of herbal industry shares about US $62 billion
per annum.
 Herb drug production of India is about US $10 billion per
annum with annual export of US $ 1.1 billion while China is
worth US $48 billion with export of US $ 3.6 billion per annum.
 India is having just 2% global herbal market share.
 India is lagging behind because of these major factors-
• Lack of scientific validation and standardization.
• Lack of Quality and regulatory aspects.
• Limited evidence based studies on efficacy and safety.
• Lack of pharmacokinetic studies of bioactive molecules.

8. Lack of scientific validation and standardization
Standardisation: The process of evaluating the quality and purity of
crude drugs by means of various parameters like morphological,
microscopical, physical, chemical and biological observations.
 Accuracy of plant identification, evaluation, and isolation of active
ingredients is key challenge.
 Active ingredients in plants are in complex form and needs special
precautions, because a single medicinal plant consist of hundreds of
constituents.
 Medicinal plant properties are influenced by the time of collection, area of
plant origin and environmental conditions.
 Hence scientific validation and technological standardization of herbal
medicines is needed for the future advancement of herbal formulation.

9. Lack of Quality and regulatory aspects
 Quality control(QC) of herbal formulations is required for its safety and
efficacy .
 QC assures quality products that reduce the risks associated with herbal
medicine.
 Regulation and legislation of herbal medicines has been enacted in very
few countries.
 Most countries do not have any proper regulation of botanicals and
quality of herbal products sold is generally not guaranteed.
 European countries- regulated by the European Directive on Traditional
Herbal medicinal products.
 UK- MHRA (Medicines and Healthcare products Regulatory agency)
 India- AYUSH

10. QUALITY EVALUATION
OF HERBAL DRUGS
Quality Evaluation of Herbal drugs

11. Limited evidence based studies on efficacy and safety
 Evidence based studies on the efficacy and safety of traditional Indian medicines are
limited.
 The essential ingredient in most formulations are not precisely defined.
 This is one of the most important challenge to scientists attempting to identify a
single bioactive compound.
 In depth studies and more stringent conditions should be followed to make a herbal
formulation so that the role of each and every component is known.
 In order for a drug regulatory agency to meet the high expectations of the public,
there is need for well designed, randomized, double-blind and placebo- controlled
clinical trails to establish the safety and efficacy of herbal medicines with allopathic
drugs.
 Systemic clinical trails will provide new opportunities for basic and applied
research in the areas of herbal products and ayurvedic remedies used in India.

12. Lack of pharmacokinetic studies of bioactive molecules
 Efficacy of drug depends upon its composition as herbal products
have complex composition.
 In vitro assays are cheap and easy, but in herbal preparations
sufficient concentration of active constituents at the site of action is
difficult.
 Herbal formulations because of which lack data on their disposition,
and biological fate in humans.
 Pharmacokinetics are vital – Drug development process of
understanding ADME.
- To know herbo-drug interaction.
- Elucidation of metabolic pathways which yields potentially new
active compounds and assessment of elimination route and their
kinetics.

13. Degradation of forests
 Degradation of forests posses threat to wild species of plant.
 10% of medicinal plants are obtained from cultivated sources rest are obtained
from wild sources.
 Nationwide Survey done by NMPB (National Medicinal Plants Board) found
that 77% medicinal plants used in the country are sourced from forests and
wastelands.
 About 50% of the tropical forests have been destroyed.
 According to international union for conservation of nature (IUCN) 19 species in
India have been extinct and 149 species have been endangered.
 Hence protection of medicinal plants and to grow them for our needs is the major
challenge and necessity.
 We need to find methods for their cultivation and other alternatives.
 Plant cell or tissue culture, clonal propagation, mass propagation potential
strategies can be incorporated.

14. INITIATIVES TAKEN SO FAR ……
 In 2000 GMP came for Ayurvedic, Siddha and Unani.
 Monographs on herbs and herbal products got included in Indian Pharmacopeia (IP)
- 59 monographs in 2007 IP - 89 monographs in 2010 IP
 In 2005, Ayurvedic Pharmacopeia of India included 258 different drugs and the Indian
Herbal pharmacopeia included 52 monographs.
 About USD 158 million (INR 775 crore) has been allocated to the AYUSH Department
during 10th five year plan.
 In 2000 NMPB was set up has taken many schemes for conservation of rare, endangered
species with outlay of USD 65.2 million.
 The Traditional Knowledge Digital Library (TKDL) is the first Indian effort and is a
proprietary and original database of traditional knowledge based on medicinal plants.
 The TKDL incorporates about 212,000 medicinal formulations from 148 books available
in public domain has signed and TDKL database access is approved to International
Patent offices.