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approaches for conducting preclinical and clinical research. One of the ef-
fective approaches could be to adopt retrospective studies in hospitals and
clinicians’ practice of a disease or herb. Since uniform practice methods are
not adopted in documentation and record maintenance, this approach is
challenging.
43
Analytical and chemical fingerprinting studies on ayurvedic
phytochemicals could be a field of interest and investigation as they offer a
direct path for the emergence of newer therapeutic agents. Furthermore,
when chemical structures of the active molecules are identified, it provides a
foundation platform for synthetic and medicinal chemists to enhance their
efficacy or nullifies toxicity properties or even creates synthetic analogs with
varied pharmacological actions targeting different diseases. For the con -
venience of Ayurvedic drug discovery, the plants widely used in Ayurveda
could be classified into 2 groups.
(a) The plants with known active constituents for which sufficient leads
are available and their biological targets have been identified. Some
well-known Ayurvedic leads and their molecular targets in cancer
therapeutics have been discussed in detail by Aggarwal et al.
44
A
comprehensive summary of Ayurvedic plants and the ir biological
targets are listed in Table 13.3.
31
(b) Botanicals with known treatment targets and proven medicinal value
based on scientific evidence are listed in Table 13.4.
31
The linkage
between ‘‘the past’’ and ‘‘the future’’ of medicine could give us new
directions for better understanding health, disease, and possible
solutions.
13.6 Ayurveda-based Approach in Drug Discovery
13.6.1 Advantages
The plants used in Ayurveda have a long history of human use enriched with
bioactive compounds belonging to wide chemical classes when compared to
synthetic small molecules and the active molecules isolated from these
plants are more likely to be safe and active. In addition, thi s minimizes the
challenges in synthesizing new compounds and evaluating their efficacy and
safety. Quinine from Cinchona officinalis, reserpine from Rauwolfia serpen-
tina, and digitalis from Digitalis purpurea are some examples of the drugs
identified from tradition al knowledge.
45
In some instances, natural com-
pounds with less potency and/or more toxicity are chemically modified to
enhance their efficacy. Analogs of these compounds can be developed
through chemical compounds followed by chemical derivatization through
semi-synthesis using the botanical product as a starting point. One of the
classic examples is Salicin from the Salix tree. This compound was hydro-
lyzed into salicylic acid and its semi-synthetic derivative is acetyl salicylic
acid which has been developed as aspirin, a pain reliever.
46
There are nu-
merous examples of natural product-based phytoconstituents that have been
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modified chemically, viz., morphine (Papaver somniferum), colchicine
(Colchicum autumnale), penicillin G (Penicillium citrinum), paclitaxel (Taxus
brevifolia), metformin (Galega officinalis), etc.
20
The proven success of these
examples set the stage for ongoing drug discovery efforts from natural
resources.
13.6.2 Concerns
As medicinal plants gain popularity with increased scientific and com-
mercial attention, there is a downside which is causing a burden on the wild,
naturally grown plant populations from which these plants are harvested.
Overharvesting leads to the risk of extinction of many valuable medicinal
species. When these plants are exploited for commercial production, it re-
sults in the unavailability of indigenous medicine to native people who live
in these areas and have relied on them for many generations. Unfortunately,
about 15 000 medicinal plant species may be threatened with extinction
worldwide and experts estimate that one potential drug is lost from the Earth
every two years.
47
In India, the Government has banned the use of about 29
plants and their worthy products as these species are considered
endangered.
48
Discovering drugs from natural resources does come with some risks, in
particular to the environment. To avoid the excessive harvesting of medi-
cinal plants, trees, and shrubs, the production could be achieved through
cultivation. If only the leaves and flowers are required, it is necessary to leave
the root, and whole-plant harvesting results in the extinction of that species.
Even though naturally occurring botanical comp ounds exhibit desirable
relevant bioactivities, obtaining intellectual property (IP) rights for these
nonmodified compounds is a hurdle as a new patent law doesn’t permit
patenting of naturally-occurring compounds in their original form, but legal
frameworks vary between countries.
49
13.7 Future of Botanical Drug Development
13.7.1 Pharmaceutical Industry – Future Trends
As per IQVIA’s recent report, the global pharma market is expected to grow at
the rate of 3–6% all the way through to 2025, and the total market size could
reach about $1.6 trillion US dollars. This excludes spending on covid-19
vaccines, which is projected to be $157 billion. Immunology, oncology, and
neurology are the therapeutic areas of focus and they represent the largest
aggregate contributors and a fair share to the growth during the next 5 years
from the continued flow of new medicines. Among these, oncology and
immunology are forecast to grow at a rate of 9–12% until 2025. Oncology
alone is projected to include about 100 new treatment drugs to the total
spending of $260 billion US dollars. Neurology is expected to see novel mi-
graine therapies and potential therapies for memory disorders, and
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Table 13.3 Successful lead compounds isolated from Ayurvedic plant products, their biological targets, and therapeutic effects. Adapted
from ref. 31 with permission from Taylor & Francis, Copyright 2007.
Plant name Ayurvedic name
Lead compound
(structures are given
in the figure) Biological targets/mechanism of action Therapeutic effects
Adhatoda
Vasika
Vasaka Vasicine Inhibition of histamine release, clearance
of airway passages. Uterine stimulant
Bronchodilator and expectorant
Allium sativum Lasuna Allicin Inhibition of cysteine protease and alcohol
dehydrogenase enzymes
Antimicrobial
Andrographis
paniculata
Kalamegha Andrographolide Inhibits NO synthesis in macrophages by
reducing iNOS protein expression
Antiinflammatory
Bacopa
monnieri
Brahmi Bacosides Repair of damaged neurons by enhancing
kinase activity, neuronal synthesis, and
restoration of synaptic activity, and
ultimately nerve impulse transmission
Cognitive function enhancer
Bergenia
ligulata
Pashanbhedi Gallic acid NFkB inhibitor, TNF-a induced p65 nuclear
translocation
Anti-inflammatory, anti-allergic
Boswellia
serrata
Shallaki Boswellic acid By non-redox inhibition of pro-
inflammatory enzyme, 5-lipoxygenase,
inhibition of NFkB
Anti-inflammatory, anti-arthritic
Commiphora
mukul
Guggulu Guggulsterone Bile acid receptor antagonist, cox-2
inhibition, NFkB inhibition
Hypolipidemic agents, anti-
inflammatory, promotes
cardiovascular health
Curcuma longa Haridra Curcumin Regulation of aryl hydrocarbon receptors,
cytochrome P450 enzymes, GST kinases,
COX, iNOS, MMP, p53 signaling, NFkB
inhibition, apoptosis inducer
Cancer, inflammation, diabetes,
and chemoprevention
Eugenia
caryophyllata
Lavangaha Eugenol Antibacterial activity through membrane
disruption
Toothache
Glychyrrhiza
glabra
Madhu yasti Glycyrrhizin P21CIP1/WAF1 inhibitor Constipation, body ache, etc.
Mucuna
Pruriens
Kapikachhu
L-dopa Production of dopamine Parkinson’s disease, nerve tonic
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Picrorhiza
Kurroa
Kutki Kutkoside Stimulate the action of nucleolar
polymerase A, resulting in ribosomal
protein synthesis and thus stimulates the
regenerative ability of the liver and the
formation of new hepatocytes
Hepatoprotective against
jaundice, hepatitis
Piper longum Pipalli Piperin Unknown Bioenhancer
Punica
granatum
Dadima Ellagic acid NFkB inhibition, Cox-2 inhibition Anticancer, anti-inflammatory
Rauwolfia
serpentina
Sarpagandha Reserpine Disrupts norepinephrine vesicular storage,
adrenergic blocking, inhibition of the
ATP/Mg
21
pump located in the
presynaptic neuron
Antihypertensive, adrenergic
uptake inhibitor, used for snake
bites
Semecarpus
anacardium
Bhallataka Biflavonoids Inhibition of NFkB Anticancer, anti-inflammatory
Tinospora
cordifolia
Guduchi Tinocordifolin Cox-2 inhibition, cytokine modulator, NFkB
translocation
Asthma, rheumatism, immune
stimulant
Vitis vinefera Draksa Resveratrol NF-kB Inhibition, inhibition of the CYP1A1,
COX-2 enzymes
Anticancer
Withania
somnifera
Aswagantha Withaferin A Inhibition of IkB kinase b,NFkB Anti-inflammatory
Zingiber
officinale
Sunthi Gingerols Capsaicin-activated VR1 (Vannilloid)
receptors agonists
Antipyretic, analgesic, antitussive,
sedative
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Table 13.4 List of Ayurvedic botanicals with potential for drug discovery. Adapted
from ref. 31 with permission from Taylor & Francis, Copyright 2007.
Botanical name
Ayurvedic/
common name Disease conditions
Acorus calamus Vacha Obesity, hypertension, speech disorders,
sedative, transquilizer, mental distress
Adhatoda zeylanica Vasa Bronchiolar constriction
Anethum Sowa Soya Appetizer, carminative
Amorphophallus
campanulatus
Soorana Piles, amenorrhea, indigestion, and
anorexia
Asparagus racemosus Shatavari Aphrodisiac, dysuria, galactagogue,
leucorrohea, peptie ulcer
Aloe vera Kumari Promotes health, heals burns, skin
diseases
Azadirachta indica Nimba Gastritis, bleeding piles, wounds,
fumigative, disinfectant against bacterial
and viral infections.
Berberis aristata Daruharidra Liver disorders, conjunctivitis, dysentery,
anti-pyretic, antiperiodic, diaphoretic
Berginia ligulate Pashanabheda Stomach, urinary and urinogenital
disorders
Boerhavia diffusa Punarnava Eye diseases, diabetes, anti-diuretic,
hepatoprotective, inflammation
Carum
Bulbocastanum
Krishna jiraka Digestion disorders and urinary tract
infections
Crataeva nurvala Varun Erysipelas, lymphadenopathy, urolithiasis
Cassia augustifolia Rechani Severe constipation
Cassia tora Chakramard Leprosy, ringworm infection, skin diseases
Centella asiatica Mandukarparni Neurological problems
Cleordendrum
serratum
Bharangi Common cold, sinusitis, chronic
respiratory problems
Commiphora wightii Balsamodendron
mukul
Arthritis
Cuminium cyminum Sweta jiraka Chronic diarrhea and dyspepsia, diabetes,
and cancer
Emblica officinalis Amalaki (Amla) Anemia, jaundice, hemorrhage, acidity,
immune stimulant
Eugenia jambolana Jamboo Diabetes
Ferula foetida Hingu (Heeng) Septic conditions, digestive stimulant,
expectorant, carminative
Garinia pedunculata Amlavetasa Cardiac stimulant, digestive, and laxative
Juniperous communis Hapusha Diuretic, anti-arthritis
Mallotus
philippinensis
Kampillak
(Kamila)
Anthelminthic, aphrodisiac
Moringa oleifera Shigru
(Sehanjana)
Abscess, septic conditions, wound
healing, piles, inflammation, neuritis,
joint diseases
Melia azedarach Mahanimba Acne, burns, measles, and prickly heat
Myristica fragrans Jaiphal nausea and vomiting, diarrhea,
leucorrhea.
Nigella sativa Kalajaji Respiratory and digestive tract
Nelumbo nucifera Kamal beej/
Kamal Gatta
Hypoglycemic
Piper longum (root) Pippalimool Malaria, insomnia, worms, piles
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Alzheimer’s and Parkinson’s diseases.
50
This forecast predicts a huge op-
portunity and an urgent need to discover new drugs from Ayurveda.
13.7.2 Current Challenges and Recommendations
In 2004, the FDA published draft guidelines for the development and
approval of botanical-based medicines, and it provided the road map for
researchers and manufacturers to follow. After the publication of these
guidelines, although more than 400 investigational new drug (IND) appli-
cations were granted for botanical medicines, surprisingly only three
medicines have since reached the new drug application (NDA) stage of de-
velopment and received approval.
1. A green tea ointment derived from Camellia Sinensis (green tea), used
for the treatment of genital warts (sinecatechins).
2. An extract of the latex of the ‘‘Devil’s blood’’ tree (Crofelemer) used for
the treatment of HIV/AIDS.
3. Cannabidiol (CBD), extracted from the cannabis plant and approved
for the treatment of three rare epilepsy conditions in children.
Regulatory approval is problematic and almost impossible if the active
principle is an extract, a mixture, or a composition rather than a pure isol-
ated compound with a known structure. US FDA is understandably very re-
luctant to approve these drug combinations consisting of multiple
molecules.
51
Polyphenon E, a topical antiviral ointment prepared from green
tea catechins was the first botanical-based drug approved in 2006, after the
publication of the FDA guidelines.
1
Cannabidiol was most recently approved
as a botanical medicine but it presents as a classic example of various issues
and challenges encountered during the development of herbal medicine.
Despite Cannabidiol’s successful emergence as a drug, another closely
Table 13.4 (Continued)
Botanical name
Ayurvedic/
common name Disease conditions
Phyllanthus emblica Amla Anti-aging
Pongamia pinnata Karanja Tumors, piles, skin diseases, and ulcers
Psoralea caryllifotia Bakuchi Vitiligo, bronchial asthma
Randia spinosa Madanaphala Gastrointestinal and hepatic disorders
Ricinus communis Eranda Patra Arthritis, muscle aches, constipation
Saraca asoca Ashok Meno-metrorrhagia, neurological
disorders, spasmogenic, uterine
infections
Terminalia arjuna Arjun Cardiac disorders
Terminalia chebula Haritaki (harad) Laxative
Trachyspermum ammi Ajwain Anthelminthic, spasmogenic carminative
Tribulus terrestris Gokshur (Gokkru) Diuretic, aphrodisiac, lithontriptic
Ayurvedic Knowledge Inspired Approach to Modern Drug Discovery 367
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related major cannabinoid, tetrahydro cannabidiol (THC), couldn’t move up
the development ladder as it provokes seizures in toxicology studies. For
these safety reasons, the FDA requires strong evidences for herbal medicines
which is the same as the level of evidence required for synthetic compounds.
This includes an understanding of drug metabolism, interactions, and
mechanism of action. Another big challenging part of botanical medicine is
to present the evidence that compounds from one batch and another are
identical in composition and do not affect efficacy and safety.
52
In addition, there are several problems arising in clinical trials of botan-
ical drugs. In addition to authentication and adulteration issues, there is no
specific protocol on how to conduct clinical trials for botanical drugs to
accommodate their complex nature where the mechanism of action may
differ from that of a single compound. Synergistic and antagonistic effects of
these combo-mixtures could favor or be unfavorable for the desired out-
come. Among a total of 195 botanical drug clinical trials registered with
clinical trails.gov (between 2016 to 2019) only 81 trials are in advanced stages
viz., phase II or phase II/III. Among these, 95% of all phase II and phase II/III
studies have only very few (B100) participants per arm 100, from which ef-
ficacy outcome is hard to determine with accuracy.
53
For ayurvedic drugs, a
phase I trial is not necessary as they have an extensive history of human use
and their efficacy is already proven. This is the biggest advantage of trans-
lating botanicals used in Ayurveda into modern drugs. It could save time and
costs in drug development. Although ayurvedic research is carried out in
various parts of India, due to a lack of appropriate communication, the
outcome is so fragmented and often not deep in its own foundational the-
ories or in its interaction with modern science.
54
Modern scientists often use
Ayurvedic formulations as the starting point (similar to reverse pharma-
cology) and try to isolate the single-molecule and determine their molecular
mechanisms and mode of action.
55
The history of botanical drug usage differs greatly between countries. In
China, like India, plant-based medicines have been used for thousands of
years and the knowledge has been passed from one generation to the next in
the form of case studies and experiences from physicians. The difficulty lies
in transforming this wealth of experience into transparent, auditable, re-
producible, high-quality data, known as real-world data (RWD) which is
essential to analyze and generate safety and efficacy evide nce in order to
attain regulatory approval.
54
China, which conducts 50% of registered bo-
tanical drug clinical trials, is implementing an Electronic Medical Record
(EMR) system to standa rdize their results and data.
56
Similarly, if India also
could translate all Ayurvedic clinical-use data into an Electronic Medical
record, this would speed up the process of discovering modern drugs from
our traditional knowledge. Although translating Ayurveda to comply with
modern drug standards is difficult, it is doable with dedication and efforts.
For botanical drugs with known active ingredients and molecular struc-
ture, Randomized Controlled Trials (RCT) are the best choice as regulatory
agencies like the FDA are familiar with this pattern, trial design, and the
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regulators could understand and review the entire process. In addition,
it can be done with a small number of patients in minimal time. Inclusion
criteria require information about target binding sites and the possible
biological interactions and endpoint should be measurable.
54
For botanical
drugs with unknown active ingredients, it is a challenge to determine ap-
propriate inclusion/exclusion criteria and trial size. Sun and Qian
54
suggested
conducting a controlled observational phase II/III study with a large sample
size that could broaden the eligibility criteria and increase enrollments to
include different types of evidence, which may increase the understanding
of the botanicals benefit-risk profile. Since active ingredients are well known
for our Ayurvedic medicines, biological tests could be performed (as shown
in Figure 13.1) to determine their target binding sites and interactions.
This would help to choose RCTs and generate EMR for further regulatory
approval.
13.8 Conclusion – Could West Meet East?
The clinical efficacy of Ayurvedic medicines is well established and they have
been proven to be safe and could help to alleviate the burden of mortality
and morbidity caused by modern drugs accompanied with numerous side
effects. Furthermore, they are effective against several infectious diseases
where these harmful microbes developed drug resistance. Botanical drugs
hold the best options for finding novel drugs when worked from the basis of
ayurvedic knowledge using advanced technological tools and in conjunction
with drug discovery scientists and it could offer the potential to discover
targeted drugs effective against a variety of human diseases. These futuristic
goals can be achieved when biomedical scientists dive deep into the system,
principles, and knowledge of Ayurveda and continue the ir research upon
exploring the scientific basis of their mechanism of action. Interdisciplinary
research is the pathway to the success of integrating this old value system of
medicine into modern drug discovery for wider acceptance.
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