Art 02
Art 02
Department of Pharmaceutical Sciences, IEC School of Pharmacy, IEC University, Baddi, Uttar Pradesh, India
ABSTRACT
Herbal medicine and treatment with herbs are not new to humanity, and it has been in practice since thousands of years back
and still going on. Both the developed and developing countries are now focusing on the treatment based on herbal medicine
because of its several benefits. India is the country of herbs, and the Indian traditional treatment system was also based on herbs
and medicinal plant that is known as Ayurveda. India is the well-known mine of well-recorded herbal plants with their medicinal
use. Herbal medicine is also called botanical medicines or phytomedicine. In a survey report of the World Health Organization,
it was found that the 80% population of the world rely on traditional herbal medicine for primary health-care need. In fact in
developed countries, alternative medicine is gaining popularity and it is increasing day by day because of their efficacy, safety,
and lesser side effects. Herbal drugs possess a long history of its application and better patient tolerance on their application. This
review article discusses the limitation and challenges faced for the production of herbal medicine.
Key words: Ayurveda, humanity, phytomedicine, traditional
INTRODUCTION has no side effect instead of being cheap and easily available.
As per the WHO , the use of phytomedicines exceeds to that of
Herbal medicine or phytomedicines is related to use different conventional medicines by about 3 times.[7]
parts of medicinal plants. Herbalism has a deep tradition of
its application outside of conventional medicine. In the past Classification of herbal medicines by the WHO on basis of their
decades, it is now becoming mainstream as advancement and origin, evolution, and forms of the current use is as follows:
developments in analysis and quality control along with advances • Indigenous herbal medicines.
in clinical research.[1] As per the World Health Organization • Herbal medicines in systems.
(WHO), phytomedicine or herbal medicine is the sum total • Modified herbal medicines.
of the knowledge, skill, and practices based on the theories • Imported products with a herbal medicine base.
and experiences indigenous to different cultures, whether
explicable or not, used in the maintenance of health as well Indigenous Herbal Medicines
as in the prevention, diagnosis, improvement, or treatment of Indigenous herbal medicines include those which were
physical and mental illness.[2] Traditional herbal medicines are historically used in local community, tribal community or in
naturally occurring, plant-derived substances with minimal or region and are very well known due to its long usage by the local
no requirement of industrial processing that has been used to or specified population in terms of its composition, treatment and
treat illness within local or regional healing practices.[3] Herbal dosage. It must be easily available and can be used freely as well
medicines have been widely used for the beneficiary of mankind as easily by the local community or in that region.
for the thousands of years much before the development of
allopathic drug system.[4] Phytomedicines initially from crude Herbal Medicines in Systems
drugs include tinctures, tea, poultices, powder, and other herbal Herbal medicines in systems have been in use since many years
formations.[5] The utilization and application of plants for healing and are documented with their special theories and concepts,
purposes predate human history and lead to the origin of much and these are accepted by the countries.
modern medicine. Research and studies based on clinical,
pharmacological, and chemical studies of these herbal medicines, Modified Herbal Medicines
which were derived predominantly from plants, were the only Modified herbal medicines have been achieved by executing
basis of most early medicines such as aspirin (willow bark), modification in shape, form including dose, dosage form, mode
digitoxin (from foxglove), morphine (from the opium poppy), of administration or application, herbal medicinal ingredients,
quinine (from cinchona bark), and pilocarpine (jaborandi).[6] methods of preparation, and medical indications.
Herbal medicines still cover up about 70–80% primary health-
care treatment of persons in the developing country of the world. Imported Products with Herbal Medicine
The percentage for primary health-care treatment with herbal Imported products with herbal medicine basically cover up all
medicine is high because of the general belief that herbal drug imported herbal medicines including raw materials and products.
Address for correspondence: Shubham Bhardwaj, IEC School of Pharmacy, IEC University, Baddi, Uttar Pradesh, India.
E-mail: [email protected]
Received: 01-05-18 Revised: 03-06-18 Accepted: 30-06-18
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http://irmhs.com/index.php/irmhsBhardwaj, et al.: Herbal medicine
Imported herbal medicines must be registered and marketed in the human body consists of four humor blood, phlegm, yellow bile,
countries of its origin.[8] We have different systems of traditional and black bile which are mainly responsible for the functioning of
medicine, and philosophy regarding the medicine and practices the body in healthy condition as well as in diseases.[21] Hippocrates
of each are influenced by the prevailing conditions, environment, only used herb and is best known for saying; “Let your food
and geographic area within which it was evolved.[9,10] be your medicine and let medicine be your food,” “Sickness is
caused by body’s inability to digest its environment.”[22] The
Historical Background early 19th century is denoted as the turning point in the field of
Natural product coming from natural sources like plants was used use and application related to medicinal plant . The discovery,
by human beings over the years as food and medicines, especially substantiation, and isolation of alkaloids from poppy (1806) and
plants parts or whole plant to cure and prevent disease.[11] It is other plants. In the meanwhile, the isolation of glycosides marked
very much difficult to calculate the exact time when people started the beginning of scientific pharmacy. With the enhancement and
using plants as medicine, but some ancient literature and other upgradation of the chemical methods, other active substances
sources are available which promises its start. from medicinal plants were also discovered.[23]
The oldest written evidence related to the use of medicinal plants Present Scenario
for the preparation of drugs has been found on a Sumerian clay slab The herbal medicines or phytomedicines continue to expand
from Nagpur which is approximately 5000 years old. It comprised rapidly throughout the world. Many people are now resorting to
of 12 recipes for drug preparation and referring to over 250 herbal products for the treatment of various health challenges in
various plants, some of them alkaloid such as poppy, henbane, and different national health-care settings. Last decades witnessed
mandrake.[12] The Indian holy books Vedas mention treatment with a surge in public interest towards natural therapies both in
the help of plants, which are present in abundance in the country. the developed and developing countries.[24] The sections of the
population that still rely on traditional practitioners and herbal
The Chinese book based on the use of roots and grasses “Pen
medicines for their primary care in developing countries like,
T’Sao,” written by Emperor Shen Nung circa 2500 BC, treats 365
Africa up to 90% and India up to 70% of the population. In China,
drugs (dried parts of medicinal plants), many of which are being
traditional medicine accounts around 40% of overall health care
used nowadays.[13,14]
delivered, and more than 90% of general hospitals in China have
Theophrastus (371–287 BC) led the foundation of botanical units for traditional medicine.[25-27] At present, herbs are applied
science through his books “De Causis Plantarium” - Plant Etiology for the treatment of chronic and acute disease and various
and “De Historia Plantarium” - Plant History. In these books, he ailments and problems such as cardiovascular disease, prostate
created a classification of about 500 medicinal plants known problems, depression, and inflammation and to boost the immune
at the time.[15,16] In the description of the plant toxicity action, system, to name but a few. In Africa, the Africa flower (traditional
Theophrastus underscored the important feature for humans to herbal medicine) has been used for decades to treat wasting
become familiar to them by a gradual increase in the doses.[17,18] symptoms associated with HIV.[28,29] Now, it is believed that
nature contributes about 90% to the new drug molecule. Nature
Each country has their own document regarding the use of has provided many effective drug agent such as dactinomycin,
plants and herbs as medicine for treatment and cure of disease, bleomycin, and doxorubicin, vinblastine, irinotecan, topotecan,
and they differ from each other. In India, Ayurveda is the oldest etoposide, and paclitaxel (anticancer), mefloquine chloroquine,
system of medicine that is about 5000 years old.[19] The Ayurveda amodiaquine artemisinin, dihydroartemisinin, artemether,
text is actually the part of Atharvaveda which was in 1000 BC. In and arteether (antimalarial), metformin and eventually the
ancient time, it was transferred orally, and the first Ayurvedic text other biguanide, harunganin, cryptolepine, and maprouneacin
book was written and preserved in Sanskrit. Instead of fighting (antidiabetic), and calanolide A, cucrcumin, phenethyl isocyanate,
with disease ancient Ayurveda was meant essentially to promote and phenoxidiol (anti-HIV drugs).[30,31] India has about 25,000
health. Main text available regarding herbal medicine is Charak effective plant-based formulations used traditionally with over
Samhita (1000 BC) and Sushrut Samhita (100 AD). Ayurveda text 1.5 million practitioners of the traditional medicinal system.
medica provides detailed descriptions of more than 1500 herbs There are 7800 medicinal drug manufacturing units in India that
and 10, 000 formulations. Diagnostics features along with signs consumes about 2000 tonnes of herbs annually.[32] The available
and symptoms of over 5000 diseases or disorders are described data suggest that the traditional medicine has a significant market.
in Madhav Nidan (800 AD). There are eight branches in the Indian herbal market is of nearly 50 billion rupees with 14%
Ayurvedic study, and these are as follows: annual growth. The worth of exported herbal product is about
• Kaya Chikitsa (general medicine), 1 billion rupees. The demand for medicinal plants is increasing
• Kaumara Bhruthya (pediatrics), everyday, and the WHO has projected that global herbal market
• Bhutha Vidhya (psychiatry), will grow up to $ 5 trillion in 2050 from the current level that is of
• Salakya (ENT and ophthalmology and dentistry), $ 62 billion. More than 70% of the global diversity are produced
• Shalya (surgery), by India and China. The significant global herbal export market
• Agada Tantra (toxicology), includes EU, USA, Canada, Australia, Singapore, and Japan, while
• Rasayana (rejuvenation therapy), and Brazil, Argentina, Mexico, China, and Indonesia are new emerging
• Vajeekarana (sexual vitality).[9] herbal market.[33]
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of drug. Many of these countries also lack effective machinery to Challenges Associated to Safety Monitoring of
regulate manufacturing practices and quality standards of the Herbal Medicines
herbal medicine. Challenges often encountered and common to In the past few years, issues relating to increasing use of herbal
many countries are those related to regulatory status, assessment or natural medicines or products in developed countries.
of safety and efficacy, quality control, safety monitoring and Furthermore, the dependence of many people living in the
inadequate or poor knowledge about traditional, complementary/ developing countries on plants as a major source of medicines
alternatives.[34,35] coupled with weak regulation of herbal medicines in most
countries and the occurrence of high-profile safety concerns has
Challenges Associated to The Regulatory Status increased awareness regarding the need to monitor safety and
of Herbal Medicines understanding of possible harmful as well as potential benefits
According to the definition, a dietary supplement is a product that linked with the use of herbal medicines.[40] Adverse effects
is ingested and is intended to supplement the diet and contains a arising from consumption of herbal medicines are due to several
“dietary ingredient.” The dietary ingredients in these products may factors among which include the use of the wrong species of
include different vitamins, minerals, herbs, or other botanicals plant, adulteration of herbal products, undeclared medicines,
required by the body.[36] Under the DSHEA, any additional toxicity contamination, overdosage, misuse of herbal medicines by
studies are generally not required if the herb has been on the either health-care providers or consumers, and use of herbal
market before 1994.[37] For this, FDA hauls the burden to prove medicines with other medicines. There is a lack of proper
that herbal medicinal product or “dietary ingredient” is toxic or knowledge regarding the importance of taxonomic botany and
not safe for use. The additional major challenge in many countries documentation by most manufacturers of herbal medicines, and
is related to the fact that regulatory information on herbal this poses peculiar challenges during identification and collection
medicines is often not shared between regulatory authorities and of medicinal plants used for herbal remedies.[40] To overcome the
safety monitoring or pharmacovigilance centers. confusion created because of the common names, it is necessary
to adopt the most commonly used binomial names for medicinal
Challenges Associated to the Assessment of plants. For example, Artemisia absinthium L., which has at least
Safety and Efficacy 11 common names, contains an active narcotic derivative. Hence,
No one can contradict the fact that the requirements as well as the effective monitoring of herbal medicine will require effective
the research protocols, standards, and methods needed for the collaboration between botanists, phytochemists, pharmacologists,
evaluation of the safety and efficacy of herbal medicines are much and other major stakeholders.
more complex than those required for conventional or orthodox
pharmaceuticals.[38] A single herbal medicine or medicinal plant
Future Prospects
Future is in the phase of increasing demand and fast-growing
may contain more than hundreds of natural constituents, and a
market of herbal medicines and other herbal healthcare products,
mixed herbal medicinal product may contain several times the
in both developing and developed countries of the world.[40]
number of one. In such an analysis of single active constituents
may practically be impossible especially where an herbal product
is a mixture of two or more herbs.[38] CONCLUSION
Challenges Associated to Quality Control of In this scenario, the global acceptance and use of herbal medicines
and related products continue to assume an exponential increase.
Herbal Medicines
Issues relating to adverse reactions in recent times are also
The quality of the raw materials used in the production of herbal
becoming more vivid, increasing in prevalence, and no longer
medicines determines to a large extent the safety and efficacy.
debatable because of the previous misconception of categorizing
The quality of source or raw materials is dependent not only on
herbal medicinal products as “safe” as they are derived from
intrinsic (genetic) factors but also on extrinsic factors such as
“natural” source. Therefore, regulatory policies on herbal
environmental conditions, good agricultural, and good collection
medicines need to be standardized and strengthened on a global
practices for medicinal plants, including plant selection and scale. It is now laid in the shoulders of the regulatory bodies to
cultivation. It is the combination of many factors that make it monitor controlled and quality flow of herbal products and to
difficult to perform quality controls on the raw materials of facilitate their development to clinical trial stages.
herbal medicines.[39] According to good manufacturing practice
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