Semester- 6th

Subject: Herbal Drug Technology

Subject code: BP603

Module -1
Herbs as Raw materials

Objectives: upon compilation of this module the student should be able to:

1. Understand raw material as source of herbal drugs from cultivation to herbal drug
product
2. Know the WHO guidelines for cultivation of herbal drugs
3. Understand about the methods for selection, identification and authentication of herbal
drugs
4. Know about the processing of herbal and medicinal plants.

Learning outcomes: the student will be able to:

1. Learn the definition of herbs as raw material, herbs, herbal medicinal products and
sources of herbs.
2. Learn about the methods for selection, identification and authentication methods for
herbal materials.
3. Learn about the processing methods of herbal drugs.
4. Learn about the safety parameters for herbal drugs.

Introduction:

Medicinal and aromatic plans constitute a major part of the flora, which provides raw materials
for use in the pharmaceuticals, cosmetics and drug industries. In one of the studies by WHO, it is
estimated ha 80 percent of the population of developing countries relies on traditional plant
based medicines for their health requirements. India and China are the two major producing
countries having 40 percent of the global biodiversity and availability of rare species. These are
well known as the home of medicinal and aromatic crops that constitute a segment of the flora
and provide raw materials to the pharmaceutical, cosmetics, fragrance, flavor etc. industries.
From the trade data available, it is clear that the global market for medicinal plants has always
been large and has been on increase in the recent past. The trade of medicinal plants from India
is estimated Rs. 550crores.

Herbs: It is defined as any plant with leaves, seeds or flowers used for flavoring, food, medicine
or perfume.
Herbal medicine: Practice of using herbs and herbal preparations to maintain health and to
prevent, alleviate or cure disease or a plant or plant part or an extract or mixture of these used in
herbal medicine.

Herbal medicinal products: these are medicinal products where the active ingredient consists
mainly of herbal substances.

Herbal drug preparations: They are prepared from herbal materials by different process, which
is extraction with various solvents, purification, concentration and other processes. It includes
such as powders, extracts and juices.

Finished herbal products: Finished herbal products consist of one or more herbal preparations
made from one or more herbs (i.e. from different herbal preparations made of the same plant
as well as herbal preparations from different plants. Products containing different plant materials
are called “mixture herbal products”.

Selection, identification and authentication of herbal drugs: Where applicable, the species or
botanical variety selected for cultivation should be the same as that specified in the national
pharmacopoeia or recommended by other authoritative national documents of the end-user's
country. In the absence of such national documents, the selection of species or botanical varieties
specified in the pharmacopoeia or other authoritative documents of other countries should be
considered. In the case of newly introduced medicinal plants, the species or botanical variety
selected for cultivation should be identified and documented as the source material used or
described in traditional medicine of the original country.

Identification tests should be specific for the herbal material and are usually a combination of
three or more of the following:

➢ macroscopic characters
➢ microscopic characters
➢ chromatographic procedures
➢ chemical reactions

Authentication is especially useful in cases of drugs that are frequently substituted or adulterated
with other varieties which are morphologically and chemically indistinguishable. Several herbal
drugs in the market still cannot be identified or authenticated based on their morphological or
histological characteristics. Use of wrong drugs may be ineffective or it may worsen the
condition.

Processing of herbal materials: Depending on the intended use, herbal materials could be
regarded as starting materials and herbal preparations could be regarded as intermediates in the
process of producing finished herbal products, or as herbal dosage forms for therapeutic
applications. In the latter case, simple herbal dosage forms may be prepared either from herbal
materials (such as unprocessed seeds or plant exudates) or herbal preparations (such as ground
powders and dried extracts) ready for administration to patients. These herbal dosage forms,
produced under GMP conditions, include decoctions, tea bags, granules, syrups, ointments or
creams, inhalations, patches, capsules, tablets and pills, among others.

1. Collection of drugs:
2. Time of collection
3. Harvesting
4. Primary processing
5. Drying
6. Specific processing
7. Garbling
8. Packing
9. Storage

Safety management of toxic herbs: Among the herbal medicines (and their source medicinal
plants) being used in traditional medicine contexts in di!erent parts of the world, some are known
to contain toxic substances that may lead to severe side-e!ects or even death. In general,
these toxic herbal materials and their preparations or dosage forms have narrow therapeutic
windows between elective dose and lethal dose. Examples of such toxic/e!ective therapeutic
agents are cardio-active herbal preparations such as Powdered Digitalis and Digitalis Capsules
which at the proper dosages, are excellent therapeutic cardio-tonic agents, but are lethal when
an overdose is taken.
 Biodynamic Agriculture

Objectives: upon compilation of this module the student should be able to:

1. Understand about the biodynamic agriculture

2. Know about the Good agricultural practices in cultivation of medicinal plants
3. Know about the concept of organic farming
4. Know about the pest management methods
5. Understand about the bio-pesticides and bio-insecticides

Learning outcomes: the student will be able to:

1. Learn the definition of biodynamic agriculture and its advantages

2. Learn about the good agricultural practices in cultivation of medicinal plants.
3. Learn the definition and significance of organic farming
4. Learn about the nutrients in organic farming
5. Learn about the pest management methods
6. Learn about the definition of bio-pesticides and bio-insecticides

Introduction:

Biodynamic agriculture was developed during the 1920s by Rudolf Steiner. Steiner argued that
spirituality lays the foundation for the renewal of agriculture. In particular, he encouraged
farmers to develop a personal relationship with plants, animals, soil, and even with manure in
order to think more holistically about agriculture. Since then, biodynamic agriculture has been
experimented with and implemented by farmers around the world. Biodynamics has much in
common with other organic approaches – it emphasizes the use of manures and composts and
excludes the use of synthetic (artificial) fertilizers on soil and plants. Methods unique to the
biodynamic approach include its treatment of animals, crops, and soil as a single system, an
emphasis from its beginnings on local production and distribution systems, its use of traditional
and development of new local breeds and varieties. Biodynamic agriculture uses various herbal
and mineral additives for compost additives and field sprays. WHO has developed a series of
technical guidelines relating to the quality control of herbal medicines of which these WHO
guidelines on Good agricultural and collection practices (GACP) for medicinal plants based.

In contrast, crop rotation and an assortment of animal life are an important part of
sustainable agriculture. The practice of rotating crops from field to field and raising varied
animal species, along with cover crops and green manures, encourages healthy soil, reduces
parasites and controls weeds and pest.
Good agricultural practices in cultivation of medicinal plants: It describes general
principles including quality control measures and provides technical details for
cultivation of medicinal plants.
Identification/ authentication of cultivated medicinal plants
➢ Selection of medicinal plants
➢ Botanical identity
➢ Specimens
➢ Seeds and other propagation materials
➢ Cultivation
➢ Site selection
➢ Ecological environment and social impact
➢ Climate
➢ Soil
➢ Irrigation and drainage
➢ Plant maintenance and protection
➢ Harvest
➢ Personnel
Organic farming: an integrated farming system that strives for sustainability, the enhancement
of soil fertility and biological diversity whilst, with rare exceptions, prohibiting synthetic
pesticides, antibiotics, synthetic fertilizers, genetically modified organisms, and growth
hormones. Organic agriculture is a production system that sustains the health of soils,
ecosystems and people. It relies on ecological processes, biodiversity and cycles adapted to local
conditions, rather than the use of inputs with adverse effects. Organic agriculture combines
tradition, innovation and science to benefit the shared environment and promote fair
relationships and a good quality of life for all involved.

Organic farming is primarily of two types, namely: Pure organic farming and integrated organic
farming

Pure organic farming involves avoiding all artificial chemicals. Every fertilizer and pesticide
that is used are derived from completely natural sources such as blood meal or bone meal.

Integrated organic farming involves integrating techniques aimed at achieving

ecological requirements and economic demands such as integrated pest management and
nutrients management.
Nutrients Management in Organic Farming: Organic farming follows a healthy way
of farming for both crops as well as consumers. In this method, composted organic
manure is used for nutrition of crops and thus, improves the organic content and fertility
of the soil. Apart from manures, bacterial and fungal biofertilizers are also used for
enhancing the soil nutrients.

Pest and pest management in medicinal plants:

Crop rotation, mixed cropping, organic control, hand weeding are the other techniques
used in organic farming to maintain soil fertility and for pest- weed control. These
systems of pest and weed management and soil protection make organic farming the best
method. Sometimes, natural or other organically approved insecticides like neem
pesticides are also used.

Disease Management: Diseases can be a major concern for organic farmers as it might
reduce crop yields. So, supplying important macro and micronutrients and adopting crop rotation
is crucial to prevent various plant diseases. Even the soil is enriched with useful microbes, fungi,
and bacteria to prevent harmful organisms in check.Organic fruits and vegetables are not the
only examples of successful organic products. Recently, dairy products which are organic are
noticeable. Livestock is another example of organic farming. Here, they follow a strict means of
farming like animals feed on organic food only. Hormones or other genetic engineering practices
for high yield are not allowed on animals.
Advantages of Organic Farming:

➢ Improves soil fertility and maintain biological diversity.

➢ Good for the environment and yields are healthy for human and animal
consumption.
➢ Prevents soil erosion, degradation and crop failure
➢ Decrease pollution and the whole farming can easily rely on renewable energy
sources.
➢ Improves the soil fertility and enhances its chemical and physical properties.

Bio-pesticides: The term bio-pesticides define compounds that are used to

manage agricultural pests by means of specific biological effects rather than as
broader chemical pesticides. It refers to products containing bio-control agents –
i.e., natural organisms or substances derived from natural materials (such as
animals, plants, bacteria, or certain minerals), including their genes or
metabolites, for controlling pests. According to the FAO definition, bio-pesticides
include those bio-control agents that are passive agents, in contrast to bio-control
agents that actively seek out the pest, such as parasitoids, predators, and many
species of entomo-pathogenic nematodes. The latter bio-control agents used to
manage potato pests. Thus bio-pesticides cover a wide spectrum of potential
products that can be classified as follows:

Microbial pesticides: pesticides that contain microorganisms, like bacteria, fungi,

or virus, which attack specific pest species, or entomo-pathogenic nematodes as
active ingredients. Although most of these agents attack insect species (called
entomo-pathogens; products referred to as bio-insecticides), there are also
microorganisms (i.e., fungi) that control weeds (bio-herbicides).

Plant-Incorporated Protectants (PIPs): these include pesticidal substances that

are produced in genetically modified plants/organisms (GMO) (i.e., through the
genetic material that has been incorporated into the plant). Both the protein and its
genetic material are regulated by Environmental protection agency, the plant itself
is not regulated. The production of transgenic plants that express insecticidal
endo-toxins derived from the soil bacterium.
 Biochemical pesticides: pesticides based on naturally occurring substances that control pests by
non-toxic mechanisms, in contrast to chemical pesticides that contain synthetic molecules that
directly kill the pest. Biochemical pesticides fall into different biologically functional classes,
including pheromones and other semi-chemicals, plant extracts, and natural insect growth
regulators.
 Examples:

1. Bacillus thuringiensis, a bacteria capable of causing disease of Lepidoptera,

Coleoptera and Diptera, is a well-known insecticide example. The toxin from
B. thuringiensis (Bt toxin) has been incorporated directly into plants through
the use of genetic engineering. The use of Bt Toxin is particularly
controversial. Its manufacturers claim it has little effect on other organisms,
and is more environmentally friendly than synthetic pesticides.

2. Entomo-pathogenic fungi (e.g. Beauveria bassiana, Isaria fumosorosea,

Lecanicillium and Metarhizium spp.), plant disease control agents: include
Trichoderma spp. and Ampelomyces quisqualis (a hyper-parasite of grape
powdery mildew).

3. Bacillus subtilis is also used to control plant pathogens and beneficial

nematodes attacking insect (e.g. Steinernema feltiae) or slug (e.g.
Phasmarhabditis hermaphrodita) pest’s entomopathogenic viruses (e.g. Cydia
pomonella granulovirus) weeds and rodents have also been controlled with
microbial agents. Various naturally occurring materials, including fungal and
plant extracts, have been described as biopesticides. Products in this category
include.

4. Insect pheromones and other semi-chemicals

5. Biopesticides may include natural plant-derived products, which include
alkaloids, terpenoids, phenolics and other secondary chemicals. Certain
vegetable oils such as canola oil are known to have pesticidal properties.
 Indian systems of Medicine

Objectives: upon compilation of this module the student should be able to:

1. Understand about the Indian systems of medicine

2. Know about the Ayurveda system of medicine
3. Know about the Unani system of medicine
4. Know about the Siddha system of medicine
5. Know about the Homeopathy system of medicine
6. Know about the basic methods of standardization and evaluation of ayurvedic
preparations

Learning outcomes: the student will be able to:

1. Learn the basic principles involved in Ayurveda

2. Learn the basic principles involved in Siddha
3. Learn the basic principles involved in Unani
4. Learn the basic principles involved in Homeopathy
5. Learn about the methods of standardization and evaluation of aristas, asvas, churanas,
lehyas and bhasmas as an ayurvedic preparation.

Introduction: The Indian systems of medicine consists of ayurveda, unani , siddha and
homeopathy and therapies such as Yoga and Naturopathy. Some of these systems are
indigenous and others have over the years become a part of Indian tradition. A separate
department of Indian systems of medicine and homeopathy was set up in 1995 to ensure
the optimal development and propagation of AYUSH an abbreviation for Ayurveda, Yoga
and Naturopathy, Unani, Siddha systems of health care.

Ayurveda: The word ‘Ayurveda’ has derived out of fusion of two separate words- Áyu’
i.e. life and ‘veda’ i.e. knowledge. Thus in literal meaning Ayurveda is the science of life.
Ayurveda is a classical system of preventive, promotive and curative healthcare
originating from the Vedas documented around 5000 years ago and currently recognized
and practiced in India and many countries in the world. It is one of the most ancient
healthcare systems having equal scientific relevance in the modern world, that take a
holistic view of the physical, mental, spiritual and social aspects of human life, health and
disease.
Diagnosis:
Ayurveda has eight ways to diagnose illness, called Nadi (pulse), Mootra (urine), Mala (stool),
Jihva (tongue), Shabda (speech), Sparsha (touch), Druk (vision), and Aakruti
(appearance). Ayurvedic practitioners approach diagnosis by using the five senses. For example,
hearing is used to observe the condition of breathing and speech. The study of the lethal points
or marman marma is of special importance.

Siddha: The Siddha System of medicine is one of the ancient systems of medicine in
India having its close bedd with Dravidian culture. The term Siddha means achievements
and Siddhars are those who have achieved perfection in medicine. Eighteen Siddhars are
said to have contributed towards the systematic development of this system and recorded
their experiences in Tamil language. The Siddha system of Medicine emphasizes on the
patient, environment, age, sex, race, habits, mental frame work, habitat, diet, appetite,
physical condition, physiological constitution of the diseases for its treatment which is
individualistic in nature Diagnosis of diseases are done through examination of pulse,
urine, eyes, study of voice, colour of body, tongue and status of the digestion of individual
patients.
Unani: Unani system of medicine is a comprehensive medical system, which provides
Preventive, promotive, curative and rehabilitative health care. The system is holistic in
nature and takes into account the whole personality of an individual rather than taking a
reductionist approach towards disease. The fundamentals, diagnosis and treatment
modalities of the system are based on scientific principles. The basic frame work of this
system is based on the Hippocratic theory of four Humours, according to which any
disturbance in the equilibrium of humours causes disease and therefore the treatment aims
at restoring the humoral equilibrium.

Yoga: The word "Yoga" comes from the Sanskrit word "yuj" which means "to unite or
integrate." Yoga is about the union of a person's own consciousness and the universal
consciousness. It is primarily a way of life, first propounded by Maharshi Patanjali in
systematic form Yogsutra. The discipline of Yoga consists of eight components namely,
restraint (Yama), observance of austerity (Niyama), physical postures (Asana), breathing
control (Pranayam), restraining of sense organs (Pratyahar), contemplation (Dharna),
meditation (Dhyan) and Deep meditation (Samadhi). These steps in the practice of Yoga
have the potential to elevate social and personal behavior and to promote physical health
by better circulation of oxygenated blood in the body, restraining the sense organs and
thereby inducing tranquility and serenity of mind and spirit. The practice of Yoga has also
been found to be useful in the prevention of certain psychosomatic diseases and improves
individual resistance and ability to endure stressful situations. Yoga is a promotive,
preventive rehabilitative and curative intervention for overall enhancement of health
status. A number of postures are described in Yoga literature to improve health, to prevent
diseases and to cure illness. The physical postures are required to be chosen judiciously
and have to be practiced in the correct way so that the benefits of prevention of disease,
promotion of health and therapeutic use can be derived from them.

Naturopathy: Naturopathy is rooted in the healing wisdom of many cultures and times
based on principal of natural healing. The principles and practices of Naturopathy are
integrated in the life style, if the people observe living close to nature. Naturopathy is a
cost effective drugless, non-invasive therapy involving the use of natural materials for
health care and healthy living. It is based on the theories of vitality, boosting the
selfhealing capacity of the body and the principles of healthy living. Naturopathy is a
system of natural treatment and also a way of life widely practiced, globally accepted and
recognized for health preservation and management of illnesses without medicines.
Naturopathy advocates living in harmony with constructive principles of Nature on
the physical, mental, social and spiritual planes. It has great promotive, preventive,
curative as well as restorative potentials. Naturopathy promotes h healing by stimulating
the body’s inherent power to regain health with the help of five elements of nature –
Earth, Water, Air, Fire and Ether.
Homoeopathy: "Homoeopathy" was introduced as a scientific system of drug
therapeutics by a German Physician, Dr. Christian Frederick Samuel Hahnemann in 1805.
While translating a medical treatise by Scottish physician and chemist, William Cullen,
from English to German, in 1790, he came across a foot note under Cinchona that
attributed its fever curing property to the astringent (decongestant) qualities of the drug.
Being sceptical of Cullen's remarks concerning the effect of Cinchona for curing malaria,
Hahnemann experimented its effect on himself by taking repeated doses of cinchona
tincture and experienced fever, shivering and joint pains: symptoms similar to those of
malarial fever. After series of experiments, Hahnemann concluded that a drug that could
produce certain symptoms in healthy individuals could also cure similar disease
symptoms, in accordance with some hidden, natural laws of similars as had been vaguely
perceived by ancient physicians. This led to the coining of the word "homoeo-pathy"
(which comes from the Greek: hómoios, "-like" and páthos, "suffering"). Based on this,
Hahnemann postulated the key principle of Homoeopathy, the Law of Similars, logically
evolving it as an experimental science, according to the method of inductive reasoning
after exact observation, correct interpretation, rational explanation and scientific
construction.
Preparation and standardization of ayurvedic formulations:
Aristas and Asvas: These are self generated herbal fermentations of traditional ayurvedic
system. They are alcoholic medicaments prepared by allowing the herbal juices or their
decotions to undergo fermentation with the addition of sugars. Aristas are made with
decoctions of herbs in boiling water while Asavas are prepared by directly using fresh
herbal juices. Fermentation of both preparations is brought about by the addition of a
source of sugar with flowers. They are moderately alcholicand mostly sweetish with slight
acidity and aggreable aroma. These medicinal wines have several advantages like better
keeping quality, enhanced therapeutic properties, improvement in drug delivery into the
human body sites.

Method of Preparation:
Preparation of Aristas: The drug is coarsely powdered and Kasaya is prepared. The
Kasaya is strained and kept in fermentation vessel. Sugar, jaggery or honey, as required, is
dissolved, boiled and added. The mouth of the vessel is covered with an earthen lid and
the edges sealed with clay- smeared cloth wound in seven consecutive layers.
A constant temperature is maintained for fermentation by keeping the container either in a
special room, in an underground cellar or in a heap of paddy. After a specified period the
lid is removed and the contents examined to ascertain whether fermentation has been
completed. The fluid is first decanted and then strained after two or three days. When the
fine suspended particles settle down, it is strained and bottled.

Preparation of Asavas: The Jaggery or sugar is dissolved in the required quantity of

water, boiled and cooled. This is poured into the fermentation vessel. Fine powder of the
drugs is added in the container which is covered with a lid and the edges are sealed with
clay smeared cloth wound in seven consecutive layers.
A constant temperature is maintained for fermentation by keeping the container either in a
special room, in an underground cellar or in a heap of paddy. After a specified period the
lid is removed and the contents examined to ascertain whether fermentation has been
completed. The fluid is first decanted and then strained after two or three days. When the
fine suspended particles settle down, it is strained and bottled.

Precaution:

1. The filtered Asavas or Aristas should be clear without froth at the top.

2. It should not become sour.

3. The preparation has the characteristic aromatic alcoholic odour.

 Standardization of asava and arista Formulation: Asavas and Aristas are alcoholic
preparations, prepared either by soaking the powdered drugs or the decoction of a drug, in a
solution of jaggery along with a fermenter for a specified period of time, during which it
undergoes fermentation to produce alcohol. These self-generated alcohols facilitate the
extraction of active principles present in the drug and also serve as a preservative.Various
methods applied for standardization of herbal drugs are depicted in figure. Due to complexity of
most Ayurvedic formulations, use of only conventional methods for standardization are not
adequate for their evaluation. The Ayurvedic Pharmacopoeia of India and Pharmacopoeial
standards for Ayurvedic formulations mention only the study of physico-chemical parameters.
Churna: It is defined as a fine powder of a drug or drugs in ayurvedic system of
medicine. Drugs mentioned in formula are cleaned properly, dried thoroughly, pulverized
and then sieved. The churna is free flowing and retains its potency for one year, if
preserved in air tight containers.

Evaluation of physical parameters:

➢ Total Ash value

➢ Acid insoluble ash value

➢ Water soluble extractive extractive value

➢ Alcohol soluble extractive value

➢ Determination of crude fibre content

➢ Determination of heavy metal contamination

Lehyas: It is a semi-solid preparation of the drugs meant for licking by tongue. It acquires the
consistency of a thick paste. After strained decotions are boiled down, sugar or jiggery is added
to it. The other similar forms are known as modaka, guda, khanda etc. Market formulation of
Lehya are Chyanvanprakash, Dashmoola rasayan, ashwagandhadi Lehyam.

1. The Avaleha preparation involves following:

2. Kaṣaya or other liquids
3. Jaggery, sugar or sugar-candy
4. Powders or pulps of certain drugs
5. Ghee or oil and
6. Honey

Jaggery, sugar or sugar-candy is dissolved in the liquid and strained to remove the foreign
particles. This solution is boiled over a moderate fire. When pressed between two fingers if paka
becomes thready (Tantuvat), or when it sinks in water without getting easily dissolved, it should
be removed from the fire. Fine powders of drugs are then added in small quantities and stirred
continuously to form a homogenous mixture. Ghee or oil, if mentioned, is added while the
preparation is still hot and mixed well. Honey, if mentioned is added when the preparation
becomes cool and mixed well.

Characteristics: The Avaleha or Lehyam should neither be hard nor be a thick fluid. When pulp
of the raw herbs is added and ghee or oil is present in the preparation, this can be rolled between
the fingers. The growth of fungus over it or fermentation is signs of deterioration. When metals
are mentioned in the formula, the bhasmas of the metals are used. In the case of specific drugs
like Bhallataka, Vatsanabha etc. purified drugs alone are included in the preparation. The colour
and smell of the prepared Avaleha depend on the drugs or herbs used as ingredients.

The Avaleha or Lehyam should be kept in glass or porcelain jars. It can also be kept in a metal
container or pet bottles which do not react with it.
Bhasmas: These are unique metal based drugs and they are suggested with herbal juices, fruits
for treating variety of chronic diseases. Bhasmas are obtained by repeated calcinations and
incineration of liquid products by special process. During incineration metals are converted into
mixed oxides. Bhasmas are most ancient form of administration having pharmacological
activities loike analgesic, anti-inflammatory, anti-oxidant activities. In addition to the major
constituent element found at % level, several other essential elements such as Na, K, Ca, Mg, V,
Mn, Fe, Cu, and Zn have also been found in μg/g amounts and ultratrace (ng/g) amounts of Au
and Co. These seem to remain chelated with organic ligands derived from medicinal herbs. The
bhasmas are biologically produced nanoparticles and are taken along with milk, butter, honey, or
ghee (a preparation from milk), thus, this makes these elements easily assimilable, eliminating
their harmful effects and enhancing their biocompatibility.

Various steps involved in the preparation of bhasma(or bhasmikaran) are:

Shodhana -Purification,

Maran̻a - Powdering,

Chalana- Stirring,

Dhavana - Washing,

Galana- Filtering,

Puttana- Heating,

Mardana- Triturating,

Bhavana- Coating with herbal extract,

Amr̻tikaran̻a - Detoxification and

Sandharana- Preservation
…………………….
 Semester- 6th
Subject: Herbal Drug Technology

Subject code: BP603

Module - 5

General Introduction to Herbal Industry

Objectives: upon compilation of this module the student should be able to:

1. Know about the present scope and future prospects of herbal drug industry
2. Know about the various plant based industries and institutions
3. Know about the various industries involved in work on medicinal and aromatic plants in
India
4. Know about the Schedule-T and its objectives
5. Know about the components of GMP and various infrastructural requirements of
working space

Learning outcomes: the student will be able to:

1. Learn about the present and future aspects of Herbal drug industry
2. Learn about the various industries involved in work on medicinal and aromatic plants
3. Learn about the components of GMP
4. Learn about the Schedule-T drugs
5. Learn about the working space, storage area and other conditions for herbal drugs

Introduction: Herbs are those remedial agents which are created by nature for curing human
illness. Herbal extracts have been used since ancient times in traditional medicine. This system
of medicine (Ayurveda, Unani and Siddha) is 5000 year old recommends a combination of
lifestyle management and treatment with specific herbs and minerals to cure various diseases.
Approximately 1250 Indian medicinal plants are being used to formulate beneficial measures
according to Ayurveda. WHO define Traditional herbal medicines as naturally occurring, plant
derived substances with minimal or no industrial processing that have been used to treat illness
within local or regional healing practices. Traditional herbal medicine and their preparations
have been widely used for the thousands of years in developing and developed countries due to
its natural origin and lesser side effects. These medicines initially used in the form of crude drugs
such as tinctures, teas, poultices, powders, and other herbal formulations. The use of plants for
healing purposes predates human history and forms the origin of much modern medicine.
Clinical, pharmacological, and chemical studies of these traditional medicines, which were
derived predominantly from plants, were the basis of most early medicines such as aspirin
(Willow bark), digitoxin (Foxglove leaves), morphine (Opium poppy), quinine (Cinchona bark),
and pilocarpine (Jaborandi). Herbal medicine is still the mainstay of about 75-80% of the world
population, mainly in the developing countries, for primary health care. This is primarily because
of the general belief that herbal drugs are without any side effects besides being cheap and
locally available. According to the WHO, the use of herbal remedies throughout the world
exceeds that of the conventional drugs by two to three times.

Recently WHO classified herbal medicines into four different classes according to their origin,
evolution and forms of current usage.

• Indigenous herbal medicines

• Herbal medicines in systems
• Modified herbal medicines
• Imported products with a herbal medicine base

Indigenous herbal medicines are those which historically used in a local community or region
and are very well known through long usage by the local population in terms of its composition,
treatment and dosage. It can be used freely by the local community or in the local region.
However, if the medicines in this category enter the market or go away from the local
community or region, they have to meet the requirements of safety and efficacy as per the
national regulations for herbal medicines. Herbal medicines in systems have been used for a long
time and are documented with their special theories and concepts, and accepted by the countries
such as Ayurveda, Unani and Siddha. Modified herbal medicines have been modified in shape,
or form including dose, dosage form, mode of administration, herbal medicinal ingredients,
methods of preparation and medical indications. They have to meet the national regulatory
requirements of safety and efficacy of herbal medicines. Imported products with herbal medicine
base covers all imported herbal medicines including raw materials and products. Imported herbal
medicines must be registered and marketed in the countries of origin. The safety and efficacy
data have to be submitted to the national authority of the importing country and need to meet the
requirements of safety and efficacy of regulation in the recipient country.

Past and Present Status of Herbal Medicines: Plants and natural products were used by
humankind over the years as food and medicines to cure and prevent diseases. It is very difficult
to point out an exact time when the use of plants was started as medicine, the carbon dating from
ancient Babylon (Iraq) records that plants were cultivated as medicines 60,000 years ago.
Written materia medica of medicinal herbs go back approximately 5,000 years in India, China
and Egypt and at least 2,500 years in Greece and Asia Minor. Neanderthal remains have been
found to contain the remnants of medicinal herbs. Ancient Ayurveda was meant essentially to
promote health, however, rather than fight disease. Charak Samhita (1000 BC) and Sushrut
Samhita (100 AD) are the main text available. Ayurveda materia medica gives detailed
descriptions of over 1500 herbs and 10,000 formulations.
Currently more than 80% of the world population depends on traditional and plant derived
medicine because plants are important sources of medicines and presently about 25% of
pharmaceutical prescriptions in the United States contain at least one plant derived ingredient. In
the last century, roughly 121 pharmaceutical products were formulated based on the traditional
knowledge obtained from various sources. In fact, it is now believed that nature contributes up to
90% to the new drug molecule. Nature has provided many of the effective agent such as
dactinomycin, bleomycin, and doxorubicin, vinblastine, irinotecan, topotecan, etoposide, and
paclitaxel (anticancer), efloquine, chloroquine, amodiaquine, artemisinin, artemether, and
arteether (anti-malarial), metformin and eventually the other biguanide, harunganin,
cryptolepine, maprouneacin (anti-diabetic), calanolide A, cucrcumin, phenoxidiol (anti-HIV
drugs) etc. India has around 25,000 effective plant based formulations used traditionally with
over 1.5 million practitioners of traditional medicinal system and 7800 medicinal drug
manufacturing units in India, which consume about 2000 tones of herbs annually.

Traditional medicine in most regions of the world takes place after WHO Traditional Medicine
Strategy 2002-2005, state member also developed their own documentation and safety concern.
The diversity of regulations and regulatory categories for Traditional medicinal products makes
it difficult to assess the size of the market for products across member states accurately.
However, available data suggests that the Traditional medicine have significant market in
member states. Indian herbal market is nearly 50 billion rupees with 14% annual growth. One
billion rupees worth of herbal product are being exported. The demand for medicinal plants is
increasing everyday and WHO has projected that global herbal market will grow up to $ 5
trillion in 2050 from the current level of $ 62 billion. India and China produce more than 70% of
the global diversity. The significant global herbal export market include EU, USA, Canada,
Australia, Singapore, and Japan while Brazil, Argentina, Mexico, China and Indonesia are new
emerging market.

Future Prospects of Herbal Medicine: It is estimated that there are about 350,000 species of
existing plants (including seed plants, bryophytes, and ferns), among which 287,655 species have
been identified as of 2004. Relatively small percentages (1 to 10%) of these are used as foods by
both humans and other animal species. It is possible that even more are used for medicinal
purposes. WHO has shown great interest in documenting the use of medicinal plants used by
tribes from different parts of the world. Many developing countries have intensified their efforts
in documenting the ethno-medicinal data on medicinal plants. Research to find out scientific
evidence for claims by tribal healers on Indian herbs has been intensified. Once these local
ethno-medicinal preparations are scientifically evaluated and disseminated properly, people will
be better informed regarding efficacious drug treatment and improved health status. The
traditional knowledge system needs to be studied, documented, preserved and used for the
benefit of humankind, before it is lost forever. This will require a holistic approach, and
involvement and participation of local inhabitants. The Associated Chambers of Commerce and
Industry of India (ASSOCHAM) has projected that the market size of herbal industry which is
currently estimated at Rs. 7,500 crores (Rs.75 billion) will double to levels at Rs.15,000 crores
by 2015 since this industry would be growing at a compounded annual growth rate of over 20%
hence forth. In a study brought out by ASSOCHAM on herbal industry and global market 2015,
it is pointed out that India’s rich resource of medicinal plants and traditional treasure of
knowledge in this area, its share at present is considered very meager. A quick estimate of the
potential reveals that India can generate raw stock of around Rs. 300 billion and easily achieve
around Rs.150 billion value added products. Thus India is hardly able to exploit less than 50% of
its potential. Interestingly both raw materials (herbs) and herbal products have ready market
globally.

Global Overview of Medicinal Plants: The current and recent trends all over the world have
clearly shown that for one reason or the othe rpeople are not only willing to try natural medicine
especially those of plant origin but alternatively are seeking nonconventional remedies. As a
result of this situation there is a global resurgence in the trade of herbal medicines. International
market for medicinal plants is reported to be over 62 billion US dollars per year during 2000-
2001, which is growing steadily at the rate of 7% annually. The botanical retail market, inclusive
of herbs and medicinal plants, in USA, is estimated to be approximately 1.6 billion US dollars
annually. It is estimated that countries in Europe annually imports about 400,000 tonnes of
medicinal plant material with an average market value of 1 billion US dollars from countries in
Africa and Asia. A growing awareness of this new and recent contributor to the foreign exchange
reserves of several national treasuries is beginning to emerge globally. To satisfy the growing
market demands for medicinal plants, surveys worldwide are being conducted by the
pharmaceutical industries and research organization to unearth and unveil new medicinal plant
sources as herbal remedies, medicines, and bio-molecules.
Trade of Medicinal plants/ Indian Scenario: India is one of the richest regions as far as the
diversity of plant species is concerned. India is the largest exporter, next to China., accounting
for about 13% of the global exports. If we look at the socio-economic scenario of Asian and
African countries, modern medicine is neither affordable nor within the reach of many villagers
and tribes inhabiting remote areas and deep forests. There are certain pockets in a country like
India where the tribal people have no access to modern amenities like roads, telecommunications
or electricity, and therefore, these communities rely only on their traditional knowledge of
medicine for day-today requirements. It is well established that industrialisation has many direct
and indirect effects on the human population. Increased stress is the most evident, although this
is offset by increased health awareness among the people and better medical facilities.
Nevertheless, increases in the incidence of diseases (mostly in urban populations) such as
coronary heart disease, diabetes, hyperlipidaemia, AIDS and cancer cannot be denied. There are
many examples where medicines have been obtained from plants known to traditional healers.
With the development of modern analytical tools, interest in natural product chemistry has led to
the isolation by Serturner of morphine alkaloid from opium, a mixture of plentiful alkaloids. This
in turn was obtained from the opium poppy (Papaver somniferum) by processes that have been
used for over 5000 years. Quinine isolated from the Cinchona tree had its origin in the Royal
household of South American Incas. Long before the first European explorers arrived, the native
people of South America had developed medical systems with complete diagnosis and treatment
of various maladies. The leaves of the coca tree have been primarily chewed by Andean people
to obtain well-known benefits. In 1860, Carl Koler isolated cocaine from the coca tree, the
chemical responsible for its biological activity, and has become infamous as a drug of abuse. The
other botanicals include atropine, hyoscine, digoxin, colchicine and emetine.

Medicinal and Aromatic Plant based industries and institutions in India

In India, it is estimated that there are about 25,000 licensed pharmacy of Indian system of
medicine. Presently about 1000 single drugs and 3000 compound formulations are registered.
Herbal Industry in India uses about 8000 medicinal plants. In India, herbal Research institute and
manufacturer of herbal formulations. However none the pharma has standardized herbal
medicine using active compounds as markers linked with confirmation of bioactivity of
medicinal plants. There are about 8000 drug manufactures in India, there are however not more
than 25 manufactures that can be classified as large scale manufactures. A large number of
academic, industrial and government institutes are conducting research on the medicinal plants
of India. There has been no systematic review of the massive work that is available from this
nation. Many international data-bases and web-sites do not cover even the work published in the
Indian Journals. Hence, there is a global lack of awareness of the mass and nature of work
carried out on diverse aspects viz. ethnobotany, phytochemistry, pharmacognosy, pharmacology,
clinical trials, safety studies and formulation-research. Following Table provides a short list of
some of the eminent institutes which are active in research on medicinal plants and in Ayurveda.
Schedule T- Good manufacturing Practices of Indian Systems of Medicine

• Components of GMP and its Objectives: Good Manufacturing Practice (GMP) is a

production and testing practice that helps to ensure a quality product. GMP guidelines are
not prescriptive instructions on how to manufacture products. These are a series of
general principles that must be observed during manufacturing. When a company is
setting up its quality program and manufacturing process, there may be many ways it can
fulfill GMP requirements. It is the company’s responsibility to determine the most
effective and efficient quality process. The Good Manufacturing Practices for ASU Drugs
as described in Rule 157 of Drugs & Cosmetics Rules 1945 with conditions as specified
in Schedule T / GMP are to ensure that:
(I) Raw materials used in the manufacture of drugs are authentic, of prescribed
quality and are free from contamination
(II) The manufacturing process is as has been prescribed to maintain the standards
(III) Adequate quality control measures are adopted
(IV) The manufactured drug which is released for sale is of acceptable quality
(V) To achieve the objectives listed above, each licensee shall evolve methodology
and procedures for following the prescribed process of manufacture of drugs which
should be documented as a manual and kept for reference and inspection. However,
under IMCC Act, 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines
on their own to dispense to their patients and not selling such drugs in the market are
exempted from the purview of Good manufacturing Practice (GMP).

Basic Principles of GMP

Many countries have legislated that pharmaceutical and medical device companies must
follow GMP procedures, and have created their own GMP guidelines that correspond
with their legislation. Basic concepts of all of these guidelines remain more or less
similar to the ultimate goals of safeguarding the health of the patient as well as producing
good quality medicine.Although there are a number of them, all guidelines follow a few
basic principles:
➢ Manufacturing processes are clearly defined and controlled. All critical processes
are validated to ensure consistency and compliance with specifications.
➢ Manufacturing processes are controlled, and any changes to the process are
evaluated.
➢ Changes that have an impact on the quality of the drug are validated as necessary.
➢ Instructions and procedures are written in clear and unambiguous language.
➢ Operators are trained to carry out and document procedures.
 ➢ Records are made manually or by instruments during manufacture that
demonstrate that all the steps required by the defined procedures and instructions
were in fact taken and that the quantity and quality of the drug was as expected
➢ Deviations are investigated and documented.
➢ Records of manufacture (including distribution) that enable the complete history
of a batch to be traced are retained in a comprehensible and accessible form.

Duties regarding regulation of manufacture for sale of ASU drugs

Subject to the provisions of section 23 and of any rules made by the Central
Government in this behalf, an Inspector may, within the local limits of the area
for which he is appointed:
• Inspect,
(i) any premises wherein any ASU drugs is being manufactured and the means
employed for standardizing and testing the ASU drugs;
(ii) any premises wherein any ASU drugs is being sold, or stocked or exhibited or
offered for sale, or distributed .
• Take samples of any ASU drug,
(i) which is being manufactured or being sold or is stocked or exhibited or
offered for sale, or is being distributed;
(ii) from any person who is in the course of conveying, delivering or
preparing to deliver such ASU drugs to a purchaser or a consignee.
• At all reasonable times, with such assistance, if any, as he considers necessary,
(i) search any person, who, he has reason to believe, has secreted about his
person, any ASU drugs in respect of which an offence under Chapter IV-A of
D&C Act has been, or is being, committed; or
(ii) enter and search any place in which he has reason to believe that an
offence under Chapter IV-A of D&C Act has been, or is being committed; or
(ii) Stop and search any vehicle, vessel, or other conveyance which, he has
reason to believe, is being used for carrying any ASU drug in respect of
which an offence under Chapter IV-A of D&C Act has been, or is being,
committed, and order in writing the person in possession of the ASU
drugs in respect of which the offence has been, or is being, committed,
not to dispose of any stock of such ASU drugs for a specified period not
exceeding twenty days, or, unless the alleged offence is such that the
defect may be removed by the possessor of the ASU drugs, seize the
stock of such ASU drugs and any substance or article by means of which
the offence has been ,or is being, committed or which may be employed
for the commission of such offence. (Clause c of Section 22 of D&C Act
1940)
Legal provisions for GMP certification

(Rules as in Drugs & Cosmetics Rules 1945 regarding) Manufacture for Sale of Ayurvedic
(including Siddha) or Unani Drugs (Part XVI of D&C Rules 1945)

151. Manufacture on more than one set of premises: If Ayurvedic (including Siddha) or Unani drugs are
manufactured on more than one set of premises, a separate application shall be made and a separate
licence shall be obtained in respect of each such set of premises.

152. Licensing Authorities For this purpose of this Part the State Government shall appoint such
Licensing Authorities and for such areas as may be specified in this behalf by notification in the Official
Gazette.

153. Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs.

(1) An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including
Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with a fee of rupees
one thousand: Provided that in the case of renewal the applicant may apply for the renewal of the licence
before its expiry or within one month of such expiry: Provided further that the applicant may apply for
renewal after the expiry of one month but within three months of such expiry in which case the fee
payable forrenewal of such licence shall be rupees one thousand and two hundred plus an additional fee
of rupees six hundred.

(2) A fee of rupees three hundred shall be payable for a duplicate copy of a licence issued under
this rule, if the original licence is defaced, damaged or lost.

153-A Loan Licence

(i) An application for the grant or renewal of a loan licence to manufacture for sale of any
Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-E to the Licensing
Authority along with a fee of rupees six hundred.

Explanation—For the purpose of this rule, a loan licence means a licence which a
LicensingAuthority may issue to an applicant who does not have his own arrangements for
manufacture but intends to avail himself of the manufacturing facilities owned by a licence in
Form 25-D:

PROVIDED that in the case of renewal the applicant may apply for the renewal of the licence
before its expiry or within one month of such expiry:

PROVIDED further that the applicant may apply for renewal after the expiry of one month, but
within three months of such expiry in which case the fee payable for renewal of such licence
shall be rupees six hundred plus an additional fee of rupees three hundred.

(ii) A fee of rupees one hundred and fifty shall be payable for a duplicate copy of a licence
issued under this rule, if the original licence is defaced, damaged or lost.
154. Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs

(1) Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale any
Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The licence shall be
issued within a period of three months from the date of receipt of the application.

(2) A licence under this rule shall be granted by the licensing authority after consulting such
expert in Ayurvedic (including Siddha) or Unani Systems of medicine as the case may be, which
the State Government may approve in this behalf.

155. Certificate of renewal : The certificate of renewal of a licence in Form 25-D shall be issued
in Form 26-D. 155-A Certificate of renewal of a loan licence The certificate of renewal of a loan
licence in Form 25-E shall be issued in Form 26-E. 155-B Certificate of award of G.M.P. of
Ayurveda, Siddha and Unani Drugs

(i) The certificate of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha or

Unani drugs shall be issued for a period of five years to licensees who comply with the
requirements of Good Manufacturing Practices (GMP) of Ayurveda, Siddha and Unani drugs as
laid down in Schedule T.

(ii) The certificate referred to in sub rule (1) shall be issued for a period of five years from the
date of issuance of the license.

156. Duration of licence: An original licence in Form 25-D or a renewed license in Form 26-D,
unless sooner suspended or cancelled shall be valid for a period of five years from the date of its
issue or renewed. PROVIDED that if the application for the renewal of a licence is made before
its expiry

or within one month of its expiry, or if the application is made within three months of its

expiry after payment of the additional fee of rupees five hundred, the licence shall continue

to be in force until orders are passed on the application. The licence shall be deemed to have

expired, if the application for its renewal is not made within three months of its expiry.

156-A Duration of loan licence

An original loan licence in Form 25-E or a renewed loan licence in Form 26-E, unless sooner

suspended or cancelled, shall be valid for a period of five years from the date of its issue

or renewed:

PROVIDED that if the application for the renewal of a loan licence is made in accordance
with rule 153-A, the loan licence shall continue to be in force until orders are passed on the

application. The licence shall be deemed to have expired, if the application for its renewal

is not made within three months of its expiry.

157. Conditions for the grant or renewal of a licence in Form 25-D Before a licence in Form 25-
D is granted or renewed in Form 26-D the following conditions shall be complied with by the
applicant, namely—

(1) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out

in such premises and under such hygienic conditions as are specified in Schedule T.

(a) For issuing of the certificate of Good Manufacturing Practices, the Licensing Authority
shall verify the requirements as per Schedule T and issue the Good Manufacturing Practices
certificate in Form 26 E-I, simultaneously along with grant or renewal of License in Form 25-D.

(2) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be conducted
under the direction and supervision of competent technical staff consisting at least one person,
who is a whole time employee and who possesses the following qualifications, namely—

(a) A degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of medicine, as the
case may be, conferred by a University, a State Government or Statutory Faculties, Councils and
Boards of Indian Systems of medicines recognized by the Central Government or a State
Government for this purpose, or

(b) A diploma in Ayurveda, Siddha or Unani system of medicine granted by a State

Government or an Institution recognised by the Central Government for this purpose, or

(c) A graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University

recognized by the Central Government with experience of at least two years in the manufacture
of drugs pertaining to the Ayurvedic or Siddha or Unani systems of medicines, or

(d) A Vaid or Hakim registered in a State Register of Practitioners of indigenous systems of

medicines having experience of at least four years in the manufacture of Ayurvedic or Siddha or
Unani drugs, or

(e) A qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems of medicine,

possessing experience of not less than eight years in the manufacture of Ayurvedic or Siddha or
Unani drugs as may be recognized by the Central Government.

(3) The competent technical staff to direct and supervise the manufacture of Ayurvedic drugs
shall have qualifications in Ayurveda and the competent technical staff to direct and supervise
the manufacture if Siddha drugs and Unani drugs shall have qualification in Siddha or Unani, as
the case may be.

Good Manufacturing Practices

Factory Premises: The manufacturing plant should have adequate space for:-

(i) Receiving and storing raw material;

(ii) Manufacturing process areas;
(iii) Quality control section;
(iv) Finished goods store;
(v) Office;
(vi) Rejected goods/drugs store.

General Requirements:

1.1 (A)Location and surroundings- The factory building for manufacture of Ayurveda, Siddha
and Unani medicines shall be so situated and shall have such construction as to avoid
contamination from open sewerage, drain, public lavatory or any factory which produces
disagreeable or obnoxious odour or fumes or excessive soot, dust or smoke.

1.1(B) Buildings- The building used for factory shall be such as to permit production of drugs
under hygienic conditions and should be free from cobwebs and insects/rodents. It should have
adequate provision of light and ventilation. The floor and the walls should not be damp or moist.
The premises used for manufacturing, processing, packaging and labeling will be in conformity
with the provisions of the Factory Act. It shall be located so as to be:

(i) Compatible with other manufacturing operations that may be carried out in the same or
adjacent premises.

(ii) Adequately provided with working space to allow orderly and logical placement of
equipment and materials to avoid the risk of mix-up between different drugs or components
thereof and control the possibility of cross- contamination by other drugs or substances and
avoid the risk of omission of any manufacturing or control step.

iii. Designed, constructed andmaintainedtoprevententryofinsectsandrodents. Interior surface

(walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and
disinfection. The walls of the room in which the manufacturing operations are carried out shall
be impervious to and be capable of being kept clean. The flooring shall be smooth and even and
shall be such as not to permit retention or accumulation of dust or waste products.

iv. Provided with proper drainage system in the processing area. The sanitary fittings and
electrical fixtures in the manufacturing area shall be proper and safe.
(v) Furnace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient
care should be taken to prevent flies and dust.

(vi)There should be fire safety measures and proper exits should be there.

(vii) Drying space- There should be separate space for drying of raw material, in process
medicine or medicines which require drying before packing. This space will be protected from
flies/insects/dusts, etc., by proper flooring, wire-mash window,glass pans or other material.

1.1(C) Water Supply- The water used in manufacture shall be pure and of potable
quality.Adequate provision of water for washing the premises shall be made.

1.1(D) Disposal of Waste- From the manufacturing sections and laboratories the waste water
and the residues which might be prejudicial to the workers or public health shall be disposed off
after suitable treatment as per guidelines of pollution control authorities to render them harmless.

1.1(E) Containers’ Cleaning- In factories where operations involving the use of containers such
as glass bottles, vials and jars are conducted, there shall be adequate arrangement separated from
the manufacturing operations for washing, cleaning and drying of such containers.

1.1(F) Stores- Storage should have proper ventilation and shall be free from dampness. It should
provide independent adequate space for storage of different types of material, such as raw
material, packaging material and finished products.

1.1(F)(A) Raw Materials- All raw materials procured for manufacturing will be stored in the
raw materials store. The manufacture based on the experience and the characteristics of the
particular raw material used in Ayurveda, Siddha and Unani system shall decide the use of
appropriate containers which would protect the quality of the raw material as well as prevent it
from damage due to dampness, microbiological contamination or rodent and insect infestation,
etc. If certain raw materials require such controlled environmental conditions, the raw materials
stores may be sub-divided with proper enclosures to provide such conditions by suitable
cabinization. While designing such containers, cabins or areas in the raw materials store, care
may be taken to handle the following different categories of raw materials:-

(1) Raw material of metallic origin.

(2) Raw material of mineral origin.

(3) Raw material from animal source.

(4) Fresh Herbs.

(5) Dry Herbs or plant parts.

(6) Excipients, etc.

 (7) Volatile oils/perfumes & flavours.

(8) Plant concentrates/extracts and exudates/resins.

Each container used for raw material storage shall be properly identified with the label which
indicates name of the raw material, source of supply and will also clearly state the status of raw
material such as ‘UNDER TEST’ or ‘APPROVED’ or ‘REJECTED’. The labels shall further
indicate the identity of the particular supply in the form of Batch No. or Lot. No. and the date of
receipt of consignment. All the raw materials shall be sampled and got tested either by the in-
house Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the
laboratories approved by Government and shall be used only on approval after verifying. The
rejected raw material should be removed from other raw materials store and should be kept in a
separate room. Procedure of ‘First in first out’ should be adopted for raw materials wherever
necessary. Records of the receipt, testing and approval or rejection and use of raw material shall
be maintained.

1.1(F)(B) Packaging Materials- All packaging materials such as bottles, jars, capsules, etc.
shall be stored properly. All containers and closures shall be adequately cleaned and dried before
packing the products.

1.1(F)(C) Finished Goods Stores- The finished goods transferred from the production area after
proper packaging shall be stored in the finished goods stores within an area marked“Quarantine”.
After the quality control laboratory and the experts have checked the correctness of finished
goods with reference to its packing/labelling as well as the finished product quality as
prescribed,, then it will be moved to ‘Approved Finished Goods Stock”area.

1.1(G) Working Space- The manufacturing area shall provide adequate space (manufacture and
quality control) for orderly placement of equipment and material used in any of the operations
for which these are employed so as to facilitate easy and safe working and to minimize or to
eliminate any risk of mix-up between different drugs, raw materials and to prevent the possibility
of cross-contamination of one drug by another drug that is manufactured, stored or handled in the
same premises.

1.1(H) Health, Clothing, Sanitation and Hygiene of Workers- All workers employed in the
Factory shall be free from contagious diseases. The clothing of the workers shall consist of
proper uniform suitable to the nature of work and the climate and shall be clean. The uniform
shall also include cloth or synthetic covering for hands, feet and head wherever required.
Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes
shall be provided. Separate provision shall be made for lavatories to be used by men and women,
and such lavatories shall be located at places separated from the processing rooms. Workers will
also be provided facilities for changing their clothes and to keep their personal belongings.
1.1(I) Medical Services- The manufacturer shall also provide:-

(i) Adequate facilities for first aid;

(ii) Medical examination of workers at the time of employment and periodical

checkup thereafter by a physician once a year, with particular attention being devoted to freedom
from infections. Records thereof shall be maintained.

1.1(J) Machinery and Equipments- For carrying out manufacturing depending on the size of
operation and the nature of product manufactured, suitable equipment either manually operated
or operated semi-automatically (electrical or team based) or fully automatic machinery shall be
made available. These may include machines for use in the process of manufacture such as
crushing, grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling,
labelling and packing, etc. To ensure ease in movement of workers and orderliness in operations
a suitably adequate space will be ensured between two machines or rows of machines. These
machinery and equipments and machinery recommended is indicated in Part II-A. Proper
standard operational procedures (SOPs) for cleaning maintaining and performance of every
machine should be laid down.

1.1(K) Batch Manufacturing Records- The licensee shall maintain batch manufacturing record
of each batch of Ayurvedic, Siddha and Unani drugs manufactured irrespective of the type of
product manufactured (classical preparation or patent and proprietary medicines). Manufacturing
records are required to provide and account of the list of raw materials and their quantities
obtained from the store, tests conducted during the various stages of manufacture like taste,
colour, physical characteristics and chemical tests as may be necessary or indicated in the
approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs
and Cosmetics Act, 1940 (23 of 1940). These tests may include any in-house or pharmacopoeial
test adopted by the manufacturer in the raw material or in the process material and in the finished
product. These records shall be duly signed by Production and Quality Control Personnel
respectively. Details of transfer of manufactured drug to the finished products store including
dates and quantity of drugs transferred along with record of testing of the finished product, if
any, and packaging, records shall be maintained. Only after the manufactured drugs have been
verified and accepted quality shall be allowed to be cleared for sale. It should be essential to
maintain the record of date, manpower, machine and equipments used and to keep in process
record of various shodhana, bhavana, burning in fire and specific grindings in terms of internal
use.

1.1(L) Distribution Records- Records of sale and distribution of each batch of Ayurveda,
Siddha and Unani Drugs shall be maintained in order to facilitate prompt and complete recall of
the batch, if necessary. The duration of record keeping should be the date of expiry of the batch,
Certain categories of Ayurvedic, Siddha and Unani medicines like Bhasma, Rasa, Kupi- pakva,
Parpati, Sindura, Karpu/Uppu/Puram, Kushta, Asava-arista, etc. do not have expiry date, in
contrast their efficacy increases with the passage of time. Hence, records need to be maintained
up to 5 years of the exhausting of stock.

1.1(M) Record of Market Complaints- Manufacturers shall maintain a register to record all
reports of market complaints received regarding the products sold in the market. The
manufacturer shall enter all data received on such market complaints, investigations carried out
by the manufacturers regarding the complaint as well as any corrective action initiated to prevent
recurrence of such market complaints shall also be recorded. Once in a period of six months the
manufacturer shall submit the record such complaints to the Licensing Authority. The Register
shall also be available for inspection during any inspection of the premises. Reports of any
adverse reaction resulting from the use of Ayurvedic, Siddha andUnani drugs shall also be
maintained in a separate register by each manufacturer. The manufacturer shall investigate any of
the adverse reaction to find if the same is due to any defect in the product, and whether such
reactions are already reported in the literature or it is a new observation.

1.1(N) Quality Control- Every licensee is required to provide facility for quality control section
in his own premises or through Government-approved testing laboratory. The test shall be as per
the Ayurveda, Siddha and Unani pharmacopoeial standard. Where the tests are not available, the
test should be performed according to the manufacturer’s specification or other information
available. The quality control section shall verify all the raw materials, monitor in process,
quality checks and control the quality of finished product being released to finished goods
store/warehouse. Preferably for such quality control there will be a separate expert. The quality
control section shall have the following facilities:

(a) There should be 150 sq feet area for quality control section.

(b) For identification of raw drugs, reference books and reference samples should be
maintained.

(c) Manufacturing record should be maintained for the various processes.

(d) To verify the finished products, controlled samples of finished products of each batch will be
kept till the expiry date of product.

(e) To supervise and monitor adequacy of conditions under which raw materials, semifinished
products and finished products are stored.

(f) Keep record in establishing shelf life and storage requirements for the drugs.

(g) Manufacturers who are manufacturing patent proprietary Ayurveda, Siddha and Unani
medicines shall provide their own specification and control references in respect of such
formulated drugs.
 (h) The record of specific method and procedure of preparation, that is, “Bhavana”, “Mardana”
and “Puta” and the record of every process carried out by the manufacturer shall be maintained.

(i) The standards foridentity,purity andstrengthas giveninrespectivepharmacopoeias of

Ayurveda, Siddha and Unani systems of medicines published by Government of India Shall be
complied with.

(j) All raw materials will be monitored for fungal, bacterial contamination with a view to
minimize such contamination.

(k) Quality control section will have a minimum of-

(i) (a) Expert in Ayurveda or Siddha or Unani who possess a degree qualification

recognized under Schedule II of Indian Medicine Central Council Act, 1970.

(b) Chemist, who shall possess at least a Bachelor Degree in Science or

Pharmacy or Pharmacy (Ayurveda) awrded by a recognized University; and

(c) A Botanist (Pharmacognosist) who shall possess at least a Bachelor Degree

in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a

recognized University.

(ii) The manufacturing unit shall have a quality control section as explained under

Section 35(ii). Alternatively, these quality control provisions will be met by getting

testing, etc., from a recognized laboratory for Ayurveda, Siddha and Unani drugs;

under Rule 160-A of the Drugs and Cosmetics Act. The manufacturing company will

maintain all the record of various tests got done from outside recognized laboratory.

(iii) List of equipment recommended is indicated in Part II-C.

1.2 Requirement for Sterile Product:

(A) Manufacturing Areas– For the manufacture of sterile Ayurvedic, Unani and Siddha drugs,
separate enclosed areas specifically designed for the purpose shall be provided. These areas shall
be provided with air locks for entry and shall be essentially dust free and ventilated with an air
supply. For all areas where aseptic manufacture has to be carried out, air supply shall be filtered
through bacteria retaining filters (HEPA Filters) and shall be at a pressure higher than in the
adjacent areas. The filters shall be checked for performance on installation and periodically
thereafter the record of checks shall be maintained. All the surfaces in sterile manufacturing
areas shall be designed to facilitate cleaning and disinfection. For sterile manufacturing routine
microbial counts of all Ayurvedic, Siddha and Unani drug manufacturing areas shall be carried
out during operations. Results of such count shall be checked against established in-house
standards and record maintained. Access to manufacturing areas shall be restricted to minimum
number of authorized personnel. Special procedure to be followed for entering and leaving the
manufacturing areas shall be written down and displayed. For the manufacturing of Ayurvedic,
Siddha and Unani drug that can be sterilized in their final containers, the design of the areas shall
preclude the possibility of the products intended for sterilization being mixed with or taken to be
products already sterilized. In case of terminally sterilized products, the design of the areas shall
preclude the possibility of mix-up between non-sterile products.

(B) Precautions against contamination and mix:

a) Carrying out manufacturing operations in a separate block of adequately isolated building or

operating in an isolated enclosure within the building,

(b) Using appropriate pressure differential in the process area.

(c) Providing a suitable exhaust system.

(d) Designing laminar flow sterile air system for sterile products.

(e) The germicidal efficiency of UV lamps shall be checked and recorded indicating the burning
hours or checked using intensity.

(f) Individual containers of liquids and ophthalmic solutions shall be examined against black-
white background fitted with diffused light after filling to ensure freedom from contamination
with foreign suspended matter.

(g) Expert technical staff approved by the Licensing Authority shall check and compare actual
yield against theoretical yield before final distribution of the batch. All process controls as
required under master formula including room temperature, relative humidity, volume filled,
leakage and clarity shall be checked and recorded.
 UNIT-I

Topic-3
INDIAN SYSTEMS OF MEDICINE
The Indian System of Medicine is of great antiquity. It is the culmination of Indian thought of
medicine which represents a way of healthy living valued with a long and unique cultural
history, as also amalgamating the best of influences that came in from contact with other
civilizations be it Greece (resulting in Unani Medicine) or Germany (Homeopathy) or our
scriptures/sages which gave us the science of Ayurveda, Siddha as also Yoga & Naturopathy.
Like the multifaceted culture in our country, traditional medicines have evolved over
centuries blessed with a plethora of traditional medicines and practices. A separate
Department of Indian Systems of Medicine and Homoeopathy (ISM&H) was set up in 1995
to ensure the optimal development and propagation of AYUSH systems of health care. The
Department of ISM&H was re-named as the Department of AYUSH (an acronym for -
Ayurveda, Yoga and Naturopathy, Unani, Siddha, Homoeopathy) in November 2003. With
an increase in lifestyle related disorders there is a worldwide resurgence of interest in holistic
systems of health care, particularly with respect to the prevention and management of
chronic, non-communicable and systemic diseases. It is increasingly understood that no
single health care system can provide satisfactory answers to all the health needs of modern
society. Evidently there is a need for a new inclusive and integrated health care regime that
should guide health policies and programs in future. India has an advantage in this global
resurgence of interest in holistic therapies as it has a rich heritage of indigenous medical
knowledge coupled with strong infrastructure and skilled manpower in modern medicine.
Medical pluralism is here to stay and the AYUSH sector has a critical role to play in the new
and emerging situation. The Department of AYUSH under Ministry of Health and Family
Welfare, promotes and propagates Indian systems of Medicine and Homoeopathy, and is
committed to infuse the wisdom of traditional medicine with the methodologies of modern
science, scientifically validating the systems and presenting them in the scientific idiom,
relating their efficacy to modern life styles.

The Department has, over the years, developed a broad institutional framework to carry out
its activities. The National Medicinal Plants Board (NMPB) functions under the Department
to coordinate activities relating to conservation, cultivation, marketing, export and policy
making for the development of the medicinal plants sector. There are two statutory regulatory
bodies, namely Central Council of Indian Medicine (CCIM) and Central Council of
Homoeopathy (CCH) for laying down minimum standards of education, recommending
recognition of medical qualifications, registering the practitioners and lying down of ethical
codes. Four research councils, for Ayurveda and Siddha (CCRAS), Unani (CCRUM), Yoga
and Naturopathy (CCRYN) and Homeopathy (CCRH) are responsible for the officially
sponsored research activities. So far, eight National Institutes are existing at national level for
teaching, research and clinical practices. For Standardization and testing of Drugs, various
agencies have been put in plan by the Government of India. Four different Pharmacopoeia
Committees are working for preparing official Formularies/Pharmacopoeias to evolve
uniform standards in preparation of drugs of Ayurveda, Siddha, Unani and Homeopathy and
to prescribe working standards for single drugs as well as compound formulations. A Drug
Quality Control Cell is working in the Department to deal with the matters pertaining to
licensing, regulation and control of drugs and the spurious manufacture of Ayurvedic, Unani
and Siddha Drugs and other matters. Two apex Laboratories, namely, Pharmacopoeial
Laboratory for Indian Medicine (PLIM) and Homoeopathic Pharmacopoeial Laboratory
(HPL) are functioning as Standard Setting-Cum-Drug-testing Laboratories for Indian
Medicines and Homoeopathy respectively. Indian Medicines Pharmaceutical Corporation
Ltd. (IMPCL), a Public Sector Undertaking, manufactures classical Ayurveda and Unani
drugs. The Department also manages the CGHS Ayurveda Hospital at Lodhi Road, New
Delhi. Bringing AYUSH into the mainstream health care delivery system of the country has
long been a major policy objective of the Department. Under the NRHM, AYUSH facilities
are being set up in PHCs and CHCs and are being manned by qualified AYUSH physicians
appointed on contract basis. Since the creation of a separate Department, there has been a
substantial increase in the infrastructural facilities under AYUSH systems in the country.
Presently, there are 3195 hospitals with about 58321 beds, 24392 dispensaries, 720937
doctors, 514 educational institutions with admission capacity of about 25586 UG student and
2493 PG students and 8785 drug-manufacturing units under AYUSH systems. Under NRHM,
AYUSH facilities have been co-located with 468 District hospitals, 2483 CHCs and 8520
PHCs.

AYUSH SYSTEMS

(i) Ayurveda

Ayurveda is a classical system of healthcare originating from the Vedas documented around
5000 years ago and currently recognized and practiced in India and many countries of the
Indian subcontinent. It is one of the oldest healthcare systems that take a holistic view of the
physical, mental, spiritual and social aspects of human life, health and disease. Scattered
references of health, disease and use of natural sources for treatment were initially made in
the Vedas (particularly in Rigveda and Atharvaveda) and around 5000 to 3000 B.C. the
knowledge of Ayurveda was first comprehensively documented in the compendia called
Charak Samhita and Sushruta Samhita. According to Ayurveda, health is considered as a
basic pre-requisite for achieving the goals of life - Dharma (duties), Arth (finance), Kama
(materialistic desires) and Moksha (salvation). As per the fundamental basis of Ayurveda, all
objects and living bodies are composed of five basic elements, called the Pancha
Mahabhootas, namely: Prithvi (earth), Jal (water), Agni (fire), Vayu (air) and Akash (ether).
The philosophy of Ayurveda is based on the fundamental correlation between the universe
and the man. Ayurveda imbibes the humeral theory of Tridosha- the Vata (ether + air), Pitta
(fire) and Kapha (earth + water), which are considered as the three physiological entities in
living beings responsible for all metabolic functions. The mental characters of human beings
are attributable to Satva, Rajas and Tamas, which are the psychological properties of life
collectively terms as ‘Triguna’. Ayurveda aims to keep structural and functional entities in a
state of equilibrium, which signifies good health (Swasthya). Any imbalance due to internal
or external factors leads to disease and the treatment consists of restoring the equilibrium
through various procedures, regimen, diet, medicines and behavior change. The treatment
approach in the Ayurveda system is holistic and individualized having preventive, curative,
mitigative, recuperative and rehabilitative aspects. The preventive aspect of Ayurveda is
called Svasth-Vritta and includes personal hygiene, daily and seasonal regimens, appropriate
social behavior and use of materials & practices for healthy aging and prevention of
premature loss of health attribute. The curative treatment consists of Aushadhi (drugs), Ahara
(diet) and Vihara (life style). Ayurveda largely uses plants as raw materials for the
manufacture of drugs, though materials of animal and marine origin, metals and minerals are
also used.

Ayurvedic medicines are generally safe and have little or no known adverse side-effects, if
manufactured properly and consumed judiciously following necessary dos and don’ts.
Initially, clinical medicine of Ayurveda was developed into eight distinct specialties, i.e.
Kayachikitsa (Internal Medicine), Shalya Tantra (Surgery), Shalakya (Eye and ENT),
Kaumar Bhritya (Pediatrics), Graha Chikitsa (Psychiatry), Agad Tantra (Toxicology),
Rasayana (Gerontology) and Vajikarana (Science of virility), on the basis of which it is called
‘Astang Ayurveda’. During the last 60 years of its development after India became
independent, Ayurveda has come up to provide 22 specialized courses of study at
postgraduation level. These specialties are Ayurveda Sidhanta (Fundamental Principles of
Ayurveda), Ayurveda Samhita (Classical Texts of Ayurveda), Rachna Sharira (Anatomy),
Kriya Sharira (Physiology), Dravya Guna Vigyan (Materia medica and Pharmacology), Rasa-
Shastra (Pharmaceuticals using minerals and metals), Bhaishajya Kalpana (Pharmaceuticals),
Kaumar Bhritya or - Bala Roga (Pediatrics), Prasuti Tantra avum Stri Roga (Obstetrics and
Gynecology), Swasth-Vritta (Social ansd Preventive Medicine), Kayachikitsa (Internal
Medicine), Rog Nidan avum Vikriti Vigyan (Diagnostics & Pathology), Shalya Tantra-
Samanya (Surgery), Shalya Tantra–Kshar Karma avum Anushastra Karma (Parasurgical
interventions & procedures), Shalakya Tantra-Netra Roga (Ophthalmology), Shalakya
Tantra–Shiro-Nasa-Karna Avum Kantha Roga ( Treatment of diseases of Head and ENT),
Shalakya Tantra – Danta Avum Mukha Roga (Dentistry), Manovigyana avum Manas Roga (
Psychology & Psychiatry), Panchakarma (Biopurification), Agad Tantra avum Vidhi
Vaidyaka (Toxicology and Medical Jurisprudence), Sangyaharana (Anesthesiology) and
Chhaya avum Vikiran Vigyan (Radiology).

Ayurveda holds the strength to treat diseases from holistic angle in accordance with the body-
mind constitution and other physic psychological attributes of the patients and as such is
proven to be effective in the treatment of chronic, metabolic and life style diseases for which
satisfactory solutions are not available in conventional allopathy medicine. Over the years,
Kshar Sutra and Panchakarma therapies of Ayurveda have become very popular among the
public. Panchakarma is a unique therapeutic procedure for the radical elimination of
diseasecausing factors and to maintain the equilibrium of tridosha. The Panchakarma therapy
minimizes the chances of recurrence of the diseases and promotes positive health by
rejuvenating body tissues and bio-purification. Kshar Sutra is a Para-surgical intervention
using an alkaline thread for cauterization, which is scientifically validated to be effective in
the treatment of fistula-in-ano and such surgical conditions as require excision of overgrown
soft tissue like polyps, warts, non-healing chronic ulcers, sinuses and papillae.

(ii) Unani

The Unani System of Medicine originated in Greece and passed through many countries
before establishing itself in India during the medieval period. This system is based on the
teachings of Hippocrates and Gallen, developed into an elaborate Medical System by Arabs.
It is based on well-established knowledge and practices relating to the promotion of positive
health and prevention of diseases. The Unani system became enriched by imbibing what was
best in the contemporary systems of traditional medicines in Egypt, Syria, Iraq, Persia, India,
China and other Middle East countries. The system of medicine was documented in Al-
Qanoon, a medical Bible, by Sheikh Bu-Ali Sina (Avicena, 980-1037 AD), and in Al-Havi by
Razi (Rhazes, 850-923 AD) and in many other books written by the Unani physicians. The
literature of the Unani system is mostly found in Arabic, Persian and Urdu languages. The
Unani System is based on the Humoral theory i.e. the presence of blood, phlegm, yellow bile
and black bile in a person. The temperament of a person can accordingly be sanguine,
phlegmatic, choleric and melancholic depending on the presence and combination of humors.
According to Unani theory, the humors and medicinal plants themselves are assigned
temperaments. Any change in quantity and quality of the humors, brings about a change in
the status of the health of the human body. A proper balance of humors is required for the
maintenance of health. Treatment in Unani consists of three components namely preventive,
promotive and curative. Unani system of Medicine has been found to be efficacious in
conditions like Rheumatoid Arthritis, Jaundice, Nervous Debility, and Skin Diseases like
Vitiligo & Eczema, Sinusitis and Bronchial Asthma. For the prevention of disease and
promotion of health, the Unani System emphasizes six essentials (Asbab-e-Sitta Zarooria):-

(a) Pure air

(b) Food and water

(c) Physical movement and rest

(d) Psychic movement and rest

(e) Sleep and wakefulness

(f) Retention of useful materials and evacuation of waste materials from the body. There are
four forms of treatment in Unani medicine- Ilaj bid Dawa (Pharmacotherapy), Ilaj bil Ghiza
(Deitotherapy), Ilaj Bid Tadbir (Regimenal Therapy) and Ilaj bil Jarahat (Surgery).
Regimenal Therapy (Ilaj Bid Tadbir) is a special technique/ physical method of treatment to
improve the constitution of body by removing waste materials and improving the defense
mechanism of the body and protect health. Some of the special techniques are Fasd (Blood-
letting), Hijama (Cupping), Dalk (Massage), Taleeq-e-Alaq (Leeching), Hammame-Har
(Turkish Bath), Riyazat (Exercise), Amal-eKai (Cauterization).

The Unani system of medicine offers various methods of treatment which are used for
specific and complicated diseases. It emphasizes the use of naturally occurring, mostly herbal
medicines and also uses some medicines of animal, marine and mineral origin. During the
last 50 years, eight Post Graduate specialties have been developed-

(i) Kulliyat (Basic Principles of Unani Medicine)

(ii) Ilmul Advia (Pharmacology)

(iii) Ilmul Saidla (Pharmacy)

(iv) Tahaffuzi-wa-Samaji Tibb (Preventive and Social Medicine)

(v) Moalijat (Medicine)

(vi) Jarahiyat (Surgery)

(vii) Ilmul Qabalat-wa-Amraz-e-Niswan (Obstetrics and Gynecology)

(viii) Ilmul Atfal (Paediatrics)

National Institute of Unani Medicine is established in Bangalore to impart good P.G.

education in Unani system.

(iii) Siddha

The Siddha System of medicine is one of the ancient systems of medicine in India having its
close bedd with Dravidian culture. The term Siddha means achievements and Siddhars are
those who have achieved perfection in medicine. Eighteen Siddhars are said to have
contributed towards the systematic development of this system and recorded their
experiences in Tamil language. The Siddha system of Medicine emphasizes on the patient,
environment, age, sex, race, habits, mental frame work, habitat, diet, appetite, physical
condition, physiological constitution of the diseases for its treatment which is individualistic
in nature Diagnosis of diseases are done through examination of pulse, urine, eyes, study of
voice, Colour of body, tongue and status of the digestion of individual patients. System has
unique treasure for the conversion of metals and minerals as drugs and many infective
diseases are treated with the medicines containing specially processed mercury, silver,
arsenic, lead and sulphur without any side effects. The strength of the Siddha system lies in
providing very effective therapy in the case of Psoriasis, Rheumatic disorders, Chronic liver
disorders, Benign prostate hypertrophy, bleeding piles, peptic ulcer including various kinds of
Dermatological disorders of non-psoriatic nature.

During the last six decades, there has been continuous development in Siddha medical
education and this has led to the establishment of the National Institute of Siddha at Chennai
as apex Institute having six specialties in postgraduate teaching leading to the award of
M.D(S) Degree. These are Maruthuvam (General Medicine), Sirappu Maruthuvam (Special
Medicine), Kuzhanthai Maruthuvam (Paediatrics), Gunapadam (Pharmacology), Noi Nadal
(Pathology) and Nanju Nool & Maruthuva Neethinool (Toxicology). For development of
focused research in Siddha System of medicine Govt. has constituted Central Council for
Research in Siddha (CCRS), an autonomous body by bifurcating Central Council for
Research in Ayurveda and Siddha (CCRAS).

(iv)Yoga

The word "Yoga" comes from the Sanskrit word "yuj" which means "to unite or integrate."
Yoga is about the union of a person's own consciousness and the universal consciousness. It
is primarily a way of life, first propounded by Maharshi Patanjali in systematic form
Yogsutra. The discipline of Yoga consists of eight components namely, restraint (Yama),
observance of austerity (Niyama), physical postures (Asana), breathing control (Pranayam)
restraining of sense organs (Pratyahar), contemplation (Dharna), meditation (Dhyan) and
Deep meditation (Samadhi). These steps in the practice of Yoga have the potential to elevate
social and personal behavior and to promote physical health by better circulation of
oxygenated blood in the body, restraining the sense organs and thereby inducing tranquility
and serenity of mind and spirit. The practice of Yoga has also been found to be useful in the
prevention of certain psychosomatic diseases and improves individual resistance and ability
to endure stressful situations. Yoga is a promotive, preventive rehabilitative and curative
intervention for overall enhancement of health status. A number of postures are described in
Yoga literature to improve health, to prevent diseases and to cure illness. The physical
postures are required to be chosen judiciously and have to be practiced in the correct way so
that the benefits of prevention of disease, promotion of health and therapeutic use can be
derived from them. Studies have revealed that Yogic practice improves intelligence and
memory and help in developing resistance to situations of stress and also help individuals to
develop an integrated personality. Meditation can stabilize emotional changes and prevent
abnormal functions of the vital organs of the body. Studies have shown that meditation not
only regulates the functions of the sense organs but also strengthens the nervous system.
Yoga today is no longer restricted to hermits, saints, sages but has gone to every home for the
global health promotion. Yoga as a part of peoples’ lifestyle has aroused a world-wide
awakening and acceptance.
(v) Naturopathy

Naturopathy is rooted in the healing wisdom of many cultures and times based on principal of
natural healing. The principals of natural healing. The principles and practices of Naturopathy
are integrated in the life style, if the people observe living close to nature. Naturopathy is a
cost effective drugless, non-invasive therapy involving the use of natural materials for health
care and healthy living. It is based on the theories of vitality, boosting the self-healing
capacity of the body and the principles of healthy living. Naturopathy is a system of natural
treatment and also a way of life widely practiced, globally accepted and recognized for health
preservation and management of illnesses without medicines.

Naturopathy advocates living in harmony with constructive principles of Nature on the

physical, mental, social and spiritual planes. It has great promotive, preventive, curative as
well as restorative potentials. Naturopathy promotes healing by stimulating the body’s
inherent power to regain health with the help of five elements of nature – Earth, Water, Air,
Fire and Ether. It is a call to “Return to Nature” and to resort to a simple way of living in
harmony with the self, society and environment. Naturopathy advocates ‘Better Health
without Medicines’. It is reported to be effective in chronic, allergic autoimmune and stress
related disorders. The theory and practice of Naturopathy are based on a holistic view point
with particular attention to simple eating and living habits, adoption of purificatory measures,
use of hydrotherapy, cold packs, mud packs, baths, massages, fasting etc.

(vi) Homoeopathy

The Physicians from the time of Hippocrates (around 400 B.C.) have observed that certain
substances could produce symptoms of a disease in healthy people similar to those of people
suffering from the disease. Dr. Christian Friedrich Samuel Hahnemann, a German physician,
scientifically examined this phenomenon and codified the fundamental principles of
Homoeopathy. Homoeopathy was brought into India around 1810 A.D. by European
missionaries and received official recognition by a resolution passed by the Constituent
Assembly in 1948 and then by the Parliament. The first principle of Homoeopathy ‘Similia
Similibus Curentur’, says that a medicine which could induce a set of symptoms in healthy
human beings would be caapable of curing a similar set of symptoms in human beings
actually suffering from the disease. The second principle of ‘Single Medicine’ says that one
medicine should be administered at a time to a particular patient during the treatment. The
third principle of ‘Minimum Dose’ states that the bare minimum dose of a drug which would
induce a curative action without any adverse effect should be administered. Homoeopathy is
based on the assumption that the causation of a disease mainly depends upon the
susceptibility or proneness of an individual to the incidence of the particular disease in
addition to the action of external agents like bacteria, viruses, etc.

Homoeopathy is a method of treating diseases by administering drugs which have been

experimentally proved to possess the power to produce similar symptoms on healthy human
beings. Treatment in Homoeopathy, which is holistic in nature, focuses on an individual’s
response to a specific environment. Homoeopathic medicines are prepared mainly from
natural substances such as plant products, minerals and from animal sources. Homoeopathic
medicines do not have any toxic, poisonous or side effects. Homoeopathic treatment is
economical as well and has a very broad public acceptance. Homoeopathy has its own areas
of strength in therapeutics and it is particularly useful in treatment for allergies, autoimmune
disorders and viral infections. Many surgical, gynecological and obstetrical and pediatric
conditions and ailments affecting the eyes, nose, ear, teeth, skin, sexual organs etc. are
amenable to homoeopathic treatment. Behavioral disorders, neurological problems and
metabolic diseases can also be successfully treated by Homoeopathy. Apart from the curative
aspects, Homoeopathic medicines are also used in preventive and promotive health care. In
recent times, there is an emergence of interest in the use of Homoeopathic medicines in
veterinary care, agriculture, dentistry, etc. Homoeopathic medical education has developed in
seven specialties in post-graduate teaching, which are Materia Medica, Organon of Medicine,
Repertory, Practice of Medicine, Pediatrics, Pharmacy and Psychiatry.

3.1 Basic principles involved in Ayurveda, Siddha, Unani and Homeopathy

Ayurvedic system of medicine:

Ayurveda is one of the oldest systems of medicine originated from india. The word Ayurveda
is made up of two parts Ayu + Veda. Ayu means life and Veda means Knowledge. Thus
Ayurveda means “science of life”.it deal both physical and mental health and also covers art
of living. In Ayurveda health is defined as a well- balanced metabolism and happy state of
being. It deals with all aspect of human life which are emanating from body, mind, extranal
factors and natural intrinsic factors. In this system diseases are cured by using drugs, diets,
exercise and surgery. Body (Sharira), mind (manas) and Soul (Atma) are the triploid of life in
which equal attention should be given for the achievement of sound health.

Ayurveda classifies the body into three basic biological elements which are known as Vata,
Pita, Kapha. These elements originate from five basic elements airs (Vayu), energy (Tej),
space (Akash), Water (Jal) and Soil (Dharti). The biochemical combination of space and air
form Vata. Pitta is composed of energy and water and Kapha is derived from the combination
of water and soils.

Siddha system of medicine

Siddha system of medicine is practiced in some parts of South India especially in the state of
Tamilnadu. It has close affinity to Ayurveda yet it maintains a distinctive identity of its own.
This system has come to be closely identified with Tamil civilization. The term ‘Siddha’ has
come from ‘Siddhi’- which means achievement. Siddhars were the men who achieved
supreme knowledge in the field of medicine, yoga or tapa (meditation).

It is a well-known fact that before the advent of the Aryans in India a well-developed
civilization flourished in South India especially on the banks of rivers Cauvery, Vaigai,
Tamiraparani etc. The system of medicine in vogue in this civilization seems to be the
precursor of the present day Siddha system of medicine. During the passage of time it
interacted with the other streams of medicines complementing and enriching them and in turn
getting enriched. The materia medica of Siddha system of medicine depends to large extent
on drugs of metal and mineral origin in contrast to Ayurveda of earlier period, which was
mainly dependent upon drugs of vegetable origin.

According to the tradition eighteen Siddhars were supposed to have contributed to the
development of Siddha medicine, yoga and philosophy. However, literature generated by
them is not available in entirety. In accordance with the well-known self-effacing nature of
ancient Indian Acharyas (preceptors) authorship of many literary work of great merit remains
to be determined. There was also a tradition of ascribing the authorship of one's work to his
teacher, patron even to a great scholar of the time. This has made it extremely difficult to
clearly identify the real author of many classics.
Unani system of medicine

Unani medicine is a system of alternative medicine that originated in ancient Greece but is
now practiced primarily in India. Involving the use of herbal remedies, dietary practices, and
alternative therapies, Unani medicine addresses the prevention and treatment of disease.
According to practitioners of Unani medicine, achieving a balance of the bodily fluids known
as "the four humors" (blood, phlegm, yellow bile, and black bile) is essential to health.
Another key principle of Unani medicine is that disease results from an imbalance in air,
earth, water, and fire, four elements thought to comprise all that exists in nature, including the
human body. In addition, Unani medicine is partly based on the principle that environmental
conditions, including the quality of water and air,) can significantly impact health. In Unani
medicine, conditions are often treated with herbal formulas containing a variety of natural
substances. For example, a formula known as Khamira Abresham Hakim Arshad Wala
contains such botanicals as saffron, cardamom, Indian bay leaf, and citron. Considered a
tonic, Khamira Abresham Hakim Arshad Wala is said to enhance heart health and aid in the
treatment of cardiovascular problems like high blood pressure and angina. Commonly
prescribed treatments in Unani medicine also include dietary changes, leech therapy, and
surgery.

Unani medicine is largely based on principles proposed by such physicians as Hippocrates

and Galen. In addition, a number of Arab and Persian scholars (including the Arab
philosopher and physicist Avicenna) have contributed to the development of Unani medicine.
The word "Unani" means "Greek" in Arabic. Unani medicine was introduced in India around
the tenth century.

Homeopathy system of medicine

Homeopathy is an alternative medical practice in which extremely dilute amounts of certain

natural substances are used to treat various ailments. Homeopathy is also known as
homeopathic medicine and was developed in Germany more than 200 years ago. Homeopathic
treatments are highly individualized, and there is no uniform prescribing standard for
homeopathic practitioners. There are hundreds of different homeopathic remedies, which can
be prescribed in a variety of different dilutions for thousands of symptoms. The holistic nature
of homeopathy means each person is treated as a unique individual. Their body, mind, spirit
and emotions are all considered in the management and prevention of disease. Taking all these
factors into account a homeopath will select the most appropriate medicine. Homeopathic
medicine based on the individual’s specific symptoms and personal level of health to stimulate
their own healing ability. Homeopathic medicines are safe to use as they rarely cause side-
effects. This means when used appropriately under the guidance of a qualified homeopath they
can be taken by people of all ages, including babies, children and pregnant or breastfeeding
women. Every science has certain fundamental principles which guide the whole system.
Homeopathy as a science of medical treatment has a philosophy of its own and its therapeutics
is based on certain fundamental principles. This include-

1. Law of Similia

Homeopathy is a system of medicine founded on a definite law ‘Similia Similibus Curantur’

which means ‘like cures like’.

2. Law of Simplex

It’s means that only one single, simple medicinal substance is to be administered in a given
case of time.
3. Law of Minimum

The suitableness of a medicine for any given case does not depend on its accurate
homeopathic selection alone, but likewise on the proper size of dose too. Under this principle
practitioners give medicine to the patients in very.

3.2 Preparation and standardization of Ayurvedic formulation

Preparation and standardization of Aristas

Aristas

Arista, an Ayurvedic preparation, is effectively used to treat many diseases. It is obtained by

soaking the crude drugs, either in powdered form or as decoction, in jaggery solution. While
doing so, it undergoes fermentation to produce alcohol, which helps to extract the
phytoceuticals from the crude drugs. Though the requirement for herbal medicines are
increasing, the major drawbacks encountered by the herbal drug companies include lack of
proper documentation, validation and determination of biomarkers besides the non-existence
of rigid quality control profiles for herbs and their formulations. This creates an urgent need
for standardization of herbal drugs, which enhances the quality, safety and efficacy of their
use for various ailments. The present investigation deals with standardization of
Saraswataristam which is majorly used as stimulant, soporific, emmenagogue, nervine tonic,
and cardio tonic, stomachic, carminative and diuretic. It is also used in the treatment of
central nervous system disorders and dermatological problems. The main objective of the
study includes formulation of Saraswataristam, subjected to phytochemical, physico-
chemical, microbiological, toxicological and pharmacological evaluations using modern
analytical tools.

Preparation

Asava Arishta is special Ayurvedic medicine made by soaking herbs (the drugs), either in the
form of dry powder or decoction–liquid (Kashaya/ kwatha), in a solution of jaggery or sugar.
It is kept such for a specified period of time so that it undergoes a process called Sandhana
kriya (fermentation) this fermentation generates alcohol which facilitates the extraction of the
active principles contained in the herbs or drugs. The alcohol is self-generated and acts as a
preservative. The alcoholic content is limited to a maximum of 11% as per the
standardization. To prepare Arishta, the mentioned herbs or drugs are coarsely powdered
(Yavakuta churna) and then decoction (Kashaya/kwatha) is prepared from them. The
prepared decoction (Kashaya) is then strained and kept in a safe place in the fermentation
vessel, pot, or barrel. Jaggery (gud), sugar or honey, according to the formula, is separately
dissolved, boiled, filtered and added in the fermentation vessel where decoction is kept.
Mentioned Prakshepa Dravyas are made into fine powder and added to that vessel. In the end,
an herb called Dhataki Pushpa, (if included in the formula) is added. The mouth of the vessel
is completely covered with an earthen lid. The edges of the lid are sealed with clay-smeared
cloth in seven consecutive layers. The container is then kept in a heap of paddy. Use of paddy
is to ensure a constant temperature during the period of fermentation and also it accelerates
the fermentation process.

After the specified period, the earthen lid is removed carefully, and the contents of the vessel
are examined to ascertain the process of fermentation (Sandhana karma) has been completed
or not. The content or fluid is then decanted and strained and kept as it is for two to three
days. It is again strained to mix sediments properly and packed in a glass or pet bottles.

Standardization

Asavas and Aristas are alcoholic preparations, prepared either by soaking the powdered drugs
or the decoction of a drug, in a solution of jaggery along with a fermenter for a specified
period of time, during which it undergoes fermentation to produce alcohol. These self-
generated alcohols facilitate the extraction of active principles present in the drug and also
serve as a preservative.

Various methods applied for standardization of herbal drugs are depicted. Due to complexity
of most Ayurvedic formulations, use of only conventional methods for standardization is not
adequate for their evaluation. The Ayurvedic Pharmacopoeia of India and Pharmacopoeial
standards for Ayurvedic formulations mention only the study of physicochemical parameters
and thin-layer chromatography of raw materials and formulations, which are not sufficient for
proper standardization in present era Therefore, modern analytical methods such as high
performance thin layer chromatography (HPTLC), high performance liquid chromatography
(HPLC), gas chromatography (GC) and hyphenated techniques such as liquid
chromatography-mass spectroscopy (LC-MS), liquid chromatography-nuclear magnetic
resonance spectroscopy (LC-NMR) and gas chromatography-mass spectroscopy (GC-MS)
are applied to ascertain the quality of herbal products. Fingerprints obtained from HPTLC,
HPLC are used as important tools for identification of marker compounds in the
phytoconstituents and for quality control development of herbal formulations. Development
and application of analytical techniques help in rapid analysis of herbal formulation in
industry and assist in maintaining the therapeutic efficacy and safety of Ayurvedic
preparations.

Thin layer chromatography (TLC) is a common fingerprinting technique used to identify the
phytoconstituents present in the drugs and thus, helps in differentiation of various plant
species simultaneously HPTLC is an important modern analytical method, where low or
moderate polar compounds can be analyzed. Pharmaceutical industries widely use this
technique for method development, identification and detection of adulterants and
substituents in the Ayurvedic formulations. Preparative and analytical HPLC methods are
used for isolation, purification and quantification of phytoconstituents in the herbal
formulation. Better resolution, sensitivity and rapid analysis are the important parameters
considered in HPLC analysis. The combination of HPLC and MS is currently the most
powerful technique for the quality control of Chinese herbal medicine. GC is used in
characterization of volatile compounds due to its powerful separation efficiency and sensitive
detection. Compounds present in essential oils are identified and quantified by GC-MS
analysis. LC-MS is another important analytical technique for determination of quality of the
drug. LC-NMR is used in pharmacokinetics, toxicity studies, drug metabolism and drug
discovery process due to its rapidity and sensitivity of detection. LC-NMR technique is also
used to detect adulterants in Chinese herbal medicine.
Preparation and standardization of Asawas

Asawas

The Asava is prepared same as that of Arishta, but the difference is here we do not prepare
decoction (kashaya/ kwatha) from the herbs or finely powdered drugs. Jaggery or honey as
mentioned in the formula is dissolved, boiled and filtered. Then this is poured into the
fermentation pot, vessel or barrel. The mentioned fine powders of the herbs (drugs) are added
in the solution of jaggery. The vessel is covered with a lid and its edges are sealed with clay-
smeared cloth in seven consecutive layers as described in Arishta preparation method. And
then the rest process is same as that of Arishta. The Jaggery or sugar is dissolved in the
required quantity of water, boiled and cooled. This is poured into the fermentation vessel.
Fine powder of the drugs is added in the container which is covered with a lid and the edges
are sealed with clay smeared cloth wound in seven consecutive layers. A constant
temperature is maintained for fermentation by keeping the container either in a special room,
in an underground cellar or in a heap of paddy. After a specified period the lid is removed
and the contents examined to ascertain whether fermentation has been completed. The fluid is
first decanted and then strained after two or three days. When the fine suspended particles
settle down, it is strained and bottled.

Preparation

The Jaggery or sugar is dissolved in the required quantity of water, boiled and cooled. This is
poured into the fermentation vessel. Fine powder of the drugs is added in the container which
is covered with a lid and the edges are sealed with clay smeared cloth wound in seven
consecutive layers. A constant temperature is maintained for fermentation by keeping the
container either in a special room, in an underground cellar or in a heap of paddy. After a
specified period the lid is removed and the contents examined to ascertain whether
fermentation has been completed. The fluid is first decanted and then strained after two or
three days. When the fine suspended particles settle down, it is strained and bottled.

The method of preparing asava arishtas is known as sandhana kalpana in Ayurveda. General
Methods used in the Extraction of Medicinal Plants in asava and arishta are infusion and
decoction. In this process, the crude drug is boiled in a specified volume of water for a time;
it is then cooled and strained or filtered. This procedure is suitable for extracting water-
soluble, heat-stable constituents. This process is typically used in preparation of Ayurvedic
extracts called “quath” or “kawath”. The starting ratio of crude drug to water is fixed, e.g. 1:4
or 1:16. The volume is then brought down to one-fourth its original volume by boiling during
the extraction procedure. Then, theconcentrated extract is filtered and used as such or
processed further Infusion. Fresh infusions are prepared by macerating the crude drug for a
short period of time with cold or boiling water. These are dilute solutions of the readily
soluble constituents of crude drugs. The basic equipment required for preparation of arishta
and asava an earthen pot sufficiently large and glazed, porcelain jar of suitable size; a lid to
close the vessel, a cloth ribbon to seal the vessel; a paddle like stirrer; a clean cloth of fine
and strong texture for filtering, vessel to keep the juices or boil the drugs . The major
components are divided into 4 types according to their specific role in the process. This
includes the main herbs from which the extract or decoction is taken out. They yield drugs,
which are pharmacologically and therapeutically much important in the given medicine and
the name of the medicine is derived from these herbs denoting their importance. The
flavouring agents used in asava and arishta not only contributing to the flavour of the
medicine but having their own pharmacological action too. The fermentation initiator
provides inoculum for the fermentation to start. The medium of sugars is required for
fermentation.

Standardization

Standardization of Ayurvedic formulations is an important step for the establishment of a

consistent biological activity, a consistent chemical profile, or simply a quality assurance
program for production and manufacturing of herbal drugs. WHO specific guidelines for the
assessment of the safety, efficacy and quality of herbal medicines as a prerequisite for global
harmonization are of outmost importance. An overview covering various techniques
employed in extraction and characterization of herbal medicines as well as herbal Nano
medicines standardization is reported. In addition, phytosomes increased bioavailability,
bhasma as a metal Nano carrier drug delivery system, potential of metabolomics in the
development of improved phytotherapeutic agents, DNA based molecular markers in
distinguishing adulterants, and SCAR markers for authentication and discrimination of herbs
from their adulterants are reported. Processed metals including Mercury, Gold, Silver, Lead,
Zinc, Copper etc. were used very frequently by seers of the Indian tradition in different
disease conditions with great authority. Recent advances in the study of minerals include
petrological studies to analyze the physical and chemical changes in particular.

Preparation and standardization of Ghutika

Ghutika

Medicine made into circular shape mass dosage form, is called as Gutika. This can be
compared with pills in modern pharmaceutics. Vati is made in the shape of flat circular mass
and it is similar to tablet. If the Gutika or Vati medicine is modified into long oval solid shape
form, then it is called as Varti. This is commonly used for local administration in anal canal,
vaginal canal, penis, eye for different diseases. Medicine moulded into big circular mass form
is known as Vataka. Aushadhi churna is mixed with Sarkara and moulded like Pinda (circular
mass) then it is called as Pinda or Pindi. Modaka will be having circular shape and having big
size, possessing weight around 20 g, 50 g.

Types of Vati

In the Ayurvedic Pharmaceutical text two types of Vati preparation methods are mentioned,
these are-

(i) Agnisadhya Vati

(ii) Anagnisadhya Vati

In case of Agni Sadhya vati preparation, the sugar or Jaggery (guda) or Guggulu is made like
lehya on mild fire then the powders of the ingredients are added to the Paka (lehya) which
become soft mass paste like then vati is to be made by rolled into circular in shape. By this
process Vati is prepared without heat. The powders of ingredients are either pounded with
Guggulu and guda, adding with any suggested liquid or honey to prepare the vati or
triturated with any suggested liquid or honey to make into vati.
Preparation

General method of preparation: The drugs of plant origin are dried and made into fine
powders separately. The minerals are made into Bhasma or Sindura, unless otherwise
mentioned. In case where Parada and Gandhaka are mentioned, Kajjali is made first and other
drugs are added with it one by one according to the formula. These are put into a Khalva and
ground to a soft paste with the prescribed fluids. When more than one liquid is mentioned for
grinding they are used in succession. When the mass is properly ground and is in a condition
to be made into Pills, Sugandha dravyas are added and ground again. The criteria to
determine the final stage of the formulation before making pills is that, it should not stick to
the fingers when rolled in between two fingers. Pills may be dried in the shade. In case where
sugar or Jaggery is mentioned, paka of these should be made on mild fire and removed from
the oven. The powders at these ingredients are added to that Paka and briskly mixed. When
still warm, Vatakas should be rolled and dried in Shade. For the preparation of Vati
Sarngadhara has mentioned the ratio of ingredients that Sita should be taken 4 times, Guda
should be taken 2 times, Guggulu and Madhu should take equal quantity and other liquids
taken 2 times more than that of Curna used for Vati.

Standardization

Standardization expression is used to describe all measures, which are taken during the
manufacturing process and quality control leading to a reproducible quality. It also
encompasses the entire field of study from birth of a plant to its clinical application. It also
means adjusting the herbal drug preparation to a defined content of a constituent or a group of
substances with known therapeutic activity respectively by adding excipients or by mixing
herbal drugs or herbal drug preparations.

Evaluation of a drug means confirmation of its identity and determination of its quality and
purity and detection of its nature of adulteration. Standardization of herbal drugs is not an
easy task as numerous factors influence the bio efficacy and reproducible therapeutic effect.
In order to obtain quality oriented herbal products, care should be taken right from the proper
identification of plants, season and area of collection and their extraction and purification
process and rationalizing the combination in case of polyherbal drugs. The herbal formulation
in general can be standardize schematically as to formulate the medicament using raw
materials collected from different localities and a comparative chemical efficacy of different
batches of formulation are to be observed. The preparations with better clinical efficacy are to
be selected. After all the routine physical, chemical and pharmacological parameters are to be
checked for all the batches to select the final finished product and to validate the whole
manufacturing process.

The World Health Organization (WHO) has appreciated the importance of medicinal plants
for public health care in developing nations and has evolved guidelines to support the
member states in their efforts to formulate national policies on traditional medicine and to
study their potential usefulness including evaluation, safety, and efficacy. Lasunadi vati is
official in Ayurvedic formulary of India and is prescribed for the treatment of diarrhea,
Irritable bowel syndrome. It contains two drugs i.e. Kutaja (Holarrhena antidysentrica) and
Ativisa (Aconitum heterophyllum). This study reports on the standardization of Kutajaghana
Vati based on macroscopic, microscopic, physic-chemical parameters and Thin Layer
Chromatographic study (TLC).
In order to have a good coordination between the quality of raw materials, in process
materials and the final products, it has become essential to develop reliable, specific and
sensitive quality control methods using a combination of classical and modern instrumental
method of analysis. Standardization is an essential measurement for ensuring the quality
control of the herbal drugs. “Standardization” expression is used to describe all measures,
which are taken during the manufacturing process and quality control leading to a
reproducible quality. Kutajaghana vati is official in Ayurvedic formulary of India and is
prescribed for the treatment of diarrhea, Irritable bowel syndrome. It is a polyherbal
preparation containing two ingredients. In this research paper, an attempt has been made to
develop standardization methods of Kutajaghana vati. In-house preparation and the marketed
drug have been standardized on the basis of macroscopic, microscopic, physic-chemical
parameters and Thin Layer Chromatographic study (TLC). The set parameters were found to
be sufficient to evaluate the Vati and can be used as reference standards for the quality
control/quality assurance.

Preparation and standardization of Churna

Churna

Churna is defined as a fine powder of drug or drugs in Ayurvedic system of medicine. Drugs
mentioned in patha, are cleaned properly, dried thoroughly, pulverized and then sieved. The
churna is free flowing and retains its potency for one year, if preserved in airtight containers.
Triphala churna, Trikatu churna, Drakeshadi churna and Sudharsana churna are some of
examples. Churna formulation is similar to powder formulations in Allopathic system of
medicine. In recent days churna is formulated into tablets in order to fix the dose easily.
These forms of medicament are prescribed generally because of their particle size. Smaller
the particle size greater is the absorption rate from g.i.t and hence the greater is
bioavailability. It is prescribed by the Ayurvedic physician for treating conditions such as
diabetes, indigestion, constipation etc. Indigestion is a common ailment affecting the general
population and in allopathy system antacids are commonly prescribed. Since the usage of
such aluminium containing antacids cause deleterious effects like Alzheimer’s disease upon
long term usage, we explored an alternative and safe remedy for indigestion. Hence we
prepared a churna with natural ingredients commonly used by mankind for culinary purposes.
Thus the present study examined the favourable influence of four spices formulated into
churna said to have digestive property.

Preparation

The drugs are cleaned and dried properly. They are finely powdered and sieved. If more than
one drug are present then each one is separately powdered, sieved, accurately weighed and
then all mixed together. The powder is fine to the extent of at least 80 mesh sieves. It should
not adhere together or become moist. The finer powder has better therapeutic value.The dose
is 2-3 gm, which may be increased or decreased according to age and severity of disease. It is
administered with water, milk, fruit juices or any other suitable liquid depending on the
nature of disease. It may be given by mixing with gur or honey in equal quantity, with sugar
twice the quantity and with milk four times the quantities as that of drug.

Standardization

In the few decades, there has been exponential growth in the field of herbal medicines. Most
of the traditional system of medicine is effective but they lack standardization. So there is a
need to develop a standardization technique. Standardization of herbal formulation is
essential in order to assess the quality, purity, safety and efficacy of the drug. Dabur Triphala
Churna is used for immune system stimulation, improvement of digestion, relief of
constipation, gastrointestinal tract cleansing, and relief of gas, treatment of diabetes and
treatment of eye disease. The present research study deals with standardization of Dabur
Triphala Churna [ex. Emblica officinalis (Garetn.) (Amla), Terminalia bellirica
(Gaertn.)Roxb. (Baheda) and Terminalia chebula (Retz.) (Harada)].

The standardization of this formulation, the organoleptic characters, physical properties, the
various physico-chemical properties such as moisture content, ash values, extractive values
were carried out. Heavy metal content studies were also carried out to ascertain the quality,
purity and safety of this herbal formulation. The quality control of herbal crude drug &
formulation is important in justifying their acceptability in modern system of medicines.
Standardization of synthetic drugs offers no problem with very well defined parameters of
analysis. It is not uncommon to have as many as five or more different herbal ingredients in
one single formulation. The batch to batch variation starts from the collection of the raw
materials itself in absence of any reference standard for identification. Standardized products
and services are valuable. User confidence builder’s being perceived as-

• Safe
• Healthy
• Secure
• High quality
• Flexible

Standardization brings important benefits to business including a solid foundation upon

which to develop new technologies and an opportunity to share and enhance existing
practices. Standardization also plays a pivotal role in assisting Governments,
Administrations, Regulators and the legal profession as legislation, regulation and policy
initiatives are all supported by standardization.

Preparation and standardization of Lehya

Lehya

Lehya are semisolid Malt/Jam like preparation of drugs, prepared by adding jaggery or sugar
and boiled with the prescribed liquid till the correct constituency is obtained. Then spices and
Ghee are added and stirred well. After cooling honey is also added. This means preserving
the water extract of medicines in Sugar media.

Preparation

Avaleha or Lehyam is one of the forms of Ayurvedic medicine which is semi-solid in

consistency. It is prepared from mentioned drugs or herbs with the addition of Gur (jaggery),
Sharkara (sugar or sugar candy) and boiled with prescribed Swarasa (drug juice) or Kwatha/
Kashayam (decoction). Avaleha is also termed as Modaka, Guda, Khanda, Rasayana, Leha,
Lehyam etc.

The lemon fruits were fried in an earthen pan and the juice was extracted. To the extracted
juice twice the amount of sugar was added and boiled till it attains pakam (a semisolid form).
The weighed amount of drugs in powdered form was added one by one slowly mixing well
till it attains Lehya pakam. The Ghee was added finally and mixed well and the resulting
Lehyam was stored in a clean container for further analysis.

In all types of Avaleha preparations, there generally have following ingredients-

 1. Kashaya (decoctions or other liquids)

2. Gur/ Guda/ Sharkara (Jaggery, sugar or sugar candy)

3. Churna (Powders or pulps of certain drugs)

4. Ghrita (Ghee) or Tailam (oil)

5. Madhu (honey).

Procedure

• First, Gur/ Guda/ Sharkara (Jaggery, sugar or sugar candy) is dissolved well in the
decoction or liquid and strained to remove the foreign particles.

• This solution is then boiled over a moderate fire.

• When the Paka (Phanita) is tantuvat (thread like) when pressed between thumb and
index finger or when it sinks down in a glass of water without getting easily
dissolved, it should be removed from the fire.

• Churna (fine powders) of herbs are then added in small quantities and stirred
continuously and vigorously to form a homogenous mixture.

• Ghita (Ghee) or Taila (oil), if mentioned, is added while the preparation is somewhat
hot and mixed well.

• Madhu (honey), if mentioned is added at the last when the mixture or preparation is
cool and mixed well.

Standardization

Standardization is an important aspect for maintaining and assessing the quality and safety of
the polyherbal formulation as these are combinations of more than one herb to attain the
desire therapeutic effect. The polyherbal formulation has been standardized on the basis of
organoleptic properties, physical characteristics, and physicochemical properties. TLC &
HPTLC fingerprint profile are used for identification of formulation as well as for deciding
the purity and strength and also for fixing standards for the Ayurvedic formulation. The
Ashwagandhadilehya was prepared classically. The lehya was evaluated organoleptically as
well as physicochemical characterization such as color, odor, taste, pH, loss on drying, total
Ash value, Acid insoluble Ash value, Water soluble extractive, methanol soluble extractive.
The prepared Ashwagandhadilehya was semisolid in appearance, brown blackish in color,
sweetish pungent in taste, with characteristic odor. Obtained result of physicochemical
parameters like pH value was 4.77, total Ash value 3.01% w/w, Acid insoluble Ash value
0.52% w/w, Water soluble extractives 38.11% w/w, methanol soluble extractives 23.91%
w/w and loss on drying at 1050 C was 17.73% w/w. Major herbal ingredients of the prepared
medicine have been identified through Thin Layer Chromatography. Lehya Kalpana means
the pharmaceutical mode which is ingested in the body by the process of licking. Lehya
Kalpana holds its speciality in many perspectives. The property of licking is very important
regarding its mode of action which starts from the tongue itself. The ingredients like
Ashwagandha, Pippali, and Masha etc. have a synergistic effect in disorders like emaciation,
weakness, disability and various other ailments of the body. In pharmaceutical study a quick
and easy preparatory procedure as compared to Avleha kalpana has been adopted, which
prove to be helpful for Ayurvedic scholars when they prepare this formulation of their own.
This pharmaceutical standardization can help and encourage in better understanding of
preparation. Standardization of any Ayurvedic formulation is utmost important now-a-days to
prove its scientific validation. Hence this attempt was made to make better understanding
with scientific approach for Ashwagandhadilehya.

Preparation and standardization of Bhasma

Bhasma

Bhasma is a calcined preparation in which the gem or metal is converted into ash. Gems or
metals are purified to remove impurities and treated by triturating and macerating in herbal
extracts. The dough so obtained is calcinated to obtain the ashes.Bhasma is a Sanskrit word
that means “bone ash,” “cinder” or “disintegration.” It comes from the root bha, meaning
“delusion,” “appearance” or “likeness,” and sma, meaning “ever” or “always.” In Hinduism
and yoga, bhasma is sacred ash. In some traditions, it is thought to contain the energy of
Shiva. In the traditional Indian medical system of Ayurveda, bhasma is a type of medicinal
powder made through calcination of stones, gems, minerals or metals. There are a wide range
of bhasmas used to treat many types of ailments. In the spiritual context, bhasma symbolizes
burning the ego to ashes in order to unite with the higher Self or the divine. It represents
liberation from the limitations of mortal life and freedom from the cycle of reincarnation. It is
also a reminder of the temporary nature of the physical body, which will one day return to
ashes. Also called vibhooti, bhasma is the sacred ash from the fire of a yogi or saint or from
the sacrificial fire known as yajna in which special wood, herbs, grains, ghee and other items
are offered as part of a worship ritual. Bhasma is thought to destroy sin and consume evil.

Preparation

The preparation of Lauha bhasma (iron ash) was carried out following the procedure
described in the Ayurvedic Formulary of India. The raw material Lauha curna (Iron powder)
was procured from the market in Trichy, India. The preparation involves the following major
steps–samanya sodhana (normal purification), vishesha sodhana (special purification),
bhanupaka (exposure to sunlight), sthali paka (roasting in an iron pan) and putapaka
(calcination).

Samanya Sodhana (normal purification) the first step in the preparation of Lauha bhasma
(iron ash) is sodhana (purification step), which involves sequential quenching in tila taila
(sesame oil), takra (butter milk), kanjika (rice gruel), gomuthra (cow’s urine), and kulatha
kasaya (horse gram decoction). As in a typical purification step, about 2 kg of the raw
material (iron powder) was heated to red hot condition and immersed in 2 L of quenching
medium (room temperature) for 2 hours. Each of the quenching processes was repeated thrice
with each treating liquid by using fresh medium every time. These steps constitute samanya
sodhana (normal purification) and the Lauha (iron) obtained at this stage is called Suddha
Lauha (iron after normal 41 purification) Vishesha Sodhana (Special purification) Coarse
powders of dried fruits, viz., Phyllanthus emblica (Indian gooseberry), Terminalia chebula
(Chebulic myrobalans) and Terminalia bellerica (Belleric myrobalans) were taken in equal
quantities (2 kg each) and mixed with 50 L of water. The resulting mixture was heated to
reduce to one-fourth of the original volume to obtain triphala kasaya (decoction of three
fruits). About 2 kg of Suddha Lauha (iron after normal purification) was heated to red-hot
condition and immersed in a mixture of 1 L each of triphala kasaya (decoction of three fruits)
and cow’s urine for 2 hours. This purification step was repeated seven times using freshly
prepared mixture of triphala kasaya (decoction of three fruits) and cow’s urine. The Lauha
(iron) obtained at this stage is called Lauha after vishesha sodhana (iron after special
purification)

Vishesha Sodhana (Special purification) Coarse powders of dried fruits, viz., Phyllanthus
emblica (Indian gooseberry), Terminalia chebula (Chebulic myrobalans) and Terminalia
bellerica (Belleric myrobalans) were taken in equal quantities (2 kg each) and mixed with 50
L of water. The resulting mixture was heated to reduce to one-fourth of the original volume
to obtain triphala kasaya (decoction of three fruits). About 2 kg of Suddha Lauha (iron after
normal purification) was heated to red-hot condition and immersed in a mixture of 1 L each
of triphala kasaya (decoction of three fruits) and cow’s urine for 2 hours. This purification
step was repeated seven times using freshly prepared mixture of triphala kasaya (decoction of
three fruits) and cow’s urine. The Lauha (iron) obtained at this stage is called Lauha after
vishesha sodhana (iron after special purification.

Bhanupaka (exposure to sunlight) Triphala kasaya (decoction of three fruits) was added to
Lauha obtained after vishesha sodhana (iron after special purification) and allowed to dry
under sunlight for 5 days. This process was repeated seven times and the Lauha at this stage
is called Lauha after bhanupaka. (Purified iron after exposure to sunlight).

Sthalipaka (frying in iron pan) Triphala kasaya (decoction of three fruits) was prepared by
adding 2.3 kg each of Indian gooseberry, Chebulic myrobalans and Belleric myrobalans to
about 110 L of water and reduced to one-eighth of its original volume. About 2.3 kg of Lauha
after bhanupaka (purified iron after exposure to sunlight) was washed with water and placed
in a sthali (iron pan), to which 13.5 L of Triphala kasaya (decoction of three fruits) was added
and heated to dryness for about one hour at 95-100°C. The solid material obtained after this
purification process is referred to as Lauha after sthalipaka (purified iron after frying in iron
pan).

Puta paka (calcination) Triphala kasaya was prepared by adding 670 g each of Indian
gooseberry, Chebulic myrobalans and Belleric myrobalans to 4 L of water and heated to
reduce to one-fourth of its original volume. The prepared triphala kasaya was added to 2 kg
of Lauha after sthalipaka (purified iron after frying in iron pan); triturated well for 3 hours
and made into cakrikas (thin flat discs), which were dried under sunlight The cakrikas(thin
flat discs) were placed in a hemi-spherical earthen container and covered with another hemi-
spherical container, with the interface between the upper and lower containers covered with a
clay-smeared cloth. This arrangement is normally referred to as Sarava Samputa (sealed
earthern plates) a brick-walled calcination chamber measuring 90 cm each in all three
directions was used for traditional calcination, in accordance with those proposed in ancient
literature. This is referred to as traditional calcination chamber in the subsequent sections.
About 150 cow dung cakes were stacked inside the pit over which the Sarava Samputa
(sealed earthern 46 plates) was placed. This was followed by stack of another 150 cow dung
cakes, ensuing uniform heat supply for the contents of Sarava Samputa (sealed earthern
plates). This is referred to as traditional heating in the subsequent sections of this work.
Calcination was initiated by igniting the cow dung cakes a Sarava Samputa (sealed earthern
plates) was left undisturbed in the calcination chamber till all the cow dung cakes were burnt
completely. The calcined intermediate was removed from Sarava Samputa, after the same
was cooled naturally. This process of grinding with Triphala decoction to make thin flat discs
and calcination in traditional chamber was repeated 60 times, as per the traditional procedure.
The product obtained after sixty calcination is called Lauha bhasma. The temperature of
Sarava Samputa during traditional calcination was measured using a K-type thermocouple
fitted indicator.

Standardization

Standardization is a measurement for ensuring the quality and is used to describe all
measures, which are taken during the manufacturing process and quality control leading to a
reproducible quality. For herbals formulations, it place major role from birth of a plant to its
clinical application. It also means adjusting the herbal drug preparation to a defined content
of a constituent or a group of substances with known therapeutic activity respectively by
adding excipients or by mixing herbal drugs or herbal drug preparations. Standardization is
not an easy task as numerous factors influence the bio efficacy and reproducible therapeutic
effect. In order to obtain quality oriented herbal products, care should be taken right from the
process of preparation.

For standard bhasma preparations, there is dearth of scientific analytical studies carried out,
and even the existing ones suffer from incomplete analysis. Thus there is an imperative need
for a scientific approach, which includes the following steps

• Physical standardization and elemental analysis of raw material and finished products.

• Determination of oxidation state of metals and association of these metals with acidic
radicals in the finished product.

• Pharmacokinetics of the prominent metallic component of bhasma using tracer

techniques or by metal extraction from tissues.

• Metal accumulation studies in different tissues and organs.

• Acute and chronic toxicity.

• Expression of heat shock proteins.

• Effect of bhasmas on normal physiological and antioxidant parameters.

• Therapeutic response of bhasmas on the recommended disease model at cellular and

molecular level (based on claims written in ayurvedic texts).

• The role of bhasmas as drug carriers,

• The role of bhasmas in body immunomodulation and physiology of gastrointestinal

tract (GI) (site of jataragani). These studies will provide evidence for the safety
behind the use of bhasmas and also provide knowledge regarding their mechanism of
action.

Standardization techniques

The standardization process include following methods-

Preliminary tests

I. Floating test: If a small quantity of bhasma is sprinkled on water surface it should

float on the surface.
 II. Fineness test: On rubbing a small quantity of the sample between the fingers it
should enter into the lines on the fingers.

III. Loss of metallic luster: When visually examined preferably in presence of sun light
no metallic luster should be observed.

IV. Loss of metallic state: This involves heating of a very thin silver sheet (600 nm
thickness) along with a small quantity of bhasma to red hot for about 5 min. After
cooling the sheet to room temperature, no traces of this sample should permanently
stick to the silver sheet indicating no alloy formation takes place, thus confirming the
metal has totally transformed into bhasma, its oxide form.

Physicochemical evaluation

The various physicochemical evaluation include colour, odour, pH, taste, fineness, loss on
drying at 1050C, total ash, acid insoluble ash, water soluble ash and particle size mesh test .
Tests for heavy/toxic metals should be carried out for standard formulation and their
permissible limits.

Microbiological evaluation

The various microbiological evaluation includes total viable aerobic count, total
Enterobacteriaceae and total fungal count, test for specific pathogen: E. coli, Salmonella spp.,
S. aureus, Pseudomonas aeruginosa.

Analytical evaluation

The various modern analytical evaluation include Atomic Absorption Spectroscopy (AAS),
Atomic Force Microscopy (AFM), X-Ray Diffraction (XRD), X-Ray Fluorescence (XRF),
X-Ray photo electron microscopy, Scanning Electron Microscopy (SEM), Transmission
Electron Microscopy (TEM), Energy Dispersive X-Ray Analysis (EDAX), Infrared
spectroscopy (IR), Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES),
FT-IR and Thermal Gravimetric Analysis (TGA) . The various analytical instrument used and
their purpose of analysis.
Very Short Questions:

Q1.What is herbal Plant.

Q2. What are herbal materials?

Q3.What is the Indian system of medicine called?

Q4.What is ancient Indian medicine?

Short and Long Type of Questions:

Q1.Which Herb is used as medicines?

Q2.Why is herbal medicine important?

Q3.What is the Example of Herbal Plants?

Q4.What is the best natural supplement?

Q5.Which is the components of Indian systems of medicine?

Q6.What is traditional system of medicine?

Master Key Words:

• Herbs are the usable parts of herbaceous plants.

• Herbal medicines are usually prepared as an extract, powder, tablet or a pill.
• The word Ayurveda is made up of two parts Ayu + Veda.
• India has a rich heritage of plant based healthcare systems.
• The Jaggery or sugar is dissolved in the required quantity of water.
• The most widely used microbial pesticides are Bacillus thuringiensis.
• Avaleha is a semisolid preparation of herbal.
• Drugs prepared in decoction or extracts of different.
• herbs by adding sweetening agents like jaggery,
 UNIT-II

Topic-2

HERBAL-DRUG AND HERB-FOOD INTERACTIONS

All medicines were derived from natural materials in the ancient time. Most of those early
medicines are described under the broad heading “herbs,” although that term may prove
misleading. Even though people often think of herbs as plants or plant-derived materials, several
commonly used items were obtained from animals and minerals. Further, although the term
“herbs” suggests something that is beneficial and has little potential for harm, numerous toxic
materials were used, such as foxglove, deadly nightshade, and jimson weed (Datura). Herbalists
sometimes processed the herbs to change them from their original form. As the science
developed the researchers attempted and succeeded to isolate some active constituents from
herbs, so that the end products were not as nature presented them. For example, aconite was
processed extensively in China to reduce its toxicity so that it could more readily be used, and
borneol, the active constituent found in a few tropical plants, was isolated centuries ago in
relatively pure form, a translucent crystal, for both internal and external use. The use of potent
and toxic substances and the intentional alteration of natural substances are characteristics of
production of modern drugs. Thus, some issues that arise today about interactions of herbs and
drugs may have already been encountered in earlier times when herbs were combined with each
other.

The ancient Indian system of Ayurveda is practicing in India since 1500 BC; the main aim of this
system is to preservation of normal health and curing the diseased one. Ayurveda has focused on
patient safety and benefits. In fact it is known that drug safety is a very basic and fundamental
concept in medical practice. The current raised issue with respect to Alternative medicine and
Ayurveda is increasing reports of Adverse Drug Reaction (ADR) related to herbal medicine. This
may be due to increase in number of people taking herbal products either as a medicine or as a
nutritional supplement. Such reports many a times neglect to identify the cause behind the event
which can be pertaining to variety of issues which are already considered in Ayurveda but are
neglected many a times either due to ignorance or negligence. There is misbelief that natural
drugs are safe and devoid of toxicity.

5.1 General introduction to interaction and classification

A drug interaction is a change in the action or side effects of a drug caused
by concomitant administration with a food, beverage, supplement, or another drug. There are
many causes of drug interactions. For example, one drug may alter the pharmacokinetics of
another. Alternatively, drug interactions may result from competition for a
single receptor or signaling pathway. The risk of a drug-drug interaction increases with the
number of drugs used. Over a third (36%) of the elderly in the U.S. regularly uses five or more
medications or supplements, and 15% are at potential risk of a significant drug-drug interaction.
When two drugs are used together, their effects can be additive (the result is what you expect
when you add together the effect of each drug taken independently), synergistic (combining the
drugs leads to a larger effect than expected), or antagonistic (combining the drugs leads to a
smaller effect than expected). There is sometimes confusion on whether drugs are synergistic or
additive, since the individual effects of each drug may vary from patient to patient. A synergistic
interaction may be beneficial for patients, but may also increase the risk of overdose.

Both synergy and antagonism can occur during different phases of the interaction between a
drug, and an organism. For example, when synergy occurs at a cellular receptor level this is
termed agonism and the substances involved are termed agonists. On the other hand, in the case
of antagonism, the substances involved are known as inverse agonists. The different responses of
a receptor to the action of a drug has resulted in a number of classifications, such as "partial
agonist", "competitive agonist" etc. These concepts have fundamental applications in
the pharmacodynamics of these interactions. The proliferation of existing classifications at this
level, along with the fact that the exact reaction mechanisms for many drugs are not well-
understood means that it is almost impossible to offer a clear classification for these concepts. It
is even possible that many authors would misapply any given classification.

Direct interactions between drugs are also possible and may occur when two drugs are mixed
prior to intravenous injection. For example, mixing thiopentone and suxamethonium in the same
syringe can lead to the precipitation of thiopentone.

The change in an organism's response upon administration of a drug is an important factor

in pharmacodynamics interactions. These changes are extraordinarily difficult to classify given
the wide variety of modes of action that exist, and the fact that many drugs can cause their effect
through a number of different mechanisms. This wide diversity also means that, in all but the
most obvious cases it is important to investigate, and understand these mechanisms. The well-
founded suspicion exists that there are more unknown interactions than known ones.

5.2 Study of following drugs and their possible side effects and interactions
Hypercium

St. John's wort is a plant with yellow, star-shaped flowers and five petals that grows in Europe,
North and South America, Australia, New Zealand, and Eastern Asia. The plant grows in sunny,
well-drained areas. It grows to be 50-100 cm tall.St. John's wort might cause serious interactions
with some medications. Because of this, France has banned the use of St. John's wort in products. In
other countries St. John's wort is only available with a prescription.St. John's wort is most
commonly used for "the blues" or depression and symptoms that sometimes go along with mood
such as nervousness, tiredness, poor appetite, and trouble sleeping. There is some strong scientific
evidence that it is effective for mild to moderate depression.St. John's wort is also used
for symptoms of menopause such as hot flashes and moodchanges.Oil can be made from St. John's
wort. Some people apply this oil to their skin to treat wounds. Applying St. John's wort directly to
the skin is risky. It can cause serious sensitivity to sunlight. For a long time, scientists thought a
chemical in St. John's wort called hypericin was responsible for its effects on improving mood.
More recent information suggests other chemicals like hyperforin may play a larger role. These
chemicals act on messengers in the nervous system that regulate mood.

kava-kava

Kava is a beverage or extract that is made from Piper methysticum, a plant native to the western
Pacific islands. The name "kava" comes from the Polynesian word "awa," which means bitter. In
the South Pacific, kava is a popular social drink; similar to alcohol in Western societies. There are
some BIG safety concerns about kava. Many cases of liver damage and even some deaths have been
traced to kava use. As a result, kava has been banned from the market in Europe and Canada. This
ban has hurt the economies of Pacific Island countries that export kava. Despite health concerns,
kava has not been taken off the U.S. market. Some people take kava by mouthto calm anxiety,
stress, and restlessness, and to treat sleeping problems (insomnia).

It is also used for attention deficit-hyperactivity disorder (ADHD), withdrawal from benzodiazepine
drugs, epilepsy, psychosis, depression, migraines and other headaches, chronic fatigue
syndrome (CFS, common cold and other respiratory tract infections, tuberculosis, muscle pain,
and cancer prevention.Some people also take kava by mouth for urinary tractinfections (UTIs), pain
and swelling of the uterus, venereal disease, menstrual discomfort, and to increase sexual
desire.Kava is applied to the skin for skin diseases including leprosy, to promote wound healing,
and as a painkiller. It is also used as a mouthwash for canker soresand toothaches.Kava is also
consumed as a beverage in ceremonies to promote relaxation. Kava affects the brain and other parts
of the central nervous system. The kava-lactones in kava are believed to be responsible for its
effects.

Ginkgobiloba

Ginkgo is a large tree with fan-shaped leaves. Although Ginkgo is a native plant to China, Japan,
and Korea, it has been grown in Europe since around 1730 and in the United States since around
1784. The ginkgo tree is thought to be one of the oldest living trees, dating back to more .Ginkgo
leaf is often taken by mouth for memory disorders including Alzheimer's disease. It is also used for
conditions that seem to be due to reduced blood flow in the brain, especially in older people. These
conditions include memory loss, dizziness, difficulty concentrating, and mood disturbances. Some
people use it for leg pain when walking related to poor blood flow .The list of other uses of ginkgo
is very long. This may be because this herb has been around for so Ginkgo biloba is one of the
longest living tree species in the world. Ginkgo trees can live as long as a thousand years. Using
ginkgo for asthma and bronchitis was described in 2600 BCE.In manufacturing, ginkgo leaf extract
is used in cosmetics. In foods, roasted ginkgo seed, which has the pulp removed, is an edible
delicacy in Japan and China. Ginkgo seems to improve blood circulation, which might help the
brain, eyes, ears, and legs function better. It may act as an antioxidant to slow down Alzheimer's
disease and interfere with changes in the brain that might cause problems with thinking. Ginkgo
seeds contain substances that might kill the bacteria and fungi that cause infections in the body. The
seeds also contain a toxin that can cause serious side effects like seizures and loss of consciousness.
Ginseng

Panax ginseng is a plant that grows in Korea, northeastern China, and far eastern Siberia. People use
the root to make medicine. Do not confuse Panax ginseng with American ginseng, Siberian ginseng,
or Panaxpseudoginseng. See the separate listings for American Ginseng, Ashwaganda, Blue
Cohosh, Canaigre, Codonopsis, PanaxPseudoginseng, and Siberian Ginseng.Panax ginseng is taken
by mouth to improve thinking, concentration, memory, Alzheimer's disease work efficiency,
physical stamina, preventing muscle damage from exercise, and athletic endurance.

Some people use Panax ginseng to help them cope with stress and as a general tonic for improving
well-being. They sometimes call Panax ginseng an "adaptogen" when it's used in this way.

Panax ginseng is also used for depression anxiety, general fatigue and chronic fatigue
syndrome (CFS), multiple sclerosis for boosting the immune system, and for fighting particular
infections in a lung disease called cystic fibrosis. These infections are caused by a bacterium named
Pseudomonas.

Some people use Panax ginseng to treat breast cancer and prevent ovarian cancer, liver cancer, lun
cancerand skin cancerOther uses include treatment of anemia, chronic bronchitis, swine
flu, prediabetesand diabetes, inflammation of the stomach lining (gastritis), fever, hangover, chronic
obstructive pulmonary disease (COPD), HIV/AIDS, fertility problems and sexual dysfunction in
men, to increase sexual arousal in women, and asthma. Panax ginseng is also used for bleeding
disorders, loss of appetite, vomiting, intestinal problems, gallstones, bad breath, fibromyalgia,
sleeping problems (insomnia), nerve pain, joint pain, dizziness, headache, hearing loss, convulsions,
disorders of pregnancy and childbirth, hot flashes due to menopause, common cold and flu, heart
failure, high blood pressure, quality of life, wrinkled skin, and to slow the aging process.
Some men apply Panax ginseng to the skin of the penis as part of a multi-ingredient product for
treating early orgasm (premature ejaculation).In manufacturing, Panax ginseng is used to
makesoaps, cosmetics, and as a flavoring in beverages.Panax ginseng contains many active
substances. The substances thought to be most important are called ginsenosides or panaxosides.
Ginsenosides is the term coined by Asian researchers, and the term panaxosides was chosen by
early Russian researchers.Panax ginseng is often referred to as a general well-being medication,
because it affects many different systems of the body.

Garlic

Garlic is an herb that is grown around the world. It is related to onion, leeks, and chives. It is
thought that garlic is native to Siberia, but spread to other parts of the world over 5000 years ago.
Garlic is used for many conditions related to the heart and blood system. These conditions
include high blood pressure, low blood pressure, high cholesterol, inherited high cholesterol,
coronary heart disease, heart attack, reduced blood flow due to narrowed arteries, and "hardening of
the arteries" (atherosclerosis). Some people use garlic to prevent colon cancer, rectal
cancer, stomach cancer, breast cancer, prostate cancer, multiple myeloma, and lung cancer. It is also
used to treat prostate cancer and bladder cancer. Garlic has been tried for treating an enlarged
prostate (benign prostatic hyperplasia; BPH), cystic fibrosis, diabetes, osteoarthritis, hay fever
(allergic rhinitis), and traveler’s diarrhea, high blood pressure late in pregnancy (pre-
eclampsia), yeast infection, flu, and swine flu. It is also used to prevent tick bites, as a mosquito
repellant, and for preventing the common cold, and treating and preventing bacterial and fungal
infections. Garlic is also used for earaches, chronic fatigue syndrome, menstrual disorders,
abnormal cholesterol levels caused by HIV drugs, hepatitis, shortness of breath related to liver
disease, stomach ulcers caused by H. pylori infection, exercise performance, exercise-induced
muscle soreness, a condition that causes lumps in the breast tissue called fibrocystic breast disease, a
skin condition called scleroderma, and lead toxicity.Other uses include treatment of fever, coughs,
headache, stomach ache, sinus congestion, gout, joint pain, hemorrhoids, asthma, bronchitis,
shortness of breath, low blood sugar, snakebites, diarrhea and bloody diarrhea, tuberculosis, bloody
urine, a serious nose and throat infection called diphtheria, whooping cough, tooth sensitivity,
stomach inflammation (gastritis), scalp ringworm, and a sexually transmitted disease called
vaginal trichomoniasis. It is also used for fighting stress and fatigue. Some people apply garlic oil to
their skin or nails to treat fungal infections, warts, and corns. It is also applied to the skin for hair
loss and thrush.Garlic is used in the vagina for yeast infections.Garlic is injected into the body for
chest pain. In foods and beverages, fresh garlic, garlic powder. Garlic produces a chemical called
allicin. This is what seems to make garlic work for certain conditions. Allicin also makes garlic
smell. Some products are made "odorless" by aging the garlic, but this process can also make the
garlic less effective. It's a good idea to look for supplements that are coated (enteric coating) so they
will dissolve in the intestine and not in the stomach.

Pepper

Black pepper and white pepper are made from the Piper nigrum plant. Black pepper is ground from
dried, whole unripe fruit. White pepper is ground from dried, ripe fruit that has had the outer layer
removed. The black pepper and white pepper powder are used to make medicine. People take black
pepper for stomach upset, bronchitis, and cancer. They take white pepper for stomach
upset, malaria, cholera, and cancer.Black pepper is sometimes applied directly to the skin for
treating nerve pain (neuralgia) and a skin disease called scabies. Black pepper and white pepper are
also used topically as a counterirritant for pain.In foods and beverages, black pepper, white pepper,
and pepper oil (a product distilled from black pepper) are used as flavoring agents.
Black and white pepper might help fight germs (microbes) and cause the stomach to increase the
flow of digestive juices. There is conflicting evidence about their role in cancer. Some evidence
suggests pepper might protect against colon cancer, but other evidence suggests it might
promote liver cancer.

Ephedra

Ephedra is an herb. Usually, the branches and tops are used to make medicine, but the root or whole
plant can also be used. Ephedra is banned in the U.S. due to safety concerns.Mormon tea and
ephedra are often confused. Mormon tea or American ephedra comes from Ephedra nevadensis, and
ephedra or ma huang comes primarily from Ephedra sinica. Mormon tea lacks the chemicals
(notably ephedrine) that give ephedra its effects and potentially serious side effects.Ephedra is used
for weight loss and obesity and to enhance athletic performance. It is also used for allergies and hay
fever; nasal congestion; and respiratory tract conditions such as bronchospasm, asthma,
and bronchitis. It is also used for colds, flu, swine flu, fever, chills, headache, inability to sweat,
joint and bone pain, and as a “water pill” to increase urine flow in people who retain fluids. There
has been a lot of debate about the safety of ephedra and legal wrangling over its status.

In June 1997, the FDA proposed restrictions on the ephedrine content of dietary supplements, new
warning labels for products that contain the active ingredients in ephedra and a ban on combination
products containing ephedra and other natural stimulants, such as guarana and cola nut, both of
which contain significant amounts of caffeine. These proposals were dropped after the link between
ephedra use and serious adverse effects was challenged by the General Accounting Office (GAO)
and the dietary supplement industry. According to the Dietary Supplement Health and Education
Act of 1994, FDA must prove a supplement is unsafe before it can be withdrawn from the market.
The FDA reviewed numerous adverse event reports involving ephedra-containing products, with
140 of the reports receiving in-depth clinical review by FDA and outside experts. Findings from
experts outside the FDA support the FDA's initial finding that ephedra is likely the cause of many of
the events noted in the reports.On December 30, 2003, the FDA announced the ban of ephedra
products in the U.S., effective April 2004. In April 2005, the dietary supplement industry
successfully challenged the FDA ban on ephedra. A year after the ban on ephedra began, a federal
judge in Utah struck down the FDA's action saying that FDA didn't prove that low doses of ephedra
are harmful. In August 2006, an appeals court reversed the Utah judge's decision and upheld the
FDA's ban of ephedra-containing dietary supplements.Ephedra use is banned by the National
Collegiate Athletic Association, International Olympic Committee, and National Football
League.Ephedra is sometimes marketed as a recreational drug "herbal ecstasy." The FDA has
announced that ephedra products marketed as recreational drugs are unapproved and that
misbranded drugs.
Ephedra contains a chemical called ephedrine. Ephedrine stimulates the heart, the lungs, and
the nervous system.
 Semester- 6th
Subject: Herbal Drug Technology

Subject code: BP603

Module -2

NUTRACEUTICALS

Objectives: upon compilation of this module the student should be able to:

1. Understand the basic concept of nutraceuticals

2. Know the market growth of nutraceuticals
3. Understand about herbs used as a nutraceuticals
4. Know about the drugs used in various aliments
5. Know about the herbal-drug interactions

Learning outcomes: the student will be able to:

1. Learn the difference between pharmaceuticals and nutraceuticals

2. Learn about global market growth and scope of nutraceuticals
3. Learn about the market preparations of nutraceuticals
4. Learn about herbs used in Cancer, CVS, Diabetes and GIT as a nutraceuticals
5. Learn about various herbal drug interactions as well as Herbal Food interactions.

Introduction: Nutraceuticals are a group of products that are more than a food but less than a
pharmaceuticals. It is a substance which may be regarded as a food or part of a food which
provides medical or health benefits, helps in prevention and treatment of a disease. These are
foods which provides health benefits to reduce the risk of chronic diseases and basic nutrition. A
nutraceutical may be a naturally nutrient- rich food such as spirulina, garlic, soy or a specific
component of a food like omega-3 oil from salmon. They are also known as medical foods,
nutritional supplements and dietary supplements. It ranges from isolated nutrients, dietary
supplements, genetically engineered „designer‟ foods, herbal products, and processed
products such as cereals and soups. They have received considerable interest because of their
presumed safety and potential nutritional and therapeutic effects. Foods and nutrients play a vital
role in the normal functioning of the body. They help to maintain the health of the individual
and to reduce the risk of various diseases. Worldwide acceptance of this fact formed a
recognition link between "nutrition" and "health", and thus the concept of "nutraceuticals"
evolve dietary active compounds in human nutrition is one of the most important areas of
investigation. Examples of nutraceuticals are natural foods, antioxidants, dietary supplements,
daisy products, citrus fruits, vitamins, minerals, milk and cereals. These products are generally
consumed without medical prescription and supervision. They play vital role in human health
and long life.

Classification of Nutraceuticals: The food sources used as nutraceuticals are all natural and can
be categorized as

1. Dietary Fiber

2. Probiotics

3. Prebiotics

4. Polyunsaturated fatty acids

5. Antioxidant

6. Polyphenols

7. Spice
Global demand of nutraceuticals: The nutraceutical industry lies under three main segments
which include functional foods, dietary supplements, and herbal/natural products.Global
nutraceutical market is estimated as USD 117 billion (INR 5148 billion). In 2007, nutraceuticals
sale is projected to reach $74.7 billion at an AAGR of 9.9%. This assumes a world economic
recovery in 2003 and an end to price competition.
According to a recent report, the total market for nutraceuticals in India is growing at 21 percent
per annum. It is currently valued at INR 44bn (€621 m), but could be worth more than INR 95bn
in four years. As a concept, “Nutraceuticals” is still in its stage of infancy in India. But it has
been growing much faster than global rates at CAGR of 18% for the last 3 years driven by
functional food and beverages categories. The most rapidly growing segments of the industry
were dietary supplements (19.5 percent per year) and natural/herbal products (11.6 percent per
year).

With the ever-changing lifestyle of humans, the antioxidant defense systems are often
overloaded resulting in oxidative stress. Moreover, the levels of antioxidant defense mechanism
decrease appreciably with age. These may result in the development of a great many diseases.
Hence research over the past several decades have primarily focussed on different nutraceuticals.
Antioxidant products may either function intrinsically to scavenge free radicals (e.g. vitamins,
PUFA) or specifically stimulate the body’s defense system. This review reflects the potential
merits and demerits of nutraceuticals among healthy individuals. However, an individual’s
susceptibility to any particular disease predominantly depends upon genetic predisposition and
lifestyle disorders like smoking, high alcohol consumption. So the response of nutraceuticals can
vary from person to person. Nutraceuticals have proven health benefits and their consumption
(within their acceptable Recommended Dietary Intakes) will keep diseases at bay and allow
humans to maintain an overall good health.
NUTRACEUTICALS AND DISEASES:

Cardiovascular diseases: Worldwide, the burdens of chronic diseases like cardiovascular

diseases, cancers, diabetes and obesity is rapidly increasing. In 2001, chronic diseases
contributed approximately 59% of the 56.5 million total reported deaths in the world and 46% of
the global burden of disease. Cardiovascular diseases (CVD) is the name for the group of
disorders of the heart and blood vessels and include hypertension (high blood pressure), coronary
heart disease (heart attack), cerebrovascular disease (stroke), heart failure, peripheral vascular
disease, etc. In 1999 CVD alone contributed to a third of global deaths and by 2010 it would be
the leading cause of death in developing countries. Majority of the CVD are preventable and
controllable. It was reported that low intake of fruits and vegetables is associated with a high
mortality in cardiovascular disease. Many research studies have identified a protective role for a
diet rich in fruits and vegetables against CVD. This apart, nutraceuticals in the form of
antioxidants, dietary fibers, omega-3 polyunsaturated fatty acids (n-3 PUFAs), vitamins, and
minerals are recommended together with physical exercise for prevention and treatment of CVD.
It has been demonstrated that the molecules like polyphenols present in grapes and in wine alter
cellular metabolism and signalling, which is consistent with reducing arterial disease. Flavonoids
are widely distributed in onion, endives, cruciferous vegetables, black grapes, red wine,
grapefruits, apples, cherries and berries. Flavanoids in plants available as flavones (containing
the flavonoid apigenin found in chamomile); flavanones (hesperidins - citrus fruits; silybin- milk
thistle flavonols (tea:quercetin, kaempferol and rutin grapefruit; rutin buckwheat; ginkgo
flavonglycosides -ginkgo) play a major role in curing the cardiovascular diseases. Flavonoids
block the angiotensin-converting enzyme (ACE) that raises blood pressure; by blocking the
"suicide" enzyme cyclo-oxygenase that breaks down prostaglandins, they prevent platelet
stickiness and hence platelet aggregation. Flavonoids also protect the vascular system and
strengthen the tiny capillaries that carry oxygen and essential nutrients to all cells.

Diabetes: Diabetes mellitus is characterized by abnormally high levels of blood glucose, either
due to insufficient insulin production, or due to its ineffectiveness. The most common forms of
diabetes are type 1diabetes (5%), an autoimmune disorder, and type 2 diabetes (95%), which is
associated with obesity. Gestational diabetes occurs in pregnancy. Globally the total number of
people with diabetes is projected to raise from 171 million in 2000 to 366 million in2003.
Docosahexaenoic acid modulates insulin resistance and is also vital for neurovisual development.
This is especially important in women with gestational diabetes mellitus which foster the
recommendation for essential fatty acids during pregnancy. Lipoic acid is a universal
antioxidant, now used in Germany for the treatment of diabetic neuropathy. It is possible that
lipoic acid may be more effective as a long-term dietary supplement aimed at the prophylactic
protection of diabetics from complications. Dietary fibers from psyllium have been used
extensively both as pharmacological supplements, food ingredients, in processed food to aid
weight reduction, for glucose control in diabetic patients and to reduce lipid levels in
hyperlipidemia. Good magnesium status reduces diabetes risk and improves insulin sensitivity;
chromium picolinate, calcium and vitamin D appear to promote insulin sensitivity and improve
glycemic control in some diabetics; extracts of bitter melon and of cinnamon have the potential
to treat and possibly prevent diabetes. However it has been suggested that Nutraceuticals with
meaningful doses of combinations may substantially prevent and presumably could be marketed
legally.

Cancer: Flavonoids which block the enzymes that produce estrogen reduce of estrogen induced cancers.
Phytoestrogens is recommended to prevent prostate/breast cancer. Soy foods are source of Iso-flavones,
curcumin from curry and soya isoflavones possess cancer chemo preventive properties. Lycopene
concentrates in the skin, testes, adrenal and prostate protects against cancer. Saponins contains
antitumor andantimutagenic activities. Curcumin (diferuloylmethane) which is a polyphenol of
turmeric possesses anti-carcinogenic, antioxidative and anti-inflammatory properties. Beet roots,
cucumber fruits, spinach leaves, and turmeric rhizomes were reported to possess anti-tumor
activity.
 Herbs as health food
1. Alfalfa: Alfalfa is an herb. People use the leaves, sprouts, and seeds to make medicine.
Alfalfa is used for kidney conditions, bladder and prostate conditions, and to increase
urine flow. It is also used for high cholesterol, asthma, osteoarthritis, rheumatoid arthritis,
diabetes, upset stomach, and a bleeding disorder called thrombocytopenic purpura. People
also take alfalfa as a source of vitamins A, C, E, and K4; and minerals calcium, potassium,
phosphorous, and iron. It is used in High cholesterol. Taking alfalfa seeds seems to lower
total cholesterol and “bad” low-density lipoprotein (LDL) cholesterol in people with high
cholesterol levels. Kidney problems, Bladder problems, Prostate problems, Asthma,
Arthritis and Diabetes

2. Chicory: Chicory (Cichorium intybus) is a perennial herbal plant of the dandelion family
Asteraceae. In addition, chicory herb plays a key role as antioxidant, anti-inflammatory,
sedative, immunological, productive and reproductive enhancer, cardiovascular,
hypolipidemic, anticancer, anti-protozoal, gastro-protective, antidiabetic, analgesic,
anthelmintic, antimicrobial, wound healing and bitter tonic without inducing therapeutic
adverse effect. Also, chicory plant is a good and very important protective source for
hepatocytes and other liver cells as well as it is used as prebiotic against some species of
pathogenic bacteria for both in vitro and in vivo.
3. Ginger: It is the dried rhizomes of Zingiber officinale, belonging to family Zingiberaceae.
It contains volatile oils, minerals, resins. Ginger oil contains zingiberine, bisaboline,
curcumene. Resins contain phenolic keteones such as gingerols, shogoals, zingerone and
other compounds. Ginger is commonly used for various types of "stomach problems,"
including motion sickness, morning sickness, colic, upset stomach, gas, diarrhea, irritable
bowel syndrome (IBS), nausea, nausea caused by cancer treatment, nausea caused by
HIV/AIDS treatment, nausea and vomiting after surgery, as well as loss of appetite. Other
uses include pain relief from rheumatoid arthritis (RA), osteoarthritis, menstrual pain, and
other conditions. However, there is not strong evidence to support the use of ginger for
these conditions. Some people pour the fresh juice on their skin to treat burns. The oil
made from ginger is sometimes applied to the skin to relieve pain. Ginger extract is also
applied to the skin to prevent insect bites. In foods and beverages, ginger is used as a
flavoring agent. In manufacturing, ginger is used as for fragrance in soaps and cosmetics.
One of the chemicals in ginger is also used as an ingredient in laxative, anti-gas, and
antacid medications.

4. Fenugreek: Fenugreek (Trigonella foenum-graecum) is a legume and it has been used as

a spice throughout the world to enhance the sensory quality of foods. It is known for its
medicinal qualities like antidiabetic, anticarcinogenic, hypocholesterolemic, antioxidant,
immunological Activity etc. It contains alkaloids, flavonoids, coumarins, proteins, amino
acids and steroidal saponins.

5. Garlic: It consists of dried bulbs of Allium sativum, belonging to the family Liliaceae.
Allium sativum pulp contains vitamins especially B-1, vitamin C, vitamin A, flavonoids,
ascorbic acid, phosphorous, potassium, sulphur, selenium, calcium, magnesium,
germanium, sodium, iron,manganese and trace iodineGarlic is being used from thousand
of years for its medicinal properties. Numerous researches have proved its beneficial role
in cardiovascular condition. Indeed, garlic does indeed have cardioprotective properties.
Researches also proved its active role as anticancer, natural immunity booster,
antioxidant, antibiotic & antidiabetic product. On other hand studies also report some side
effects of garlic if it is used with blood-thinners, anti-HIV, or hypoglycemic drugs.

6. Honey: It is a sugar like secretion deposited in honey comb by the bees Apis mellifera,
Apis dorsata and other species of Apis belonging to family: Apidae. Honey is an aquesous
solution containing 35% glucose, 45% fructose and 2% sucrose. It is used as demulcent,
sweetening agent, nutrient, antiseptic and expectorant.
7. Amla: Emblica officinalis (i.e., Phyllanthus emblica/ Indian gooseberry/ Amla) has been
used extensively as a nutraceutical in several diseases since it is known to boost immunity
and offers numerous health benefits such as antioxidant, anti-inflammatory, and anti-aging
effects. Phytochemically, it is composed of several bioactive compounds such as
flavonoids (i.e, Quercetin, Kaempferol), phenolic compounds (i.e., gallic acid, methyl
gallate, ellagic acid, trigallayl glucose), tannins (i.e., Emblicanin A and B, phyllaemblicin
B, punigluconin, pedunclagin, Chebulinic acid, Corilagin, Geraniin, Ellagotannin), amino
acids (i.e., glutamic acid, aspartic acid, alanine, lysine, proline, cystine), fatty acids (i.e.,
stearic acid, oleic acid, palmitic acid, myristic acid, linolenic acid, linoleic acid), alkaloids
(i.e., Phyllantine, Phyllembein, Phyllantidine), pectin, citric acid, ascorbic acid (Vitamin
C), cellulose, gum, and albumin. It is used in the treatment of Anaemia, Diarrhoea, and
Jaundice etc.

8. Gingeng: It consists of roots of the plant Panax gingeng and other species of pabax
belonging to the family Araliaceae. It contains saponins, glycosides, volatile oilssterols,
polysaccharides, minerals vitamin-B, biotin etc. Ginseng has beneficial antioxidant and
anti-inflammatory properties. Ginseng could help improve brain functions like memory,
behavior and mood. Ginseng has been shown to benefit mental functions, feelings of
calmness and mood in both healthy people and those with Alzheimer's disease.

9. Ashwangandha: It consist of dried roots and stem bases of the plant Withania somnifera
belonging to the family Solanaceae. The name “ashwagandha” is derived from two
Sanskrit words: “ashwa” meaning “horse” and “gandha” meaning “smell,” which roughly
translates to “horse-like smell,” or “horse essence,” which could be a reference to the
traditional belief that the root provides the strength, character, essence, or stamina of a
stallion. Ashwagandha, has health benefits which are as follows such as it controls
cholesterol levels, increases fertility in men, reduces anxiety, relieves stress, fights
diabetes, controls hair fall, hinders, treat osteoporosis, rheumatic arthritis, treats cancer,
increases blood production, prevents seizures, aids in muscle growth, stimulates the
thyroid gland, reduces ocular diseases, anti-tumor, anti-inflammatory and antibacterial
properties etc.

10. Spirulina: Spirulina is a biomass of cyanobacteria (blue-green algae) that can be

consumed by humans and animals. The two species are Arthrospira platensis and A.
maxima. As an ecologically sound, nutrient-rich dietary supplement, spirulina is being
investigated to address food security and malnutrition, and as dietary support in long-term
space flight or Mars missions.Its advantage for food security is that it needs less land and
water than livestock to produce protein and energy. Dried spirulina contains 5% water,
24% carbohydrates, 8% fat, and about 60% (51–71%) protein (table). Provided in its
typical supplement form as a dried powder, a 100-g amount of spirulina supplies 290
 kilocalories (1,200 kJ) and is a rich source (20% or more of the Daily Value, DV) of
numerous essential nutrients, particularly protein, B vitamins (thiamin, riboflavin, and
niacin, providing 207%, 306%, and 85% DV, respectively), and dietary minerals, such as
iron (219% DV) and manganese (90% DV) (table). The lipid content of spirulina is 8% by
weight (table) providing the fatty acids, gamma-linolenic acid, alpha-linolenic acid,
linoleic acid, stearidonic acid, eicosapentaenoic acid (EPA), docosahexaenoic acid
(DHA), and arachidonic acid.

Herbal- drug and Herb Food Interactions

Introduction: According to the World Health Organisation, herbal medicines are defined as
‘finished, labelled medicinal products that contain as active ingredients aerial or underground
parts of plants, or other plant material, or combinations thereof, whether in the crude state or
as plant preparations. Plant material includes juices, gums, fatty oils, essential oils, and any
other substances of this nature. Herbal medicines may contain excipients in addition to the
active ingredients. Medicines containing plant material combined with chemically defined
active substances, including chemically defined, isolated constituents of plants, are not
considered to be herbal medicines. Thus, herbal medicines contain a combination of
pharmacologically active plant constituents that are claimed to work synergistically to
produce an effect greater than the sum of the effects of the single constituents. There is a
general belief by the public that herbal medicines are safe because they are natural. However,
this is a hazardous oversimplification. Many different side effects to herbs have been reported
and recently reviewed, including adverse events caused by herb-to-drug interactions. Since all
herbal medicines are mixtures of more than one active ingredient, such combinations of many
substances obviously increase the likelihood of interactions taking place. Hence, theoretically,
the likelihood of herb-to-drug interactions is higher than drug-to-drug interactions, if only
because synthetic drugs usually contain single chemical.

Mechanisms of Herb-to-Drug Interactions:

Herb-to-drug interactions are based on the same pharmacokinetic (changes of plasma drug
concentration) and pharmacodynamic (drugs interacting at receptors on target organs)
principles as drug-to-drug interactions.

The pharmacokinetic interactions that have been identified so far all point towards the fact
that a number of herbs, most notably St. John’s wort, can affect the blood concentration of
different conventional medicines that are metabolized by cytochrome P450 (CYP, the most
important phase I drug-metabolizing enzyme system) and/or are transported by P-
glycoprotein (a glycoprotein which influences drug absorption and elimination by limiting the
cellular transport from the intestinal lumen into epithelial cells and by enhancing the excretion
of drugs from hepatocytes and renal tubules into the adjacent luminal space). Polymorphisms
in the genes for CYP enzymes and P-glycoprotein may influence the interactions mediated
through these pathways [12]. Probe drugs used in pharmacokinetic trials include midazolam,
alprazolam, nifedipine (CYP3A4), chlorzoxazone (CYP2E1), debrisoquine,
dextromethorphan (CYP2D6), tolbutamide, diclofenac and flurbiprofen (CYP2C9), caffeine,
tizanidine (CYP1A2) and omeprazole (CYP2C19). Fexofenadine, digoxin and talinolol have
been extensively used in pharmacokinetic trials as P-glycoprotein substrates.

Pharmacodynamic interactions have been less studied but may be additive (or synergetic),
i.e. the herbal medicines potentiate the pharmacological/toxicological action of synthetic
drugs, or antagonistic, i.e. the herbal medicines reduce the efficacy of synthetic drugs.
Warfarin interactions are a classical example of pharmacodynamic interactions. Theoretically,
increased anticoagulant effects could be expected when warfarin is combined with coumarin-
containing herbs (some plant coumarins exert anticoagulant effects) or with antiplatelet herbs.
Conversely, vitamin K-containing herbs can antagonize the effect of warfarin (the action of
warfarin is due to its ability to antagonize the cofactor function of vitamin K).entities.
 Study of drugs and their side effects and interactions:

1. Hypercium: St. John’s Wort (Hypericum perforatum) extracts are widely used as a safe
alternative to conventional antidepressant drugs for mild to moderate forms of depressive
disorders. The herb contains numerous compounds with documented biological activity,
including the naphthodianthrone hypericin, a broad range of flavonoids, and the
phloroglucinol hyperforin, which inhibits the re-uptake of several brain neurotransmitters,
including 5-hydroxytryptamine (5-HT, serotonin). Pharmacodynamic interactions may
occur when St. John’s wort is given together with drugs that enhance 5-HT signaling in
the brain (e.g. 5-HT re-uptake inhibitors, 5-HT ligands). St. John’s wort has been shown
to clinically interact with a number of conventional drugs mostly via these
pharmacokinetic and/or pharmacodynamic mechanisms; such interactions take place with
immunosuppressants (cyclosporine, tacrolimus, prednisone), hormones (oral pill,
tibolone), cardiovascular drugs (the anticoagulants warfarin and phenprocoumon, the
cardiac inotropic drug digoxin, the antilipidaemic drugs simvastatin, rosuvastatin and
atorvastatin, the calcium blockers nifedipine and verapamil.

2. Kava- kava: Kava (Piper methysticum): Preparation from the rhizome and roots of
Piper methysticum (Fam. Piperaceae) are used for the treatment of anxiety, and the
available evidence suggests that kava extracts are superior to placebo for treating patients
with anxiety disorders. Unfortunately, in the UK and various other European countries,
the sale of kava is currently prohibited due to reports of potential hepatotoxicity. In vitro,
kavalactones, the active ingredients of kava, have been shown to be potent inhibitors of
several enzymes of the CYP450 system. However, clinical trials have shown that, at
therapeutic doses, kava inhibits CYP2E1 but not other CYP isoforms, such as CYP3A4,
CYP2D6 or CYP1A2. Some possible pharmacodynamic interactions, highlighted by
single case reports have been postulated to occur when combining kava with
benzodiazepines, anti-Parkinson or antidepressant drugs.

3. Ginkobiloba: Extracts from the leaves of the ginkgo tree (Ginkgo biloba, Fam.
Ginkgoaceae) are used for the treatment of cognitive impairments, dementia, intermittent
claudication and tinnitus. The effect of ginkgo on various CYP isoforms as well as on P-
glycoprotein has been investigated in a number of clinical trials by using different probe
drugs, such as alprazolam, midazolam, diazepam, nifedipine (CYP3A4), caffeine
(CYP1A2), chlorzoxazone (CYP2E1), debrisoquine (CYP2D6), tolbutamide, diclofenac,
flurbiprofen (CYP2C), omeprazole, voriconazole (CYP2C19), fexofenadine, digoxin and
talinolol (P-glycoprotein substrates). It is often mentioned that ginkgo can interact with
anticoagulant drugs. Clinical trials have also shown that ginkgo has no additive effect with
aspirin on platelet aggregation, does not change the antiplatelet activity of clopidogrel and
cilostazol.
4. Ginseng: Panax quinquefolius (Fam. Araliaceae), commonly known as ‘American
ginseng’, is a herbaceous perennial herb native to North America. A clinical study showed
that American ginseng reduced the anticoagulant effect of warfarin in healthy volunteers..
On the other hand, two clinical trials have recently shown that American ginseng did not
affect the pharmacokinetics of the antiretroviral drugs indinavir and zidovudine.

5. Garlic: (Allium sativum L., Fam. Alliaceae) is used in modern phytotherapy to treat
hypercholesterolaemia and prevent arteriosclerosis although the clinical evidence is far
from compelling. Garlic preparations include garlic powder standardized to contain 1.3%
alliin and 0.6% allicin, garlic aged extract, which does not contain allicin but is high in
water soluble phytochemicals, such as diallyl sulphides and garlic oil (i.e. essential oil
obtained from the distillation of the cloves). Two garlic preparations, namely garlic oil
and garlic powder, have been evaluated for their potential to affect CYP enzymes in
clinical trials. The results suggest that garlic oil may selectively inhibit CYP2E1, but not
other CYP isoforms (such as CYP1A2, CYP3A4 or CYP2D6) and that garlic powder has
no effect on CYP3A4 [54,55,56,57,58]. Recently, it has been shown that a 21-day garlic
treatment (aged garlic extract) induces intestinal expression of P-glycoprotein without
affecting intestinal or hepatic CYP34A in humans.

6. Pepper: The black pepper (Piper nigrum L) vine and its extracts have been used as a folk
medicine in a variety of cultures and are the source of the most commonly used spice
worldwide. The chemical piperine is a major bioactive component present in black pepper
(and white pepper as well) that has numerous reported physiological and drug-like actions.
The various evidences shows that black pepper may have health benefits, particularly in
enhancing digestive tract function. There is suggestive evidence that black pepper piperine
may have nervous system benefits and may influence body energy usage in rats.
Preliminary evidence in cell culture studies suggests that black pepper contains
antioxidant constituents and possesses anti-inflammatory and antimicrobial properties.

7. Ephedra: Ephedra is an herb. Usually, the branches and tops are used to make medicine,
but the root or whole plant can also be used. Ephedra is banned in the U.S. due to safety
concerns Ephedra is used for weight loss and obesity and to enhance athletic performance.
It is also used for allergies and hay fever; nasal congestion; and respiratory tract
conditions such as bronchospasm, asthma, and bronchitis. It is also used for colds, flu,
swine flu, fever, chills, headache, inability to sweat, joint and bone pain, and as a “water
pill” to increase urine flow in people who retain fluids. Ephedra contains a chemical called
ephedrine. Ephedrine stimulates the heart, the lungs, and the nervous system.

…………………
 Semester- 6th
Subject: Herbal Drug Technology

Subject code: BP603

Module - 3

Herbal Cosmetics
Objectives: upon compilation of this module the student should be able to:

1. Know the herbal cosmetics, natural sweeteners and herbal excipients

2. Understand about the methods for preparation and evaluation methods of herbal cometics
3. Know about the novel drug delivery systems like Phytosomes

Learning outcomes: the student will be able to:

1. Learn the sources and description of raw materials for herbal origin used as a fixed oil,
colorants, antioxidants, hair care and dental care.
2. Learn about the significance of herbal excipients.
3. Learn about the standardization of herbal formulations.
4. Learn about the novel drug delivery system like Phytosomes and their advantages over
herbal extracts.

Introduction: The concept of beauty and cosmetics dates back to ancient mankind and
civilization. Generally herbal cosmetics are also referred to as natural cosmetics. Herbal
cosmetics are formulated, using different cosmetic ingredients to form the base in which one or
more herbal ingredients are used to cure various skin ailments. Plants are highly used for
development of new drug products for cosmeceuticals and pharmaceutical applications. Herbal
cosmetics are the products in which herbs are used in crude or extract form. Herbal Cosmetics,
referred as Products, are formulated, using various permissible cosmetic ingredients to form the
base in which one or more herbal ingredients are used to provide defined cosmetic benefits only,
shall be called as “Herbal Cosmetics”. Herbs do not produce instant cures. They offer a way to
put the body in proper tune with nature. A huge number of cosmetic and toiletry formulations
have been designed and developed based upon Indian Herbs recently. Other than traditionally
documented applications, some modern trials have also been using the utility of Indian herbs in
Personal Care products. The demand of herbal medicines is increasing apidly due to their skin
friendliness and lack of side effects. The best thing of the herbal cosmetics is that it is purely
made by the herbs and shrubs and thus is side-effects free. The natural content in the herbs does
not have any side effects on the human body; instead provide the body with nutrients and other
useful minerals. The term Cosmeceuticals was first used by Raymond Reed founding member of
U.S Society of Cosmetics Chemist in 1961. He actually used the word to brief the active and
science based cosmetics.

Natural products: The name itself suggests that herbal cosmetics are natural and free from all
the harmful synthetic chemicals which otherwise may prove to be toxic to the skin. Instead of
traditional synthetic products different plant parts and plant extracts are used in these products,
e.g. aloe-vera gel and coconut oil. They also consist of natural nutrients like Vitamin E that
keeps skin healthy, glowing and beautiful. For example, Aloevera is a herbal plant
species belonging to liliaceae family and is naturally and easily available. There are a rising
number of consumers concerned about ingredients such as synthetic chemicals, mineral oils who
demand more natural products with traceable and more natural ingredients, free from harmful
chemicals and with an emphasis on the properties of botanicals.

Skincare Products:
Coconut oil: It is produced by crushing copra, the dried kernel, which contains about 60-65% of
the oil. Coconut oil contains a high amount of glycerides of lower chain fatty acids. Coconut oil
is derived from the fruit or seed of the coconut palm tree Cocos nucifera, family Arecaceae. The
melting point of coconut oil is 24 to 25°C (75-76ºF) and thus can be used easily in liquid or solid
forms and is often used in cooking and baking. Coconut oil is excellent as a skin moisturizer and
softener.

Sunflower oil: It is the non-volatile oil extracted from sunflower seeds obtained from Helianthus
annuus, family Asteraceae. Sunflower oil contains lecithin, tocopherols, carotenoids and waxes.
It hassmoothing properties and is considered non-comedogenic. A simple yet cost-effective oil,
well tried and tested for generations in a wide variety of emulsions formulated for face and body
Products.

Jojoba oil: It is a mixture of long chain, linear liquid wax esters extracted from the seeds of the
desert shrub Simmondsia chinenesis, family simmondsiaceae. Jojoba oil is easily refined to
remove any odor, color it is oxidatively stable, and is often used in cosmetics as a moisturizer
and as a carrier oil for exotic fragrances. Human sebum and jojoba oil are virtually identical.
Sebum protects and moisturizes the skin and hair but is stripped away by chemicals, pollutants,
sun and the aging process, resulting in dry skin and hair. Jojoba oil replenishes what skin and
hair lose and restores them to their natural pH balance.

Olive oil: This oil is a fixed oil extracted from the fruits of olea europaea, family oleaceae. The
major constituents are triolein, tripalmitin, trilinolein, tristearate, monosterate, triarachidin,
squalene, β-sitosterol and tocopherol. It is used as skin and hair conditioner in cosmetics like
lotions, shampoos etc. It is a potent fatty acid penetration enhancer.

Aloevera: Aloevera is a herbal plant species belonging to liliaceae family that is found only in
cultivation, having no naturally occurring populations, although closely related aloes do have
presence in northern Africa. It is an ingredient in many cosmetics because it heals, moisturizes,
and softens skin. Simply cut one of the aloe vera leaves to extract the soothing gel. Aloe vera
contains amino acids like leucine, isoleucine, saponin glycosides that provide cleansing action,
vitamins A,C,E,B, choline, B12 and folic acid and provide antioxidant activity.

Anti-aging Herbs
Rhodiola rosea- It is commonly known as golden root, roseroot, Aaron's rod, arctic root, king's
crown, lignum rhodium, orpin rose. It is a plant in the Crassulaceae family that habitats in cold
regions of the world. Traditional folk medicine used R. rosea to increase physical endurance,
work productivity, longevity, resistance to high altitude sickness, and to treat fatigue, depression,
anemia, impotence, gastrointestinal ailments, infections, and nervous system disorders. R. rosea
is rich in phenolic compounds, known to have strong antioxidant Properties.

Carrot: It is obtained from the plant Daucus carota belonging to family Apiaceae. It is a
valuable herb since ages as due to its richness in Vitamin A along with other essential vitamins.
Carrot seed oil is used as anti-aging, revitalizing and rejuvenating agent. The carrot gets its
characteristic and bright orange colour from β-carotene, and lesser amounts of α-carotene and γ-
carotene. α and β-carotenes are partly metabolized into vitamin A in humans.

Gingko: In China and Japan, the leaves and nuts of the Ginkgo biloba (G. biloba) tree have been
used for thousands of years to treat various medical conditions, including poor blood circulation;
hypertension; poor memory, and depression, particularly among the elderly; male impotence. In
addition, it is gaining a similar reputation as an antioxidant and anti-inflammatory agent. Ginkgo
biloba belongs to family Ginkgoaceae, which grows to a huge size.

Neem: Neem or Margosa is a botanical relative of mahogany. It belongs to the family Meliaceae.
The Latinized name of NeemAzadirachta indica-is derived from the Persian. Azad=Free,
dirakht=Tree, i-Hind=of Indian Origin. The common treatment for the dandruff is Neem as it
produces antifungal, antibacterial, pain-relieving, and anti- compounds that would treat dandruff.

Dandruff treatment:

Ayurveda has numerous natural medications wherein the most common herbs include Neem,
Kapoor (naphthalene), and Henna, Hirda, Behada, and Amalaki, Magic nut, Bringaraj, Rosary
Pea, Sweet Flag, Cashmere tree and Mandor.

Henna: Henna comes from the plant Lawsonia inermis family Lythraceae, which contain a dye
molecule called Lawsone, which when processed produces Henna powder. Besides lawsone
other constituents present are gallic acid, glucose, mannitol, fats, resin (2%), mucilage and traces
of an alkaloid. Leaves yield hennatannic acid and an olive oil green resin, soluble in ether and
alcohol. Lawsone osisolated from the leaves of L.inermis has shown significant antifungal antibiotic
effect.
Shikakai: Acacia concinna Linn. (Leguminosae) is a medicinal plant that grows in tropical
rainforests of southern Asia. The fruits of this plant are used for washing hair, for improving hair
growth, as an expectorant, emetic, and purgative. The powder of Acacia Concinna Linn shows
the presence of saponins, alkaloid, sugar, tannin, flavanoids, anthraquinone glycosides.

Hair-care

Amla: Amla is the name given to the fruit of a small leafy tree (Emblica Officinalis), which
grows throughout India and yields characteristics. edible fruit. It is highly praised both for its
high vitamin C content and for the precious oil, which is extracted from its seeds and pulp and
used as a treatment for hair and scalp problems. It is used in eye syndromes, hair loss, and
children ailments etc.

Rose: There are mainly four species of roses for oil production. These are Rosa damascena Mill.,
R. gallica L., R. moschata Herrm. and R. centifolia L. Rose oil and rose water have many
therapeutic effects. Rose oil helps soothe the mind and heals depression, grief, nervous stress and
tension. It also helps to heal wound and skin health.

Eucalyptus oil: There are around 700 different species of Eucalyptus in the world, of which at
least 500 produceatypeofessential oil. It is produced by steam distillation from the leaves of
Eucalyptus species (E. cinerea F. Muell., E. baueriana F. Muell., E. smithii R. T. Baker, E.
bridgesiana R. T. Baker, E. microtheca F. Muell., E. foecunda Schau., E. pulverulenta Sims, E.
propinqua Deane and Maiden, E. erythrocorys F. Muell.) etc. They are widely used in the
preparation of liniments, inhalants, cough syrups, ointments, toothpaste and also as
pharmaceutical flavors. The European Pharmacopoeia monograph for Eucalyptus oil sports a
chromatographic profile: 1,8-cineole (eucalyptol; not less than70%), limonene (4- 12%), α-
pinene (2-8%), α- phellandrene (less than 1.5%), β-pinene (less than 0.5%), camphor (less than
0.1%) .

Grape seeds: It promotes proliferation of hair follicle cells invitro and that they possess
remarkable hair cycle converting activity from the telogen phase to anagen phase invivo.

Ginkobiloba: This leaf extract also promotes hair regrowth through combined effects on
proliferation and apoptosis of the cells in the hair follicle, thus suggesting potential as a hair
tonic.

Aloe: Aloe gel is used traditionally for hair loss and for improvement in hair growth following
alopecia. Aloenin is the major constituent responsible for promoting hair growth without
irritating the skin.
Oral care: Oral health/dental health is an inseparable part of general health. Oral health has an
effect on general health as it causes considerable pain and suffering. It has an impact on a
person's speech, selection of food, quality of life, and well-being. In view of the prevalence of
oral diseases, their impact on individuals and society, and the expense of their treatment, oral
diseases may be considered a major public health problem and they are listed among the most
common of the chronic diseases that affect mankind. Oral diseases are the fourth most expensive
diseases to treat in certain countries. According to the World Health Organization (WHO) report,
dental caries, though exhibiting a declining trend in many parts of the industrialized world, is
still an important public health concern in many developing countries. The statistics suggest that
dental caries affect 60-90% of schoolgoing children in developing countries. Loss of teeth
because of periodontitis often causes discomfort, and compromises the esthetics and function.
Moreover, recent studies suggest an association between chronic low-grade infections such as
periodontitis and systemic health problems (preterm low birth weight, cardiovascular diseases,
diabetes mellitus, and chronic obstructive pulmonary disease).There is an immediate need for
promoting preventive strategies that are socially acceptable, easily available, and at the same
time be cost-effective. This calls for the evolution of innovative strategies that are robust,
efficient, and feasible.

Clove oil: Cloves are the aromatic flower buds of a tree in the Myrtaceae family, Syzygium
aromaticum. In the past cloves were used as a remedy to ease the pain of toothache. Clove oil has
a local anaesthetic effect and temporarily numbs and relieves pain. It is used in the preparation of
some tooth pastes and in Clovacaine solution, a local anaesthetic used in oral ulceration and
inflammation. Eugenol, which is extracted from essential oils including clove oil, is also mixed
with zinc oxide to form temporary tooth restorations.

Eucalyptus saligna mouthwash gargle is used in Cameroon to treat mainly toothache, sore
throat and halitosis. It has been shown that the essential oil of the leaves of Eucalyptus globulus
has antimicrobial activity against gram-negative bacteria (E. coli) as well as gram-positive
bacteria (S. aureus) which are found in the oral cavity.

Moringa oleifera roots are also used to treat toothache in Cameroon by direct application on the
tooth cavity. This plant has been found to be specific against Staph. Aureus, Vibrio cholerae, and
Escherichia coli and have no antifungal activity. Its antibacterial activity is responsible for its
ability to calm toothache.

Allium sativum: It is one of the most extensively researched medicinal plants with a typical
odor. Its antibacterial activity depends on allicin produced by enzymatic activity of allinase on
allicin produced by enzymatic activity of allinase on allicin after crushing or cutting garlic clove.
Garlic extract inhibits the growth of Streptococcus mutans, and therefore can be used as an
effective remedy in the prevention of dental caries when used it is used as a constituent in
toothpaste or mouthwash.

Tulsi (Ocimum sanctum): Tulsi consists of tannins (4.6%) and essential oil (up to 2%), eugenol
(up to 62%), methyleugenol (upto 86%), and α- and β-caryophyllene (up to 42%),
methylchavicol, linalool and 1,8-cineole. It has got antihelminthic, analgesic, antipyretic,
immune stimulatory, antiulcer, antimicrobial, anti – inflammatory property. Used in
periodontitis. Contraindicated in pregnant and lactating women, used with caution in children.

Green Tea (Camellia sinensis): Green tea contains polyphenol contents comprising catechin
(C), epicatechin (EC), gallocatechin (GC), epigallocatechin (EGC) epicatechingallate (ECG),
and epi-gallocatechingallate. It is anti-inflammatory, antibacterial, anti-viral. Used in the
treatment of periodontal disease.

Marigold (Calendula officinalisL.) It is native to the Mediterranean areas. It is used for the
treatment of skin disorders and pain, to facilitate healing after oral surgery and in oral cavity
inflammations. It has also anti-edematous activity.

Grape Seed Extract: Grape seed extract contains pro-anthocyanidins (PA) which are potent
antioxidants and are known to possess anti-inflammatory, antibacterial and immune-stimulating
effects. It has been reported to strengthen collagen based tissues by increasing collagen cross-
links. In a study conducted to determine re-mineralizing effects of grape seed extract on artificial
root caries, results showed that is a promising natural agent for noninvasive root caries therapy.

Papaine: Papaine is a proteolytic enzyme that comes from the latex of the leaves and fruits of
the green adult papaya. It has an anti-inflammatory, bacteriostatic, bactericidal characteristic and
is effective against gram positive and gram negative organisms. Similar to human pepsin,
papaine acts as a chemical debridement ant-iinflammatory agent, which does not damage healthy
tissues and accelerates cicatrization process. Papaine acts only in infected tissue as it lacks a
plasmatic antiprotease called α-1-anti-trypsin.

Meswak: It is a derivative from Arak tree, is used by many people in different cultures as
traditional toothbrush for oral hygiene. The meswak extract has also found its way into the
dentrifrices in the recent years as antiplaque and antigingivitis agents. Chewing sticks should be
obtained from fresh stems of medicinal plants.
 Herbal Excipients
Excipients are defined as ‘the substance used as a medium for giving a medicament. The
specific application of natural polysaccharide polymers in pharmaceutical formulations
include to aid in the processing of the drug delivery system during its manufacture,
protect, support or enhance stability, bioavailability or patient acceptability, assist in product
identification, or enhance any other attribute of the overall safety, effectiveness or
delivery of the drug during storage or use. Several pharmaceutical excipients of plant
origin, like starch, agar, alginates, carrageen an, guar gum, xanthan gum, gelatin, pectin,
acacia, tragacanth, and cellulose find applications in the pharmaceutical industry as binding
agents, disintegrates, sustaining agents, protective’s, colloids, thickening agents, gelling
agents, bases in suppositories, stabilizers, and coating materials.
ADVANTAGE OF HERBAL EXCIPIENTS

Biodegradable: Naturally occurring polymers produced by all living organisms. They show no
adverse effects on the environment or human being.

Biocompatible and non-toxic: Chemically, nearly all of these plant materials are
carbohydrates in nature and composed of repeating monosaccharide units. Hence they are
non-toxic.

Economic: They are cheaper and their production cost is less than synthetic material.

Safe and devoid of side effects: They are from a natural source and hence, safe and
without side effects.

Easy availability: In many countries, they are produced due to their application in many
industries.

CLASSIFICATION OF EXCIPIENTS:

Excipients are commonly classified according to their application and function in the drug
products:

Herbal Sweetners

Binders, diluents

Disintegrants

Colorants

Viscosity builders

Perfumery agents and flavoring agents

Herbal sweetners:
1. Stevia: It is a very popular low-calorie sweetener.It’s extracted from the leaves of a plant
called Stevia rebaudiana. Several sweet compounds are found in stevia leaves. The main
ones are stevioside and rebaudioside A. Both are hundreds of times sweeter than sugar,
gram for gram.Therefore, stevia is very sweet but has virtually no calories. Additionally,
a few human-based studies suggest stevia has health benefits. Stevia can lower high
blood pressure in people with hypertension by 6–14%. However, it has no effect on blood
pressure that is normal or only mildly elevated. Stevia has also been shown to lower
blood sugar levels in people with diabetes.
2. Erythritol: It is another low-calorie sweetener. It’s a sugar alcohol found naturally in
certain fruits. However, powdered erythritol available for purchase is most likely made
via an industrial process. It contains 0.24 calories per gram, or about 6% of the calories in
an equal amount of sugar, with 70% of the sweetness. Erythritol doesn't spike blood
sugar or insulin levels and has no effect on blood lipids like cholesterol or
triglycerides.It’s absorbed into the body from the intestine but eventually excreted from
the kidneys unchanged.

3. Glycyrrhiza glabra: Liquorice roots, which are wrinkled and brown on the outside and
yellow on the inside, contain glycyrrhizin, a compound that is 50 to 150 times as sweet as
cane sugar.
4. T h a u m a t i n : The Thaumatins are a family of very sweet proteins present in
the fruits of the tropical plant Thaumatococcus danielli (marantaceae) a bushy
plant.Thaumatin elicits a very sweet taste that is rated to be 2000 to 10000 times
sweeter than sucrose, depending on purity and concentration. Thaumatin I and II
are soluble in water and dilute alcohol. Thaumatin is effective at masking bitter
notes often associated with pharmaceuticals or vitamins.
Natural Binding agents: A binding agent (or binder) is a substance that holds or draws
other materials together mechanically, chemically or as an adhesive, to form a cohesive whole.

Pectin: Pectins are non-starch, linear polysaccharides extracted from the plant cell walls. In
the food industry, folic acid incorporated microcapsules were prepared using alginate and
combinations of alginate and pectin polymers so as to improve stability of folic acid. The
blended alginate and pectin polymer matrix increased the folic acid encapsulation efficiency and
reduced leakage from the capsules as compared to those made with alginate alone; they showed
higher folic acid retention after freeze drying and storage.

Guar gum: Guar gum comes from the endosperm of the seed of the legume plant Cyamopsis
tetragonolobus. Refined guar splits are obtained when the fine layer of fibrous material, which
forms the husk, is removed and separated from the endosperm halves by polishing. Strong acids
cause hydrolysis and loss of viscosity, and alkalies in strong concentration also tend to reduce
viscosity. It is insoluble in most hydrocarbon solvents.

Khaya gum: Khaya gum is a polysaccharide obtained from the incised trunk of the tree Khaya
grandifoliola (family Meliaceae). The fact that the gum is naturally available, inexpensive and
non-toxic has also fostered the interest in developing the gum for pharmaceutical use. Further
work has also shown its potential as a directly compressible matrix system in the
formulation of 61 controlled release tablet.

Different starches like rice, maize, corn wheat are also used a a natural binding agents. They are
added to the tablet formation to increase inter-particulate bonding strength in the tablets. The
binder is added either in dry mix or mix in granulating liquid and form matrix with fillers and
drug embedded in it.

Herbal diluents: Natural diluents include starches, hydrolyzed starches, and partially
pregelatinized starches. Common diluents include anhydrous lactose, lactose monohydrate, and
sugar alcohols such as sorbitol, xylitol and mannitol. Diluents provide better tablet properties
such as improved cohesion or to promote flow.

Classification of diluents:

Diluents are classified on the basis of chemical nature and solubility. Organic materials
Carbohydrates and modified carbohydrates are the major examples. i.e. lactose, starch and
pre‐gelatinized starch, sucrose, mannitol, sorbitol, powdered and microcrystalline cellulose.

Methyl-cellulose:
Methylcellulose is the organic material used as a diluent in the pharmaceutical formulation.
It is the cellulose derivative. On the long term use as a diluent in the pharmaceutical
formulation it causes the various side effects . Mostly it causes the abdominal fullness,
difficulty swallowing, nausea, rectal bleeding, stomach pain, and vomiting .
Dicalcium phosphate: Dicalcium phosphate (DCP) is a combination of positively charged
particles of calcium and negatively charged particles of hydrogen phosphate which is
interchangeable with the phosphate in the body. Long term use of DCP
results in upset in the balance of phosphates and other chemicals in the body. According to
the material safety data sheet, the powdered form of DCP may irritate skin. Prolonged skin
contact may lead to dry or chapped skin.

Binders: Excipients are also known as additives, which are used with active pharmaceutical
ingredients to convert in to a pharmaceutical dosage form for suitable administration. As name
indicates, Binders are the excipient which is use to bind or hold all ingredients used in
formulation of the dosage form. Binders are mixed in formulation to convey plasticity or to
increase the bonding strength between the particles in formulation. The griping of ingredients in
tablets and granules is very important which is enhanced by binders. They ensure that the
formulations are manufactured according to required physical strength and quantity. Binders are
used either in a solution or in a dry form depending on the ingredients in the formulation & the
method of preparation of dosage form. Generally, binders are used in solid or semi-solid
formulations. Examples of dosage form in which binders are used are as follow: Tablets, Pills,
Pallets, Granules, and Pastes etc.

Viscosity builders: These are substances, which added to mixture, to increase its viscosity
without substantially modifying its other properties, such as taste.They increase stability. It is
desirable to increase the viscosity of dosage form to provide or to improve palatability or
pourability.

Flavoring agents: Flavors are the mixed sensation of taste, touch, smell & sight. Nowadays,
many artificial flavors are manufactured with the help of technology in flavoring industries.
Many pharmaceutical industries use flavors in many formulations like: cough syrups, sedatives,
anti-malarial and anti-biotic. Flavors are used as taste masking agents which hides the unpleasant
taste or order of dosage form. A flavor enhances the likelihood of medicine and makes them
more compatible for patient’s administration. Due to the use of flavors in dosage form children
take medicines without any problem. Flavoring agents may be artificial or natural. Artificial
flavoring agents are synthesized in laboratories while natural flavoring agents are extracted from
plants.Sweetening agents also separated from plants and also manufactured synthetically.
Examples of dosage form in which flavoring agents are used are as follow: Tablets, Pills, Pallets,
Capsules, Pastes, Syrups, Emulsions, Suspensions, Mouth washes etc. Examples of flavoring
agents are Black pepper, Cardamom, Fennel, Ginger, Peppermint, Nutmeg and saffron.

Coloring agents: Coloring agents comes under the category of organoleptic agents. Coloring
agents are widely used in pharmaceuticals, cosmetics and food industries. Coloring agents
promotes the appearance in pharmaceutical formulations. If any dosage form has unacceptable
color, the consumers avoid the dosage form for administration. Coloring agents give the
attractiveness to the dosage form. Coloring agents are also used for differentiate of dosage form
or for easy identification of dosage forms. Due to the use of coloring agents in dosage forms
psychologically patients are attracted towards the dosage forms. Coloring agents are also used as
dyes and widely used in cosmetics industries. All coloring agents used in pharmaceutical
industries is approved or certified by FDA. Example of dosage forms in which coloring agents
are used:- Tablets, Pills, Pallets, Capsules, Pastes, Ointments, Syrups, Emulsions, Suspensions
etc.

Perfumery agents: An active ingredient is a compound which imparts the aroma to the perfume
compositions or enhances the aroma of an existing perfume compostion. Perfumary agents includes
Musk, sandalwood oil, Rose oil, Jasmine oil, benzoin, Turpentine and Levender oil.

Herbal Formulations
Herbal formulations means a dosage form consisting of one or more herbs or processed herbs in
specified quantities to provide specific nutritional, cosmetic benefits meant for use to diagnose,
treat, mitigate diseases of human beings or animals, alter the structure or physiology of human
beings or animals.

Herbal syrup: Syrup is a concentrated mixture of sugar in purified water. The oral use of liquid
pharmaceutical has generally been justified on the basis of ease of administration to those
individuals who have difficulties in swallowing solid dosage forms. Ayurvedic herbal cough
syrup comprising goodness of herbs such as Tulsi, Liquorice, Ginger, Vasaka which has been
reported to provide effective relief in cough without causing adverse effects like those associated
with the use of antihistamines. Combination of these herbs with honey is intended to provide
additive benefit in relieving symptoms of acute non-productive cough.

Preparation of Herbal Syrup: An herbal syrup is prepared by combining a concentrated

decoction with either honey or sugar, and sometimes alcohol. The base of such a syrup is a
strong herbal decoction. Mixing a decoction with honey or sugar helps to thicken and preserve
the decoction. This increases the shelf life of the decoction and often creates a soothing
application that benefits situations such as sore throat, cough, dry irritated tissues, and digestive
issues. The added sweetener can also help to increase the palatability of some herbs. Many folks,
including children, find syrups to be delicious. The basic proportions you want to use are 2 parts
herbal decoction to 1 part honey or sugar. This is called a 2:1 ratio. This means that if you start
with your herbs added to 4 cups of water and simmer down the liquid to 2 cups of decoction,
then you will want to add 1 cup of honey or sugar to create and adequately preserve your syrup.
Some herbalists like to use a 1:1 ratio of decoction to honey/sugar while others find a 1:1 ratio to
result in a syrup that is too sweet. The increased amount of honey/sugar relative to decoction in a
1:1 ratio will be better preserved and hence last longer.
Herbal Tablets: Tablets may be defined as the solid unit dosage form of medicament or
medicaments with suitable excipients and prepared either by molding or by compression. It
comprises a mixture of active substances and excipients usually in powder form, pressed or
compacted from a powder into a solid dose. The excipients can include diluents, binders, glidants
and lubricants to ensure efficient tableting. Disintegrants to promote tablet break-up in the
digestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets visually
attractive or aid in visual identification of an unknown tablet. A polymer coating is often applied
to make the tablet smoother and easier to swallow, to control the release rate of the active
ingredient, to make it more resistant to the environment (extending its shelf life), or to enhance
the tablet's appearance.

Tablet Evaluation:

Before a tablet is released out into the market it has to pass a few quality checks, which is
mandatory. Evaluation of tablet includes the assessment of tablets physical, chemical and
biological properties. To studies them the following test are formulated:

• Appearance

• Size and Shape,

• Organoleptic properties,

• Uniformity of thickness,

• Hardness,

• Friability,

• Determination of pH

• Specific gravity

• Stability testing

Novel drug delivery system:

“Novel Drug delivery System (NDDS) refers to the formulations, systems and technologies for
transporting a pharmaceutical compound in the body as it is needed to safely achieve its
desired therapeutic effects. Drug delivery systems (DDS), are based on approaches that are
interdisciplinary and that combine pharmaceutics, bio conjugate chemistry, and molecular
biology.It is a novel approach to drug delivery that addresses the limitations of the traditional
drug delivery systems. Our country has a vast knowledge base of ayurveda whose potential is
only deing realized in the recent years.
The therapeutic benefits of these new systems include: Increased efficacy of the drug, Site
specific delivery, and decreased toxicity/side effects, increased convenience, viable treatments
for previously incurable diseases, Potential for prophylactic application, Better patient
compliance.

PHYTOSOMES
Phytosomes are also known as herbosomes, are recently added herbal formulations that are better
absorbed than extracts. Phytosomes are prepared through the attachment of individual
ingredients of herbal extracts to phosphatidyl-choline, resulting in a formulation having higher
solubility and hence better absorption leading to promoted pharmacokinetic and
pharmacodynamic properties compared to the conventional herbal extracts. Various popular
herbal extracts including Ginkgo biloba, grape seed, hawthorn, green tea, and ginseng have been
incorporated in phytosomes. The active components of these herbal extracts were successfully
bound to phosphatidyl choline. Phytosomes, also known as phospholipid complexes, are well-
known delivery systems that are closely related to liposomes in terms of their structure and
configuration. Phytosomes have a higher capacity for nutraceutical compounds to be added to
them, as they have a quite stable, chemically bound structure. Plant extracts can bind quite easily
to phosphatidylcholines due to the presence of terpenoids and flavonoids. As delivery systems,
phytosomes have proved to be superior to liposomes. The chemical bonding ensures the stability
of phytosomes, enhances the encapsulation efficiency and stability of bioactives, generally at a
stoichiometric molar ratio of 1:1 or 1:2 (phospholipids: phytochemicals) Phytosomes were found
to improve solubility, permeability rate and bioavailability of active compounds in various cases
and inhibit or delay physical and chemical degradation and could be implemented without
generating any toxic effects. The choline head of the phosphatidylcholine molecule binds to
these compounds while the fat-soluble phosphatidyl portion comprising the body and tail
envelops the choline-bound material. The phytosome process also intensifies the action of herbal
compounds by improving absorption, increasing biological activity, and enhancing delivery to
the target tissue.
Methods of Preparation: For the preparation of Phytosomes the phytoconstituents like
bioflavonoids, flavolignan and polyphenolic compounds reacting drop by drop by the
solution of natural or synthetic phospholipids like Phosphatidycholine with vigorous stirring.
Phytosomes of ginsenoside, puerarin and kushenin are prepared in this manner. Another
example is the Curcumin phospholipids complexes which can be prepared when the ethanol
solution of the hydro-alcoholic extract of turmeric rhizomes adding the phospholipids,
under reflux and with stirring. Phytosomes which are prepared by the non solvent, freeze
drying, spray drying or vacuum drying are called the prepared complex phytosome.

ADVANTAGES OF PHYTOSOMES

1. Improve the absorption of lipid insoluble polar phytoconstituents, enhance the bioavailability.

2. Appreciable drug entrapment which becomes very beneficial.

3. Reduce the dose due to increased absorption.

4. Phosphatidylcholine shows synergistic effect because it is a hepatoprotactive also.

5. Phytosomes are more stable because of the chemical bonding between the
phytoconstituents and carrier i.e. phophatidylcholine.

6. Effective in cosmetics.