This document defines key terms related to phytopharmaceuticals and herbal medicine. It describes phytopharmaceuticals as plant-based drugs containing at least four bioactive compounds that are purified and standardized for human or animal use. Active ingredients are the therapeutic components of herbal medicines. Botanical drug substances, herbal preparations, and finished herbal products are other terms defined. The document also discusses regulatory affairs, traditional medicine, pharmacovigilance, and pharmacoeconomics as they relate to herbal products.

1. Phytopharmaceutical
Technology Terms

2. Content
• Phytopharmaceuticals
• Active ingredient
• Botanical Drug Substance,
• Ethnomedicine,
• Herbal Medicine,
• Phytomedicine,
• Phytopharmaceutical Science,
• Regulatory affairs,
• Traditional medicine,
• Folklore medicine,
• Finished herbal product,
• Pharmaco-vigilance of herbals,
• Phytopharmacoepidemology and
• Phytopharmacoeconomics

3. Phytopharmaceutical
• Phytopharmaceutical drug is defined as purified and
standardized fraction with defined minimum four bio-active
or phytochemical compounds (qualitatively and
quantitatively assessed) of an extract of a medicinal plant or
its part, for internal or external use of human beings or
animals for diagnosis, treatment, mitigation, or prevention
of any disease or disorder but does not include
administration by parenteral route.

4. Active ingredient
• Active ingredients refer to ingredients of herbal medicines
with therapeutic activity.
• In herbal medicines where the active ingredients have been
identified, the preparation of these medicines should be
standardized to contain a defined amount of the active
ingredients, if adequate analytical methods are available.
• In cases, where it is not possible to identify the active
ingredients, the whole herbal medicine maybe considered
as one active ingredient.

5. Botanical drug substance
• A drug substance derived from one or more plants, algae, or
macroscopic fungi.
• It is prepared from botanical raw materials by one or more
of the following processes: Pulverization, decoction,
expression, aqueous extraction, ethanolic extraction, or
other similar process.
• It may be available in a variety of physical forms, such as
powder, paste, concentrated liquid, juice, gum, syrup or oil.
• A botanical drug substance can be made from one or more
botanical raw materials.
• A botanical drug substance does not include a highly
purified or chemically modified substance derived from
natural sources.

6. Ethnomedicine
• Ethnomedicine is a study or comparison of the traditional
medicine practiced by various ethnic groups, and especially
by indigenous peoples.
• The word ethnomedicine is sometimes used as a synonym
for traditional medicine.

7. Herbal medicine
• Herbal medicines include herbs, herbal materials, herbal
preparations and finished herbal products, that contain as
active ingredients parts of plants, or other plant materials,
or combinations.
• Herbs: crude plant material such as leaves, flowers, fruit,
seed, stems, wood, bark, roots, rhizomes, or other plant
parts, which may be entire or fragmented or powdered.
• Herbal materials: in addition to herbs, fresh juices, gums,
fixed oils, essential oils, resins and dry powders of herbs.
• In some countries, these materials may be processed by
various local procedures, such as steaming, roasting or stir-
baking with honey, alcoholic beverages or other materials.

8. Herbal medicine
• Herbal preparations: the basis for finished herbal products
and may include comminuted or powdered herbal
materials, or extracts, tinctures and fatty oils of herbal
materials. They are produced by extraction, fractionation,
purification, concentration, or other physical or biological
processes. They also include preparations made by steeping
or heating herbal materials in alcoholic bevarages and/or
honey, or in other materials.

9. Herbal medicine
• Finished herbal products: herbal preparations made from
one or more herbs. If more than one herb is used, the term
mixture herbal product can also be used. Finished herbal
products and mixture herbal products may contain
excipients in addition to the active ingredients.
• However, finished products or mixture products to which
chemically defined active substances have been added,
including synthetic compounds and/or isolated constituents
from herbal materials, are not considered to be herbal.

10. Phytomedicine
• Herbal based traditional medical practice that uses various
plant materials in modalities considered both preventive
and therapeutic.

11. Phytopharmaceutical science
• Phytopharmaceutical science is the development of drugs
from plants and other natural compounds.

12. Regulatory affairs
• Regulatory affairs is also known as government affairs. A
regulatory affair is a profession within regulated industries,
such as pharmaceuticals, medical devices, energy, banking,
telecom etc.
• Regulatory affairs have a very specific meaning within the
healthcare industries including pharmaceuticals, medical
devices, biologics and functional foods.

13. Regulatory affairs
• Regulatory affairs to ensure that
• Ensuring that their companies comply with all of the
regulations and laws pertaining to their business.
• Working with federal, state, and local regulatory agencies
and personnel on specific issues affecting their business,
i.e., working with such agencies as the
• Food and Drug Administration or
• European Medicines Agency (pharmaceuticals and medical
devices);

14. Regulatory affairs
• Regulatory affairs to ensure that
• Advising their companies on the regulatory aspects and
climate that would affect proposed activities. i.e. describing
the "regulatory climate" around issues such as the
promotion of prescription drugs and Sarbanes-Oxley
compliance.[
• Drug Regulatory Affairs refers to all aspects within the
pharmaceutical development process and how they are
subject to various degrees of regulation. The
pharmaceutical law frame, guidelines covering Quality,
Safety and Efficacy as well as Health Authorities' attitudes
and requirements etc. have a great influence on the drug
development process and the success of it. Regulatory
affairs professionals deal with these aspects.

15. Traditional medicine
• Traditional medicine is the sum total of the knowledge, skills
and practices based on the theories, beliefs, and
experiences indigenous to different cultures, whether
explicable or not, used in the maintenance of health as well
as in the prevention, diagnosis, improvement or treatment
of physical and mental illness.

16. Folklore medicine
• Traditional medicine as practiced non-professionally
especially by people isolated from modern medical services
and usually involving the use of plant-derived remedies on
an empirical basis.
• It is the sum total of the knowledge, skills, and practices
based on the theories, beliefs, and experiences indigenous
to different cultures, whether explicable or not, used in the
maintenance of health as well as in the prevention,
diagnosis, improvement, or treatment of physical and
mental illnesses.

17. Finished herbal product
• It consist of herbal preparations made from one or more
herbs.
• If more than one herb is used, the term “mixture herbal
product” can also be used.
• Finished herbal products and mixture herbal products may
contain excipients in addition to the active ingredients.
• However, finished herbal products or mixture herbal
products to which chemically defined active substances
have been added, including synthetic compounds and/or
isolated constituents from herbal materials, are not
considered to be herbal.

18. Pharmaco-vigilance of herbals
• Pharmacovigilance is the process of monitoring, evaluating
and communicating drug safety with profound implications
that depend on the integrity and collective responsibility of
all parties such as consumers, health professionals,
researchers, academic, media, pharmaceutical industry,
drug regulators, governments, and international
organizations.
• The main objective of pharmacovigilance is to extend the
safety monitoring and detect any adverse drug reactions
that have previously been unrecognized in the evaluation of
clinical trials.
•

19. Pharmaco-vigilance of herbals
• There is an ongoing problem with unexpected toxicity of
herbal products due to quality issues, including the use of
poor quality herbal materials, incorrect or misidentified
herbs, incorrect processing methods, and supply of
adulterated or contaminated herbs or products.
• Problems in the regulation of herbal medicines:
• Lack of knowledge about the product being used
• Limited use of yellow card adverse drug reporting
scheme which represents underreporting rather than
indicating an absence of adverse reactions
• Uniform manufacturing standards mostly of unlicensed
products
• Herb drug interactions of herbal medicines.

20. Pharmaco-vigilance of herbals
• These quality issues can be addressed to some degree by
improved regulation requiring GMP standards for
manufacturing.
• Pharmacovigilance is very essential tool for developing
reliable information on the safety of herbal medicines.
• The existing systems were developed for synthetic
medicines and require some modification to address the
specific differences of herbal medicine.
• Systematic pharmacovigilance is essential to build up
reliable information on the safety of herbal medicines for
the development of appropriate guidelines for their safe
and effective use.

21. Pharmaco-vigilance of herbals
• Possible challenges:
• Herbal toxicity & herb drug interactions
• No discrimination between chemically defined drugs
and herbal drugs in the filing of procedure of adverse
events.
• Being polyherbal, can change pharmacokinetics
characteristics
• Therapeutic failures or adverse effects if used
concomitantly with other drugs

22. Pharmacoepidemiology
• It is the study of the uses and effects of drugs in well
defined populations. With the growing availability of large
healthcare databases, non-experimental studies of
prescription medications are becoming increasing common.
However, the appropriate design and analysis of such
studies can be challenging. The issue which are addressed
pharmacoepidemiology are
• Drug utilization research/ quality of care
• Drug effects (effectiveness and safety)
• Analytical methods

23. Phytopharmacoepidemology
• Phytopharmacoepidemiology concerns itself with phyto or
herbal drug uses by, and effects on, large number of people.
• Benefits:
• Improving herbal drug markets
• Improving timely detection & adverse reaction of botanical
medicines
• Recognizing beneficial effects of herbal preparation
• Increasing social and economic knowledge about herbal
drugs by correlating the utilization patterns of these
preparations to socially relevant determinants and prices.

24. Pharmacoeconomics
• It refers to scientific discipline that compares the value of
one pharmaceutical drug or drug therapy to another.
• It serves to guide optimal healthcare resource allocation in a
standardized & scientifically grounded manner.
• Objective:
• Acceptable clinical outcomes
• Acceptable humanistic outcomes
• Acceptable economical outcomes

25. Phytopharmacoeconomics
• There seems to be no compelling need for
pharmacoeconomic analyses of herbal over-the-counter
medicines, but such analyses are certainly warranted for
herbal prescription medicines that have a high level of
reimbursement.
• The need of the hour is to take control of some herbal
remedies and caution need to be exercised with the trend
towards licensing of all herbal remedies.
• The licensing of herbal remedies with equivocal benefits
and few risks, as evidenced by a long history of safe use,
increases barriers to entry and increases societal healthcare
costs.

26. References
• Evidence based validation of herbal medicine by
Pulok Mukherjee
• Contemporary phytomedicine by Amritpal Singh
Saroya
• https://www.sciencedirect.com/science/article/pii/
B9780081020814000022