This document provides an overview of pharmacovigilance and phytoresearch. It discusses the process of pharmacovigilance including adverse drug reaction reporting and its history and purpose. Key terms in pharmacovigilance like causation and stakeholders are defined. The document also covers the identification, extraction, and detection methods used in phytoresearch like chromatography, spectroscopy, and endophyte evaluation. Skills gained in pharmacovigilance like risk management and report writing and those in phytoresearch like instrumentation use and formulation development are summarized. The conclusion emphasizes the goals of ensuring drug safety and discovering bioactive plant compounds.

1. PHARMACOVIGILANCE
& PHYTORESEARCH

2. CONTENT
1. Introduction and Process of Pharmacovigilance.
2. Pharmacovigilance and Drug/System Organ Classes, Regulatory,
Ethical and Social consideration.
3. Phytoresearch: Identification of phytoconstituents.
4. Evaluation of endophytes. Extraction and isolation of phytoconstituents.
5. Standardization of drug.
6. Detection methods.
7. Development of Phyto formulation.
8. Knowledge Gain.
9. Skill Acquired.
10. Conclusion.
11. Reference.

3. Introduction and Process of Pharmacovigilance
• Pharmakon is a Greek word means medicinal substances and vigilare
means 'to keep watch’. So, Pharmacovigilance is keeping watch on
medicinal substances.
• The main goal of this activity to promote safe and rational use of
medicine and provide health care of patient and public health and
awareness.
• It is a multi disciplinary field involves many professionals like doctors,
pharmacists, nurses, paramedical staff, patients, etc.
• Reporting of drug reaction in country helps to build national database
and to promote culture of scientific analysis of drug usage.

4. Pharmacovigilance has been defined by the World Health Organisation as
“The science and activities relating to the detection, assessment, understanding
and prevention of adverse effects or any other possible drug-related problem”.
HISTORY
Pharmacovigilance came in existence after this tragedy:-
1. Thalidomide Tragedy-(1961-62)
It is a greatest disasters of drug. This drug is used for antiemetics and
Hypnotic. Became popular for vomiting in early pregnancy but its shown a
potent human teratogen caused a birth defect in estimated 10,000 children. The
children's were born with deformity with limb called Phocomelia.
2. Sulfanilamide Tragedy-(1937)
It’s a first antimicrobial drug used for streptococcal infection in form of tablet
powder but later it used by diluting with diethylene glycol in liq. Form that’s
shown more than 100 people died in US by drug. Later on investing diethylene
glycol was toxic ingredient in formulation shown.

5. SCOPE AND PURPOSE OF PV
• Pharmacovigilance conducting advanced drug monitoring study based Adverse
drug reaction, adverse events report of new drugs include: Medication errors and
irrational use of medicines, Herbal traditional and complimentary medicines,
substandard medicines and counterfeit medicines, Blood products, biologicals,
medical devices and vaccines.
• Pharmacovigilance main aim is to give clear information regarding drug safety
and its Risk or benefits of drugs to the patients. Patients are main end users of
medicine.
• activities relating to the detection, assessment, understanding and prevention of
adverse effects or any other possible drug-related problem.
• The ultimate purpose of pharmacovigilance is to minimize, in practice, the
potential for harm that is associated with all active medicines. Although data
about all types of ADRs are collected, the main focus is on identifying and
preventing those which are defined to be serious.

6. SOME IMP TERMS IN PV:
• Adverse Drug Reaction- A response which is noxious and unintended, and
which occurs at doses normally used in humans for the prophylaxis,
diagnosis, or therapy of disease, or for the modification of physiological
function. (WHO, 1972).
• Concept of safety- Safety is a state in which hazards and conditions leading
to physical, psychological or material harm are controlled in order to
preserve the health and well-being of individuals and the community. The
respect of the values and the physical, material and psychological integrity of
individuals.
• Causation- Causality assessment is the assessment of relationship between a
drug treatment and the occurrence of an adverse event.

7. Sources of data collection
1. pre-clinical studies(animal study)
2. Human volunteers
3. Clinical trials(Phase 1-4)
Risk Management The process starts with identification of a possible hazard, this is then
evaluated and investigated and if necessary, some action is then taken with a view to
minimising risk.A risk management plan (RMP) is a document that describes the current
knowledge about the safety and efficacy of a medicinal product.
Stake holders
Patient, Healthcare professionals, Public healthcare programs, media, community leader
market authorizing holders.
Conflict of interest A conflict of interest arises when what is in a person’s best interest is
not in the best interest of another person or organization to which that individual owes loyalty.
For example, an employee may simultaneously help himself but hurt his employer by taking a
bribe to purchase inferior goods for his company’s use.
 REGULATORY GUIDELINES
PV is governed by guidelines by USFDA and Code of Federal Regulations.
 Good Pharmacovigilance Practices and Pharmacoepidemiologic assessment.
 Post Marketing Safety Reporting on Human Drug Biological sub and Vaccines etc.

8. INTRODUCTION TO PHYTORESEARCH
Crude Drug: A crude drug is any naturally occurring, unrefined substance derived from organic or
inorganic sources intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in humans or other animals. Example: Agar, Acacia, Beeswax, Clove, Cinnamon, etc.
Phytoconstituents: Phytoconstituents are chemicals present in plant naturally which are produced by
primary or secondary metabolism pathway.
Preliminary phytochemical screening:Preliminary screening of phytochemicals is a valuable step,
in the detection of the bioactive principles present in medicinal plants and subsequently may lead to
drug discovery and development. Ex. Chemical tests, physical evaluation.
 Tests for alkaloids: Mayer's test(white cream) , Dragendorffs test( yellow).
 Tests for Glycosides: Bontrager's test. (Pink or reddish color).
 Tests for phenols: Lead acetate test.( bulky white).
 Tests for carbohydrates: Molisch’s test ( violet ring).

9. Extraction procedure involves soaking the crude drug, in the form of either a powder or a
decoction (kasaya), for a specified period of time, during which it undergoes fermentation and
generates alcohol in situ; this facilitates the extraction of the active constituents contained in the plant
material. Methods: Infusion, Percolation, Decoction, Supercritical fluid extraction, Soxhlet Extractor.
Soxhlet Extraction:
The fixed oils from seeds and alkaloids from the drug are extracted by
continuous hot percolation process using benzene, chloroform, petroleum ether etc.
The apparatus consists of three parts:
1. Flask containing boiling solvent.
2. Soxhlet Extractor in which the drug to be extracted is packed.
3. A condenser in which the vapors of the solvent are condensed again into solvent.
The drug to be extracted is packed in a paper cylinder and it is placed in the body of Soxhlet
extractor. The solvent is placed in the flask. When solvent is boiled on heating the flask, it gets
converted into vapors. These vapours enter into the condenser through the side tube and get
condensed into hot liquid which falls on the column of the drug. When the extractor gets filled with
the solvent, the level of siphon tube also raises up to its top. The solvent containing active
constituents of the drug in the siphon tube run into the flask, thus emptying the body of extractor.
This alternation of filling and emptying the body of extractor goes on continuously. Normally the
process is repeated about 15 times for complete exhaustion of the drug.

10. IDENTIFICATION OF CRUDE DRUG
Chromatography is an important biophysical technique that enables the separation, identification,
and purification of the components of a mixture for qualitative and quantitative analysis.
Types:
1. Thin layer chromatography.(TLC):-
2. Gas Chromatography.(GC):-
3. Column Chromatography:-
4. High performance liquid chromatography.(HPLC):-
Application of chromatography:
 Qualitative study.
 Purification.
 Identification.

11. Spectroscopy is the study of the interaction between matter and electromagnetic radiation as a
function of the wavelength or frequency of the radiation.
Types:
1. UV Spectroscopy: In a spectroscopy experiment, electromagnetic radiation of a specified range of
wavelengths is allowed to pass through a sample containing a compound of interest. The sample
molecules absorb energy from some of the wavelengths, and as a result jump from a low energy
‘ground state’ to some higher energy ‘excited state’. Other wavelengths are not absorbed by the
sample molecule, so they pass on through.
2. IR spectroscopy: It is a electromagnetic radiation of electrons when a dipole moment of sample
matches to dipole moments of radiation its shows the IR spectrum.
3. Mass Spectroscopy: The basic principle of mass spectrometry (MS) is to generate ions from either
inorganic or organic compounds by any suitable method, to separate these ions by their mass-to-
charge ratio (m/z) and to detect them qualitatively and quantitatively by their respective m/z and
abundance.

12. Endophytes: Endophytes are organisms, often fungi and bacteria, that live between living plant cells.
Some of the more interesting compounds produced by endophytic microbes are
Taxol: the world’s first billion-dollar anti-cancer drug, Crypton antifungal agent, Oocydin antifungal
agent, Isopestacin antioxidant, Kanamycin antibiotic.
PREPARATION AND FORMULATION OF HERBAL DRUGS
 ASAVA & ARISTA.( SELF GENERATED ALCOHOL PREPARATIONS BY DECOCATION).
 CHURN.(POWDER FORMULATION BY SIZE REDUCTION).
 BHASMA.( POWDERED DRUG BY CALCINATION OF METALS MINERALS)
 LEHA/AVALEHA.( SEMISOLID PREPARATIONS).
 VATI & GHUTIKA ( TABLETS AND PILLS).

13. KNOWLEDGE GAINED
In pharmacovigilance gained knowledge about :-
 Process of PV, reporting ADR, importance of drug survey.
 Clinical pharmacy study, phases, Drug Development and Importance of safety and efficacy of
drug for human health.
 Stakeholder and there role in safety, regulatory guidelines, difference terms in pv
 Risk management planning.
In Phytoresearch gained knowledge about :-
 Came to know how to handle various Instruments.
 Studied the types of Extraction- infusion, decoction, percolation, Soxhlet extraction, supercritical
fluid extraction.
 Different types of Chromatography Techniques.: Column chromatography , Paper
chromatography, Thin-layer chromatography, Gas chromatography High-pressure liquid
chromatography (HPLC).
 Studied Detection methods.
 we studied development of Phyto-formulation

14. Skill Acquired
PHARMACOVIGILANCE
 In Pharmacovigilance Program We Learn About Organizing Clinical Research.
 Learn How to Manage Data in Your Pharmacovigilance Program.
 We Learn How to Write Reports During Your Pharmacovigilance Training.
 We learned about Drug Development Process and required document.
 We learn about responsibilities of stakeholders.
 And legalisation and guidelines for pharmacovigilance studies.
 We learned about ADR and ADR related to Drug/system classification.
 And concept of safety and safety guidelines.
 Risk and benefit study.
PHYTORESEARCH
 Information of crude drug and its Pharmacognostic studies.
 Identification of Phytoconstituents by preliminary phytochemicals testing.
 Details about Extraction and isolation methods and factors affecting extraction.
 Detection of phytoconstituents by Chromatography techniques.
 Standardization of phytoconstituents by spectroscopy methods.
 Development of Phyto formulation and its evaluation.

15. Conclusion:
• The main goal of Pharmacovigilance is thus to promote the safe and effective use of health
products, in particular by providing timely information about the safety of health products to
patients, health-care professionals, and the public.
• Our data confirm that ADRs are an important cause of hospital admission of geriatric patients and
occur frequently during their hospital stay.
• The phytochemical research approach is considered effective in discovering bioactive profile of
plants of therapeutic importance. Several phytochemical surveys have been carried on for detecting
diverse groups of naturally occurring phytochemicals.
• Medicinal plants are main source for potent bioactive compounds.
• The results of present study are helpful for the discovery of potent remedies on various diseases.

16. REFERENCE
 Textbook of Pharmacognosy and Phytochemistry Dr. Brien Shah, M.Pharm., Ph.D., is currently Associate
Professor at Vidyabharti Trust College of Pharmacy, Umrakh, Gujarat.
 Textbook of Pharmacognosy Dr. C. K. Kokate, S. B. Gokhale, A. P. Purohit, Nirali Publication, Edition Jan
2009.
 Practical Pharmacognosy, Dr. Khandelwal K.R. M. Pharm PhD Department of Pharmacognosy, Bharati
Vidyapeeth Deemed University, Poona College of Pharmacy, Erandwane, Pune. March 2008.
 An Introduction to Pharmacovigilance, 2010 by Patrick Waller Blackwell Publishing was acquired by John
Wiley & Sons in February 2007. Blackwell’s publishing program has been merged with Wiley’s global
Scientific, Technical and Medical business to form Wiley-Blackwell.
 Jill, Madison, Stephen, W. page. David, B. Church. (2008): Small animal veterinary medicine clinical
pharmacology .2nd ed. ELBS Bailer, Scotland.Pp.44-45.
 de Oliveira Costa LE, de Queiroz MV, Borges AC, de Moraes CA, de Araújo EF. Isolation and characterization
of endophytic bacteria isolated from the leaves of the common bean (Phaseolus vulgaris). Braz J Microbial.
2012 Oct;43(4):1562-75. doi: 10.1590/S1517-838220120004000041. Epub 2012 Jun 1. PMID: 24031988;
PMCID: PMC3769033.
 K.D, Tripathi’s. (2003): Essential of medical pharmacology .5th ed. Butlera Tanners Ltd. London, Uk.Pp.60-67.
 North Clin Istanu. 2016; 3(2): 156–160. Published online 2016 Nov 11. doi:10.14744/nci.2016.32757 PMCID:
PMC5206469 PMID: 28058406 Özlem Coskun Department of Biophysics, Canakkale Onsekiz Mart
University, Canakkale, Turkey.
 Shaikh, Junaid & Patil, Matsyagandha. (2020). Qualitative tests for preliminary phytochemical screening: An
overview. 8. 603-608. 10.22271/chemi.2020.v8.i2i.8834.
THANK YOU…..