Herbal medicines have gained lot of popularity, however the side effects associated have been neglected due to lack of knowledge and belief. Hence the Pharmacovigilance of herbal drugs needs to be addressed by educating the common people though campaigns.

1. PHARMACOVIGILANCE OF
HERBAL DRUGS
Dr. Nisha Sharma
Associate Professor, University Institute of Pharmacy, C.S.J.M. University,
Kanpur
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2. Medicinal
Plants/parts of
plant
CRUDE DRUG
Herbal Products
Formulations/
Natural Products
Ayurvedic
Drugs
Herbal Drug
Formulations based on
Ancient systems of
Medicine-Ayurveda, Utilizing
Herbal Plants
Essential oils, Herbal Cosmetics & Toiletries, Value
added products based on Herbal Products or Extracts
Contains active constituents
WHAT ARE HERBALS DRUGS
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3. Drugs From Ethnobotanical leads
Drug Medicinal Use Source Plant
Aspirin Reduces pain & Inflammation Filipendula ulmaria
Codeine Eases pain, suppresses coughing Papaver somniferum
Pilocarpine Reduces pressure in eyes Ephedra sinica
Quinine Combats malaria Cinchona officinalis
Reserpine Lowers B.P Rauwolfioia serpentina
Theophylline Opens bronchial passages Camellia sinensis
Vinblastine Antileukemic Catharanthus roseus
(Galegine)
Metformin
Hypoglycemic (guanides) Galega officinalis
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4. Some Phytopharmaceuticals of Indian origin
Plant Species Phytochemical Clinical use
Picrorhiza kurroa Picrosides,
kutkosides (Gly)
Hepatoprotective
Centella asiatica Asiaticiside
(TT)
Brain, nerve tonic
Gloriosa superba Colchicine (AL) Anti-gout
Curcuma longa Curcumin (PP) Anti-inflammatory
Boswellia serrata Boswellic acid
(TT)
Anti-inflammatory
Coleus furskohii Furskolin (DT) Cardiotonic
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5. Countries where the highest use of traditional
medicines are practiced include
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0
10
20
30
40
50
60
70
80
90
100
Uganda Tanzania UAE China India Pakistan Africa Rwanda Ethiopia
% of population using traditional medicine

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FACTORS OF
POLPULARITY
Source of direct
therapeutic agents
Affordable
Less adverse effects
than synthetic drugs
myth that natural are
safe
Greater interest by
the West
Raw material base for
the elaboration of
more complex semi
synthetic chemical
compounds
Why Medicinal plants are popular to be used

7.  In India the herbal remedy is so popular that the
government of India has created a separate
department—AYUSH—under the Ministry of
Health & Family Welfare.
 The National Medicinal Plants Board (NMPB) was
also established in 2000 by the Indian
government in order to deal with the herbal
medical system.
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8. Associated problems with herbal Medicine
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Drug interaction OTC availability Patients don’t take
herbal as drug
Multiple ingredient
in one preparation
Difficulty to
identify ingredients
Lack of knowledge
of ADR’s of herbal
drugs
Lack of GMP’s
Lack of disclosure by
patients about the
use of alternative
therapies
False but attractive
claims by
manufacturers and
prescribers

9. SOME EXAMPLES OF UNSAFE HERBS
Herb Indication used Side effects Drug interaction
Ephedra Anorexia
decongestant
Palpitations
Death
Caffeine digoxin
theophylline
Piper
methysticum
Anxiety stress
sleep disorders
hepatotoxicity Sedative medicine
alcohol
St John’s
wort
Depression
Nervousness
Poor appetite
Photosentivity
Phototoxicity
insomnia headache
Cyclosporin
warfarin oral
contraceptive
Ginseng Boost energy
Antidiabetics
Lower cholesterol
Insomnia lowers
blood glucose alters
immune fn
Antidiabetics
warfarin
Ginko Memory boost
Cardioprotective
Antioxidant
GIT disturbance
bleeding
hypersentivity
Anticoagulant
antiplatelets inhibits
mono amine oxidase
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Herbal is safe????
ADR
Herb -Food, Herb Drug
Herb – Herb interactions
Toxicity of Isolated phytoconstituent
NEED OF PHARCOVIGILANCE

11. What is PHARMACOVIGILANCE
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 Science and activities relating to the detection,
assessment, understanding, and prevention of the
adverse effects of drugs or any other possible drug-
related problems
OBJECTIVE OF PHARMACOVIGILANCE
 To extend safety monitoring and detect drug
adverse events that have previously been
unrecognised despite evaluation in clinical trials.
 To improve medical health and safety of the patient
during therapy and medical care and thus actively
encourages the rational use of medications

12. PHARCOVIGILANCE PROGRAM
 Department of AYUSH , Ministry of Health
and Family Welfare, Government of India,
implemented a
 National Pharmacovigilance Program for
Ayurveda, Unani, and Siddha systems of
medicine, in order to systematically monitor
adverse drug reactions (ADR).
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13.  Although a technical term equivalent to
“pharmacovigilance” does not feature in
Ayurvedic texts, the spirit of
pharmacovigilance is vibrant throughout
Ayurveda’s classical literature.
 Ayurvedic pharmacology (Dravyaguna)
pharmaceutics ( Rasa Shastra ) have clearly
mentioned it’s importance
 The Ayurvedic literature gives details of drug-
drug and drug-diet incompatibilities.
PHARCOVIGILANCE IN AYURVEDA
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 According to World Health Organization, it is mandatory
for its Member States “to develop, establish, and
promote international standards with respect to food,
biological, pharmaceutical and herbal products
 In 1968 WHO initiated its Pilot Research Project for
International Drug Monitoring.
 In 1997, WHO drew up the Erice Declaration , an
international agreement signed by all member states to
agree on uniform standards for reporting ADR’s.
 In 2002, India agreed to send all its ADRs arising from
use of conventional medicine to WHO’s ADR Monitoring
Centre in Uppsala, Sweden.
PHARCOVIGILANCE- ROLE OF WHO

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 PV in 2003- under Central drug Standard control
Association, New Delhi
 November 2006, idea of pharmacovigilance
program for traditional medicine began in
Department of Clinical Pharmacology, B.Y.L. Nair
Hospital, Mumbai.
 Institute of Post Graduate Teaching and
Research in Ayurveda (IPGTRA), Jamnagar took
concrete steps sponsored by WHO Specialists in
different fields (i.e. Physicians, Pharmacologists
and Vaidyas, Hakeems) worked hard under the
guidance of WHO national office.
PHARCOVIGILANCE- ROLE OF WHO

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 The draft was finalized and released by
Department of AYUSH.
 On 29 September 2008, IPGTRA was subsequently
declared National Pharmacovigilance Resource
Centre for ASU drugs Since then India’s present
ASU Pharmacovigilance program has been in
operation.
 The program was reviewed on 21 January 2009 by
the National Pharmacovigilance Consultative
Committee for ASU drugs (NPCC-ASU).
 At present, besides the National Center in
Jamnagar, 8 Regional Centers and 30 Peripheral
centers are present.

17. PHARMACOVIGILANCE CENTRES IN INDIA
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National PV centre Jamnagar
08 Regional PV centers
Varanasi, Thiruvananthapuram, Guwahti
Jaipur, Bhopal, New Delhi, Bengaluru Chennai
30 Peripheral centers

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 Reporting of all suspected drug related adverse events,
including interactions with any other drugs or food.
 Reporting of insignificant or common adverse reactions
may also be important.
 Suspected events in the following categories
 (a) Life threatening (real risk of dying)
 (b) Death
 (c) Hospitalization (initial or prolonged)
 (d) Disability (significant, persistent, or permanent)
 (e) Required intervention to prevent permanent
impairment or damage.
 (f) Congenital anomaly
What to report?

19. Who can report
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 Any health care professional
 Medical Practitioner
 Scientist
 Pharmacist
 Qualified person from Pharma Industry (Regulatory
Manager)
 Patients themselves can report through the physician
under whom they have undergone treatment.

20. Where and How to report
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 Reporting should be done in a prescribed format
through pharmacovigilance center.
 Information in the forms should be kept
confidential
 Peripheral pharmacovigilance centers forward to
regional pharmacovigilance centers where causality
analysis is carried out.
 The information is then forwarded to the National
Pharmacovigilance Resource Centre, where it is
consolidated, analyzed, and forwarded to the Dept
of AYUSH

21. Why Pharmacovigilance is negligible ?
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 The number of adverse reactions to Herbal
drugs reported in the National
Pharmacovigilance Program in India is
Negligible Due to:
 The strong belief that Herbal medicines are
safe.
 The lack of knowledge about the concept and
importance of Pharmacovigilance in Herbal
medicine

22. Some Key Points
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 “ Natural” does not mean absolutely safe.
 There is a need for a proper post-marketing surveillance program
to observe quality, safety, and efficacy of herbal drugs.
 National Pharmacovigilance Program for ASU Drugs.
 Pharmacovigilance system success lies in its ability to prevent
further adverse reactions on the basis of information received.
 Possible only when physicians are vitally alert to the onset or
offset of any ADRs.
 Prioritize contributions to make the Pharmacovigilance program for
herbal medicines a success.
 Patients should be educated and encouraged to tell physicians,
nurses, and pharmacists about herbal therapy use (documentation).
 Herbal-pharmaceutical interactions do occur Lack of
standardization, Lack of quality control and regulations further
increase chances

23. CONCLUSION
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 Pharmacovigilance in herbal medicine is perhaps a
less thought of concept as yet.
 However, we do not need “Herbal Thalidomide” to
wake the Pharmacovigilance community
 Physicians
 Pharmacist
 Paramedicals
 Patients
 Policy makers

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