1. Dr. Prajeesh Nath E N
PG Dept. of Rasasastra & Bhaishajya Kalpana
Amrita School of Ayurveda

2. Content
 Etymology and Definition.
 Historical Background.
 Aims of Pharmacovigilance.
 Pharmacovigilance in India.
 National Pharmacovigilance Programme for ASU.
 Reporting Culture.
 Ayurvedic concept of PV.
 Need of PV for Ayurvedic Medicines.
 Challenges in introducing PV in Ayurveda.
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3. Etymology and Definition
Pharmakon
Greek
vigilare
Latin
Drug
to be awake or alert,
to keep watch
• Is the pharmacological science related to the
detection,collection,assessment,understanding
and prevention of adverse effects particularly long
term, short term side effects of medicine.(WHO 2002).
• Post-Marketing tool.
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4. Technical terms
 Adverse Drug Reactions(ADRs) - A response to a drug
which is noxious and unintended, and which occurs at
doses normally used in man for the
prophylaxis, diagnosis, or therapy of disease, or for the
modification of physiological function.
Eg. Hypersensitivity rash with intake of guggulu
 Adverse Event/Experience(AE) - Any untoward
medical occurrence that may present during treatment
with a pharmaceutical product but which does not
necessarily have a causal relationship with the
treatment.
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5.  Side Effect(SE) - Any unintended effect of a
pharmaceutical product occurring at doses normally
used in human which is related to the pharmacological
properties of the drug .
Eg. Use of Atropine in oraganophosphorus poisoning achieves
therapeutic action by its anticholinergic activity but at same time
causes dryness of mouth & dilatation of pupil which is not
noxious.
 Serious Adverse Event (SAE) – Any adverse event
which is fatal, life- threatening, permanently disabling or
which results in hospitalisation.
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6.  Expected adverse reaction - As opposed to
“unexpected”, an event that is noted in the brochure or
labeling.
 Unexpected adverse reaction - The nature or
severity of which is not consistent with the domestic
labeling or market authorization, or expected from
characteristics of the drug.
 Signal - Reported information on possible causal
relationship between an adverse event and a drug, the
relationship being unknown or incompletely
documented previously.
 Usually more than one single report is required to
generate a signal
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7. Historical Background…
 Thalidomide tragedy (1961)- greatest of all drug
disasters.
 1960 marketed in 46 countries (hypnotic, prevention
of nausea in pregnancy) .
 Tragically the drug proved to be a potent human
teratogen that caused major birth defects in an
estimated 20,000 children.
 Phocomelia(Absence of proximal part of limbs) was
a characteristic feature.
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8. 1962
1963
1964
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• Amendment to Federal
Food, drug & Cosmetic Act required both safety & efficacy
data
• British Committee on Safety of
drug monitoring
• UK starts “yellow cards” system
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9. 1964-65
1968
1978
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• National ADR reporting
system UK, Australia, New
Zealand, Canada, West
Germany, Sweden.
• WHO: Programme for
International Drug
Monitoring
• WHO center moved
from Geneva to Uppsala
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10. UMC(Uppsala monitoring centre)
 Uppsala monitoring centre(UMC,Swedan) is a field
name of the WHO collaborating Centre for
International Drug Monitoring.
 It is responsible for the management of the WHO
program for International Drug Monitoring.
 UMC has >3 million AE case reportes from over 75
countries.
 The data are supplied by national health authorities
 Does not review or assess the individual cases put into
database, but it does pharmacovigilance analyses and
signaling.
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11. 4 common drugs banned in other
countries but not in India
S.N
o
Drug
Use
Reason for ban
Brand name
1
Nimesulide
Pain
killer,Fever
Liver failure
Nise,
Nimulid
2
Phenylprapanolamine
Cold &
Cough
Stroke
D’cod, Vicks
Action500
3
Quiniodochlor
Antidiarrheal
Damage to
sight
Enteroquinol
4
Analgin
Pain killer
Bone marrow
depression
Novalgin
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12. Aims of Pharmacovigilance
 Improve patient care and safety.
 Improve public health and safety.
 To contribute to the assessment of
benefit, harm, effectiveness and risk of medicines.
 To promote understanding, education and clinical
training.
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14. Pharmacovigilance in India
1986
1997
• ADR monitoring system
for India proposed (12
regional centres)
• India joined WHO-ADR
monitoring programme
(3 centres:
AIIMS, KEM, JLN)
2010
2004 – 2008
• Pharmacovigilance
programme of India
(PvPI)
• National PV Prog. (2
Zonal, 5 Regional, 24
Peripheral) overseen by
CDSCO
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15. Pharmacovigilance in India
 PV was established since 2003 under the control of
Central Drug Standard Control Association(CDSCO)
under the aegis of Ministry of H & FW, DGHS (Directorate
General of Health Service) New Delhi.
 WHO emphasized that it should include Traditional
medicines in PV system and has published guidelines
on safety monitoring of herbal medicines in
pharmacovigilance systems in 2004.
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16.  IPGT & RA ,Jamnagar conducted a two days
workshop on 3rd & 4th December 2007, on
“Pharmacovigilance for Ayurvedic Drugs:
Scope, Limitations & Methods of Implementation”.
 Based on the recommendations from the
workshop, Pharmacovigilance Cell (PV Cell), has
been established .
 Reporting Form for Suspected ADRs of Ayurvedic
Formulations has been developed.
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17. National Pharmacovigilance
Programme for ASU (NPP-ASU)
 ASU drugs are considered as safe drugs.
 This perception is likely to change in the light of some
recent incidences of ADR during their use.
 The first National Consultative meet of National
Pharmacovigilance Programme for ASU Drugs was
organized at Dept. of AYUSH, Ministry of Health &
FW, New Delhi on August 2008, sponsored by WHO.
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18.  Based on the feed back received from the
meet, National Pharmacovigilance Programme for ASU
drugs was launched on 29th Sept 2008.
 The purpose of the programme is to collect and collate
data, analyse it and use the inferences to recommend
informed regulatory interventions, beside
communicating risks to healthcare professionals and
the public.
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19. Objectives
 Short-term objectives - To develop the culture of
notification.
 Medium-term objectives - To involve healthcare
professionals and professional associations in the drug
monitoring and information dissemination processes.
 Long-term objectives - To achieve operational efficiencies
that would make NPP for ASU drugs a benchmark for
global drug monitoring endeavours.
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20. National PV centre
PV Centres in India
IPGT
& RA
N
TVM
Guhwat
BHU
W
NIA
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E
BHU
30 Pheripheral
PV centres
S
8 Regional PV
centres
C
CCR
AS
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Chennai
B’lore
Bhopal
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21. REPORTING CULTURE
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22. WHAT TO REPORT?
 All suspected adverse reactions.
 Lack of effects.
 Resistance.
 Drug interactions.
 Reactions suspected of causing:
a. Death
b. Life threatening (real risk of dying)
c. Hospitalisation (initial or prolonged)
d. Disability (significant, persistent or permanent)
e. Congenital anomaly
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25. WHO CAN REPORT ?
 Any health care professional can report .
 Shall not accept reports from lay members of the
public.
 Others can report through the physicians under whom
he / she had undergone treatment.
 Consumer can directly report to the concerned PPC /
RPC / nearest health centre or physician regarding the
suspected ADR.
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26. WHERE TO REPORT?
Regional
Centre
Hospital
Patient
Health
Professional
National
Centre
Manufacturer
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27. WHAT HAPPENS TO THE INFORMATION
SUBMITTED ?
 Confidential.
 PPC forward the form to the respective RPC (causality
analysis). This information shall be forwarded to
the NPRC.
 The data will be statistically analysed and forwarded
to the Dept. of AYUSH
 PPC
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RPC
NPRC
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AYUSH
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28. RESPONSIBILITIES OF CENTRE'S
 To collect ADR reports.
 To fill in the ADR form properly.
 To forward duly filled in ADR forms to next higher
centre.
 To maintain a log of all ADR notification forms.
 To provide general technical support,coordinate and
monitor the functioning of Centres.
 To carry out causality analysis of all ADR forms.
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29.  To forward all duly-filled ADR forms as per
pre-determined time line.
 To report all SADRs within 24 Hrs.
 To forward periodic reports to next higher
centre.
 To orgnize and attend training programs/
interactive meetings for all lower level
centres.
 Organize the public campaigns.
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31. Ayurvedic concept of PV
 Term PV does not feature in Ayurvedic texts.
 Rational drug use are reccurent themes of Ayurvedic
pharmacology(DRB) and therapeutics(chikitsa).
 Along with descriptions related to actions & benefits of
medicines, Ayurvedic pharmacology describes detailed
adverse reactions & also how to deal with ways to
minimize adverse effect such as
1. Precaution in manufacture techniques.
2. Time of drug administration.
3. Compliment diet and life style and so on.
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32. 
ll(Ca.Su.
15/4)
 Effectiveness of all actions depends on proper
administratoin, Conversely failure is the result of
improper administration.

-
ll (Ca. Vi.
1/15)
 Of all the substances , one should not resort too much
to the 3, Pippali, Kshara, Salt
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33.  Pippali when used properly alleviates dosas,however
their excessive and continous use for long time , leads
to aggravation of dosas.
 Kshara is used for
purpose but if
used excess proves harmful for hair, eyes,heart and
sexual ability. Continous use causes
.
 Lavanam is used as
, but excess uses
produces
.

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f
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l
ll (Ca. Su. 1/124)
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34. Need of PV for Ayurvedic Medicines
 In ancient times, physicians prepared medicines for
their patients themselves.
 Today production and sale of Ayurveda drugs is
formalized into a thriving industry.
 Ayurvedic medicines –
1.Classical Ayurvedic formulations
2.Patent and proprietry formulations.
 This industrialization has brought many challenges
about safe use of Ayurvedic medicines.
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35. Challenges in introducing PV in Ayurveda
 NPP encouraged reporting of all suspected ADRs, But
number of reports related to Ayurvedic /herbal drugs
are abnormally low.
 Concept & terminologies related to ADR monitoring
are not covered in the Ayurvedic curriculum.
 Methods to study drug safety problems have not
evolved adequately in Ayurveda.
 Information related to medicines are in the form of
slokas in the texts, it is not easily available for general
public.
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36.  Signal detection is difficult because of inherent
belief that Ayurvedic medicines are safe.
 Patients often use medicines from different
systems of medicine concomitantly - difficulty
in assigning causality.
 Lack of quality assurance and control in
manufacture of Ayurvedic medicine.
 Most Ayurvedic formulations are multiingredient.
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37. Summary and Conclusion
 By incoperating PV, we will be able to prepare
medicines with good efficacy,,quality, safety and
minimum harmful effect.

In all, Pharmacovigilance will promote:
 Systematic and rational use of medicines
 Boost confidence for safety.
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38. THANKS
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