Adverse drug reaction is most common problem due to drug abuse,drug overuse or drug withdrawal leads many hazards .Not only in modern but ayurved also explained adverse drug action in text combined here

1. ADR
ADVERSE DRUG REACTION
BY DR. HELI
DEPARTMENT OF DRAVYAGUNA

2. Current scenario
• It is estimated that 3-5% of all hospital
admission are related to ADR.
• 5-8%hospitalized patients experience serious
ADR
• Study in south india 0.7% admission due to
ADR and 1.8 % accounted death due to ADR.

3. What is ADR?
• ADR-adverse effect
• Adverse drug event- drug relation with salbutamol
given asthma but in fever cause adverse reaction .
• Side effect-extended pharmacological action of drug
• Atropin –Anticholinergic drug-dryness
• DEFIATION of ADR by WHO
• A response of drug that is noxious and unintended
that occurs at the therapeutic doses used in humans
for the prophylaxis ,diagnosis or therapy of diseases or
for medication of physiology function is known as ADR.

4. FDA defines adverse drug experience are
“Any adverse events associated with the use of
drug in humans ,like
• adverse event occurig overdoses, weither
accidental or intentional,
• adverse event occurring from drug abuse
• adverse event occurring from drug withdrawal
• failure of pharmacological action.”

5. Causes
• Overdose – Intentional or unintended.
• Drug interaction.
• Drug intolerance.
• Idiosyncrasy
• Drug allergy

6. Classification

7. Based on pharmacological effect
• Year 1970s,rowlins-thompson
• Type A-(augmented)-extetion/ over dose: due
to an extension of the active pharmacological
properties of the drug.
• Predictable or anticipated events.
• Exaggerated desired effect:-higher than normal
dose
• Undesired effect:-after normal dose,or high
dose-due to stimulation of untargeted receptor.

9. • Type B :-bizarre (some people)-idiosyncratic
adverse reaction
• Unexpected ,unpredictable.
• Caused by,
• Immunologic:an allergy or hypersensitivity
reaction occurs due to immunological mechanism
• Idiosyncratic:qualitative abnormal adverse
reaction given in individual whose mechanism is
not yet understood.
• Quite rare, may be due to genetic,not related to
dose.

11. • Type C: chronic
• Drug continues use effect
• Ex.NSAIDS –Nephrotoxicity.

12. • Type D: delayed
• Effect of drug delayed action from prolong use
• carcinogenic effect

13. • Type E: End of use
• After stopping use of the drug abruptly
• Ex.Atenolol –Angina
• Rebound hypertension-clonidine

14. • Type F:failure of efficacy
• Fail to show efficacy
• Due to resistance,drug
interaction,antagonism.

15. Severity wise classification
Mild reaction-
• self limitig
• resolve over time without treatment
Moderate reaction
• Required hospitalization
• prolonged by 1 day but resolved in
• 24 hours.
Severe reaction
• Life threatning ,producing disability
• Required intensive medical care
• Can led to Death of patient
http://www.bio-add.org/ADReCS/Quicksearch

16. Overall drug risk wise classification
• iGuard drug rating system
• Five colour rating scale system
• Red –high risk
• Orange- elevated risk
• Yellow-guarded risk
• Blue-general risk
• Green- low risk

17. Location wise
• Local-reaction is limited to certain area or
location
• Systemic-reaction thoughout systemic
circulation.

18. Onset wise
• Acute : reation generated within 60 minute
• Sub acute: generation of reaction is blw. 1-24
hours.
• Latent:reaction found after 2 days.

19. FDA outcome of patient as serious
adverse event
• Patient outcome is;
• Death
• Life threating
• Hospitalizationn
• Disability
• Congenital anomaly

20. ADR in AYURVEDA
• It is known that “A drug administered without
proper knowledge may act like poison but on the
contrary a known drug with good knowledge will
act like nectar.”
• The concept of safety and safety issues are
animated throughout ayurveda samhita such as
patient safety profile with resultant effect of
ignorance-
• Prakruti(nature of drug) Guna (properties)karma
Prabhava(action) Desa(habitat) Ritu(season)etc.to
be considered while collecting the raw drug.

21. • Relevant modes of preparation techniques of the drug like
Shodhan ,maran ,bhavana etc. to be followed mentioned.
• If medicine is of good quality then obtain optimum efficacy
and minimise vyapad one need to assess prakruti ,vaya
etc.before prescribing medicine
• If at all vyapad occurs could be use of
akala(untimely),puran(expired),nch bhavitam(improperly
triturated)and Abhesaj(drugs adverse effect).
• Impropely prosessing metallic or visha dravyas
• Improperly administerd panchkarma
• Virrudhaushadhi Contribute to the occurance of ADR.

22. • In general ayurveda has given utmost important
to safety and benefit of patient in every step of
treatment right from selection of raw
drug,collection ,different processing techniques
,their proper administration,in appropriate
diagnosed patient,deviation in any of this factor
would cause occurance of unintended drug event
• All this indicate ayurved is well aware of concepts
of ADR.

23. Mechanism of ADR in Ayurveda
ADR IN
AYURVEDA
Drug
Patient
Physician
Drug –imp karan ,4 upstambh
treatment
Drug induced ADR over dosage,
abhesaja,toxicity,ahitam dravya(drug
incompetibility,drug tangible
property idiosyncrasy.
Vaidhya- 3 type ADR due to failure
to certain the quality of drug wrong
selection of patient,improper
diagnosis,improper drug
administartion and follow up.

24. • Rogi – not follow the instuction
• Violation of drug ,over dose ,poly pharmacy
• Factors failure of therapy
• Chikitsa vyapad –in spite of proper care in all
aspect complication may arise especially in
panchkarma such might be intended or
unintende.

25. Comparative study of ADR in
allopathy and ayurveda
Sl.
n
o.
Character Allopathy Ayurveda
1. ADR Unintended drug response
which is not documented
during various phase of
clinical trials
Possible ways and
mechanism of event h
documented
2. Causes of ADR Drug excessive effect,
interaction, drug
intolerance, drug allergy,
Drug interaction,
iatrogenic , overdose,
umwholesome drugs,
drug pharmacokinetic
interaction, procedura
complication, GMP
concern.

26. 3. Concept of prakruti Not decribed Potential role
causing ADR
4. Alteration of drug action
due to exercise or mental
status
No theoritical
explanation
Alteration of drug
action due to
physical or mental
activity
5. Description of
wholesome and
unwholesome drugs
Not described Described
6. Improper administration
of therapeutic instrument
Not known to
cause ADR
Known to cause
failure of theory

27. 8. Relevance of diet
restiction during drug
administration
Generally not
applicable
Relevent for
therapeutic
success
9. Therapeutic restriction Not related to
ADR
Has potential
role in causing
ADR
10. Seasonal variation in
drug action
Not described Alteration of
drrug action
11. Concept of satmya Not described Violation of
this during
drug
administration
cause ADR

28. Drug related ADR
• occur due to inherent deleterious quality of the
drug are categorised under Abhesaja
• Siddha Laksana in preparation.
• Starting from raw material collection,
preservation, preparation methods, quality
assurance, storage etc. each and every aspect
plays pivotal role in therapeutic efficacy and
safety. Deviations at any level may result in failure
of treatment as well as ADRs.
• भिषग्द्रव्याण्युपस्थाता रोगी पादचतुष्टयम्।
गुणवत्कारणंज्ञेयंववकारव्युपशान्तये।। (च.स. 9/3)

29. Nature of drug and its sources
• Dravya has been derived from various sources
viz. Herbs, Minerals, Metals, Acquatic and
Animal origin.

30. • Based on the mode and method of
administration of these sources, the therapies
in Ayurveda have been categorized into
• Yuktivyapäśraya (empirical therapy),
• Sarvavajaya (psychotherapy) and
• Daivavyapaśraya (spiritual therapy).

31. Types of ADR with respect to source of
Drug:
• Herbal drug related ADR: Adulteration
• pepper with papaya seeds, Kampillaka with
brick power
• Different botanical sources are being used for
one herb.(controversy)
• could be very hazardous

32. • Mineral drug related ADR:
• Poisonous minerals like Arsenic, Lead, Mercury etc.
have been employed as medicines in Ayurveda
• undergo meticulous and tedious purificatory strict
quality control tests described in classics.
• Present day Ayurvedic pharmaceutical companies have
started modifying formulations for different reasons
using artificial prepared minerals like CuSo in the name
of Tuttha, artificial Siläjitu etc.
• mineral drugs may also be adulterated
• eg. Śilajitu being adulterated with iron pieces

33. Animal source drug related ADR:
• In Ayurveda, milk and milk products including
ghee, bones, feathers, meat etc. animal origin
products are used for preparing various dosage
forms.
• During collection of these byproducts it is
prudent to take into account the health status,
age of the animal etc
• Preservation and preparation methods are also to
be considered before being used as medicines.
• ghee adulterated with vanaspati and honey with
jaggery

34. Role of mind in ADR:
• Daivavyapaśraya (spiritual therapy) and
Satvävajayachikitsa (psychic therapy).
• Mantra, Mani, Yoga, mangala, music etc. are
prescribed as part of these psychotherapies
• Any improper administration occurance of ADR.
• A study reported headache with failure of
treatment with improper administration of
Mantra (chanting) in patients of breast cancer.“
• अनेनोपदेशेन नानौषभचभूूतंजगतत। कक
ं ञ्चचरव्य
रव्यमुपलभ्यतेतांतांयुञ्ततमथंच तंतमभिप्रेत्य।। (च.स.
26/12)

35. Abhesaja
• The substances which are antagonist in action
to the medicines or therapy are considered as
Abhesaja and these are contraindicated for
use.
• They are classified as Bädhana and
Sanubadhana.

36. 1. Badhana (Immediate effect): immediately
exhibit undesirable symptoms. For example
poison
2. Sänubadhana (Delayed effect): prolonged
period of consumption with the event
persisting for longer duration.
• Example: Kuştha (skin disease) due to the use
of incompatible food articles.

37. On the basis of effect Dravya
• Ekänta Hitakara:drugs absolutely beneficial
• Ekanta Ahitakara Dravyas: completely harmful
to the body
• Avasthānusara Hitähitakara: substances which
are sometimes beneficial or sometimes
harmful
• In ch su 25- Sukadhanya, Samidhanya-Yavaka,
Masa

38. • Drugs act as wholesome or unwholesome on
the body by two ways.
• Svabhavatah (Nature) :Agni, Kşara, poisons
etc also termed as ahitatama dravyas.
• Samyogatah (Interaction):Combination of two
or more drugs Combination with Desa
(habitat), Kala (time) Conjugation of drugs
while undergoing Sańskära

39. • Ahitatama Dravyas may be beneficial in some
instances or at particular Rogavastha. For
example a fruit bitten by a poisonous cobra is
Ahitamadravya in general; however the same
is useful as medicine in patients of Udara

40. • 1. Sadyaprāņahara āhāra and Vihāra like
Putimamsa, Vrddha Stri, Kanyarasi Stri.
Prabhata Nidra, Taruna Dadhi (M.P.N. 13/56)

41. Tangible Properties of Drug
• In addition to the primary and desired therapeutic effect,
every drug exerts secondary effects that may be beneficial
or harmful
• Dosasamana, Dosakopana, Svasthahita
• E.g. Bhallataka (Semecarpus anacardium Linn.) is the drug
of choice for Kustha, however it may increase Pitta if not
administered judiciously
• Aguru Ahiphena-Pittala,vatpittal
• Dhatki-madakarak etc.
• Bimbi –vishtambhi.
• Tila taila-pittaprskop
• Sarshap taila-mutrakruchha karak

42. Idiosyncrasy and Pharmacogenomics
in Ayurveda
• "Host vulnerability"." According to
this theory the effect of drug varies
from person to person
• Prakṛti idiom:one's own
constitution or expressions of
individual structural functional and
psychological aspects.
• Bhallataka (Semecarpus anacardium
Linn.)is contraindicated in
constitution of Pitta and diseases of
Pitta.

43. • Pharmacogenomics:medicine focuses
on DNA alone
• single-nucleotide polymorphisms with
a drug's efficacy or toxicity.
• Tridosa theory forms the basis of
Prakrti-based medicine
• प्रक
ृ ततस्तुस्वावोोः। (च vi. ८/९५
चक्रपाणण टीका)

44. Anupāna (Adjuvants)
• Anupanās are to be diligently used otherwise
may result in ADRs.
• Kulattha is contraindicated with Silajitu (Su.Ci
13/18) (Table No. 4.5.1), Uṣṇa Jala with
Bhallataka Taila and Tuvaraka Taila (Su.Su
46/428).
• If water not avoided as Anupana in Siroroga,
Hikka, Sväsa, Käsa, Kṣaya etc. the diseases may
aggravate (C.Sü.27/327).

45. • These quality concerns are controlled by
formulary guidelines called AFI (Ayurvedic
drug manufacturing, these lack strict
implementation
• Qualities of excellent medicine are, those
which are effective in small dose,
therapeutically active, have multiple utility, do
not produce any Vikara or Vyapad (ADR),
easily digestible and acceptable.

46. Drug Quality Concern
• Recently European countries also banned the
marketing of all the Ayurvedic medicines in their
countries with the issue of excessive heavy metal
contents. But eventually it was noted that the
culprit was poor drug processing.
• Hence, the quality of drug has special role in
giobalizing Ayurveda.
• Ashudhha gandhaka-kushta, raktavikara
• अकालेऽल्पाततमात्रंच पुराणंन च भूूाववतम्।
अस्म्यतसंस्क
ृ तं चैव व्यापद्येतौभषंरतु म।ू
् । (च.स. ६/२८)

47. Iatrogenic (Vaidyakrt)
• Quack medical practice is a major cause for
occurance of AEs in Ayurveda.
• Poor Drug quality
• wrong diagnosis
• wrong selection of patient for therapy,
erroneous dose and combination
• Leads AE.

48. Factors
• Multiple pharmacological effects
• Yastimadhu is commonly used as an
expectorant. A study observed that
Yastimadhu when prescribed in a person
concomitantly using antihypertensive drug
adversely reduced the efficacy of the modern
drug because of its own hypertensive effect."

49. • Medical pleuralism: prescribing multiple
drugs which may lead to either additive or
antagonistic drug-drug interaction.
• It is reported that the combination of Trikatu
with Rifampicin, propranolol and theophylline
leads to accentuated effect of the modern
drugs. The bio-availibity of Rifampicin,
propranolol and theophylline were enhanced
by herbal piperin present in Trikatu."

50. Itrogenicity due to procedural therapy
• Pürvakarma (pre-operative care) • Pradhana
Karma (Main procedure) • Pascätkarma (post
procedural care
• Atiyoga and ayoga lakshana
• like Hajmola, Pudinahara, Pañcarista with
laxatives such as Kayamcürna, Triphalā Cūrṇa
etc.

51. • • Sastrakarma • Anusastrakarma •
Kṣärakarma • Agnikarma • Raktamokṣaṇa
• Use of faulty equipment can lead to ADRs.
BastiNetradoṣās (faulty nozzles) like Hrsvät,
Dirghät, Sthülät, Jimat, Sithilabandhanāt,
Pärsvachidrat, Vakrat
• Bastiputapäkadosas like Visaya, Māmsala,
Chinnachidrayukta, Sthüla, Jalayukta, Vätala,
snigdha, Klinna etc. may contribute to ADR.

52. Viruddhadravyaprayoga
(Drug interaction/incompatibility)
• Certain combinations of Diet or Herbs are so
incompatible that they vitiate the Dosas,
interrupt the metabolism resulting in
untoward effects in the body and therefore
termed as Viruddha

53. • Drug-drug interaction
• Drug-herb interaction
• Drug-food interaction
• Drug-mineral interaction

54. • of Upodika (Basella alba L) along with
Tila pisti (Sesamum indicum L).
• Intake of Varuni (alcoholic products)
along with Kakamäci (Solanum nigrum
Linn), Pippali (Piper longum Linn),
Marica (Piper nigrum Linn) has been
quoted to result in unintended
reactions or death.
• Kapotamamsa (meat of pigeon) with
Sarsapa Taila
• Kulattha (Dolichos biflorus Linn) is
contraindicated with Silajitu. Brhati
(Solanum indicum Linn), Bilva (Aegle
marmelos L correa) are to be avoided
during Päradasevana

55. • Herb-regimen interaction
• Exposing to sun while on medication with
Guggulu.
• Drug-disease interaction
• Some of such examples include Haritaki
(Terminalia chebula Retz.) avoided in
malnourished.
• Ardraka (Zingiber officinale Roscoe.)
should be avoided in Kuştha (skin disease),
Pändu (anaemia), Mütrakṛcchra (dysurea),
Raktapitta (Bleeddisorders), Vra (ulcer),
Jvara (fever), and Daha (burning
sensation).
• 18-Types of incompatible combinations
have been illustrated in the classics

56. Avasthānusāra Dravya Prayoga
(Administration of medicine based on
the Stage of Disease, season)
• Roga-Vastha Viruddha Dravya Prayoga
• Ex. Kaşaya Rasa (astringent drugs) is
contraindicated in Taruna Jvara and if given leads
to Vişamajvara
• Use of Sangrähaka drugs in Amaja Atisära leads to
Dandalasaka, Adhmāna, Grahaṇi Dosa, Arśa,
Sotha, Panduroga, Plihavṛddhi, Kuştha, Gulma,
Udara, Jvara."

57. • Kāla viruddha Dravya Prayoga:
• The medicines should not be contradictory to
season or time.Usage of Ardraka (Fresh ginger) in
Grişma (summer) and Sarad
• Prakrti Viruddha Dravya Prayoga:
• Jambu (Syzygium cumini L) is Vätajanaka hence
contraindicated in Vätavyadhis etc.

58. (Atimātra Dravya Prayoga (Over dose)
• Drug action differs in different pathological
conditions when its dose is changed. Eg. one
tablet of Sanjivini Vati is administered in
Amajirna, two in Gulma and similarly three
tablets in snakebite.
• “वटी संजीवनी नाम्ना संजीवयतत मानवम्।। (शा.म.
७/१८-२१)
•

59. Drug abuse
• Intentional:
• good taste but causing intoxicating effect
Drākṣārista is sweet and many a times because of
the taste and intoxicating effect some individuals
may consume in excess dose. Another common
example is the use of laxatives in constipation or
even weight loss. Long term use of these may
result in electrolyte imbalance, lazy colon, IBS or
even colon cancer.

60. • Un-intentional:
• effective dose of medicine in Mrdu Kosta is
less compared to Krüra Kostha. Improper
assessment of these parameters may cause
over dose
• OTC drugs, Home remedy
• Multiple prescribers
• excessive intake of Pippali (Pipper longum L.),
Kşára (alkalis) and Lavana (salts); Gandhaka
(sulphur) along with Ksära (alkalis

61. Detection of ADR
• Identification of ADR is the initial process of
Pharmacovigilance.

62. • Anecdotal reporting –incomplete by
Individual and medical practitioner:
• “Spontaneous reporting system“This system
is used to generate signal for ADR and used to
detect, Previously undetecte is associated
with the drug or not.
• Each case report is analysed carefully, coded,
document, and is followed over long time

63. • ADR Reporting Form ADRS are initially notified
by hospitals/physicians/pharmacists/or any
other health workers and documented under
a separate documentation form.
• These information are carefully and cautiously
collected.

64. • Age, sex and a brief medical
history of the consumer/patient
(when relevant); in some
countries, ethnicity may need to
be specified.
• Details of suspected herbal
product(s) if known: species
name (Latin binomia, name and
common vernacular name of
medicinal plant) and/or brand or
ingredient name including the
part of medicinal plant, seed,
preparation methods;
manufacturer, country of origin,
batch number, expiry date and
provider

65. • Administration details: Dose
and quantity supplied,
dosage form, route,
start/stop dates
• Indication or reason for use
• Adverse reaction data: date
of onset (or duration from
first administration to onset
of event), description with
symptoms and signs, severity
and seriousness,
• clinical investigations and
tests

66. • course and outcome
• De-challenge/re-challenge with the
same product, where ever
applicable and appropriate.
• All other medicines used (including
self-medication), with
administration details.
• Risk factors, e.g. age, impaired
renal function, previous exposure to
the herbal medicine (s) concerned,
previous allergies, drug misuse or
abuse, the social use of drugs
• Name and address of reporter (to
be considered confidential and to
be used only for data verification,
completion and case follow-up)

67. Method for detection
• Premarketig safety evaluation
• Post market surveillance
Spotaneous reports
Clinical study
1. Cohort ,case control etc.
2. Meta analysis of clinical study
3. Published cell report
4. Correcting action concerning-newly identified-letter
,package in revision,medicine recall

68. • Causality assessment-(linking ADR to drug)
1. Strength of association
2. Temporality of relationship
3. Dose response relationship
4. Confounding report
Postal survey method-by practitioner
• Dechallenge and rechallenge

69. • The WHO International Monitoring
Programme Around 70 National
Pharmacovigilance centers
network under this programme
but function independently.
Uppsala Monitoring Centre
(UMC), located in Uppsala, Sweden
coordinates and facilitate these
centres.
• forwards the risk assessments
National Pharmacovigilance
centres and to others concerned
with drug safety
Centres

70. National Pharmacovigilance
Programme for ASU drugs.
• started in 2007, when a workshop, sponsored by WHO
was organised at IPGT and RA, Jamnagar, India
• Under the aegis of Department of AYUSH, Ministry of
Health & Family Welfare, Government of India
• India for ASU drugs with 8 regional Pharmacovigilance
Centres
• 30 Peripheral Pharmacovigilance Centres for ASU
drugs were opened. Option of new centre space based
on the need in that region could open through consent
from NPCC-ASU.

71. • All India Institute of Ayurveda is
recommended as the National
Pharmacovigilance co ordination centre
(NPVCC) for the implementation of the
National Pharmacovigilance Program for
ASU&H drugs.
• The following institutes have been identfiled as
Intermediary Pharmacovigilance centres
(IPvCs).
• i. National Institute of Ayurveda, Jaipur.
• ii. Institute for Post Graduate Teaching and
Research in Ayurveda (IPGT&RA),
• Jamnagar.
• iii. National Institute of Unani Medicine,
Bengaluru.
• iv. National Institute of Siddha, Chennai.
• v. National Institute of Homoeopathy, Kolkata

72. Assessment and Evaluation of ADR
• Initial notified ADR report is
further analysed for its
relationship between the intake
medicine and adverse drug
event.
• Assessment of ADR:
• made using a standard
approach

73. • The outcome of de-challenge and
re-challenge
• Known pharmacology
• Testing for adulterants or
contaminants that could be the source of
adverse events
• Quality of medicine -whether medicine
was processed & prepared as per classics
and possess quality standards as per
classics
• Administration of drug-whether the drug
was administered in the way it has to be
administered including the person who
administered i.e. qualified/un-
qualified/folk/traditional practitioner

74. Causality assessment
• method to establish the relationship between a
drug and suspected reaction.
• Karch & Lasagna scale
• Naranjo's algorithm
• WHO - UMC probability scale
• Spanish quantitative imputation scale
• Kramer's scale
• Jones scale
• European ABO system
• Bayesian system etc.

77. Assesment in Ayurveda

78. If the answer is Yes to Parameters 1,2,3,4,5,8 and 10 then it is due to Vaidyakrt.
If the answer is Yes to Parameters 7,9,11,12,13 and 14 then it is due to
Dravyakrt.
If Yes to Parameters 6 and 15 it is due to Rogikṛt. If otherwise then it is termed
as an adverse event and analysed by Naranjo scale which seems more apt for
Ayurvedic Drug Event Analysis.

79. Preventive Measures
• A subsequent causality analysis would allow us to identify
the possible underlying reason in an Ayurvedic context and
therefore such adverse reactions may be preventable.
• GMP guidelines in Ayurveda:
• Identification of raw drugs, quality standards, raw material
storage, method of preparation including Sodhana &
Marana, quality standards of finished products, packaging
materials and storage of finished products.
• Quality concerns are controlled by formulary guidelines
called AFI

80. • Guidelines for drug administration in Ayurveda:
• Daśavidhapariksa
• Auşadhasevanakala,Anupana , Pathya-apathya.
• Ayurveda documented tangent qualities of drug,
various interactions, effect of over dose, effect of
improperly processed drug administration,
vyapad (secondary effect) of Pancakarma
therapies etc

81. • Drug surveillance study:
• monitoring, surveillance and safety data of
marketed drug would certainly reduce ADRs in
Ayurveda.
• Unbiased drug information:
• Proper Drug information of Ayurvedic
medicines including ADRs must be readily
accessible for practitioners and lay public.

82. • Poly pharmacy : Poly pharmacy practice is
believed to be one of the main causes in drug
drug interaction and needs to be addressed
with appropriate policy and education.
• OTC practice: There is a misconception among
the public that Ayurveda is safe and will not
produce any adverse effect. The
misconception is leading to OTC practices
leading to drug Preventive measure.

83. • Informative paucity in herbs of Ayurved : Only
few studies have been published re- garding
adverse effect, contraindications, disadvantages
and toxicity of herbs. More information is to be
generated and made freely accessible to people
• Awareness and active participation : A major
aspect that needs to be addressed to prevent
ADRs is to change the mind set of patients and
doctors by conducting various workshops and
seminars stressing the importance of
Pharmacovigilance.

84. • Mandatory reporting: It must be made
mandatory for practitioners to report ADRs if
at all found in their routine practice so that
enough data is generated.
• Research encouragement: PG and PhD
scholars may be encouraged to take up
research works in pharmacovigilance.
Encouragement may in terms of financial
grants, awards etc

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