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Abstract
Ayurveda or Indian system of medicine has been serving mankind since time immemorial and
now it is spreading worldwide. The commonest myth prevailed regarding Ayurveda medicine is
that these medicines are completely safe and do not have any side effects. Improper
manufacturing, self-medication, failure of proper dosing etc are leading to disappointing end
results and adverse effect. It is necessary to incorporate new system of safety and awareness
towards Ayurveda which is known as Pharmacovigilance. Pharmacovigilance is the science
dedicated to the monitoring, detection, assessment, evaluation and prevention of adverse effects
or any other medicine related problems. The increasing global acceptance of Ayurveda led
regulators to implement a similar program for Ayurveda particularly when some scientists,
medical professionals, and patients reported cases of adverse drug reaction of Ayurveda
medicines. In order to promote Ayurveda as global medicine and meet global healthcare
standards there is urgent need to equip Ayurveda with tool of Pharmacovigilance. Government of
India has implemented a Pharmacovigilance program for Ayurveda, as a measure to ensure
safety and efficacy of Ayurvedic medicines. Pharmacovigilance helps in monitoring of adverse
drug reaction thus help to protect public health. This review article provides an overview of the
need of the Pharmacovigilance and future aspects of Pharmacovigilance for Ayurvedic system of
medicine.
Keywords
Pharmacovigilance , Ayurveda, ADRs ,Safety, Efficacy
Greentree Group
Received 20/08/16 Accepted 02/09/16 Published 10/09/16
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Ayurveda, Siddha and Unani medicine any adverse effect reported. Serious question
alternative healthcare in India out of which regarding toxic level of heavy metal in
preventive and curative holistic system of scope for adulteration, preparation of low
medicine originating from the Vedas quality drugs and formulations without
thousand years ago and currently practiced standard reference has increased. Further
in India and many countries1. It is the most with respect to change in environmental
advices, and their combinations with various adulteration of herbs and concomitant use of
90% of Indian population is using Ayurveda medicine has increased. These changes may
medicines for their medical needs2. The have deep impact on the safety and efficacy
increasing popularity of Ayurveda in the of the ASU drugs hence, safety monitoring
Western world health care facilities creates has become very essential. Mechanism is
need for regulation of Ayurveda education required to put in place to address these
use of Ayurvedic medicines has increased establishment is the first step towards
about the safety of Ayurveda medicines4,5,6. harms to patients. In era of increasing global
In the age of modern technology, scientific acceptance of Ayurveda, there emerges need
advancements, and consumer safety, there is to implement similar program for Ayurveda
supporting safety of Ayurveda drugs except professionals, and patients reported cases of
the fact that Ayurveda has been practiced adverse drug reaction of Ayurveda
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ADR of ASU drugs. There is a need to graduate and post-graduate levels, thus
engage health-care professionals and the never exposing the young physicians to
public at large for monitoring adverse drug concept of Pharmacovigilance in Ayurveda.
reactions caused due to ASU medicines. The 3. There is lack of awareness regarding
purpose of the program is to collect data, Pharmacovigilance among ASU
analyze it and use the inferences to practitioners.
recommend regulatory measures to 4. Methods to study drug safety
healthcare professionals and the public. problems have not evolved adequately in
Ayurveda.
CHALLENGES IN 5. The Ayurvedic pharmaceutical
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relatively larger healthcare facilities attached directly however they may report through
ASU medical colleges identified as RPC - their physician.
ASU. They are assigned as second level Where to Report?
centers in the administrative structure of the Reporting should be done in a prescribed
NPP. Peripheral Pharmacovigilance Centers format through a local Pharmacovigilance
for ASU or Primary Pharmacovigilance centre.
centres are relatively small ASU medical Aim of PV
Colleges including individual ASU medical To improve patient care and safety
practitioners' clinics, nursing homes private To maintain efficacy of drug which
hospitals, pharmacies etc. They will will improve patient wellbeing
function as first contact ADR data collection To develop the culture of notification
unit at a health care facility. and ADR reporting
What to report under NPP-ASU To involve healthcare professionals
Reporting of all suspected ASU expert in the drug monitoring and
drugs associated adverse reactions either information dissemination processes.
alone or in combination with other drugs To achieve operational skills that
Suspected drug interactions of ASU would make National Pharmacovigilance
drugs Program for ASU drugs as standard model
Reactions to any other drugs for global drug monitoring endeavors.
suspected to affect a patient’s management
to major extent, including reactions DISCUSSION
suspected for events like Death, Life
Ayurveda has been a wonderful system of
threatening risk requiring hospitalization and
medicine serving mankind from centuries
medical interventions
ago. Effectiveness and safety of Ayurveda is
Who can Report?
not at all questionable but some
Health care professional may report
circumstances and definitions have changed
suspected cases of adverse drug events. The
over the period of time. One the one side
cases reported by lay members and other
practice, production and sale of Ayurvedic
than healthcare professionals not accepted
drugs has become a thriving industry due to
which there emerges scope for adulteration,
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2014.pdf 2873.
Ayurveda and modern health science: The 9. National Pharmacovigilance Protocol for
Proceedings of the first international Ayurveda. Siddha and Unani (ASU) Drugs.
meaning of life ‑ awareness, environment, Health and Family Welfare, GOI; 2008.
Available from:
and health” March 21 ‑ 22, 2009, Milan,
http://www.ayurveduniversity.
Italy. Evid Based Complement Alternate
edu.in/downloads/Protocol.pdf. [Last
Med 2011;2011:929083.
accessed on 2013 May 12].
4. Saper RB, Kales SN, Paquin J, Burns
10. The importance of Pharmacovigilance-
MJ, Eisenberg DM, Davis RB, et al. Heavy
Safety Monitoring of Medicinal Products,
metal content of Ayurvedic herbal medicine
WHO, and medicine WHO guideline on
products. JAMA 2004;292:2868‑73.
safety monitoring of herbal medicines in
5. Kales SN, Saper RB. Ayurvedic lead
pharmacovigilance system. Available from:
poisoning: An under ‑ recognized
http://www.whoindia.org/LinkFiles/Traditio
international problem. Indian J Med Sci
nal [last accessed on 2002]
2009;63:379 81.
11. Kashinath Shastri and Gorakhnath
6. Parab S, Kulkarni R, Thatte U. Heavy
Chaturvedi, Charaka Samhita of Agnivesha
metals in ‘herbal’ medicines. Indian J
elaborated Vidyotini Hindi commentary,
Gastroenterol 2003;22:111‑2. Nidana sthana 8/23, Chaukhambha Bharati
Sansthan,Varanasi, reprint edition; 2005.
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