INTERNATIONAL AYURVEDIC

MEDICAL JOURNAL

Review Article ISSN: 2320-5091 Impact Factor: 6.719

PHARMACOVIGILANCE IN AYURVEDA AND ADVERSE DRUG REACTION

Bhogavalli Jhansi1, Vaishali2, Madhusudhana Rao K3

1
P.G Scholar, 2 P.G Scholar, 3Associate Professor & HOD
Department of Dravyaguna, Dr. N.R.S. Govt. Ayurvedic College, Vijayawada, India

Corresponding Author: [email protected]

https://doi.org/10.46607/iamj04p6042022
(Published Online: May 2022)
Open Access
© International Ayurvedic Medical Journal, India 2022
Article Received: 29/04/2022 - Peer Reviewed: 30/04/2022 - Accepted for Publication: 31/05/2022

ABSTRACT
Pharmacovigilance is the science which encompasses the activities concerning the detection, assessment, under-
standing, and prevention of Adverse Drug Reaction. A common misconception prevails among the masses and
also a large population of practitioners is that Ayurveda drugs are safe and do not have any adverse reactions. The
major goals of pharmacovigilance, namely, to improve patient care and safety about drug use and thus promote
rational drug use are recurrent themes of Ayurvedic pharmacology Dravyaguna vigyana (Ayurvedic pharmacolo-
gy), and Chikitsa (therapeutics)1. Pharmacovigilance is an important tool to analyze the drug effect, particularly
its side effects, if any. This paper outlines briefly the concept, the Need for Pharmacovigilance for Ayurvedic
medicines, and implementation of the National Pharmacovigilance Program for Ayurveda, Siddha, Unani Drugs,
Challenges in introducing PV in Ayurveda, and Recommendations.

Keywords: Pharmacovigilance, Adverse Drug Reaction, Side effects, Challenges.

INTRODUCTION
Ayurveda as a science has a vast history of research state during treatment.3A lot has been said and dis-
and development. The holistic approach of this an- cussed the effectiveness of one drug or the other in a
cient science envisions the prevention of disease,2 wide spectrum of therapeutics but concerns regarding
under its basic principles of healthy lifestyle man- the safety and efficacy of these drugs have always
agement, dietary intake, and the uniqueness of keep- been on the back seat. In the age of modern technolo-
ing in view the individual's physiology and mental gy, scientific advancements, consumer awareness,
 Bhogavalli Jhansi et al: Pharmacovigilance in Ayurveda and Adverse Drug Reaction

and the advent of evidence-based medicine, there is ➢ Long-term objectives – To achieve operational
very sparse evidence supporting the efficacy and efficiencies that would make NPP for ASU drugs
safety of Ayurveda drugs, except that this system is in a benchmark for global drug marketing.
practice for hundreds of years and there is rarely any Ayurvedic concept of PV
adverse effect reported. Some time back serious con- Pharmacovigilance means monitoring the effect of
cerns were raised about Ayurveda drugs that they medicine after it has been licensed for use and admin-
contained heavy metals and were a threat to life.4 It istered for a particular condition. Vigilance means to
was only after that study, that the authorities in India be more careful, especially in order to notice possible
initiated some concrete steps to regulate the drug in- danger or difficulties.
dustry more effectively. As per Ayurveda, any drug/management/procedure
Etymology: - Pharmaco – Drug, Vigilance - To be that, when administered, produces any untoward ef-
Awake/ Alert fect other than expected beneficial action is not con-
Definition - It is the Pharmacologically related sci- sidered a perfect treatment. Not only this, the promo-
ence related to the detection, collection, assessment, tion of health and prevention of disease is the first
understanding, and prevention of adverse effects par- approach
ticularly long-term, and short-term side effects of in Ayurveda. Before starting any treatment, multifac-
Medicine. eted analysis of the status of the patient is mandatory
Some Technical Terms Used – so
ADR – Adverse Drug Reaction – A response to a that the possibility of untoward symptoms due to er-
drug that is noxious and unintended, and which oc- ror in diagnosis and planning of treatment is negligi-
curs at doses normally used in man. ble.
SE - Side Effect – Any unintended effect of a phar- A possibility to consider environmental factors along
macological product occurring at doses normally with psychological status further adds evidence that
used in man. Ayurveda incorporates such concepts of being vigi-
SAE – Serious Adverse Event – Any fatal adverse lant in the treatment. Instructions and guidelines in
event which is fatal, life-threatening, permanently the form.
disabling, or which results in hospitalization. of Dashavidha Parikshya Bhava and Dashavidha
History-Thalidomide tragedy – 1961 Pariksha (tenfold examination along with the
Thalidomide is used in pregnant women to prevent consideration of ten factors to be examined before
nausea. It is a Potent human teratogen Caused major proceeding for treatment) indicate vigorous efforts to
birth defects like Phocomelia (Absence of proximal avoid errors in the diagnosis and management.
part of limbs) in estimated 20,000 children. A list of adverse drug events may occur due to mis-
Aim: - use of these preparations is elaborately along with
➢ A patient care, public health & safety. probable antidotes and precautions. Standard op-
➢ Assessment of benefit, harm, effectiveness, and erating procedures along with the implementation
risk of medicine. of the Pre and Post -patient care for Panchakarma
➢ Understanding, Education & Clinical training. procedures or para surgical interventions such as
Objectives: - Rakta mokshana, Agnikarma, and a vigilant ap-
➢ Short-term objectives – To develop the culture proach for the management of possible complications
of notification. can be also considered as a part of implementation of
➢ Medium-term objectives – To involve pharmacovigilance.
healthcare professionals & associations in the Not only this, for Shadvidha upakrama such as
drug monitoring & information dissemination Langhana – Lightness/Deprivation, Brihmana -
process. Nourishing, Snehana -Oleation, Rookshana -Drying,

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 Bhogavalli Jhansi et al: Pharmacovigilance in Ayurveda and Adverse Drug Reaction

Sthambana – Cooling, Swedana -Sweating, a strate- Where to report?

gy in the form of Samyak Lakshana has been men- Patient
tioned with a warning that, if these procedures are not
stopped after achieving the Samyak Lakshana, ad- Health Professional
verse effects may be attained by the patient. Hence,
guidelines along with medicines to be used for further Hospital/Manufacturer
possibilities are framed for such conditions.
Few factors may increase the chances of Adverse Regional Centre
Drug Reactions (ADR) related to Ayurvedic medi-
cines aggravate the need for reporting, such as the National Centre
use of substitute drugs due to reduced availability of What to report? All suspected adverse reactions,
herbs, the emergence of new diseases and treatment Lack of effects, Resistance, Drug interactions, and
modalities, and changing social structure and food Reactions suspected of causing – Death, Hospitaliza-
habits, or chances of an irrational combination of tion, Disability, and Congenital anomaly.
medicines. Who can report? Any health care professional may
Term PV does not feature in Ayurvedic texts. Ration- report suspected adverse drug events. The case re-
al drug use is a recurrent theme of Ayurvedic phar- ported by lay members of the public or non-health
macology and therapeutics. Along with descriptions care professionals are not accepted under the pro-
related to actions & benefits of medicine. Ayurvedic gram. But they can report the physician under whom
pharmacology describes detailed adverse reactions they have undergone treatment.
& also how to deal with ways to minimize the ad- Need for PV for Ayurvedic Medicines
verse effect in detail. On the other hand, the classical In ancient times, physicians prepared medicines for
texts of Ayurveda promptly describe all the adverse their patients themselves. Today production and sale
reactions to irrationally procured, prepared, and ad- of Ayurveda drugs are formalized into a thriving in-
ministered drugs or formulations. dustry.
Initiatives taken by the Government of India for Ayurvedic medicines –
starting the National Resource Center for Phar- 1. Classical Ayurvedic formulations
macovigilance is a beginning step for it. Pharma- 2. Patent and proprietary formulations.
covigilance in India was initiated way back in 1986 This industrialization has brought many challenges
with a formal Adverse drug reaction (ADR) monitor- to the safe use of Ayurvedic medicines.
ing system, under the supervision of the drug control- Challenges in introducing PV in Ayurveda: -
ler of India. Later, the National Program of Pharma- National Pharmacovigilance Program (NPP) encour-
covigilance was launched in 2005 and was renamed aged reporting of all suspected ADRs, but number of
the Pharmacovigilance Program of India (Pv PI) reports related to Ayurvedic / herbal drugs is abnor-
in 2010. mally low. Concepts & terminologies related to ADR
PV CENTERS IN INDIA monitoring are not covered in the Ayurvedic curricu-
• National -IPGT &RA Jamnagar lum. Methods to study drug safety problems have not
• Regional -8 centre’s -B.H. U, Trivandrum, Guha- evolved adequately in Ayurveda. Information related
ti, NIA, CCRAS, Chennai, Bangalore, Bhopal to medicines is in the form of slokas in the texts, it is
• Peripheral-30 centre’s not easily available to the general public. Signal de-
tection is difficult because of the inherent belief that
Ayurvedic medicines are safe. Patients often use med-
icines from different systems of medicine concomi-
tantly - difficulty in assigning causality. Lack of qual-

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 Bhogavalli Jhansi et al: Pharmacovigilance in Ayurveda and Adverse Drug Reaction

ity assurance and control in the manufacture of Ayur- Bhasma can be dispensed in capsule forms. Pharma-
vedic medicine. Most Ayurvedic formulations are ceutical houses need to share the burden and as well
multi-ingredient. as responsibility for the proper implementation of the
Recommendations: - pharmacovigilance program. Data generated from
Introduce pharmacovigilance concepts into the cur- various studies like clinical or pharmacological trials
riculum of Ayurveda at the under-graduate and post- should be regularly updated in the textbooks. Experts
graduate levels. Encourage studies on drug safety. of Ayurveda may also be reoriented and trained as
Make reporting of adverse reactions to regulators experts in pharmaco-vigilance. The drug information
mandatory for ayurvedic formulations. Make unbi- should be easily available and should be completely
ased and easily accessible drug information available. digitalized so that the knowledge is available instant-
Create awareness about the science of pharmacovigi- ly. Though, the Traditional Knowledge Digital Li-
lance among Ayurvedic physicians, patients, and par- brary is a positive step in this direction.
amedical staff.
CONCLUSION
DISCUSSION By implementing the Pharmacovigilance and taking
A general misconception that prevails among the the appropriate measures right from the collection of
common people is that Ayurveda medicines are al- raw materials, preparation of drugs, clinical trials for
ways safe. This mindset needs to be changed. Though new formulations, awareness of the products, long
these medicines are safer, their intake of being im- term, and short-term adverse effects, data collection
mune from any side effects is not the case. If a drug of benefits and risks from the subject experts, health
is not manufactured as per set protocols or if any in- care providers, patients and analyzing them by utiliz-
compatible (viruddha) intake is done and then side ing digital technology adds benefit to the society for
effects are bound to occur. The Department of attaining timely and fruitful results.
AYUSH has gone a long way in creating infrastruc-
ture for pharmacovigilance reporting. Though this is REFERENCES
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drugs is a major issue and steps should be taken to Source of Support: Nil
monitor it. Dispensing of Churna (powders) in sa- Conflict of Interest: None Declared
chets can be done to provide a fixed-dose. Similarly, How to cite this URL: Bhogavalli Jhansi et al:
Pharmacovigilance in Ayurveda and Adverse Drug Reaction.
International Ayurvedic Medical Journal {online} 2022 {cited
May 2022} Available from:
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doi: 10.46607/iamj04p6042022 | IAMJ April - May 2022 | www.iamj.in 3478